Tag Archives: chmp

Bristol-Myers, Pfizer, Regeneron Drugs Get EU Nods

Several key drugs from major drugmakers got endorsements from the European Medicines Agency (EMA) Friday, making commercial approval in the European Union’s enormous market much more likely. Bristol-Myers Squibb’s (BMY) hepatitis C drug daclatasvir, now branded Daklinza, was endorsed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) for use in combination with other hep C drugs, notably Gilead Sciences’ (GILD) Sovaldi. Sovaldi and

PTC Muscular Dystrophy Drug Wins EU Panel Vote

Biotech PTC Therapeutics’ (PTCT) muscular-dystrophy drug got a surprise recommendation from a European Union panel Friday, sending the stock up 50% in early afternoon trading on the stock market. Earlier, the stock rose more than 70%. The Committee for Medicinal Products for Human Use (CHMP), the advisory panel of the European Medicines Agency, recommended conditional approval of PTC’s drug Translarna for patients with Duchenne muscular dystrophy

Biogen, Gilead, Celgene Drugs Get Thumbs Up In Europe

Top-rated biotechs Biogen Idec, Gilead Sciences and Celgene all got good news from Europe Friday, sending their stocks to all-time highs. Biogen’s (BIIB) multiple sclerosis drug Tecfidera moved a step closer to launch in the European Union after it was ruled as a “new active substance” by the EU’s Committee for Medicinal Products for Human Use (CHMP). Under EU rules, a new active substance can be protected from competition for 10