In fact, in a study we did specific to biologics, we found that provisions that protect biologics in the U.S.-Chile Free Trade Agreement increased the unit price of biologics in Chile.
|
|
His mother is a vice president of chemistry, manufacturing and control management in Cambridge for Wuxi Biologics, a global open-access biologics technology platform company.
|
|
Historically, biologics have enjoyed long market life because there was no approval pathway for biosimilars or follow-on biologics, that are copies of an originator biologic medicine.
|
|
Creating and manufacturing biologics is, however, expensive, owing largely the complexity and time scales involved; the MIT study notes that biologics represent a key driver in escalating health-care expenditures.
|
|
Accounting experts told BioLogics that according to IFRS rules, the possibility of the call option being exercised meant Bioepis needed to be categorized as an affiliate, not a unit, which in turn meant the stake needed to be reflected in BioLogics' books by fair value, not book value, BioLogics said on Wednesday.
|
|
February 6 (PM): ADMA Biologics (US, biotech) - $75m ABB.
|
|
SEOUL (Reuters) - Shares in Samsung BioLogics Co Ltd (207940.
|
|
In the last 12 months he has consulted for Entasis, Nabriva, Pfizer, Cempra, Bayer, Forge, Shionogi, Alexion, Synthetic Biologics, Paratek, and Ovagene, and he owns equity in BioAIM, Synthetic Biologics and Mycomed.
|
|
ANNOUNCES UPDATE TO MANAGEMENT CEASE TRADE ORDER * LATTICE BIOLOGICS LTD - EXPECTS IT WILL FILE REQUIRED FILINGS BY APRIL 30TH, 2018 * LATTICE BIOLOGICS LTD - THERE IS NO INSOLVENCY PROCEEDING AGAINST IT * LATTICE BIOLOGICS LTD - THERE IS NO OTHER MATERIAL INFORMATION CONCERNING AFFAIRS OF COMPANY THAT HAS NOT BEEN GENERALLY DISCLOSED Source text for Eikon: Further company coverage:
|
|
But it's common in the world of biologics and biosimilars.
|
|
Bioepis is 94.6 percent owned by contract drugmaker Samsung Biologics.
|
|
Biologics are the products produced by biotech and biopharma firms.
|
|
"Those protections, particularly for biologics, have been eroded," Bolten said.
|
|
Biologics are an ever-increasing share of the U.S. drug market.
|
|
Biologics account for about 14 percent of Catalent's consolidated revenue currently.
|
|
SEOUL (Reuters) - Shares in South Korea's Samsung BioLogics Co Ltd (220.
|
|
Prosecutors accused the two Samsung Electronics officials of ordering employees at biopharmaceutical firm Samsung BioLogics to destroy internal documents, as authorities looked into an alleged violation of accounting rules at the BioLogics, according to local media reports.
|
|
BioLogics expects to announce final pricing for the IPO on Oct. 28.
|
|
Samsung is joined by Tokyo-based Fujifilm Kyowa Biologics as a claimant.
|
|
NEW YORK, Feb 7 (IFR) - PRICED ADMA Biologics (US, biotech) - $82.3m ABB.
|
|
Once finalized, Stability Biologics will be a wholly owned subsidiary of MiMedx.
|
|
Most of these new drugs belong to a class known as biologics.
|
|
Biologics including Humira are manufactured in living cells, then extracted and purified.
|
|
But biologics manufacturers have also spread "misleading information" about biosimilars, Woollett said.
|
|
SEOUL (Reuters) - South Korean biotech drug manufacturer Samsung BioLogics Co Ltd (207940.
|
|
Both Samsung Electronics and Samsung BioLogics were not immediately available for comment.
|
|
Vaccines, antibiotics, biologics and other therapies have saved and transformed countless lives.
|
|
Samsung BioLogics denied wrongdoing and filed an administrative lawsuit against the regulator.
|
|
Seven of the world's top 22029 selling drugs in 22029 were biologics.
|
|
Notable exceptions are biologics — including insulin — controlled substances and intravenously injected drugs.
|
|
It's these biologics that are the biggest driver of high drug prices.
|
|
Celltrion and Samsung BioLogics closed down 8.5 percent and 3.6 percent respectively.
|
|
As a result, regulators are approving products deemed "similar" enough as biologics.
|
|
Under Scott Gottlieb, the FDA has dramatically reversed the downward trend in drug approvals, with 68 new drugs and biologics approved in 763 (including those by the FDA's Center for Biologics Evaluation and Research), the highest in decades.
|
|
We see a lot of variants when we take a look -- when we use our new analytical tools to look at currently marketed biologics, we see a lot of variants in lot-to-lot manufacturing of existing biologics and also a lot of variance in the products over time where there's drift in the sort of formulation of the biologics that are currently on the market.
|
|
S: * FDA ACCEPTS EMAPALUMAB BIOLOGICS LICENSE APPLICATION WITH PRIORITY REVIEW Source text: bit.
|
|
Samsung BioLogics shares rose 4.8 percent in early Friday trade after the news.
|
|
And special protections for biologics, a booming category of drugs, have been suspended.
|
|
Biologics are more complex than traditional pills and cannot be copied with precision.
|
|
Synthetic Biologics' shares were up 12 percent at 99 cents in premarket trading.
|
|
SEOUL (Reuters) - South Korea's top financial regulator said Samsung BioLogics Co Ltd (15.9300.
|
|
In no area is competitive relief needed more than in the biologics market.
|
|
It would exclude biologics, infused drugs, injected drugs and inhaled drugs for surgery.
|
|
Humira and Enbrel are biologics, which are complex proteins made in living cells.
|
|
The chronic and rare illnesses biologics are used to treat are often precarious.
|
|
Biopharmaceuticals, or biologics, are pharmaceutical drugs produced from biological rather than chemical sources.
|
|
Dr. Marks is director of the agency's Center for Biologics Evaluation and Research.
|
|
The Blood, Vaccines and Other Biologics Advisory Committee meets at 8:30 a.m.
|
|
Previously, only three TPP countries protected new biologics for longer than five years.
|
|
We're going to be putting out a set of policies to compel the branded drug makers who have biologics on the market to tighten up their manufacturing, to have less variance of their biologics that are currently on the market.
|
|
Samsung Biologics is the majority shareholder in Samsung Bioepis, which plans its own listing.
|
|
The big picture: Biologics are a class of highly complex, generally very expensive drugs.
|
|
Samsung Electronics is the second-biggest shareholder of BioLogics with a 31.5 percent stake.
|
|
Biologics have been found to be the most significant driver of prescription medicine prices.
|
|
In fact, seven of the world's top 22019 selling drugs in 2015 were biologics.
|
|
That included a memo detailing why the biologics provision doesn't need to be changed.
|
|
Lighthizer conceded weakening the biologics provision made the trade deal worse on that point.
|
|
Biologics are made from living cells and are therefore difficult to copy with precision.
|
|
Samsung Biologics has yet to make a profit since its 2011 founding as investment continues.
|
|
The USMCA would require Canada and Mexico to guarantee 10 years of exclusivity for biologics.
|
|
It was the minds of the biologics that gave the insertion ship the greatest difficulty.
|
|
Samsung BioLogics dropped 5.4 percent, while the sub-index for medical supplies plunged 4.7 percent.
|
|
Stock in WuXi Biologics, a biotechnology firm, popped 39 percent on its June trading debut.
|
|
Many biologics are administered intravenously or by injection and in doctors' offices or hospital settings.
|
|
Shares of WuXi Biologics popped as much as 39 percent on their debut on Tuesday.
|
|
Most of those biologics - drugs made using living cells - went on to notch blockbuster sales.
|
|
Adherence to transparent mandatory public quality standards is essential for ensuring the quality of biologics.
|
|
About two-thirds of Part B drug spending is for biotechnology drugs known as biologics.
|
|
The United States has led the world in the development of new pharmaceuticals, particularly biologics.
|
|
The original provision would have given biologics 10 years of market exclusivity in each country.
|
|
Shares of Hyundai Motor and Samsung Biologics also plunged 3.9 percent and 5 percent, respectively.
|
|
Samsung BioLogics' IPO had priced at the top of an indicative range, making the shares vulnerable.
|
|
Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products.
|
|
"The last major issue outstanding has to do with biologics and intellectual property rights," Froman said.
|
|
At the same time, biosimilars — which are comparable to generic biologics — are struggling to break through.
|
|
It would exclude biologics, infused drugs, injected drugs, inhaled drugs for surgery and certain parenteral drugs.
|
|
Vantage provides radiation and other cancer care services, while Biologics manages cancer-related costs for patients.
|
|
Congress created such a path in 85033, through the Biologics Price Competition and Innovation Act (BPCIA).
|
|
WuXi Biologics was indicated to open at HK$25, compared to its HK$20.60 IPO price.
|
|
Other group headaches include investigations at Samsung BioLogics Co Ltd which prosecutors suspect breached accounting rules.
|
|
The IPO will fund BioLogics' effort to become the world's biggest contract maker of biotech drugs.
|
|
In contrast to most drugs that are chemically synthesized, many biologics are produced using living cells.
|
|
How it works: The trade deal gives biologics 10 years of data protection in all 3 countries.
|
|
Due to the uniqueness and complexity of biologics, they are impossible to copy in a generic form.
|
|
Because injectable biologics are made in living cells, they cannot be exact replicas of the original medicine.
|
|
Its biologics and specialty drug business generated about $602 million in revenue in the 2018 financial year.
|
|
PBMs and insurers may stick with branded biologics because they receive discounts from manufacturers on these treatments.
|
|
Without the trade agreement, however, drug companies have no monopoly protections for biologics data in some countries.
|
|
Spending on biologics is expected to increase by 4.57%, while nonbiologic spending will go up by 3.87%.
|
|
Copies of biologics are called biosimilars, not generics, because they are more difficult to imitate with precision.
|
|
"This bill is better now with the exception of biologics, which is a big exception," said Lighthizer.
|
|
The change would leave it up to the individual countries to set their own laws on biologics.
|
|
In the case of biologics, the most visible cost of intellectual property protections are the increased prices.
|
|
Europe has approved four times as many biosimilars — generic versions of biologics, whose savings can exceed 50% — as the U.S. In the next few years, nine of the 20 bestselling biologics are going off-patent, but price relief will only come when generic versions enter the U.S. market.
|
|
Drug contract manufacturer Samsung BioLogics said in a separate regulatory filing on Friday that the additional shares Biogen would receive by exercising its call option were valued at about 2.26 trillion won ($2 billion), and Biogen would pay Samsung BioLogics 748.6 billion won to exercise its call option.
|
|
"We've done small molecules, we've done biologics, we've tried DNA, naked RNA, we've even tried Crispr," he says.
|
|
Samsung BioLogics said in a regulatory filing that it will prove it had engaged in proper accounting practices.
|
|
Unlike traditional drugs, biologics are made inside living cells and cannot be copied exactly to make generic versions.
|
|
BioLogics and Bioepis are central to Samsung Group's pharmaceuticals push, championed by de facto leader Jay Y. Lee.
|
|
He started as a biologics assistant, rose to team leader in 20143 and was most recently platelet supervisor.
|
|
Prellis is actually pitching its pre-made vascular scaffolds to researchers for their work on 3D printed biologics.
|
|
Most Canadian provinces have started limiting coverage of branded biologics for new patients, without forcing patients to switch.
|
|
Prosecutors on Thursday also raided Samsung Biologics' auditing firms Samjong KPMG and Deloitte Anjin, Yonhap News Agency reported.
|
|
At this point, Republican and Democratic lawmakers say there are constructive conversations being held around the biologics issue.
|
|
Biologics are unique and complex medicines made from living materials and are impossible to copy in generic form.
|
|
Biologics look like the future of drug development, but the biosimilars market has been slow to heat up.
|
|
Biologics are drugs made from living organisms, and they include treatments for diabetes, rheumatoid arthritis, and Crohn's disease.
|
|
Many recent peer-reviewed studies suggest that biologics are not as time-consuming to develop as initially believed.
|
|
Through increasing competition in the biologics market, the PRICED Act will lower prescription drug prices across the country.
|
|
Samsung Electronics saw its stock drop 1.7%, while Samsung C&T plunged 4.05% and Samsung Biologics plummeted 4.89%.
|
|
Also included was cancer treatment Tyvyt, or Sintilimab, co-developed by Chinese drugmaker Innovent Biologics and Eli Lilly.
|
|
Unlike traditional drugs, biologics are made from living cells and cannot be copied exactly to make generic versions.
|
|
Biologics account for an ever-increasing share of U.S. prescription drug costs, according to an insurer trade group.
|
|
This will bring more rapidly and inexpensively to market not only entirely novel molecules, both small (what we think of as "drugs" in common parlance) and large and complex ("biologics"), but also generics and biosimilars, created to replicate the structure and/or effect of existing drugs and biologics at lower cost.
|
|
In the U.S., biologics are protected from generic competition for 12 years, but one of the legislative solutions eyed by House progressives is a bill that would lower the exclusivity period of biologics to seven years — something that would have violated the trade agreement if the language had not been dropped.
|
|
Samsung BioLogics Co Ltd's IPO raised 2.25 trillion won in November 2016, in South Korea's second-largest ever listing.
|
|
Why it matters: The drug market is increasingly composed of biologics, which are pricier than traditional small-molecule drugs.
|
|
The Denmark unit has a facility equipped with six 15,000 liter bioreactors that can manufacture cell culture-derived biologics.
|
|
BioLogics is controlled by Samsung Group's de facto holding company Samsung C&T Corp and Samsung Electronics Co Ltd.
|
|
Biosimilars are lowering the price of biologics in the US, being priced 35 percent lower than the originator biologic.
|
|
Biologics and their related biosimilars currently share that nonproprietary name, which is designated by U.S. Adopted Names (USAN) Council.
|
|
The FDA's naming convention might also impact international efforts to harmonize drug names and develop unique identifiers for biologics.
|
|
South Korea's main stock exchange on Monday said Samsung BioLogics was qualified to continue being listed on the bourse.
|
|
Herceptin and other complex medicines called biologics are made from living cells, making them difficult to copy with precision.
|
|
Until the 2010 Affordable Care Act authorized the F.D.A. to approve biosimilars, biologics were insulated from the generic competition.
|
|
Pharmacy benefit managers and insurers may stick with branded biologics because they receive discounts from manufacturers on these treatments.
|
|
"But for drugs that lack clinical substitutes — including some patented drugs and complex biologics — competition doesn't work," he said.
|
|
The current USMCA language provides too much protection for biologics at the expense of access to medicine, he argued.
|
|
After negotiations between House Democrats and the Trump administration, "those protections, particularly for biologics, have been eroded," Bolten said.
|
|
Many patients using biologic treatments live with chronic and rare diseases that may only effectively be treated by biologics.
|
|
ANNOUNCES INITIAL RECRUITMENT OF PATIENTS FOR A PHASE 1 CLINICAL TRIAL TO ACCESS SAFETY AND EFFICACY OF AMNIOBOOST FOR TREATMENT OF COVID-19 * LATTICE BIOLOGICS LTD - INITIAL PATIENT ENROLLMENT IN TRIAL WILL BE LIMITED TO 10 PATIENTS AND CONDUCTED IN SEATTLE AREA * LATTICE BIOLOGICS LTD - CO WAS NAMED IN STATEMENT OF CLAIM FILED FORMER CFO, FOR WRONGFUL DISMISSAL IN AMOUNT OF $2.5 MILLION * LATTICE BIOLOGICS - CO AND PLAINTIFF IN STATEMENT OF CLAIM BY FORMER CFO HAVE COME TO SATISFACTORY RESOLUTION Source text for Eikon: Further company coverage:
|
|
"This could be considered paradigm-shifting in that it adds a new class of biologics," study author Torres tells Axios.
|
|
In November the firm plans to take public its subsidiary BioLogics, a drugmaker, hoping to raise more than $2 billion.
|
|
ComPACT secreting OX40L increased tumor infiltrating lymphocytes in preclinical models DURHAM, N.C., July 07, 2016 (GLOBE NEWSWIRE) -- Heat Biologics, Inc.
|
|
Senate Finance Committee Chairman Orrin Hatch argued that the exclusivity period for biologics was not long enough in that deal.
|
|
Prosecutors raided the head office of Samsung BioLogics in December as part of their criminal probe into alleged accounting fraud.
|
|
"There is a consensus on moving forward and USP is fully committed," said Fouad Atouf, USP's Science-Global Biologics head.
|
|
However, the court rejected the prosecution's request for a warrant to arrest the chief executive of Samsung BioLogics Co Ltd.
|
|
Innovent Biologics Inc has lifted sentiment in the sector with its stock up 13 percent since debuting on Oct. 31.
|
|
After FSC's decision on Wednesday, BioLogics repeated its denial, and said it would file an administrative lawsuit against the regulator.
|
|
The FSC also fined BioLogics 8 billion won ($7 million) for the breaches and sent the case to state prosecutors.
|
|
Innovent Biologics Inc has lifted sentiment in the sector with its stock up 55 percent since debuting on Oct. 13.
|
|
Some lawmakers and an activist group have claimed BioLogics violated accounting rules to inflate net profit before its 2016 listing.
|
|
Bennewith is Vice President, Government Relations with United Spinal Association, and a member of Patients for Biologics Safety and Access.
|
|
IP protections for biologics certainly funnel investment into the sector, and have helped the United States become a world leader.
|
|
NEW YORK (Reuters) - MiMedx Group Inc finalized a deal Sunday to acquire Stability Biologics for $10 million in cash and stock.
|
|
Lawsuits filed by biologics manufacturers also create a hurdle for biosimilars — well before they're in any position to negotiate with insurers.
|
|
Biosimilars work in the same way as biologics, but unlike generics they are not identical to the drug they are copying.
|
|
CanSino Biologics is up 89 percent from its IPO price while CStone Pharmaceuticals is up 30 percent from its offer price.
|
|
S: * SUBMITS BIOLOGICS LICENSE APPLICATION IN US FOR ITS LEAD DRUG EMAPALUMAB Source text for Eikon: Further company coverage: (Gdynia Newsroom)
|
|
Samsung BioLogics had been touted as a new growth engine for Samsung Group amid a slowdown in the global smartphone market.
|
|
Kline, who has since retired from Congress, said he could not recall if he or anyone else raised the biologics issue.
|
|
Options include just biologics (new breakthrough drugs that use living tissue) or only drugs that have lost their US patent protection.
|
|
The deal gives Catalent access to Cook Pharmica's Bloomington, Indiana facility, which specializes in developing biologics-based drug compounds or products.
|
|
Jak inhibitors compete with injected biologics, including top-selling Humira, which in 2016 generated global sales of more than $16 billion.
|
|
Earlier this month, South Korea's top financial regulator said Samsung BioLogics had intentionally breached accounting rules ahead of its 2016 listing.
|
|
Last June, shares in the drug developer Wuxi Biologics rose 39 percent on their debut and now stand 167 percent higher.
|
|
However, the competing products will not benefit from interchangeability with the originator biologics, requiring competitors to spend on marketing and selling.
|
|
For example, nine out of the 10 drugs that accounted for the most Medicare Part B spending in 85033 were biologics.
|
|
Rituxan faces competition from near-copy biologics, called biosimilars, this quarter, with Herceptin exposed in the second half as patents expire.
|
|
The FDA is also reviewing a Biologics License Application for CT-P10, with action expected in the first half of 2018.
|
|
Biosimilars (or as they are known in other parts of the world, "follow-on biologics") are copies of innovator biological drugs.
|
|
The FDA monitors drug shortages through its Center for Biologics Evaluation and Research and its Center for Drug Evaluation and Research.
|
|
Current U.S. law protects drug patents for 12 years, but there are currently no data exclusivity protections for biologics in NAFTA.
|
|
It is among a new class of drugs known as biologics, which are made from living cells rather than synthetic chemicals.
|
|
The most expensive drugs, sometimes costing tens or even hundreds of thousands of dollars, are a class of pharmaceuticals called biologics.
|
|
As such, I have worked extensively with all three FDA centers — drugs, biologics and devices — in the development of novel products.
|
|
There may be a defensible argument that strengthening the U.S. biologics industry is more important than providing cheaper medication to Malaysians.
|
|
And since coily hair is the tightest — and driest — don't hesitate to use heavy creams, like Qhemet Biologics Amla & Olive Heavy Cream.
|
|
They have arrested eight managers from Samsung BioLogics and Samsung Electronics, the group's most valuable company, whom they suspect of manipulating evidence.
|
|
A biologics license application (BLA) for Dupixent was accepted for Priority Review by the U.S. Food and Drug Administration (FDA) in September.
|
|
All six companies had an interest in biological drugs, which are grown from live cells and are known for short as biologics.
|
|
In 2015 the congressman bought about $10,000 worth of shares in Innate Immunotherapeutics, a small biologics firm with an office in Sydney.
|
|
The data collected during clinical trials of drugs can save competitors time in developing the cheaper alternatives to biologics known as biosimilars.
|
|
"Samsung BioLogics is trying to prove the legitimacy of its accounting management through the administrative lawsuit," the company said in a statement.
|
|
A 2010 federal law, the Biologics Price Competition and Innovation Act, allows companies to seek approval to sell near-copies called biosimilars.
|
|
The first three rheumatoid arthritis (RA) biologics - drugs made using living cells - were approved between 1998 and 2002, starting with Amgen's Enbrel.
|
|
Indeed, drug spending for biologics accounts for 28 percent of all prescription drug spending, with both use and cost expected to grow.
|
|
Big Pharma has told us again and again that biologics are especially costly to develop and manufacture because of time and complexity.
|
|
Samsung BioLogics said it priced its offering at 136,000 won a share, versus an indicative range of 113,000 won to 7503,000 won.
|
|
The IPO price values Samsung BioLogics at 9 trillion won, making it the 31st largest South Korea-listed firm by market capitalization.
|
|
These provisions require Mexico and Canada to honor newly negotiated standards for data exclusivity rights on biologics developed by American drug companies.
|
|
The listing of Samsung BioLogics in November last year was the second largest in on record and raised 2.25 trillion won ($1.97 billion).
|
|
The company said it expects submit its Biologics License Application with the FDA by the 2016, subject to the results of the trial.
|
|
"We continue to advance the state of technology in biologics manufacturing," Esteban Santos, head of operations at Amgen, told Reuters in an interview.
|
|
While Congress fixed the problem for biosimilars (akin to the generic version of biologics) last year, it left traditional small-molecule drugs unaddressed.
|
|
Driving the news: Collins introduced a bill yesterday that would ensure that biologics' patents are included on a list the FDA already maintains.
|
|
Pending data results, the two companies anticipate submitting a biologics license application for cemiplimab with the FDA in the first quarter of 2018.
|
|
How it works: Doctors' financial incentives matter just as much as patients', since most biologics and biosimilars are administered at a doctor's office.
|
|
"If a decision is made that we cannot accept, we plan to file an administrative lawsuit," BioLogics' Vice-President Byunghwa Shim told reporters.
|
|
Samsung BioLogics' shares fell as much as 13 percent to their lowest since late January, before paring losses to trade down 21 percent.
|
|
Samsung Electronics led the gains, while Samsung Biologics Co got a boost after the financial regulator unveiled revised accounting guidelines for the sector.
|
|
Vaccines are brand biologics (large-molecule, protein-based drugs made by living organisms, not by chemical processes), which normally command very high prices.
|
|
They each have referenced the biologics issue as well as a provision affecting tobacco as among the most controversial parts of the agreement.
|
|
Four pharma heavyweights including Amgen Inc as well as smaller drug developer Alder Biopharmaceuticals Inc are racing to bring their biologics to market.
|
|
That leaves one main issue to settle, supporters say, over provisions reducing American pharmaceutical companies' monopoly control of advanced drugs known as biologics.
|
|
A biologics license application (BLA) for Dupixent was accepted for Priority Review by the U.S. Food and Drug Administration (FDA) in September 2016.
|
|
These drugs – safe, effective and more affordable alternatives to costly brand biologics – can help increase access and reduce costs to these powerful medicines.
|
|
Because of their complexity, originator biologics can require years of research and testing to be brought to market, and are traditionally expensive treatments.
|
|
To help American patients better handle the expense of biologics, Congress passed the Biologics Price Competition and Innovation Act (BPCIA) as a provision of the American Care Act (ACA.) This provision allowed for the introduction of biosimilars to the prescription drug market under the theory that a biosimilar could provide some of the same medicinal therapies of a biologic for a lower cost.
|
|
To help Americans manage the expense of biologics, Congress passed the Biologics Price Competition and Innovation Act (BPCIA) as a provision of the Affordable Care Act (ACA.) This provision allowed for the expedited development and introduction of biosimilars to the prescription drug market because a biosimilar could, in theory, provide some of the same therapeutic benefits of a biologic at a lesser cost.
|
|
The offering is primarily aimed at funding an ambitious expansion in production capacity to make BioLogics the world's largest contract manufacturer of biotech medicines.
|
|
BioLogics said 780 billion won of the proceeds will be used for factory investment, while another 400 billion won will be invested in Bioepis.
|
|
Shares in Samsung C&T Corp, which holds a 43 percent stake in drug contract manufacturer Samsung BioLogics, also fell more than 5 percent.
|
|
S. DEPARTMENT OF AGRICULTURE CENTER FOR VETERINARY BIOLOGICS GRANTED CONDITIONAL LICENSE FOR CANINE OSTEOSARCOMA VACCINE,AT-014 Source text for Eikon: Further company coverage:
|
|
In May prosecutors ripped open the floorboards in a BioLogics factory and found a stash of electronic devices which they say contain important evidence.
|
|
Samsung Bioepis, an unlisted unit of contract drug manufacturer Samsung BioLogics Co Ltd, received U.S regulatory approval to launch its biosimilar, Renflexis, in April.
|
|
An itinerary for the trip reviewed by ProPublica mentions TPP in relation to one of the meetings, but does not list the biologics provision.
|
|
In 2019 alone, the FDA plans to issue 85033 guidances (Center for Drug Evaluation and Research: 93, Center for Biologics Evaluation and Research: 18).
|
|
The makers of the brand-name biotechnology drugs for years argued that biologics were such complex molecules that they could not be exactly copied.
|
|
Available safety and efficacy data on the new crop of biologics, however, has been encouraging and there is not much to differentiate the drugs.
|
|
Pharmaceutical companies want 12 years of data protection for biologics, which is the U.S. standard, but the agreement instead sets the maximum at eight.
|
|
These actions threaten to undermine the patient protections established by Congress in crafting the BPCIA and its rigorous standard for approval of interchangeable biologics.
|
|
Biologics will receive 12 years of patent protections, as opposed to the current eight years in Canada and less than half that in Mexico.
|
|
The average annual number of new drug approvals, including biologics, was 240 from 236-53, 25 from 214-22020 and 41 from 2010-2018.
|
|
Rather, the FD&C intended the FDA to adjudicate safety and effectiveness in allowing entry of new drugs and biologics into the medical armamentarium.
|
|
However, the discovery of additional immune pathways associated with plaque psoriasis allowed for updated biologics that were more targeted in blocking the immune response.
|
|
Mexico is considering a U.S. proposal to leave biologics protections out of the new trade deal between the two countries and Canada, Bloomberg reports.
|
|
Spanish skin-health focused pharmaceutical company said it had signed two collaboration deals with 23ANDME and with Wuxi Biologics for antibodies targeting dermatology diseases.
|
|
If they rule that BioLogics violated accounting rules, South Korea's stock exchange could then debate whether to delist the firm, an exchange official said.
|
|
Among the revisions are an end to intellectual-property protections for biologics, a specific class of drug, and weaker patents for pharmaceuticals in general.
|
|
Among the revisions are an end to intellectual-property protections for biologics, a specific class of drug, and weaker patents for pharmaceuticals in general.
|
|
New biologics get 12 years of market exclusivity in the U.S. market, but 10 years is longer than they currently receive in Canada or Mexico.
|
|
BioLogics has denied any wrongdoing and said the change was necessary to reflect different accounting standards in the event its partner exercised its call option.
|
|
Biogen's call option exercise will be one of the matters considered when the FSC decides whether BioLogics' accounting was sound, regulatory sources previously told Reuters.
|
|
The new recommendation applies "across the board to anyone collecting blood," explained Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
|
|
Biologics are more complex than traditional pills and cannot be copied with precision, and so, their knock-off versions are called biosimilars instead of generics.
|
|
First though, the White House needs to calm his concerns over the truncated length of patent protections for high-tech medicines called biologics, Hatch said.
|
|
Trump may receive some respectful consideration but should not expect any conciliation on tough issues like currency manipulation, tobacco, dairy and protection for U.S. biologics.
|
|
Bioepis is part of South Korean conglomerate Samsung Group's biopharmaceutical bet as a future growth engine, along with contract manufacturer parent Samsung BioLogics Co Ltd.
|
|
Samsung BioLogics recently broke ground on its third production plant which, when up and running, will make it the world's largest manufacturer of such drugs.
|
|
JPMorgan analysts forecast that China's biologics industry will double in size to $52 billion by 2021 compared with a global growth rate of 60 percent.
|
|
To make this happen, the FDA must instill ironclad patient safety standards that ensure biosimilars are as safe and effective as the reference innovative biologics.
|
|
Michael Miille, a vice president at Bayer Crop Science's biologics group, said launching this venture as a startup was intended to keep it more nimble.
|
|
Use of such "biologics" has grown rapidly in the last decade and now accounts for a majority of Part B drug spending, the administration said.
|
|
In 2014, the latest year data is available, six of the 10 best-selling medicines globally were biologics, with about $49 billion in combined sales.
|
|
Deploying biologics in developing regions of the world, in battlefield scenarios, and in emergency situations is a formidable challenge with consequences for basic drug availability.
|
|
Polpharma Biologics will develop, manufacture and supply the drug, while Sandoz will commercialise and distribute the medicine in all markets through an exclusive global license.
|
|
Biologics are a small share of prescription drugs taken today, but they make up a rapidly expanding share of medical spending in the United States.
|
|
"Many of the new agents are biologics," said Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center.
|
|
Samsung Electronics shares declined 1.7% on Thursday after the ruling, while those of affiliates Samsung BioLogics and Samsung C&T fell 4.89% and 4.05%, respectively.
|
|
Despite those issues, more drugs have been approved in recent years, especially in the category of biologics, which are often used to treat autoimmune diseases.
|
|
Details: The original version of the new trade pact gave biologics 10 years of market exclusivity, but Democrats want this time period to be reduced.
|
|
New data on switching between biosimilars and reference biologics continues to be published, providing further evidence of the match between biosimilars and their reference products.
|
|
Samsung Biologics' IPO could be South Korea's largest of 2016 after Hotel Lotte Co Ltd's up to $4.5 billion planned listing was scuppered earlier this year.
|
|
Democrats take issue with the USMCA's protections for pharmaceutical companies, as it would codify intellectual property rules that would block cheaper biologics alternatives for 10 years.
|
|
Shares of Samsung BioLogics surged 8.3%, driving the medical sub-index up 4.3%, as investors bet the drugmaker would win a contract manufacturing deal from Biogen.
|
|
Samsung BioLogics shares plunged in early May after the financial watchdog said it had breached accounting rules concerning its valuation of subsidiary Samsung Bioepis in 2015.
|
|
It has also acquired a slew of medical businesses in recent years, including a cell culture media firm, a biologics factory, and an endoscopic instruments maker.
|
|
Why it matters: The authors were refuting an April post in Health Affairs that argued biologics are a natural monopoly, so biosimilars aren't going to work.
|
|
The ministry has also considered potential vaccines developed by China's CanSino Biologics and the Russian research institutes Rospotrebnadzor and Gamaleya, but those discussions are less advanced.
|
|
Activist group the People's Solidarity for Participatory Democracy and lawmakers raised questions last year about Samsung BioLogics' 1.9 trillion won ($1.77 billion) net profit in 2015.
|
|
Biologics, the largest oncology-focused specialty pharmacy in the United States, will help McKesson engage its drug manufacturing customers with patients, insurers and healthcare service providers.
|
|
The biotech, LUCA Biologics, is betting that the "vaginal microbiome," a collection of bacteria in the vagina, could hold the key to better treating these conditions.
|
|
Biologics are typically more expensive than traditional drugs but Amgen and its rivals may end up pricing their migraine treatments more conservatively to avoid regulatory scrutiny.
|
|
The country's financial regulator last month filed a complaint against Samsung Biologics claiming the biotech drug arm of conglomerate Samsung Group had intentionally breached accounting rules.
|
|
CanSino Biologics Chinese vaccine-maker CanSino is reportedly developing a viral vector-based vaccine against Covid-2019 but no further information is available at this time.
|
|
As of 2018, China ranked second among countries that exported drugs and biologics to the United States, and first for medical devices, according to the FDA.
|
|
As of 2018, China ranked second among countries that exported drugs and biologics to the US, and ranked first for medical devices, according to the FDA.
|
|
In a major concession to Democrats, the Trump administration agreed to pare back certain protections for an advanced and very expensive class of drugs called biologics.
|
|
The sale involved 25 percent of Samsung BioLogics, comprising 11 million new shares and 5.5 million existing shares owned by Samsung Electronics Co Ltd (005930.KS).
|
|
For that reason, the so-called "oral biologics" space presents a huge opportunity for life sciences start-ups, but it also comes with significant technological hurdles.
|
|
The guidance called for the addition of non-meaningful and distinct four-letter suffixes attached to the nonproprietary names of biosimilars and their brand-name biologics.
|
|
Alder develops preventative treatments of migraine in adults and has submitted a Biologics License Application for its eptinezumab antibody to the FDA in February this year.
|
|
While the regulator did not elaborate, some lawmakers and an activist group have previously said BioLogics breached rules to inflate net profit before its 2074.2700 listing.
|
|
ANNOUNCES UPDATE TO MANAGEMENT CEASE TRADE ORDER * LATTICE BIOLOGICS - EXPECTS IT WILL FILE REQUIRED FILINGS BY APRIL 30TH, 2018 Source text for Eikon: Further company coverage:
|
|
The agreement offers many benefits, but contains several troubling provisions, including one that would force member countries to implement strong monopoly protections for newly introduced biologics.
|
|
One could certainly argue that biologics are a unique market not subject to these generalized claims, but the truth of the matter is muddled at best.
|
|
With the funds, BioLogics plans to become the world's biggest contract maker of biotech drugs, while also providing more capital to subsidiary Samsung Bioepis, which develops biosimilars.
|
|
"This IPO has been in high demand," said a person with direct knowledge of the WuXi Biologics deal, who was not authorized to discuss the IPO publicly.
|
|
SEOUL (Reuters) - South Korean prosecutors raided Korea Exchange as part of an investigation into Samsung BioLogics' suspected violation of accounting rules, a bourse official said on Friday.
|
|
The ministry has also considered potential vaccines developed by China's CanSino Biologics, the Russian company Rospotrebnadzor and Russian research institute Gamaleya, but those discussions are less advanced.
|
|
In 2014, 10 of the top 25 best-selling drugs were "biologics" – drugs made up of recombinantly produced proteins – including blockbuster treatments for arthritis, cancer and diabetes.
|
|
Fidelity Investments-backed Innovent Biologics and Ascentage Pharma both plan to float in the second half of this year and are working with several advisers, they added.
|
|
The Obama administration is working with Republican leaders to address the issues they have with the deal, including data protections for high-tech medicines known as biologics.
|
|
Innovent Biologics' stock leapt almost 20 percent on its debut in October, boosting hopes for the sector after the first few companies plunged below their IPO prices.
|
|
ADMA Biologics' RI-002, a blood-derived treatment for primary immune deficiency diseases - a class of inherited genetic disorders, is slated for regulatory review in April, 2019.
|
|
In Europe, Celltrion's Herceptin copy is a few months behind a rival from Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, which already has approval.
|
|
The intricacy and delicate nature of biologics call for biosimilars to be carefully tested and put through a scrupulous approval process at the hands of the FDA.
|
|
Because of the Pentagon's initial priorities, the steps outlined Tuesday focus on collaboration between the Defense Department and the FDA's Center for Biologics Evaluation and Research (CBER).
|
|
Rheumatologists are counting on biosimilars — near-copies of patent-expired, name-brand biologics that cannot be exactly replicated but demonstrate the same efficacy — to expand patient options.
|
|
Biotech drugs known as biologics are injected medicines, typically containing proteins like antibodies made from living cells, and often carry price tags north of $100,000 a year.
|
|
The immediate goal for the new accelerator is to catalyze the evaluation and development of new and repurposed drugs and biologics to treat patients with COVID-19.
|
|
Another class of treatments that FDA's Hahn discussed are so-called biologics, which include vaccines, antibodies to the coronavirus, immune-system triggering drugs, and other genetic treatments.
|
|
Right now, biologics have 12 years of market exclusivity in the U.S. They have only eight in Canada and five in Mexico, per The Globe and Mail.
|
|
Executives at Samsung Electronics and biotech affiliate Samsung BioLogics have also been jailed on charges of sabotaging union activities and accusations about a suspected accounting fraud, respectively.
|
|
Drug companies are protesting the elimination of a provision that would have given them 10 years of market exclusivity for an innovative type of drug called biologics.
|
|
Samsung Bioepis is 91 percent-owned by Samsung Biologics, which manufactures biological drugs and is in turn mostly owned by Samsung C&T Corp and Samsung Electronics.
|
|
Samsung BioLogics is owned by smartphone giant Samsung Electronics Co Ltd and Samsung C&T Corp, in which Samsung Group heir Jay Y. Lee is the top shareholder.
|
|
Samsung BioLogics has been touted as a new growth engine for the corporate empire that includes crown jewel Samsung Electronics amid a slowdown in the global smartphone market.
|
|
In the case of WuXi Biologics, underwriters ended up allocating 30 percent of the IPO to mom and pop investors, meaning fewer shares were available for professional buyers.
|
|
Earl Blumenauer (D-Ore.), who chairs the Ways and Means trade subcommittee, said he didn't think the agreement could pass his subcommittee without changes to the biologics provisions.
|
|
Pandya came from nonprofit Mass Biologics which is a division of the University of Massachusetts medical school, where Gandhi was working on a master's degree in tissue engineering.
|
|
PARIS (Reuters) - The U.S Supreme Court decision to speed access to copycat biologics drugs on Monday was expected but has an "immediate impact", Sanofi Chief Executive told Reuters.
|
|
Inside, four biologics began to grow within molecular initiators, attaining physical patterns the ship's sentience had designed, based on the information it had acquired during the long voyage.
|
|
"Our platform focuses on utilizing these novel biologics to 'reprogram' cancer cells in tumors to an earlier state when they were still normal," said CEO Ira S. Pastor.
|
|
Last year a financial regulator found that Samsung BioLogics did indeed inflate the value of Bioepis by $3.9bn, though it did not opine on the motive for this.
|
|
Samsung Biologics last year said it would build an additional 180,000 liter plant, bringing combined investment in production lines for the 2011-2018 period to 2 trillion won.
|
|
Share of biologics, or drugs manufactured from living organisms, will account for about 21 percent of the combined entity's pro-forma revenue, Catalent said on a conference call.
|
|
Samsung Biologics, a contract manufacturer of bio-pharmaceutical treatments, plans to sell a total of 11,027,558 new shares priced at 113,000 won ($102.61) each, Samsung C&T (028260.
|
|
One way to think about this is that heretofore the two lists of drugs and biologics, from Part D and Part B, couldn't be played against each other.
|
|
BioLogics shares have slumped 30 percent since the regulators began a review into the allegations in May, leading to a loss of about $13 billion in market value.
|
|
BioLogics Chief Executive Kim Tae-han, who is not a member of the controlling family, has been with Samsung Group since the beginning of his career in 1979.
|
|
The latest cancer immunotherapies — biologics for inflammatory arthritis and skin conditions — as well as the latest insulins are very effective but many times more expensive than their precursors.
|
|
The Bayer-Gingko startup plans to hire 50 people and have offices at Ginkgo's Boston facilities and in West Sacramento, California, home to Bayer's plant biologics test facilities.
|
|
CCTV described the vaccine being developed by Chen's team alongside Tianjin-based CanSino Biologics as the front-runner among nine possible treatments being worked on by Chinese scientists.
|
|
Many participants pointed to a need for policies that promote more competition from biosimilars, which are akin to generic versions of the complex new drugs known as biologics.
|
|
Six years later, only a singular biosimilar is available to patients, a woeful situation for patients requiring biologics, and a reflection on the inadequacy of support for biosimilars.
|
|
Rheumatoid arthritis is currently treated with older drugs such as methotrexate, Pfizer's JAK inhibitor Xeljanz as well as injected biologics such as Amgen Inc's Enbrel and AbbVie's Humira.
|
|
During her time at Canaan, Julie also led the investment for Cellular Research and supported Dermira, Labrys Biologics, CytomX, Unchained Labs, Chrono Therapeutics, Genome Medical, Glooko and Truveris.
|
|
Mylan and Fujifilm Kyowa Kirin Biologics said on Thursday they had won a European Commission green light to market their version of the injectable medicine, known as Hulio.
|
|
In making the switch of the valuation method, BioLogics said it followed accounting rules and recommendations by accounting experts, with the approval of country's three major accounting firms.
|
|
"Health plans welcome the introduction of generic biologics, or biosimilars, as a way to give patients quicker access to more affordable medicines," the group said in a statement.
|
|
The original USMCA extended the period that certain drugs (known as "biologics") can be protected from generic competition to 20163 years (it's already 12 years in the US).
|
|
Moreover, she said, "the research pipeline is full of products like orphan drugs, biologics and personalized medicines that face little competition and will undoubtedly command even higher prices."
|
|
If the FDA doesn't receive an increase in funding each year, would this unduly inhibit the agency from its on-going activity of approving drugs, biologics and devices?
|
|
" Dr. Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, heralded the judgment as a victory "to stop these bad actors and to protect patients.
|
|
The upper end of the price range would also value BioLogics at 9 trillion won, a market value that could make it South Korea's 30th largest publicly traded company.
|
|
Several provisions are intended to please corporate lobbyists, among them protection for ten years for drugs known as biologics and an extension of copyright from 50 years to 75.
|
|
Shares of Samsung Elec, which owned a 31.5 percent stake in Samsung BioLogics as of end-2017, were on a trading halt on Wednesday ahead of a stock split.
|
|
She adds that the Biologics Price Competition and Innovation Act that speeds licensing for biologic drugs similar to those that already exist was a step in the right direction.
|
|
Decades after my diagnosis, I've had six major orthopedic surgeries followed by months of physical therapy, more physician visits than I can count and a hefty monthly biologics bill.
|
|
Samsung BioLogics opened at 135,000 won per share, versus an IPO pricing of 136,000 won per share, while the wider market was up 1.5 percent as of 0003 GMT.
|
|
SANOFI Sanofi said the U.S. Food and Drug Administration has accepted for review the Biologics License Application for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma.
|
|
Biologic medications ("biologics") have been described as miraculous given their potential to help patients suffering from a myriad of serious diseases in ways more traditional small molecule medicines cannot.
|
|
The bill would make prescription drugs more affordable and accessible by reducing the exclusivity period for biologics from 12 to five years, the same as for all other medications.
|
|
Lilly partnered with privately-held AbCellera Biologics Inc last week to co-develop antibody products for the treatment and prevention of COVID-19, the disease caused by the coronavirus.
|
|
Trump's trade pact also gives pharma the opportunity to jack up prices in Mexico, which currently lacks any exclusivity period for biologics, and Canada, which only has eight years.
|
|
The biologics provision is one of four key issues raised by Democrats standing in the way of congressional approval of USMCA, the Trump administration's top legislative priority this year.
|
|
But some senators are not shedding too many tears for the pharmaceutical industry's loss in this instance "The people with the biologics can take care of themselves," said Sen.
|
|
"Even with strict avoidance, inadvertent exposures can and do occur," Peter Marks, M.D., Ph.D., director of the FDA&aposs Center for Biologics Evaluation and Research, wrote in a statement.
|
|
Patients for Biologics Safety & Access (PBSA), a coalition comprising more than twenty patient and consumer advocacy organizations, is dedicated to bringing the patient voice to the biosimilar approval process.
|
|
Earlier this year, Sanofi and Swiss manufacturer Lonza said they would spend 270 million euros by 2020 on a new large-scale biologics facility that will produce monoclonal antibodies.
|
|
Proponents of intellectual property protections for biologics claim that the increased medical progress outweighs the higher prices that pharmaceutical companies will be able to charge in the short term.
|
|
The Financial Supervisory Service (FSS) had decided to conduct a special audit review on Samsung BioLogics' pre-listing bookkeeping, Yonhap news agency reported earlier, citing an unnamed FSS source.
|
|
An FSS official declined comment but confirmed that a regulatory committee was briefed on Wednesday about allegations from an activist group and others concerning issues in Samsung BioLogics' accounting.
|
|
SEOUL (Reuters) - Samsung BioLogics Co Ltd submitted an application on Friday to South Korea's bourse seeking approval for its planned initial public offering (IPO), Korea Exchange said in a statement.
|
|
SEOUL, May 2 (Reuters) - Shares in Samsung BioLogics Co Ltd fell over 18 percent on Wednesday as South Korea's watchdog Financial Supervisory Service provisionally decided it had breached accounting rules.
|
|
The cutting-edge medicines known as biologics are a case in point—the old NAFTA did not protect them for the simple reason that they had not yet been invented.
|
|
O) said it had exercised its option to purchase additional shares of biopharma developer Samsung Bioepis Co Ltd, a joint venture established in 20173 by Samsung BioLogics Co Ltd (207940.
|
|
They say it inflated the value of Samsung Bioepis, an affiliate of Samsung BioLogics which at the time was part of Cheil, to the detriment of investors in C&T.
|
|
Also in South Korea, Samsung Group's bio-pharmaceutical manufacturing unit BioLogics said its planned initial public offering was expected to raise up to 2300.87 trillion won ($20.3 billion), Reuters reported.
|
|
In this case, though, the Orange County district attorney says two companies, DaVinci Biosciences and DV Biologics, which share some of the same owners, illegally sold fetal tissue for profit.
|
|
Since then, the FDA has approved a biosimilar to Herceptin from Celltrion Inc, and one developed by Samsung Bioepis Co Ltd, a joint venture between Samsung BioLogics and Biogen Inc.
|
|
Critics have said Samsung BioLogics breached accounting standards by switching the valuation method of its stake in a joint venture in 2015 to inflate profits before listing a year later.
|
|
Those concerned by the naming guidance say it could impact how providers view and use biosimilars, a still emerging market that is expected to drive down prices for costly biologics.
|
|
NDCs are also mostly used in pharmacies, where only a small percentage of biologics are administered, said Felix, a member of the American Medical Informatics Association (AMIA) public policy committee.
|
|
Talks are ongoing on patent protections for biologics and, while progress has been made, an agreement has yet to be reached with the pharmaceutical industry and concerned lawmakers, Froman said.
|
|
At least one company in Kenya, Kenya Biologics, now sells pheromone traps locally, and Dr. Khamis's team is looking into other options as well, like fungal biopesticides and specialized nets.
|
|
The Trump administration hopes that shifting high-cost biologics from Part B to Part D could foster the development of biosimilar competitors, to generate comparable savings on physician-administered drugs.
|
|
With nearly two decades of experience in clinical development and medical affairs, she has extensive expertise working with small molecules, biologics, and vaccines in both small and large pharmaceutical companies.
|
|
The BDRL operates similarly to companies like StemExpress, Advanced Bioscience Resources, and Da Vinci Biologics: as a middleman go-between for abortion clinics and end-users of aborted baby parts.
|
|
Vocations Luis Lora, 49, is a master tissue technician at MTF Biologics in Edison, N.J., where he processes human tissue that can be used to treat sick or injured patients.
|
|
Drugmaker Novartis's Sandoz division has licensed from Polpharma Biologics a proposed biosimilar version of multiple sclerosis drug natalizumab, the companies said on Tuesday without giving financial details of the accord.
|
|
"[We] are seriously disappointed by the removal of certain intellectual property provisions, including but not limited to the biologics provision," CEO Thomas Donohue said in a statement released on Wednesday.
|
|
Why it matters: The biologics provision has been one of the final sticking points keeping the USMCA from finalization, with Democrats fighting for it to be removed or watered down.
|
|
However, it's not clear there is a majority in Congress in support of reducing the biologics data protection period from the 12 years set in the 2010 Affordable Care Act.
|
|
It also offers increased protections for biologics, certain types of drugs, from eight years to 10 years — which basically extends the period that a drug can be protected from generic competition.
|
|
This week's New York initial public offering of Shanghai-based Zai Lab highlights a new breed of innovative eastern drug makers specializing in treatments made from living cells known as biologics.
|
|
Although dozens of antibiotics and biologics -- medical products made from natural sources -- may be in the pipeline, new drugs have just a 14% chance of gaining approval for use in humans.
|
|
The Trump administration may agree to China's demand that biologics receive only 8 years of market exclusivity as part of a trade deal, a blow to the drug industry, Bloomberg scooped.
|
|
At the same time, BC announced that it would begin covering two newer biologics: Boehringer Ingelheim and Eli Lilly's Jardiance, a diabetes drug, and Eli Lilly's Taltz, which treats psoriatic arthritis.
|
|
The unit holds Biogen's biologics manufacturing operations in Hillerod, Denmark and about 13 employees at the subsidiary are expected to continue employment under Fujifilm, Biogen said in a statement on Tuesday.
|
|
ADMA Biologics, which specializes in plasma-based products for treating infectious diseases, acquired Bivigam in 2017 from privately-held Biotest Pharmaceuticals, along with its plasma processing facility in Boca Raton, Florida.
|
|
The unit holds Biogen's biologics manufacturing operations in Hillerød, Denmark and about 13 employees at the subsidiary are expected to continue employment under Fujifilm, Biogen said in a statement on Tuesday.
|
|
BioLogics has denied wrongdoing, citing an agreement with its U.S. partner as the reason for valuing its stake in the joint venture at fair market value instead of at book value.
|
|
Maynard argued that the 180-day period should come after the 85033-year data exclusivity that brand-name companies get for creating biologics, outlined in the law to incentivize drug innovation.
|
|
At issue is guidance that calls for the addition of different suffixes to the names of original brand name biologics — complex drugs made from living materials — and their copies, called biosimilars.
|
|
In individual movers, Samsung Biologics rose 2.64 percent after the South Korean company said Biogen, a U.S. biotechnology firm, would exercise its call option to increase its stake in Samsung Bioepis.
|
|
Sean O'Hollaren, senior vice president of government and public affairs for Nike, said resolution of any outstanding issues, especially on biologics, would help business groups match the firepower of the opposition.
|
|
SEOUL, Dec 13 (Reuters) - South Korean prosecutors on Thursday raided Samsung Biologics Co Ltd's head office outside of Seoul as part of a probe into alleged accounting fraud, the company said.
|
|
The announcement is only a proposal for a test, but it has huge implications for the pharmaceutical industry, especially for the big, fast-growing category of specialty drugs known as biologics.
|
|
Samsung Electronics shares extended losses to a decline of 2% after the ruling, while those of affiliates Samsung BioLogics Co Ltd and Samsung C&T Corp fell nearly 8% and 6%.
|
|
In their agreement, Democrats were able to eliminate language which would have given a certain class of drugs, biologics, 10 years of patent protections, in a blow to the pharmaceutical industry.
|
|
The current language in the U.S.-Mexico-Canada Agreement (USMCA) gives branded biologics — drugs that are made from living organisms rather than synthetic chemicals — 10 years of protection from cheaper alternatives.
|
|
The current language in the U.S.-Mexico-Canada Agreement (USMCA) gives branded biologics -- drugs that are made from living organisms rather than synthetic chemicals -- 10 years of protection from cheaper alternatives.
|
|
SEOUL (Reuters) - Samsung BioLogics Co Ltd said on Thursday its bookkeeping would pass any scrutiny although it has not received official notice from South Korea's financial regulator concerning a special audit.
|
|
Samsung Biologics, Bioepis' parent company, is planning an initial public offering in South Korea by the end of the year that analysts say could raise up to 3 trillion won ($2.5 billion).
|
|
The move announced by the U.S. biotech company late on Thursday is expected to be taken into consideration by South Korean regulators who are investigating Samsung BioLogics' bookkeeping in 2015, sources said.
|
|
The regenerative medicine company MiMedx said the acquisition of Stability Biologics, a provider of human tissue and bone graft products, adds a new sales channel and roughly 100 salespeople to the company.
|
|
Enbrel generated $5.01 billion in sales for Amgen in 2018 and belongs to a class of medicine known as biologics, made from living cells and are therefore difficult to copy with precision.
|
|
The Financial Supervisory Service (FSS), South Korea's financial regulator, said on Tuesday it had given preliminary notice to Samsung BioLogics and its auditors of measures it could take concerning the suspected breach.
|
|
Ryan, like other trade supporters in Congress, is calling on the administration to fix several issues, including providing longer intellectual property protections, upward of 12 years, for high-tech medicines called biologics.
|
|
South Korea's bourse operator Korea Exchange said on Thursday it approved Samsung Biologics' application for an IPO, without saying when the firm will list, nor how much the company plans to raise.
|
|
More problematic is the complaint of Republicans, led by Mr. Hatch, and the pharmaceutical industry that the agreement would undercut drug makers' intellectual property protections on the advanced drugs known as biologics.
|
|
Biologics are complex drugs made from living organisms and are both larger and more complex than traditional chemical drugs — their size and complexity makes them impossible to copy in a generic form.
|
|
Kim Yong-beom, vice chairman of the Financial Services Commission, said trading of BioLogics shares would be suspended following the decision and that the bourse would review the validity of its listing.
|
|
One analysis of the Trans-Pacific Partnership (TPP) — a deal that was scrapped — stated that it ended up having many of the same provisions for pharmaceuticals and biologics that the USMCA has.
|
|
Engler said that businesses are concerned high-tech drugs known as biologics are getting less than the 12 years of intellectual property protections set in the United States by the healthcare law.
|
|
According to the non-partisan Medicare Payment Advisory Commission, Medicare and its beneficiaries paid $29 billion in 2016 for physician administered drugs and biologics – an amount that is rapidly increasing every year.
|
|
"From currency manipulation, to rules of origin for automobiles, to protection for U.S. biologics — we can do better," said Portman, who served as U.S. Trade Representative under former President George W. Bush.
|
|
SEOUL, Nov 10 (Reuters) - Shares in Samsung BioLogics Co Ltd , Samsung Group's contract biotech drug manufacturing arm, fell slightly from the initial public offering price in their market debut on Thursday morning.
|
|
" • "Now, they are also looking for revisions to the trade deal's pharmaceutical provisions, in particular a measure providing an advanced class of drugs called biologics 10 years of protection from cheaper alternatives.
|
|
Now, they are also looking for revisions to the trade deal's pharmaceutical provisions, in particular a measure providing an advanced class of drugs called biologics 10 years of protection from cheaper alternatives.
|
|
Dr. Daniel C. Adelman, Aimmune's chief medical officer and the paper's senior author, said the company plans to submit a biologics license application to the F.D.A. by the end of the year.
|
|
BioLogics and subsidiary Samsung Bioepis, which makes lower-cost copies of complex biotech drugs known as biosimilars, are central to the conglomerate's pharmaceuticals push championed by de facto leader Jay Y. Lee.
|
|
Twelve years — as opposed to five that most other drugs get — means biologics get a much longer time to dictate prices on the market before they have to face generic-like completion.
|
|
The provision that was removed from the trade deal would have required the three countries to provide at least 10 years of exclusivity for biologics, which are complex and costly to make.
|
|
PARIS (Reuters) - Sanofi announced plans to invest 600 million euros ($673 million) annually over the next two to three years in the field of biologics production, an area of strong growth potential.
|
|
SEOUL, April 28 (Reuters) - Samsung Biologics Co Ltd, the biopharmaceutical contract manufacturing affiliate of Samsung Group, said on Thursday that it decided to pursue an initial public offering in South Korea in 2016.
|
|
"About 150 of 400 are focused on food inspections, rest are focused on other aspects of mission including medical devices (about 100 staff), drugs (about 70 staff) and biologics (90 staff)," Gottlieb tweeted.
|
|
Some 10 companies - mostly Chinese, including the Temasek-backed Innovent Biologics and Shanghai Henlius Biotech - are already planning floats and some have dropped U.S. IPO plans in favor of listing closer to home.
|
|
The other would be things around personalized medicine, so rare immunotherapies, cell gene therapies, biologics that require temperature control, humidity control and monitoring of the shipments while they're moving through the supply chain.
|
|
Samsung BioLogics said it would prove it followed rules backed by South Korea's three major accounting firms, and would sue if the country's top financial regulator, which makes the final decision, found otherwise.
|
|
Despite the Obama administration's trade negotiators reportedly pushing for 12 years of data exclusivity for biologics, including during Secretary Clinton's time as Secretary, the final TPP text provides between 5 and 8 years.
|
|
As of end-June, Bioepis was 91.2 percent owned by Samsung BioLogics, which separately on Tuesday announced plans for an initial public offering that could raise up to 2.25 trillion won ($2 billion).
|
|
Renflexis, which received U.S. approval in April, is the first medicine available in the United States under a global biosimilars agreement between Merck and Samsung Bioepis, a unit of Samsung BioLogics Co Ltd.
|
|
Some 10 companies — mostly Chinese, including the Temasek backed Innovent Biologics and Shanghai Henlius Biotech — are already planning floats and some have dropped U.S. IPO plans in favor of listing closer to home.
|
|
"One that most definitely needs to get fixed, and there's no way to fix outside of the agreement, is biologics," he said, referring to biologic drugs, which are therapies derived from living organisms.
|
|
The court on Wednesday weighed two key issues that could reshape the rules and timeline for creating cheaper versions of drugs known as biologics, which offer the potential to help curb drug costs.
|
|
Wuxi AppTec is a unit of WuXi Biologics, which last week priced Hong Kong IPO shares at HK$20.60 each, at the top of its range, to raise HK$13 billion ($511 million).
|
|
JERUSALEM (Reuters) - Teva Pharmaceutical Industries and South Korea's Celltrion said on Monday the U.S. Food and Drug Administration has accepted for review a biologics application for a biosimilar drug to treat breast cancer.
|
|
The biotech, LUCA Biologics, is focusing first on urinary tract infections, a common problem among women that accounts for an estimated 10 million doctors visits each year, according to the National Kidney Foundation.
|
|
If approved, each would end up with a license for biologics, a category that refers to treatments like cell, tissue and gene therapies that come from natural sources rather than being chemically synthesized.
|
|
While biologics represent only 2628 percent of U.S. prescriptions, they have contributed to 28500 percent of the net growth in drug costs since 6900, in large part due to the lack of competition.
|
|
Generic drug manufacturers are helping Democrats by pushing back against the idea that a protection period of even 10 years is required for brand-name companies to recoup the costs of developing biologics.
|
|
The Food and Drug Administration (FDA) is getting close to approving the third and fourth biosimilar drugs under the Biologics Price Competition and Innovation Act (BPCI), which was signed into law in 2010.
|
|
Unfortunately, the biologics are expensive, and insurance companies usually insist that patients fail to get relief from three months of treatment with each of two other drugs before they will cover the cost.
|
|
Unfortunately, the biologics are expensive, and insurance companies usually insist that patients fail to get relief from three months of treatment with each of two other drugs before they will cover the cost.
|
|
"He was a very, very vibrant person, very dedicated to his work," Kelly Gollert, director of manufacturing for the OneBlood blood bank in Orlando, where Ayala-Ayala worked as a Biologics Assistant, tells PEOPLE.
|
|
Why it matters: Advocates say that they need lawmakers' help soon, or else drugmakers will see biosimilars as a lost cause and the system will lose its only check on the cost of biologics.
|
|
SEOUL (Reuters) - South Korean drugmaker Samsung Biologics Co plans to issue about 1.23 trillion won ($1.12 billion) of new shares as it lines up an initial public offering, its biggest shareholder said on Friday.
|
|
French drugmaker Sanofi and Swiss manufacturer Lonza will invest 270 million euros ($285 million) in a new large-scale biologics facility that will produce monoclonal antibodies by 2020, the two companies said on Monday.
|
|
The Korea Exchange said in a statement the suspension in trading of BioLogics shares would continue for at least 15 business days while the bourse conducts a review which could lead to de-listing.
|
|
The scope of required switching studies should consider this and account for the fact that many patients take biologics for chronic conditions for many years, and could be switched back and forth multiple times.
|
|
SEOUL, Nov 14 (Reuters) - South Korea's top financial regulator on Wednesday said it found Samsung BioLogics Co Ltd intentionally breached accounting rules in inflating the company's value ahead of its 2016 stock exchange listing.
|
|
"We're about to witness an explosion of innovative drugs in China," said Liu Weimin, partner at Eight Roads, which has invested in over 150 Chinese companies including Alibaba Group, WuXi AppTec and Innovent Biologics.
|
|
At Pelosi's behest, the renegotiated deal also killed a provision pushed by pharmaceutical companies that would have guaranteed them 10 years of market exclusivity for biologics, a class of drugs that are especially costly.
|
|
Though that will continue to be necessary with Palforzia, the risk of a reaction will be lessened, says Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in a statement.
|
|
Sandra Beach Lin is a board member of a board member of American Electric Power, Interface Biologics, PolyOne Corporation, and Wesco International, as well as the retired president and chief executive officer of Calisolar.
|
|
The announcement boosted Samsung BioLogics' share price by as much as 8 percent as analysts said it cleared some of the uncertainty about the investigation into the drugmaker's valuation of the joint venture, Samsung Bioepis.
|
|
The bottom line: "Although prices likely will not reach close to marginal costs ... this does not imply that biologics, writ large, are natural monopolies in any traditional sense of the concept," Brill and Ippolito write.
|
|
The biosimilar, Ontruzant, is sold by Merck Sharp & Dohme Corp, a unit of Merck & Co Inc, and is developed by Samsung Bioepis Co Ltd, which is a joint venture between Samsung BioLogics and Biogen Inc.
|
|
HONG KONG, Oct 31 (Reuters) - Innovent Biologics climbed 2.3 percent in a Hong Kong debut closely watched as a test of investor appetite for Chinese biotechs after three rivals saw their shares slide post-listing.
|
|
ZURICH, Sept 3 (Reuters) - Swiss drugmaker Novartis's Sandoz division has licensed from Polpharma Biologics a proposed biosimilar version of multiple sclerosis drug natalizumab, the companies said on Tuesday without giving financial details of the accord.
|
|
Other disagreements center on the trade pact's definition of biologics, as well as rules governing other ways drug companies can extend protections, like putting existing products to new uses or combining them with other drugs.
|
|
Making sure generics (and their equivalent in the biologics space, biosimilars) can get to market as soon as possible does help lower costs for patients — once a brand-name drug's monopoly has ended, that is.
|
|
The big picture: The protections are a big win for U.S. drug companies, as they would extend the length of time that biologics can reap the benefits of monopoly pricing in those two other countries.
|
|
"Unless the USMCA text is amended, it would limit Congress' ability to adjust the biologics exclusivity period, [by] locking the U.S. into policies that keep cancer [drugs] and other drug prices high," the lawmakers said.
|
|
However, in a move that is disappointing to brand-name drug manufacturers, the deal does not include any increased intellectual protections for biologics, a class of expensive but life-saving drugs made from living organisms.
|
|
With passage of the Biologics Price Competition and Innovation Act (BPCIA), Congress paved the way for a new class of drugs, biosimilars, which have the potential to increase patient access to life-saving biologic treatments.
|
|
HONG KONG, Dec 13 (Reuters) - WuXi Biologics' biggest shareholder has launched a sale of 107.5 million shares in the Chinese contract drug research and development company, a term sheet seen by IFR on Wednesday showed.
|
|
The Affordable Care Act also increased the minimum rebates that pharmaceutical companies must pay in Medicaid and created the approval process for biosimilar drugs, which are cheaper versions of complex, costly medications known as biologics.
|
|
"Today's approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range," Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research, said in an announcement.
|
|
Fund managers said the stock price gains of BioLogics, which raised 2.25 trillion won ($1.97 billion) in South Korea's second-largest ever share sale, reflected the removal of sector-specific uncertainties following Republican Trump's presidential win.
|
|
"While we support this area of scientific discovery, it's important to note that FMT does not come without risk," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement.
|
|
While for many other diseases, the researchers are focused on just one modality, ongoing ALS research uses each of the four key modes of medical treatment: small molecules, proteins and biologics, gene therapy and stem cells.
|
|
What they're saying: The number of biosimilars in development is increasing, and two biologics facing biosimilar competition — Neupogen and Remicade — have begun offering bigger discounts to stay competitive, even though their list prices haven't come down.
|
|
"The big news is the rebalancing in the long-run on tech and startups," said Capapé, who highlighted Temasek's $800 million funding in Verily Life Sciences and investments in Innovent Biologics and Iora Health last year.
|
|
In the letter to Zhang, Mary Malarkey, director at the Office of Compliance and Biologics Quality, told Zhang that he would need to obtain approval from the FDA for the procedure — which the FDA cannot give.
|
|
"The transfusion of a pregnant woman with blood infected with the Zika virus could have terrible consequences," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a conference call with reporters.
|
|
"Medarex's technology platform, people and pipeline provide a strong complement to our company's biologics strategy, specifically in immuno-oncology," James M. Cornelius, then-CEO and the current chairman at Bristol-Myers Squibb, said at the time.
|
|
If those patents hold, by 2029, Enbrel will have been on the market without generic competition for 31 years, far longer than the 12 years of exclusivity for biologics called for in the Affordable Care Act.
|
|
"This is the first approval from our respiratory biologics portfolio and the latest in a series of significant milestones for our company as we deliver on our pipeline-driven transformation," said AstraZeneca Chief Executive Pascal Soriot.
|
|
The shift in focus to original research is a change in mindset, although it builds on the success of contract research and manufacturing company WuXi Biologics, which does much of the legwork for China's budding biotechs.
|
|
Novartis also will shut down its Shanghai biologics group and shift its Institute for Tropical Diseases in Singapore to near San Francisco, California, saying it wanted researchers to work on infectious diseases from a single location.
|
|
The market designed to create competition for biologics — typically our most expensive drugs — has been slow to take off, but some experts say that even its best-case scenario doesn't do enough to lower drug prices.
|
|
Bach and Trusheim proposed that the government instead regulate the price of older biologics after they've been on the market for a certain period of time, which they wrote could save around $50 billion a year.
|
|
Without reliable intellectual property protections from OECD nations, to recoup these costs, pharmaceutical companies may scale back R&D, depriving the world of potential future cures in promising new categories such as biologics and personalized medicine.
|
|
"We will continue to actively conduct research in this area and further revise our policies as new data emerge," Peter Marks, deputy director of the FDA's Center for Biologics Evaluation and Research, said at the time.
|
|
Just as the Drug Price Competition and Patent Term Restoration Act of 85033, better known as the Hatch-Waxman Act, helped to speed up and simplify generic drug approvals, BPCI will do the same for biologics.
|
|
Another area of concern for Toomey is the reduction of intellectual property protection for the makers of biologics, drugs manufactured from living organisms or cellular components such as proteins and DNA such as Botox and Humira.
|
|
"Today's approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement.
|
|
Reflecting buoyant sentiment, WuXi Biologics (Cayman) Inc priced its Hong Kong initial public offering (IPO) at the top of its indicative range, raising $511 million in the largest new listing in the Asian financial centre this year.
|
|
"We are moving into a very complicated area in oncology where drugs and devices and biologics are going to be used in combination or sequentially," Dr. Richard Pazdur, the FDA's cancer drug director, said in an interview.
|
|
"Today, the FDA finalized its efforts to streamline the process used by physicians to request expanded access, often called 'compassionate use,' to investigational drugs and biologics for their patients," FDA Commissioner Robert Califf said in a statement.
|
|
"The researchers are careful to craft their findings in neutral language: these are the characteristics that appear to be associated with safety issues after the drugs and biologics get to market," he told me in an email.
|
|
For more news, click French drugmaker Sanofi and Switzerland's Lonza will invest 270 million euros ($285.2 million) to build a large-scale biologics facility that will produce monoclonal antibodies by 13, the two companies said on Monday.
|
|
First, while your hair is damp or wet, apply an ultra-moisturizing curling cream like Qhemet Biologics Amla & Olive Heavy Cream that minimizes breakage, and use a boar-bristle brush to distribute it evenly through your hair.
|
|
The Federal Trade Commission is not on board with the Food and Drug Administration's decision to assign different suffixes to the names of biosimilars and their reference biologics, arguing it could hurt the market for cheaper versions.
|
|
"As the number of approved biosimilars continues to grow, so does the anticipated potential to increase physician choice and patient access to biologics," Jean-Paul Kress, head of global therapeutic options at Biogen, said in a statement.
|
|
However, for the past 22019 years or so the innovator companies have increasingly focused on complex, "large molecule" drugs, mostly biologics, often intended to treat "rare diseases," affecting 200,000 or fewer people — and often only several thousand.
|
|
"Today's approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range," Dr. Peter Marks, director of the F.D.A.'s Center for Biologics Evaluation and Research, said in a statement.
|
|
Alector Inc: * ALECTOR ENTERS INTO A LICENSING AGREEMENT WITH INNOVENT BIOLOGICS TO DEVELOP AND COMMERCIALIZE AL008 IN ONCOLOGY INDICATIONS IN CHINA * ALECTOR INC - WE WILL CONTINUE TO DEVELOP AL008 GLOBALLY Source text for Eikon: Further company coverage:
|
|
Its gene therapy subsidiary AveXis "voluntarily self-disclosed to the FDA and subsequently to other health authorities that some data previously submitted to the agency as part of our [biologics license application] was inaccurate," the company said.
|
|
"Eliminating the biologics provision in the USMCA removes vital protections for innovators while doing nothing to help US patients afford their medicines or access future treatments and cures," said Stephen Ubl, CEO of PhRMA, a trade group.
|
|
HONG KONG (Reuters) - Chinese biotech firm Innovent Biologics is looking to raise up to $231 million in its Hong Kong IPO, three sources said, in what could be the biggest biotech IPO in the financial hub this year.
|
|
SEOUL, Aug 8 (Reuters) - Samsung Biologics Co Ltd, the biopharmaceutical contract manufacturing affiliate of Samsung Group, is expected to apply on Thursday for Korea Exchange approval for a planned initial public offering, two exchange officials said on Monday.
|
|
LONDON, Sept 20 (Reuters) - Mylan and Fujifilm Kyowa Kirin Biologics said on Thursday they had won European approval to market a cheaper copy of AbbVie's $18-billion-a-year biologic drug Humira, the world's best-selling prescription medicine.
|
|
The new plant, which will employ about 150 people, is modeled after Amgen's Singapore facility, which opened in 2014 and is also set up to allow for faster, more efficient production than traditional biologics plants with fixed bioreactors.
|
|
Some experts fear, however, that even once there's a competitive biosimilars market in the U.S., these orphan approvals will give biologics a leg up — even though these orphan approvals don't legally bar biosimilars from competing on other uses.
|
|
It's too soon to throw in the towel on biosimilars, especially because there's evidence that they're lowering the net costs of biologics, Alex Brill and Benedic Ippolito of the American Enterprise Institute argue in a Health Affairs blog.
|
|
SEOUL (Reuters) - Samsung Biologics Co Ltd, a contract manufacturer of biotech drugs for global pharmaceutical firms, said it was planning an IPO this year, an offering that analysts have estimated as being worth as much as $20113 billion.
|
|
The Financial Services Commission (FSC), which has been reviewing the matter after a complaint by an activist group and politicians that the Samsung Group arm unfairly inflated its value, also called for Samsung BioLogics' CEO to be fired.
|
|
A $511 million Hong Kong IPO of WuXi Biologics (Cayman) Inc, a Chinese contract drug research and development company, on Thursday was covered multiple times on the first day of book-building, according to Thomson Reuters publication IFR.
|
|
The COVID-19 Therapeutics Accelerator will evaluate new and repurposed drugs and biologics to treat patients with COVID-19 in the immediate term, and other viral pathogens in the future, according to a statement from the Gates Foundation.
|
|
SEOUL (Reuters) - Contract drugmaker Samsung BioLogics Co Ltd priced its initial public offering (IPO) at the top of its indicative range on Friday, making the share sale South Korea's second-largest ever at 005930 trillion won ($1.97 billion).
|
|
Details: The original trade pact, which was a renegotiation of NAFTA, would have given biologics 10 years of market exclusivity in each of the three countries — an extension of their monopoly period under current Mexican and Canadian law.
|
|
Samsung BioLogics, the South Korean conglomerate's contract biotech drug manufacturing arm, is also developing a range of biosimilars through its Samsung Bioepis subsidiary, as the government in Seoul champions a sector it sees as a major future exporter.
|
|
Democrats took control of the House in part by campaigning on lowering drug prices, and one of the legislative solutions eyed by House progressives is a bill that would lower the exclusivity period of biologics to seven years.
|
|
The deal probably won't have much effect in the US, where biologics already receive 12 years of protection and the law is relatively friendly to evergreen patents, but it will have a bigger impact in other TPP countries.
|
|
"Analysts estimate the severe asthma biologics market by the early 2020s to be between $6.5 billion and $10 billion (a year), and we expect to have a competitive share of that based on this clinical profile," Keith-Roach said.
|
|
The Marietta, Georgia-based biotech company specializes in "regenerative and therapeutic biologics," like skin grafts and allografts, which are basically sheets of processed skin, placenta, or umbilical cord tissue that pack the growth factors that turn on stem cells.
|
|
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, will be a featured speaker at the three-day event, which will be hosted at the Renaissance Hotel in Washington, D.C. More information is available at www.pda.org.
|
|
"Teva plans to submit a Biologics License Application to the U.S. Food and Drug Administration for fremanezumab later this year in both episodic and chronic migraine with anticipated approval and launch in the second half of 2018," it said.
|
|
Though Big Pharma has complained that it didn't get the 12 year protections on new biologics—cutting-edge biomedical drugs often used to treat cancer—the TPP would guarantee five to eight years of a monopoly on these discoveries.
|
|
Traveling congressional delegations typically meet with a variety of local officials, and at the time of the visit to Australia it wasn't unusual for Republican lawmakers to side with the pharmaceutical industry on the trade deal's protections for biologics.
|
|
"We believe the new recommendations will help reduce the risk of collecting blood and blood components from donors who may be infected with the Zika virus," Dr. Peter Marks, director of the FDA's biologics division, said in a statement.
|
|
But the Obama administration is still working to resolve several issues with congressional Republicans, including a way forward on intellectual property protections for high-tech medicines called biologics, that they hope will generate more support for the TPP deal.
|
|
She has served as the global head of biologics of Novartis AG, the senior vice president of R&D strategy and operations of Millennium Pharmaceuticals (now Takeda) and the vice president of protein technologies of the Wyeth Research facilities.
|
|
The groom, 64, is the chief executive officer of Adello Biologics, a biotechnology company, which is based in Piscataway, N.J. He received a master's in chemistry and a Ph.D. in biochemistry from the Albert Ludwigs University in Freiburg, Germany.
|
|
SEOUL (Reuters) - Samsung Biologics Co Ltd is expected to apply for stock exchange approval this week for its IPO, two officials with the Seoul bourse said, as part of its bid to become the world's largest biopharmaceutical contract manufacturer by capacity.
|
|
SEOUL (Reuters) - Samsung BioLogics Co Ltd, a contract manufacturer of biotech drugs for global pharmaceutical firms, said on Tuesday its initial public raising could raise up to $2.9000 billion in an offering set to be the country's third-largest IPO.
|
|
Samsung BioLogics makes drugs for firms such as Swiss-based Roche under license, while it owns a stake of more than 90 percent of Samsung Bioepis, which makes biosimilars, versions of complex molecule drugs such as autoimmune disease therapy Enbrel.
|
|
Demand from retail investors - who can have a significant impact on first-day trading in Hong Kong share offerings - accounted for 37.5 times the number of shares on offer in the deal, WuXi Biologics said in a filing on Monday.
|
|
"If you could engineer a single strain, or maybe even a consortia of strains that grow together, to manufacture combinations of biologics or antibodies, that could be a very powerful way of producing these drugs at a reasonable cost," Lu said.
|
|
Background: Biologics get 12 years of market exclusivity in the U.S., and the administration secured a 10-year agreement as part of the trade deal it reached with Mexico and Canada last year (which hasn't yet been approved by Congress).
|
|
The bottom line: "Americans and their representatives are ignoring history if they expect the inclusion in the USMCA of longer exclusivity for biologics to redress the U.S. trade deficit, loss of manufacturing jobs, and high prescription-drug prices," the authors conclude.
|
|
Aimmune Therapeutics Inc - The biotech firm was notified by the FDA that as a result of the shutdown it will not start a review of company's Biologics License Application (BLA) for Ar101 - an oral immunotherapy for treating peanut allergy in children.
|
|
In late 2015 and early 13, when BioLogics' books for 2015 were being compiled, the perceived market value of its unit Samsung Bioepis skyrocketed on the back of approvals for its copies of blockbuster biotech drugs in Europe and South Korea.
|
|
Novartis also will shut down its Shanghai biologics group, shedding its 18 positions, but will continue with the bulk of activities at its newly opened $1 billion campus in the Chinese city where 500 people work in research and development.
|
|
However, we all have to be realistic about the chances for passage, as there are some major unsettled issues (biologics, investor-state disputes, etc.), and there is also the problem of a tight time window in which to get it done.
|
|
"Kymriah is a first-of-its-kind treatment approach that fills an important unmet need for children and young adults with this serious disease," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement.
|
|
The first is exclusivity granted by the FDA that gives new small molecule drugs (like aspirin) and biologics (such as antibody or protein drugs) windows of five to seven years and 12 years, respectively, before generic versions can be sold.
|
|
According to a recent report by the prescription drug analytics firm IQVIA, the class of drug that includes branded biologics represents roughly 2202 percent of the prescriptions in the U.S., but account for a disproportionate 2628 percent of total drug spending.
|
|
So far, Phononic chips have been used in wine chillers, medical refrigerators that are used to keep vaccines and biologics at a steady temp, and even in fiber-optic cables, which heat up undesirably as light and data travel through them.
|
|
"We're hoping in next quarter or 2 there will be a vaccine that will be ready to move" into human trials, Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said at a conference in New York.
|
|
Or when a drug is very expensive, like the biologics used to treat rheumatoid arthritis that cost $4,000 a month, patients are less likely to take them or they take less than the prescribed dosage, which renders them less effective.
|
|
" Ubl said eliminating the biologics provision "removes vital protections for innovators while doing nothing to help U.S. patients afford their medicines or access future treatments and cures … We cannot support abandoning provisions that protect American companies and raise standards abroad.
|
|
He has co-authored sweeping proposals to increase access to cheaper versions of the complex, costly drugs known as biologics, as well as to allow Americans to import medications and to cap patients' monthly out-of-pocket spending on drugs.
|
|
In later concessions to the Democratic-led House, the White House agreed to eliminate language that would have given 10-year patent protections for the classification of drugs known as "biologics," which are often the most cutting edge in the industry.
|
|
Samsung Biologics surged 17.79 percent on the day after South Korea's stock exchange decided on Monday to allow it to continue trading following a suspension in mid-November over concerns it had intentionally breached accounting rules ahead of its listing in 2016.
|
|
"The IPO price reflected all of the upside such as future orders expected to be won, but not the risks, such as unforeseen changes," said Shin Jae-hoon, analyst at eBEST Investment & Securities, referring to the weak opening of Samsung BioLogics' shares.
|
|
PARIS, June 14 (Reuters) - French drugmaker and healthcare group Sanofi on Wednesday announced plans to invest 600 million euros ($673 million) annually over the next two to three years in the field of biologics, seen as an area with a strong growth potential.
|
|
The troubled offering could prompt rethinks about the valuations of other big-ticket South Korean IPOs in the works, such as Samsung BioLogics Co Ltd's up to $2 billion planned offering or that of the country's largest mobile games company, Netmarble Games Corp.
|
|
Hotel Lotte's deal was expected to pave the way for other conglomerate listings, including a $2.5 billion IPO by Samsung BioLogics Co Ltd, the biopharmaceutical contract manufacturing affiliate of Samsung Group, and a $1 billion offering by construction equipment maker Doosan Bobcat Inc.
|
|
"The opening of new sites like AbbVie's biologics manufacturing facility and the ramp up of others including Amgen and Novartis reflect strong fundamentals ... we expect the manufacturing activity to remain robust for 503," said Ho Weng Si, director of biomedical sciences for EDB.
|
|
A partnership of Mylan NV and Biocon Ltd has filed for U.S. and European Union approval of their biosimilar version, while Celltrion Inc and Samsung Bioepis Co, a joint venture of Samsung Biologics Co and Biogen Inc, are each seeking approval in Europe.
|
|
"We believe this approach could result in a misperception among physicians that biosimilars differ in clinically meaningful ways from their reference biologics' drug substances," Tara Koslov, acting director of the FTC's Office of Policy Planning, said in an email to The Hill Extra.
|
|
Also moving beyond the TPP, the new NAFTA understanding mandates 10-year data protection for so-called biologics patents, something the U.S. pharmaceutical industry had urgently sought but failed to achieve in the TPP (where a fuzzy 8-year protection is the rule).
|
|
HONG KONG, June 13 (Reuters) - Shares in WuXi Biologics (Cayman) Inc were set to open up 21.4 percent in their debut on Tuesday, as investors that couldn't buy into the initial public offering jostled for a piece of the fast-growing business.
|
|
Enable Injections is using a platform from the German software firm SAP to be able to produce millions of its wearable drug-delivery devices overnight to tap into the expected $400 billion biologics market, which involves advanced medications made from living organisms.
|
|
At MBC Biolabs, an incubator for biotech startups in San Francisco's Dogpatch neighborhood, a team of scientists and interns working for the small startup Prellis Biologics have just taken a big step on the path toward developing viable 2024D-printed organs for humans.
|
|
These include accusations that Samsung BioLogics, an affiliate, fiddled its accounts to ease Mr Lee's succession, and that executives from Samsung Electronics, the group's crown jewel, were complicit in destroying evidence, possibly at Mr Lee's behest (Mr Lee and Samsung deny the charges).
|
|
In 23, around the time where some of the biologics were just starting to be used, scientists at the DNAX Research Institute in Palo Alto, California were looking to develop a more targeted biologic medication to treat immune disorders like plaque psoriasis.
|
|
McCarthy told Trump they didn't need to alter the biologics provision of the trade deal for Democrats to eventually agree to finalize it because House Speaker Nancy Pelosi needed to pass the trade deal to show Democrats could get things done amid impeachment.
|
|
For example, the FDA Export Reform and Enhancement Act of 1996 virtually eliminated the regulatory obstacles previously associated with exporting drug, device and biologics products made in but not approved for sale in the United States to countries where they are approved.
|
|
Treatments involving live cells, known as "biologics" are generally far more difficult to manufacture than standard drugs, and the panelists also expressed concerns about whether Novartis would be able to produce consistent treatments and maintain quality control as it scaled up its operation.
|
|
Steven Bauer, chief of the cellular and tissues therapy branch in the Center for Biologics Evaluation and Research, gave the keynote presentation at Thursday's Grand Rounds and focused on how, when multipotent stromal cells are studied for use as therapies, predictability is key.
|
|
"Simply put, we're concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies," write FDA Commissioner Scott Gottlieb and Peter Marks, director of FDA's Center for Biologics Evaluation and Research in the warning.
|
|
Samsung BioLogics' valuation of Samsung Bioepis jumped 18 times to about $4.5 billion in 2015 after it switched to valuing the unlisted firm at fair market value instead of book value, a result of it being treated as an affiliate instead of a unit.
|
|
The unlisted unit of contract drug maker Samsung BioLogics Co Ltd plans to start phase 3 clinical trials for its copy of Lucentis, currently called SB11, in September, according to a filing in a clinical studies database maintained by the U.S. National Library of Medicine.
|
|
"Based on the best available evidence, we believe the new recommendations will help reduce the risk of collecting blood and blood components from donors who may be infected with the Zika virus," noted Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
|
|
"The fact that they could identify types of drugs more likely than others, like biologics or psychiatric drugs" was important, and should possibly lead to increased scrutiny once these drugs hit the market, Dr. Jean-David Zeitoun, first author of the EMA study, told Gizmodo.
|
|
"We strongly urge you not to include language in the TPP implementing legislation committing the United States to 12 years of exclusivity or enter into side letters to extend the biologics exclusivity period for any TPP signatory country," the groups wrote in the letter.
|
|
As the company shifts to gene therapies and biologics like arthritis treatment Cosentyx, Narasimhan said the cuts were needed to help him boost the drugs unit's operating margin to around 35 percent of sales, what he calls the industry standard, from 31.3 percent now.
|
|
However, as a physician who prescribes biologics and supports growth of the biosimilars market, prescriber confidence in the safety and effectiveness of biosimilars plays at least as important a role in whether biosimilars meet their intended purpose of reducing the costs of biological medicines.
|
|
Lifting the restriction on sexually active gay men would raise the risk of H.I.V. infection to one per 375,000 donations, which the agency considers unacceptably high, Dr. Peter W. Marks, the deputy director of its Center for Biologics Evaluation and Research, said in December.
|
|
"The bottom line is we are going to work with blood centers in Puerto Rico to try to help as many as possible make use of the investigational test," said Dr. Peter Marks, director of the F.D.A.'s Center for Biologics Evaluation and Research.
|
|
While legitimate research on stem cells has tremendous promise, some "bad actors" are trying to cash in on patients' hopes with "purported therapies," according to a statement by Dr. Scott Gottlieb, the F.D.A. commissioner, and Dr. Peter Marks, director of the agency's biologics center.
|
|
Dr. Scott Gottlieb, the FDA commissioner, and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, co-authored a new paper detailing the delicate balance between safety and innovation when it comes to the possibilities of using stem cells in medicine.
|
|
"In the future, should Zika virus transmission occur in other areas, blood collection establishments will be able to continue to collect blood and use the investigational screening test, minimizing disruption to the blood supply," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
|
|
With the revitalization of top level FDA leadership, it's equally important to spread the message throughout the organization that FDA's role is to approve safe and effective drugs, devices, and biologics, and can only accomplish this by being an engaged partner in the drug approval process.
|
|
Although the FDA notes that the labeling does not need to be identical to information based on the reference product, it's a pretty safe bet that manufacturers of biologics will likely take issue with competitors using their data for a product that is not exactly the same.
|
|
"I think it's human nature to be suspicious of anything unfamiliar or something new that could replace a product (the innovator biologics) that you already are comfortable with," said Donald Miller, a pharmacy researcher at North Dakota State University in Fargo who wasn't involved in the study.
|
|
Azar managed well a law office of hundreds of attorneys who were dedicated to HHS' program objectives, including clinical research, ensuring safe and effective drugs, biologics, and medical devices, providing health care coverage, supporting improvements in patient care through health information technology and providing essential human services.
|
|
As a result, the agency is halting a number of clinical trials until the researchers conducting them can demonstrate that they have procedures in place to screen donated stool for dangerous organisms, said Dr. Peter Marks, director of the agency's Center for Biologics Evaluation and Research.
|
|
Because AveXis didn't inform the FDA of the issue until after Zolgensma was approved, the agency will "use its full authorities to take action, if appropriate, which may include civil or criminal penalties," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
|
|
But many Democrats, backing arguments made by manufacturers of cheaper generic medications, want USMCA to provide earlier access to proprietary test data used to develop biologics, in order to increase competition and lower prices for patients — a key political issue on both sides of the aisle.
|
|
"There certainly is a real risk to investors that are investing in the health care sector, specifically in drugs and biologics, that stocks might be (affected) by the ebb and flow of the debate over drug prices, and potentially by the compromise, if one's found in Washington," Campbell added.
|
|
Late last month Prellis Biologics announced an $8.7 million round of funding and some significant advancements that point the way forward for 3D-printed organs while a company called Volumetric Bio based on research from a slew of different universities unveiled significant progress of its own earlier this year.
|
|
If it prices in the mid-to-high indicative range, the KOSPI listing is expected to be the second-largest for South Korea, beating Samsung BioLogics Co Ltd's 2.25 trillion won IPO last year and just behind the 4.9 trillion won IPO of Samsung Life Insurance in 2010.
|
|
"But if you could engineer a single strain," offers MIT bioengineer Tim Lu in a statement, "or maybe even a consortia of strains that grow together, to manufacture combinations of biologics or antibodies, that could be a very powerful way of producing these drugs at a reasonable cost."
|
|
Why it matters: The issue of drug companies' patent exclusivity period was a huge deal as the Trans-Pacific Partnership was being debated, and there are warning signs that the same lawmakers who took issue with the handling of biologics in that deal also are worried about this one.
|
|
" The F.D.A. replied in July with a statement saying the tissue was obtained legally and ethically, used in a small fraction of its total research and "has been used in situations where it is critical to understanding how the human immune system responds to certain drugs and biologics.
|
|
During the first eight months of his leadership, the FDA approved a record number of generic drugs (1,027), hastened the approval of a record number of novel drugs and biologics (333) and eliminated the backlog of "orphan" drug applications (200), drugs for rare diseases that won't make a profit.
|
|
The change in the method helped BioLogics swing to a net profit of 1.9 trillion won in 2015 from a loss of 28 billion won a year earlier, bringing criticism that the process, ahead of its $2 billion IPO in 2016, lacked transparency and may have misled investors.
|
|
While many experts believe it is regrettable TPP does not include lengthier protections for pharmaceutical companies to recoup their investments in expensive biologics, the final TPP draft undercuts Secretary Clinton's argument that the agreement provides too much protection for pharmaceuticals – it provides less than when she was effusively praising the agreement.
|
|
One problem for companies trying to create these medicines is that branded biologics can change over time, requiring them to test more patients to prove biosimilars are as effective as their branded peers, FDA Commissioner Scott Gottlieb said in an interview with Meg Tirrell at CNBC's "Healthy Returns" conference on Wednesday.
|
|
Board of Directors ■ Aura Biosciences* (cancer startup) ■ Bristol-Myers Squibb ■ Foghorn Therapeutics (cancer startup) ■ Grail* (cancer testing startup) ■ Infinity Pharmaceuticals* (cancer startup) ■ Varian Medical Systems (radiation equipment) Scientific or Clinical Advisory Board ■ ApoGen Biotechnologies (cancer startup) ■ Aura Biosciences (cancer startup) ■ Grail (cancer testing startup) ■ Juno Therapeutics* ■ Northern Biologics (cancer startup) ■ Paige.
|
|
ANNOUNCES USDA APPROVAL OF NEW VETSCAN FLEX4 RAPID TEST * ABAXIS INC - USDA, CENTER FOR VETERINARY BIOLOGICS, APPROVED ITS NEW VETSCAN FLEX4 RAPID TEST FOR VETERINARY USE * ABAXIS INC - ABAXIS PLANS TO BEGIN SHIPPING FLEX4 RAPID TESTS TO ITS DISTRIBUTOR NETWORK LATER THIS QUARTER Source text for Eikon: Further company coverage:
|
|
With an agreement to bring up USMCA in the House seen as being within reach, both PhRMA and the Association for Accessible Medicines say they do not know how the biologics provision will be decided because of the strict confidentiality agreements House negotiators signed that bar them from discussing the proposals.
|
|
Vaccines are also regulated by the FDA's Center for Biologics Evaluation and Research, which does so under the authority of both the Public Health Service Act of 1944 (not "Health Services Act," as the Williamson campaign put it) and the Food, Drug, and Cosmetic Act of 1938, not just the former.
|
|
Additionally, with a clear regulatory pathway established and the approval of the first U.S. biosimilar following the enactment of the Biologics Price Competition and Innovation Act (BPCIA), Zarxio® in 2015, six biosimilars have been approved in total, including three biosimilars that were approved by the FDA this year alone.
|
|
The pharmaceutical giant on Thursday announced that it has teamed up with the privately held AbCellera Biologics to co-develop a medicine for COVID-19, the disease caused by the virus that has sickened more than 137,000 people across the world and at least 1,700 in the U.S. as of Friday.
|
|
Contract manufacturing firm Samsung BioLogics has denied allegations it juggled its accounting to show a surprise profit ahead of a listing last year on the South Korea stock exchange, saying a revaluation of its stake in biosimilar maker Samsung Bioepis was in line with accounting practices, The Korea Herald reported on Friday.
|
|
"Chairman Hatch continues to believe that the standard of protection for biologics should be consistent with U.S. law, but he is encouraged that the administration was able to secure 10 years of data protection with Canada and Mexico, the highest standard in any trade agreement," a spokesman said in a statement yesterday.
|
|
They're tackling the middlemen who can add layers of costs between manufacturers and patients; they're eyeing ways to keep foreign countries from paying less for drugs and biologics on the backs of U.S. consumers and taxpayers; and they're facilitating new means of helping Medicare patients benefit from competition and negotiation to cut prices.
|
|
America's pharmaceutical and biotech sectors have been stagnant throughout the past presidential administration This is partly because of structural impediments to streamline drug approval and in part because the drugs, devices, and biologics required for the next century simply cannot be approved with the procedures that served us in the last century.
|
|
Upcoming deals include Samsung BioLogics Co Ltd's up-to-$13 billion planned offering or that of the country's largest mobile games company, Netmarble Games Co. Doosan Bobcat's new indicative price range is 29,000-33,000 won per share, with 30 percent of the company to be sold in a listing planned for Nov.
|
|
Election-year antitrade politics aside, the biggest hurdle to Republicans' consideration of the Pacific pact was objections from some — led by Senator Orrin G. Hatch of Utah, chairman of the committee responsible for trade — to intellectual-property provisions that would have limited monopoly protections for brand-name pharmaceutical companies' so-called biologics.
|
|
" CAGW agreed with the Federal Trade Commission's opinion that the final adoption of the draft guidance "could result in physicians incorrectly believing that biosimilars' drug substances differ in clinically meaningful ways from their reference biologics' drug substances, especially since differences in drug substance names have traditionally connoted meaningful differences in drug substances.
|
|
Dave ReichertDavid (Dave) George ReichertLymphedema Treatment Act would provide a commonsense solution to a fixable problem Yoder, Messer land on K Street Ex-GOP lawmaker from Washington joins lobbying firm MORE (R-Wash.) said progress was being made on the biologics front and a solution would help sell the TPP to wary GOP lawmakers.
|
|
Biologics research and development is supposedly a higher-risk endeavor, with: According to pharma, a failure to include substantial data exclusivity as part of a statutory framework for "biosimilars" would undermine incentives to invest in biomedical innovation and thus would slow progress in the development of breakthrough therapies for patients suffering from currently untreatable conditions.
|
|
But list prices do set the market, so to speak.) To get a little more granular: Prices for specialty drugs (often "biologics" produced from living cells to treat conditions) rose the most, followed by brand-name drugs (your classic small-molecule medications), and then generics (the knockoff versions of drugs that have lost their patent protections).
|
|
The supply of shares to institutional investors was further reduced as WuXi Biologics sold 7 percent of the shares on offer to four so-called crossover investors, or existing shareholders that wanted to add to their holdings - Fubon Life Insurance Co Ltd, which is a unit of Taiwan's Fubon Financial Holding Co Ltd , Taikang Insurance Group Inc IPO-TKLI.
|
|
"The way drugs are produced and made now is quite different from the way they were produced and made in the early '80s, and that's both because…you have a lot of these drugs being made for small populations, and for biologics the science is so much more complicated," said Rachel Sachs, a professor at Washington University.
|
|
"Today's safety communication underscores the importance of why new therapies are thoroughly studied to ensure the benefits of taking them outweigh the risks to patients, and we will continue to aggressively monitor clinical trials to ensure patients are protected when safety concerns arise," Peter Marks, director of FDA's Center for Biologics Evaluation and Research, said in an FDA statement.
|
|
Dr. Peter Marks, director of the F.D.A.'s center for biologics evaluation and research, said that the agency would continue to pursue unscrupulous clinics, but that those performing orthopedic procedures — injecting the fat-derived cells into joints — would take a back seat to clinics that inject or infuse cells into the central nervous system or bloodstream.
|
|
Since that first hospital stay, I've had colonoscopies, biopsies, CT scans, X-rays, blood and stool tests, enemas, suppositories, rectal foams, antiemetics, antidiarrheals, antivirals, antibiotics, anti-inflammatories, opiates, steroids, immunoglobulin, biologics and three fecal transplants (if you want to hear a story about my 9-year-old poop donor and a blender, find me on Twitter).
|
|
In the letter to the president, the groups — the AARP, Doctors Without BordersAFL-CIO, Oxfam and the Consumers Union — said they are concerned about recent reports that the Obama administration is working on a compromise with the pharmaceutical industry and Republican leaders in Congress that would lengthen monopoly protections for biologics beyond what is included in the Trans-Pacific Partnership (TPP).
|
|
"We're alerting consumers and health care providers that treatments using plasma from young donors have not gone through the rigorous testing that the FDA normally requires in order to confirm the therapeutic benefit of a product and to ensure its safety," Dr. Scott Gottlieb, food and drug commissioner, and Dr. Peter Marks, director of the agency's Center for Biologics Evaluation and Research, said in a statement.
|
|
A South Korean legislator, Sim Sang-jeung, chairwoman of the minor opposition Justice Party and local civic group People's Solidarity for Participatory Democracy, suggested that Samsung BioLogics, which was unprofitable since starting operations in 2011 reported a net profit of 1.9 trillion won ($1.66 billion) in 2015 based on a revaluation of its holdings in the Samsung Bioepis unit in which US-based Biogen holds about 8 percent.
|
|
FRANKFURT, Aug 20.8365 (Reuters) - The following are some of the factors that may move German stocks on Thursday: The group said it had submitted a Biologics License Application with the U.S. Food and Drug Administration (FDA) for BAY94-9027 for the treatment of Hemophilia A. German court ruling expected in legal test case brought against Volkswagen by consumer rights champion MyRight for selling cars with software banned under EU regulation.
|
|
Should the FDA finalize the August guidance and not remove the biosimilarity statement in the March guidance, the agency would be creating obstacles to biosimilars by both sending a signal that they are not as safe or effective as their corresponding brand-name biologics, and raising questions about the two types of drugs that are not broached with respect to brand-name chemical drugs and their generic versions.
|
|
"As a libertarian, I was inclined to believe that the regulatory costs that the FDA impose kill a lot of people and provide a lot of harm to the economy, and I don't deny that… but one thing that surprised me is that the actual human beings at the Food and Drug Administration like science; they like curing disease and they actually like approving drugs and devices and biologics," he said in a 2014 talk.
|
|
Ron KindRonald (Ron) James KindProtect American patients and innovation from a harmful MedTech Tax increase We should repeal the medical device tax on veterans House panel approves bills on tax extenders, expanding tax credits MORE of Wisconsin, who voted for fast track and is supportive of the TPP, told The Hill that "it is certainly doable to be north of 28" but that there needs to be a landing zone on biologics and other issues.
|
|
Other measures include a restoration of funding used to help consumers find and sign up for coverage under the health law, new disclosure requirements for prescription drug rebate programs, several measures intended to reduce drug costs and increase access to advanced medications known as biologics, and the allocation of $10 billion per year in new "reinsurance" payments that would help lower health care premiums by offsetting the costs of the most expensive insurance claims.
|
|
As a member of the working group assigned to lead negotiations on pharmaceutical section of the agreement, Congresswoman Schakowsky told United States Trade Representative Robert LighthizerRobert (Bob) Emmet LighthizerGOP senator warns quick vote on new NAFTA would be 'huge mistake' Pelosi casts doubt on USMCA deal in 2019 Pelosi sounds hopeful on new NAFTA deal despite tensions with White House MORE that the biologics exclusivity protections would need to be removed entirely.
|
|
AND BIOCON BIOLOGICS HAVE ACTIVATED BUSINESS CONTINUITY PLANS ACROSS THEIR FUNCTIONS * BIOCON LTD -BIOCON WILL CONTINUE TO OPERATE ESSENTIAL PHARMACEUTICAL MANUFACTURING * BIOCON LTD -WORKING TO MINIMISE DISRUPTION TO PRODUCTION SCHEDULES AND SUPPLY OF DRUGS * BIOCON LTD -DO ANTICIPATE DELAYED DELIVERIES FOR SOME PRODUCTS DUE TO PARTIAL SHUTDOWN * BIOCON LTD -CURRENT INVENTORY OF MOST OF OUR RAW MATERIALS IS ESTIMATED TO LAST US FOR NEXT FEW MONTHS Source text for Eikon: Further company coverage:
|
|
"By including 10 years in a treaty, we are locking ourselves in to a higher level of monopoly protection for drugs that are already taking in billions of dollars a year," Jeffrey Francer, the general counsel for a group representing generics, told AP. The other side: Generous exclusivity periods are designed to help drugmakers recoup the cost of developing a new drug, including the cost of failed products, and biologics are particularly complex (which is why they are particularly expensive).
|
|
PARIS, June 27 (Reuters) - Sanofi/Regeneron : * Sanofi and Regeneron announce approval of Kevzara(®) (sarilumab) to treat adult patients with moderately to severely active rheumatoid arthritis in the European Union * "We are pleased to bring Kevzara to European patients who may not be responding to the most commonly used biologics such as TNF inhibitors, or who may be seeking an effective monotherapy to reach their treatment goals," said George D. Yancopoulos, M.D., Ph.D., Founding Scientist, President, and Chief Scientific Officer, Regeneron
|
|
Last weekend, the Orange County District Attorney's office in southern California completed the first successful prosecution of a major node in Planned Parenthood's alleged baby body parts network: Sister companies DaVinci Biosciences and DV Biologics, business partners with Planned Parenthood of Orange & San Bernardino Counties (PPOSBC), signed a $7.8 million settlement in which they were banned from doing business in the state of California ever again and admitted breaking state and federal laws by selling aborted fetal organs and tissue from Planned Parenthood for profit.
|
|
AI (pathology startup) ■ Peptomyc* (cancer startup) ■ PMV Pharmaceuticals (cancer startup) ■ Seragon Pharmaceuticals* (breast cancer) Founder or Co-Founder ■ Mosaic Biomedicals* ■ Tango Therapeutics (cancer startup) Paid Consultant ■ AstraZeneca* ■ Eli Lilly* ■ Novartis* ■ Roche/Genentech* Board of Directors ■ Aura Biosciences* (cancer startup) ■ Bristol-Myers Squibb ■ Foghorn Therapeutics (cancer startup) ■ Grail* (cancer testing startup) ■ Infinity Pharmaceuticals* (cancer startup) ■ Varian Medical Systems (radiation equipment) Paid Consultant ■ AstraZeneca* ■ Eli Lilly* ■ Novartis* ■ Roche/Genentech* Scientific or Clinical Advisory Board ■ ApoGen Biotechnologies (cancer startup) ■ Aura Biosciences (cancer startup) ■ Grail (cancer testing startup) ■ Juno Therapeutics* ■ Northern Biologics (cancer startup) ■ Paige.
|
|
Sorrento Therapeutics Inc: * SORRENTO LAUNCHES NOVEL I-CELL™ COVID-19 CELLULAR VACCINE PROGRAM * SORRENTO THERAPEUTICS INC - I-CELL VACCINE IS EXPECTED TO ELICIT BOTH T CELL AND B CELL IMMUNITIES AGAINST SARS-COV-2 * SORRENTO THERAPEUTICS INC - INTENDS TO SUBMIT A FULL PACKAGE FOR AN IND FILING THAT WOULD ENABLE HUMAN CLINICAL TRIALS TO START AS SOON AS POSSIBLE * SORRENTO THERAPEUTICS INC - IN DISCUSSIONS WITH FDA'S CENTER FOR BIOLOGICS EVALUATION & RESEARCH UNDER IND#019724 FOR REQUIRED IND-ENABLING STUDIES * SORRENTO THERAPEUTICS INC - BELIEVES IT MAY BE IN A POSITION TO INITIATE HUMAN VACCINATION TRIALS AS EARLY AS MID-YEAR 2020 FOR COVID-19 VACCINE Source text for Eikon: Further company coverage:
|
|