UPDATED: Alexion grabs an FDA OK–the 41st of ’15–for rare-disease drug Kanuma

John Carroll Seven months after Alexion bagged the rare-disease drug Kanuma in its $ 8.4 billion buyout of Synageva, the FDA has come through with a marketing approval. The agency ...

UPDATED: Novartis falls short in controversial IPR process as board nixes Gilenya patent

Tracy Staton The U.S. Patent and Trademark Office's review board has dealt its first blow to Big Pharma. The appeal panel nixed a patent on Novartis' multiple sclerosis blockbuster ...

UPDATED: Melinta’s CEO steps down amid a big Phase III push

Damian Garde Melinta Therapeutics CEO Mary Szela has left the company in the middle of a late-stage program for its lead antibiotic, a move that comes just months after the biotech ...

UPDATED: On the ropes, GlaxoSmithKline admits to another PhIII debacle

John Carroll GlaxoSmithKline, which recruited more than 16,000 patients in a monumental postapproval effort to distinguish Breo Ellipta by improving the mortality rates of high-risk ...

UPDATED: AstraZeneca scores FDA nod for long-term Brilinta use

Carly Helfand AstraZeneca's blood thinner Brilinta is officially one step closer to living up to the British pharma's $ 3.5 billion ambitions. The FDA has handed down an approval ...

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., ...

UPDATED: Verastem shares crater on Twitter chatter around cancer data

John Carroll Shares of Verastem cratered Wednesday morning as the Twitter crowd passed around an abstract on the company's defactinib (VS-6063), highlighting an extremely poor response ...

UPDATED: Heard the latest Kite Pharma rumor? CEO says it ain’t so

John Carroll Kite CEO Arie Belldegrun has a simple message for investors this morning: Relax. FierceBiotech News

UPDATED: GSK site closed after Legionella bacteria detected in cooling tower

Eric Palmer After detecting the bacteria for Legionnaires' disease in its cooling tower, GlaxoSmithKline has temporarily closed a manufacturing plant in North Carolina and sent ...

UPDATED: Allergan bags NMDA depression drugs in $560M-plus Naurex buyout

John Carroll The big news in biopharma this weekend is the unconfirmed report that Allergan is looking to sell its generics business to Teva. But Allergan execs didn't let the headlines ...

UPDATED: Sanofi and Regeneron pick up a blockbuster cardio approval–with a catch

Damian Garde Sanofi and Regeneron won an expected FDA approval for the first of a new class of cholesterol drugs expected to alter the landscape in cardiology, but regulators stopped ...

UPDATED: Celgene chief Bob Hugin isn’t done betting on ‘binary’ biotech deals

John Carroll By all accounts, the bidding war for Receptos was intense. But for Celgene CEO Bob Hugin and his go-to deals chief George Golumbeski, strategically this was exactly the ...
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