EMA backs approval of key drugs from Celgene and Aegerion

Ryan McBride Two drugmakers reported regulatory victories for therapies in the important European market. A European Medicines Agency committee endorsed approval of Celgene's ($ ...

AIBioTech Receives Subcontract Award From DynPort Vaccine Companyfor Continued Development and FDA Approval of a Nerve Agent Prophylactic

barbara.lempert RICHMOND, Va., May 23, 2013 (GLOBE NEWSWIRE) — AIBioTech is pleased to announce receipt of a firm fixed price subcontract from DynPort Vaccine Company LLC (DVC), ...

AbbVie and Eisai Announce Humira Pre-filled Syringe Has Received Approval for the Treatment of Intestinal Behçet’s Disease in Japan

barbara.lempert HUMIRA is the First Biologic Approved to Treat Intestinal Behçet’s Disease in Japan AbbVie GK Eisai Co., Ltd. AbbVie GK (Headquarters: Tokyo, President: ...

Novo Nordisk Says Will Seek Approval of Obesity Drug Next Year

barbara.lempert Novo Nordisk reports 8% weight loss in phase 3a obesity trial with liraglutide 3 mg Bagsværd, Denmark, 23 May 2013 – Novo Nordisk today announced the headline results ...

UPDATED: GlaxoSmithKline gains blockbuster FDA approval of lung drug Breo

Ryan McBride GlaxoSmithKline and Theravance have won FDA approval for their drug Breo Ellipta for treating chronic obstructive pulmonary disease, the third-biggest killer of Americans, ...

FDA’s Hamburg touts rising approval record and promises swifter interaction

John Carroll Margaret Hamburg, the head of the FDA, turned up at Reuters Health Summit with a bullish assessment of both the agency's responsiveness as well as the biopharma industry's ...

Bristol-Myers gains FDA’s ‘breakthrough’ track in race for hep C drug approval

John Carroll Bristol-Myers Squibb just gained an inside regulatory track in the frantic race to get new interferon-free hepatitis C drugs to the FDA. The big biotech reported in its ...

GlaxoSmithKline picks up FDA panel plug for Breo approval

Ryan McBride GlaxoSmithKline took its Breo Ellipta program a step forward Wednesday afternoon, winning the endorsement of an FDA committee for approval of the once-daily treatment ...

FDA seeks more data from Sarepta to decide on accelerated approval

Ryan McBride Sarepta Therapeutics ($ SRPT) has kept hopes alive for gaining accelerated approval for its lead drug eteplirsen for Duchenne muscular dystrophy. Yet the FDA wants additional ...
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