Amgen’s Repatha wins first PCSK9 OK in Japan

Carly Helfand Amgen and the Sanofi and Regeneron team have been duking it out with their PCSK9 meds in the U.S., racing to ink payer deals in an effort to get ahead. But now, Amgen ...

Pfizer’s Ibrance clears first hurdle to early access in U.K.

Carly Helfand Pfizer's new cancer standout, Ibrance, has taken its first step toward joining the U.K.'s Early Access to Medicines program, winning the "promising innovative ...

Samsung and Biogen win first EU approval for an Enbrel copycat

Damian Garde A joint venture between Biogen and South Korean giant Samsung won Europe's first approval for a lower-cost version of Amgen and Pfizer's blockbuster Enbrel, planning ...

Chimerix shares crash as antiviral flops and deaths spike in first PhIII challenge

John Carroll High hopes for Chimerix's antiviral turned into a bad case of data shock Monday morning after the biotech revealed that brincidofovir had failed its first Phase III ...

Wings, fries and tacos come first when pharma reps order for docs

Carly Helfand It's all about Southern, American and Mexican food–at least, when pharma reps are ordering in for events at doctors' offices. FiercePharma News

Sanofi gets first approval for long-anticipated vaccine against dengue fever

Eric Palmer After two decades and $ 1.65 billion in research, French drugmaker Sanofi has gotten an approval for the world's first vaccine against the sometimes deadly dengue fever, ...

UPDATED: Novo to spend $1.2B, hire 700 for its first major drug plant in U.S.

Eric Palmer With a game-changing oral diabetes treatment moving through clinical trials, Novo Nordisk will spend about $ 2 billion on its first API plant in the U.S., ...

Shire raise its $30B Baxalta bid? It’s going to need some details first

Carly Helfand Earlier this week, Baxalta CEO Ludwig Hantson called Shire's $ 30 billion bid for his company a "lowball" offer, urging shareholders instead to look to ...

Eyeing first profits, Tillman Gerngross’s Avitide nabs one last VC round

John Carroll When serial biotech entrepreneur and Dartmouth scientist Tillman Gerngross co-founded Avitide in early 2013, he had some specific ideas on how to quickly capitalize on ...

Bluebird bio builds its case for gene therapy as first sickle cell patient responds

John Carroll FierceBiotech News

Hedge funder’s first assault on iffy drug patents? Acorda’s MS med Ampyra

Tracy Staton Last month, Texas hedge fund manager Kyle Bass said he had pharma and its "questionable" patents in his sights. Now, he's made his first move–and he's ...

Here’s a first: Regeneron cuts forecast after hard-charging Eylea sales miss

Carly Helfand Here's something Regeneron isn't used to: Cutting sales forecasts for blockbuster eye drug Eylea. But that's just what the New York biotech did Tuesday amid ...
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