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30 марта, 01:25

Bill Ackman's Insider Trading Lawsuit May Cost Pershing Square Investors $75 Million

Pershing Square is setting aside $75 million to cover a class action insider trading lawsuit surrounding its efforts to merge Allergan with now-embattled Valeant, which made Bill Ackman $1.1 billion according to Forbes.

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28 марта, 18:47

Allergan Acne Candidate Meets Endpoints in Phase III Studies

Allergan plc (AGN) in collaboration with Paratek Pharmaceuticals, Inc. (PRTK) has announced positive results from two phase III studies on sarecycline

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27 марта, 14:43

Allergan, Paratek Pharma report positive results in trial of acne treatment

This is a Real-time headline. These are breaking news, delivered the minute it happens, delivered ticker-tape style. Visit www.marketwatch.com or the quote page for more information about this breaking news.

24 марта, 18:27

Amgen's (AMGN) Humira Biosimilar Receives Approval in EU

Amgen, Inc. (AMGN) announced that its biosimilar version of AbbVie Inc.'s (ABBV) rheumatoid arthritis (RA) drug Humira has been approved by the European Commission (EC).

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24 марта, 17:54

Teva Pharma Denies Rumors of Global Workforce Reduction

According to recent reports, Teva Pharmaceutical Industries Ltd (TEVA) is likely lay off almost 11% of its global workforce to cut costs and improve growth prospects.

23 марта, 17:59

AstraZeneca Stock Rising in '17: What's Working in its Favor?

Shares of London-based pharma giant, AstraZeneca plc (AZN) have risen 13.4% this year so far, while the Zacks classified Large-Cap Pharma industry increased 6.4%.

23 марта, 17:19

Allergan's Restasis Now Available in Multidose Bottle in U.S.

Allergan plc (AGN) recently announced that its marketed drug Restasis (cyclosporine ophthalmic emulsion) 0.05% is now available in multidose bottles in the U.S.

23 марта, 15:59

AptarGroup (ATR) Unit Unveils Ophthalmic Squeeze Dispenser

AptarGroup (ATR) unit has introduced an innovative and patented preservative-free multi-dose Ophthalmic Squeeze Dispenser.

21 марта, 21:58

Allergan's Dermal Filler for Wrinkle Correction Gets FDA Nod

Allergan plc (AGN) announced yesterday that the FDA has approved its Juvederm Vollure XC dermal filler for correction of facial wrinkles and folds in adults over the age of 21.

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17 марта, 16:58

Teva Launches Authorized Generic of Allergan's Minastrin

Teva Pharmaceutical Industries Ltd. (TEVA) recently launched an authorized generic version of Allergan plc???s (AGN) oral contraceptive, Minastrin 24 Fe1, in the U.S.

17 марта, 16:27

Pharma Stock Roundup: AstraZeneca's Lynparza Impresses in Study, Merck Drug Label Expanded

Regulatory and pipeline updates from companies like AstraZeneca (AZN) and Merck were in focus this week.

16 марта, 00:46

Allergan (AGN) and Editas Tie Up to Treat Eye Diseases

Allergan plc's (AGN), and Editas Medicine, Inc. (EDIT), entered into a strategic research and development agreement.

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14 марта, 14:24

Editas Medicine surges 8% on $90 million Allergan research and development deal

This is a Real-time headline. These are breaking news, delivered the minute it happens, delivered ticker-tape style. Visit www.marketwatch.com or the quote page for more information about this breaking news.

13 марта, 16:40

Acorda's Four Ampyra Patents Upheld by PTAB, Shares Rise

U.S. Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) upheld four patents of Acorda's key growth driver, Ampyra.

13 марта, 16:16

Aerie Resubmits Rhopressa NDA, Roclatan Gains Traction

Aerie Pharmaceuticals is a development-stage company focused on the development and commercialization of eye disease therapies, including glaucoma and other eye-diseases.

10 марта, 22:55

Donald Trump Poised To Nominate Scott Gottlieb To Head FDA: Reports

WASHINGTON (Reuters) - The White House is expected as early as Friday to nominate Dr. ScottGottlieb, a physician and conservative health policy expert, to lead the U.S. Food and Drug Administration, sources familiar with the matter said. If confirmed by the Senate, Gottlieb would be in charge of implementing President Donald Trump’s plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements and tobacco. Gottlieb, 44, is a resident fellow at the conservative American Enterprise Institute think tank and a partner at a large venture capital fund. He is a former FDA deputy commissioner who has frequently advocated a loosening of requirements needed for approval of new medical products. Gottlieb is well-known on Capitol Hill, where he has testified multiple times on hot-button health issues, including complex drug pricing matters, and is viewed favorably by the pharmaceuticals industry. A survey conducted by Mizuho Securities USA Inc of 53 pharmaceutical executives found that 72 percent favored Gottlieb over other potential candidates. Many described him as knowledgeable, experienced and balanced. “He will be a pragmatic leader with an eye toward both expedited approvals and safety,” one executive wrote. Between 2005 and 2007 Gottlieb was FDA deputy commissioner for medical and scientific affairs. Previously he was a senior advisor to the commissioner and acted as the agency’s director of medical policy development. “Scott knows how the agency works and he will move it forwards, though maybe not always in ways the agency is comfortable with,” said John Taylor, a lawyer with the FDA consulting firm Greenleaf Health and a former acting FDA deputy commissioner. Gottlieb was chosen over Jim O’Neill, a libertarian investor close to Silicon Valley billionaire Peter Thiel, a PayPal co-founder who now advises Trump on technology and science matters. O’Neill’s stated view that drugs should be approved before being proven effective generated widespread alarm. One of Gottlieb’s areas of interest is streamlining the process for approving generic versions of complex, difficult-to-copy therapeutics. He has stated publicly that he does not believe the FDA has good tools or policies to move such products and has advocated the creation of different approval standards. CLINICAL TRIAL FLEXIBILITY Gottlieb declined to comment on the pending nomination, which was going through last-minute vetting on Friday. He is expected to encourage the agency to increase flexibility in the clinical trial development process. In this he will be supported by the recently passed 21st Century Cures Act which instructs the FDA among other things to consider the use of “real world evidence” to support new drug applications. This could include anecdotal data, observational studies and patient reports. “People don’t want to take chances with safety, but there’s increasingly some clamor to be more flexible on the efficacy side,” said Kathleen Sanzo, who leads the FDA practice at the law firm Morgan, Lewis & Bockius. “You need to have some signal of efficacy. The question is, how much?” The FDA has attempted to push back against moves to sideline randomized clinical trials, long considered the gold standard. In January it issued a report documenting 22 cases in which drugs that appeared to show promise in early trials turned out to be either ineffective or unsafe or both in larger trials. Critics say moves to water down clinical trials could jeopardize patient safety. “Destroying medication and device approval standards at the FDA will have devastating, life-and-death consequences for hundreds of thousands of Americans,” Robert Weissman, president of the watchdog Public Citizen, said recently in a statement. The agency has already taken multiple steps to speed the approval process, though not enough for some. “They can always do more.” Brent Saunders, chief executive of Allergan Plc said. Last year, Dr. Janet Woodcock, the agency’s powerful head of pharmaceuticals ordered the approval of Sarepta Therapeutics Inc’s drug to treat Duchenne muscular dystrophy based on little more than a hint of efficacy. In doing so she overrode the recommendation of a panel of outside advisors and top scientists at the agency and set what some say is a precedent for approving drugs based on minimal data. “How can you say it’s ok for this company but not that company?” Mark Mansour, a partner with the law firm Mayer Brown LLP said. “The administration is going to be pushing for quicker approval of drugs for all sorts of diseases with similar, vociferous patient populations who are crying out for a solution.” Other companies that may benefit from Gottlieb’s presence are manufacturers of electronic nicotine delivery systems such as e-cigarettes. The American Enterprise Institute has consistently argued that there is no evidence to show that the risk of vaping comes near to the risk of smoking.   (Reporting by Toni Clarke; Editing by Meredith Mazzilli and Alistair Bell) -- This feed and its contents are the property of The Huffington Post, and use is subject to our terms. 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