Progenics tanks after two trial deaths cast doubt on its lead program

Damian Garde Two patients died of sepsis in a Phase II trial of Progenics Pharmaceuticals' in-development prostate cancer treatment, spurring concern that the drug is too toxic ...

Ranbaxy will need new markets as FDA closes window on U.S., analysts predict

Eric Palmer What is a generic drugmaker going to do when the FDA finds flies filling its analytics laboratory and shuts down a yet another plant key to serving the U.S. market? Start ...

C-suite shuffle: Amgen CFO Peacock resigns

Eric Palmer The company named Michael Kelly, an 11-year Amgen veteran, to hold the CFO position on an interim basis. FiercePharma News

China suspends imports of Pfizer’s AIDS-related drug on a paperwork problem

Carly Helfand Foreign drugmakers have had their fair share of struggles in China this year as the country looked to cut down on healthcare spending and root out bribery. But neither ...

Karolinska’s Axelar comes up short in Phase II with lung cancer drug

Damian Garde Swedish biotech Axelar's lung cancer drug failed to beat out standard docetaxel in a mid-stage trial, but bankroller Karolinska Development isn't giving up, planning ...

The Affordable Care Act Gives Drugmakers A Boost: CMS

esilverman What hath the Affordable Care Act wrought? For drugmakers, there looks to be a big boost in spending on prescription medicines. Projected spending is forecast to ...

As Pfizer Readies New Business Units, Amy Schulman Exits

esilverman Just a few months after Pfizer tapped general counsel Amy Schulman to head one of three so-called innovative business units that are supposed to take shape in January ...

Idenix fires off a shot in patent battle over Gilead’s sofosbuvir

Damian Garde As Gilead nears a virtually guaranteed FDA approval for the hepatitis C-fighting sofosbuvir, the biotech is facing intellectual property challenges from a bevy of competitors, ...

U.S. access group aims to block Indian patent for Gilead’s hot hep C drug

Tracy Staton Gilead Sciences' new hepatitis C drug sofosbuvir won preliminary backing from European regulators on Friday, with marketing approval expected to follow soon. The FDA ...

Dompé Carries out Internationalization Plan

mia.burns By (mia.burns@ubm.com) Dompé, S.p.A, an Italian pharma company based in Milan, is setting its sights on New York with new offices. Associate Web Editor Mia Burns interviewed ...

FDA staffers throw cold water on Sanofi’s Lemtrada hopes

Tracy Staton If you're a drug developer, which 6 words do you never, ever want to see in an FDA review of a potential new product? The 6 words applied to Sanofi's multiple sclerosis ...

Keryx Updates on Ongoing Zerenex Study

mia.burns Keryx Biopharmaceuticals Provides Update From Ongoing Zerenex(TM) (ferric citrate coordination complex) Long-Term Safety Extension Study in Patients With Hyperphosphatemia ...
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