Bayer, Raptor reel in endorsements from EMA for new therapies

Ryan McBride The European Medicines Agency's experts have backed approval for two drugs that have already gained green lights for the U.S. market. FierceBiotech News

FDA sends J&J CRL on Xarelto for stent thrombosis

Eric Palmer The FDA keeps offering up tough news to Johnson & Johnson for its warfarin replacement, Xarelto. It has twice turned it down for treatment of acute coronary syndrome ...

The Op-Ed: Time To Mind The Generic Safety Gap

esilverman Earlier this week, the US Supreme Court narrowly ruled that state lawsuits claiming drugmakers failed to adequately design their medications cannot proceed because ...

Lab animal wars: Scientists blast living conditions of stolen mouse models

Ryan McBride After recent animal-rights victories, scientists on the other side of the fight have used photographs from activists to criticize their detractors in the activist community. ...

Dendreon’s Provenge gets recommendation in Europe

Eric Palmer Dendreon today got the best news it has had in a long time for its prostate cancer vaccine Provenge, a thumbs up from the Europe's Committee for Medicinal Products for ...

Raptor Pharmaceutical’s Procysbi Receives Positive Recommendation From CHMP

barbara.lempert Raptor Pharmaceutical’s PROCYSBI(TM) Receives Positive Recommendation From CHMP NOVATO, Calif., June 28, 2013 (GLOBE NEWSWIRE) — Raptor Pharmaceutical ...

EU regulators give landmark backing to Remicade biosimilars

Ryan McBride Two developers of biosimilars won a major victory in Europe. A European Union regulator backed approval of two copycat versions of Johnson & Johnson's blockbuster ...

Glaxo Duchenne Treatment Gets Breakthrough Designation

barbara.lempert GlaxoSmithKline’s drisapersen (previously GSK2402968/PRO051) to receive Food and Drug Administration Breakthrough Therapy designation for potential treatment ...

Pfizer returns to buyback strategy to appease shareholders

Eric Palmer Pfizer has been hit hard by patent losses and some of its new drugs are not performing as well as it would like, but something CEO Ian Read is really strong at is buying ...

GlobalData: Upcoming Novartis chronic heart failure drug expected to dominate market by 2022

mia.burns By Mia Burns Research and consulting firm GlobalData has released a new report, PharmaPoint: Chronic Heart Failure – Global Drug Forecast and Market Analysis to 2022 ...

Prosensa harvests $78M as biotech IPOs continue to sizzle

John Carroll Prosensa picked the right day to price its IPO. The Dutch biotech rang up the offering at $ 13 a share, at the top of the range, raising $ 78 million after bumping the ...

Merck Selling Some Sites, Product Options for $1B

barbara.lempert Merck Selling Manufacturing Sites, Product Options to Aspen Healthcare PHILADELPHIA, Pa., June 28, 2013 (PHILADELPHIA INQUIRER)–Drugmaker Merck & ...
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