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The FDA March 6 gave a green light to the first U.S. biosimilar, finding Sandoz’s Zarxio clinically comparable to Amgen’s blockbuster chemotherapy product Neupogen. Read More
The House yesterday passed a bill that would allow drugs to be sold before the Drug Enforcement Agency permanently assigns them to a controlled substance schedule. Read More
The European Medicines Agency Tuesday approved Novartis’ Jakavi for patients with polycythemia vera — a rare blood cancer — who cannot take hydroxyurea. Read More
Generics maker Sandoz will pay out $12.64 million to settle accusations it misrepresented average sales price information in reports to Medicare. Read More
The FTC is fighting to keep secret the reports drugmakers must file with the commission on patent infringement litigation in an ongoing and closely watched pay-for-delay lawsuit with Actavis. Read More
Actavis’s planned acquisition of Allergan could close as early as today after the European Commission signed off on the $66 billion purchase. Read More