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 ...

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 ...

Cebix hangs it up after raising $50M for diabetes drug

Damian Garde La Jolla, CA's Cebix has quietly closed up shop, Xconomy reports, after its once-promising diabetes candidate failed to hit the mark in Phase IIb. FierceBiotech News

Lilly’s new insulin is likely DOA after latest delay, analyst says

Damian Garde Eli Lilly's already-delayed new insulin has run into another roadblock, as potentially harmful liver side effects have sent the company back to the clinic, putting ...

Bayer rolls up its sleeves for major reorg after plastics unit departs

Tracy Staton After Bayer hives off its plastics business, it's going to remake the rest. The German conglomerate will merge its HealthCare and CropScience divisions into one life-science-focused ...

Pfizer’s still a likely buyer after its $17B ‘hors d’oeuvre’

Damian Garde After signing up to acquire Hospira for $ 17 billion, Pfizer is just getting started, analysts say, pointing to Pfizer's failed quest for AstraZeneca as evidence that ...

Novo hopes for European Saxenda launch this year after CHMP nod

Carly Helfand Novo Nordisk's obesity therapy Saxenda is on a roll. Just over a month after snagging FDA approval, the drug scored a positive recommendation on Thursday from Europe's ...

Indivior CEO looks beyond 2015 after troubled Reckitt pharma unit’s spinoff

Carly Helfand It's new year, new company for Reckitt Benckiser's pharma unit, spun off into Indivior last week. And while 2015 might not be the easiest for the newly minted ...

Japan unveils sunshine data of its own, raising eyebrows after Diovan scandal

Tracy Staton Just as the dust is settling after the big rollout of doctor-payment data in the U.S., a new round has made its debut–in Japan. According to The Japan News, the country's ...

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 ...

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 ...

Geron shares rocket up after FDA takes the cuffs off its lead drug

John Carroll After putting up evidence to show that the liver toxicity triggered by its lead drug can be reversed, the FDA has lifted the full hold placed on its lead–and only–cancer ...
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