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Celldex vaccine improves long-term brain cancer survival in study

New data from a midstage trial show that Celldex Therapeutics Inc’s experimental brain cancer vaccine, combined with standard therapy, continues to improve chances of survival for patients with recurrent cancer. The updated results sent shares of Celldex up $1.74, or 12 percent, to $16.23 on the Nasdaq. The therapy, designed to enlist the body’s immune […]

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Data doesn’t support nod for BioMarin’s muscle-wasting drug: FDA staff

U.S. Food and Drug Administration staff reviewers said clinical data to date did not merit approving BioMarin Pharmaceutical Inc’s muscle-wasting disorder drug. The FDA staff reviewers raised questions over the clinical benefit of the drug, drisapersen, and said long-term data submitted by BioMarin did not support an approval at this time. BioMarin’s shares fell 8.7 […]

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Biotech’s Bad Boy Martin Shkreli Named CEO of KaloBios

November 20, 2015 By Alex Keown, BioSpace.com Breaking News Staff SOUTH SAN FRANCISCO – A day after acquiring 70 percent of KaloBios (KBIO), Martin Shkreli, the embattled founder and chief executive officer of Turing Pharmaceuticals, has been named to the top spot of a company that was on the verge of shuttering. Company stock has […]

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Embattled Valeant (VRX) to Offer Cash and Stock to Keep Anxious U.S. Employees

LAVAL, Quebec – Embattled Valeant Pharmaceuticals International Inc. (VRX) is offering stock and cash incentives in an effort to keep key employees from jumping to another company, Reuters reported this morning. A Valeant spokesperson told Reuters that approximately 70 employees “below the executive level” have been offered incentives to stay with the company. It is […]

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Clovis slumps after FDA asks for more data on lung cancer drug

Clovis Oncology Inc said the U.S. Food and Drug Administration asked for additional clinical data on the effectiveness of its experimental lung cancer drug, rociletinib, which could delay its approval. Clovis’s shares slumped 69 percent in premarket trading on Monday. The company had a market value of $3.8 billion as of Friday’s close. Clovis said […]

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Genfit could bring NASH liver disease treatment to market in 2019

French biopharmaceutical company Genfit said on Monday it is to launch a phase 3 study of its treatment for liver disease NASH by year-end as part of an accelerated approval procedure which could allow it to be brought to market in 2019. Genfit shares rose 5 pct to 42.71 euros on the news. There is […]

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Panel recommends Merck & Co. continue cholesterol drug study

Merck & Co said an independent data monitoring committee recommended that the drugmaker continue a study of its experimental cholesterol drug, anacetrapib. The recommendation comes a month after Eli Lilly & Co stopped testing a similar cholesterol drug, belonging to a class of drugs called CETP inhibitors. Merck said on Friday that the committee reviewed […]

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U.S. FDA approves Gilead’s hepatitis C drug for expanded use

Drugmaker Gilead Sciences Inc said on Thursday the U.S. Food and Drug Administration had approved the expanded use of its blockbuster hepatitis C drug, Harvoni.   The drug can now be used to treat patients with subtypes of chronic hepatitis C virus (HCV) and patients who are co-infected with Human Immunodeficiency Virus (HIV), Gilead said […]

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Derma Sciences to stop tests on only experimental drug, shares slump

Derma Sciences Inc said it would stop tests on its only drug in development after an outside assessment showed the drug was unlikely to heal foot ulcers caused by diabetes. The company’s shares slumped about 25 percent premarket on Thursday. Derma Sciences, which already has drugs on the market, said it will also stop developing […]

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Sophiris’ prostate drug meets main goal in late-stage study

(Reuters) – Sophiris Bio Inc said on Tuesday its sole drug in development met the main goal of a late stage study, reviving hopes for approval 11 months after the company’s interim analysis suggested the treatment would fail the study. Sophiris’s stock, which has traded as low as 42 cents this year, more than quadrupled […]

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