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Two new analyses showing Gilead Sciences’ Sovaldi and Harvoni hepatitis C drugs are largely cost-effective could convince payers to cover the therapies, which — at roughly $7,000 and $7,875 per week, respectively — are the costliest drugs ever marketed in the U.S. Read More
A federal court agreed Tuesday to hear Mylan’s appeal in patent infringement litigation with AstraZeneca, in a case that could determine in which states brandmakers can file lawsuits against generic firms. 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
The FDA warned Cadila Pharmaceuticals for cGMP violations that include quality controls, complaint handling and data integrity at its Gujarat, India, active pharmaceutical ingredients manufacturing plant. Read More
Takeda’s monoclonal antibody Entyvio got a tentative green light from the UK’s health cost watchdog as a treatment for severe colitis, paving the way for a final consultation and adoption by the National Health Service. Read More
The FDA approved an under-the-tongue formulation of Actavis’ atypical antipsychotic Saphris for 10- to 17-year-old children with bipolar 1 disorder. The company plans to begin marketing the new formulation in the second quarter. Read More