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 ...

AstraZeneca ties up with little Mirati on another PD-L1 combo trial

John Carroll AstraZeneca's big MedImmune subsidiary has a new partner for its closely-watched PD-L1 checkpoint inhibitor durvalumab (MEDI4736). Little Mirati Therapeutics, which ...

Cara Therapeutics scores another positive PhII for lead opioid

John Carroll FierceBiotech News

Aveo endures yet another FDA setback

Damian Garde An optimistic Aveo Oncology recently plotted a path back to Phase III with its thrice-failed cancer drug, but the FDA wants to see more data before signing off on that ...

Novartis nixes another $600M buyout deal for Gamida Cell

John Carroll Novartis won't be pulling the trigger on a $ 600 million buyout deal for Israel's Gamida Cell after all. Elbit Imaging, the majority owner of a minority stakeholder ...

Acadia craters as takeover buzz is silenced by (another) NDA delay, CEO exit

John Carroll San Diego-based Acadia Pharmaceuticals put out word on Wednesday evening that it is delaying its expected NDA for pimavanserin from Q1 back to some time in the second half ...

Synta cuts another 20% of staff and rallies around its cancer drug

Damian Garde Synta Pharmaceuticals is again slashing its payroll, cutting costs across the board as it presses ahead with ganetespib, a long-delayed cancer treatment. FierceBiotech ...

Celgene’s Abraxane wins another OK in Europe

Eric Palmer Celgene's Abaxane is one of those cancer fighters that has proven effective against many forms of cancer, and so the company has sought approvals far and wide, sometimes ...

Bayer runs into another German roadblock in marketing vision drug Eylea

Tracy Staton Germany's cost-effectiveness watchdog said Bayer eye drug Eylea doesn't perform any better than its Novartis rival, Lucentis, as a treatment for diabetic macular ...

Bayer may hive off another unit as it doubles down on pharma, consumer health

Carly Helfand Turns out it may not be just Bayer's plastics business that's on its way out the door. The company is reportedly exploring a sale of its diabetes device business ...

Amgen takes another stride in frenzied race toward the PCSK9 finish line

John Carroll Amgen now has a deadline in place for an FDA decision on its cholesterol-lowering drug evolocumab. The Big Biotech put out the word Monday morning that the FDA has accepted ...

Eisai ‘speechless’ after another Fycompa price smack-down from Germany

Carly Helfand Germany's cost-effectiveness gatekeepers have delivered another blow to Eisai over the price of Fycompa. And the verdict, just the drugmaker's latest frustration ...
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