New name, but same old problems for Posimir as FDA hits Durect again

Ben Adams Durect may have changed the name of its post-pain gall bladder surgery drug from "Posidur" to "Posimir" this year, but this has not stopped its run of ...

Wockhardt spanked again by FDA as agency ticks off violations at new sterile injectables plant

Eric Palmer Wockhardt saw a new plant that will make sterile injectable drugs as its best shot at restoring a U.S. business devastated by FDA product bans. But the Indian ...

U.K. investor Woodford calls again for breakup of ‘complicated’ GSK

Carly Helfand In October, high-profile U.K. fund manager Neil Woodford advocated for a four-way breakup of GlaxoSmithKline, a company he said could unlock "significant shareholder ...

Think we’ve seen the last of pharma’s M&A tidal wave? Think again

Carly Helfand If you think 2015 was a big year in pharma M&A, just wait. That train won't be slowing down any time soon, industry watchers say. On the contrary, they're ...

Merck may appeal to Supreme Court after again losing fight to protect Cubicin patents

Eric Palmer Merck & Co. is running low on options after a federal appeals court Thursday again declined to back four patents that would have held at bay for 5 more years generics ...

Ackman’s Valeant ties pay off yet again with Sprout buy

Carly Helfand Bill Ackman's relationship with Valeant has paid off big-time since the hedge fund manager first teamed up with the Canadian pharma on its hostile pursuit of Allergan. ...

Perrigo CEO: Think Mylan’s buyout will come easily? Think again

Carly Helfand Perrigo has stayed quiet since Teva dropped its hostile pursuit of Mylan, choosing instead to snap up Allergan's generics business for $ 40.5 billion. Mylan's ...

Hep C landscape shifts again as BMS combo nabs breakthrough tag

Eric Palmer Gilead Sciences and AbbVie caught a break for their hepatitis C treatments when the FDA rescinded breakthrough designations earlier this year for potential competitors being ...

AstraZeneca partner Ardelyx dives (again) as lead drug flunks PhII

John Carroll FierceBiotech News

J&J’s 2018 Remicade patent smacked down at PTO again

Tracy Staton Johnson & Johnson said the U.S. Patent and Trademark Office rejected a 2018 Remicade patent for the second time, putting the blockbuster anti-inflammatory's exclusivity ...

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 ...

Exclusive: Pfizer is once again cutting back R&D staff in reorganization

John Carroll Pfizer is once again trimming its R&D staff. Responding to a query from FierceBiotech regarding word of cutbacks at research facilities in Cambridge, MA, and Collegeville, ...
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