Shire’s binge-eating push on Vyvanse feeds Q1 earnings beat

Carly Helfand When Vyvanse in February won the FDA's first-ever approval for binge eating disorder (BED), Shire predicted the indication could help the med rake ...

FDA panel gives a thumbs up to Amgen’s T-Vec for melanoma

John Carroll Amgen's regulatory team for talimogene laherparepvec (T-Vec) was grilled by a group of outside FDA experts who picked up on some major questions regarding ...

Mylan recalls injectable cancer meds, most produced for Pfizer

Tracy Staton Mylan is recalling 8 lots of injectable cancer drugs, most of them manufactured for Pfizer, after particulate was discovered in vials. FiercePharma News

FDA opens floodgates to generics of Bristol-Myers’ Abilify

Eric Palmer Just hours after Bristol-Myers Squibb beat Wall Street expectations with earnings that got a goose from antipsychotic Abilify, the FDA opened the floodgates to generics ...

Israel awaits $250M fund, ThromboGenics spins out oncology asset, MolMed licenses CAR-T

Nick Paul Taylor In this week's EuroBiotech Report, OrbiMed Advisors is in the early stages of preparing a second Israel-focused fund that could transfer $ 250 million (€235 ...

Sanofi expands PA vaccine facility to prepare for dengue launch

Tracy Staton Sanofi plans to manufacture its highly anticipated dengue vaccine in a French facility built specifically for the product. But Sanofi Pasteur's vaccine operation in ...

Onglyza’s label should flag heart failure risks, FDA panel says

Tracy Staton AstraZeneca escaped the worst with an FDA panel vote on Onglyza. The agency's expert advisers almost unanimously backed the drug's cardiovascular safety. But the ...

Allergan drops Valeant-Ackman insider trading lawsuit

Carly Helfand Allergan–now owned by Actavis–and its former hostile suitors, Valeant and Bill Ackman's Pershing Square, are putting the past behind them. FiercePharma ...

Eisai gets EMA nod for Lenvima just weeks after FDA approval

Eric Palmer Eisai has gotten its second dose of good news in as many months. Weeks after getting an FDA approval for its thyroid cancer drug Lenvima, the struggling Japanese drugmaker ...

GlaxoSmithKline tags 180 sales-and-admin jobs for cutting in NC

Carly Helfand Last year, GlaxoSmithKline announced plans to slim down its Research Triangle Park, NC-based operations, chopping 900 jobs. Now, it's telling state officials that ...

Third Rock’s faded Ember gets resuscitated in merger deal

Damian Garde Ember Therapeutics, a Third Rock Ventures-founded biotech startup that closed its doors late last year, is getting a second chance thanks to a small New York drug developer. FierceBiotech ...

AcelRx hammered (again) after FDA demands a new Zalviso study after all

John Carroll When the FDA rejected AcelRx's drug/device Zalviso for pain last summer, the biotech said no new trials were required–suggesting it could be back in front of ...
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