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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
India’s patent office sided with a challenge from generics maker Cipla and struck down a patent protecting Boehringer Ingleheim’s blockbuster COPD drug Spiriva. Read More
A federal appeals court has extended an injunction barring four companies from marketing generic versions of AstraZeneca’s blockbuster inhaled asthma drug Pulmicort Respules while it hears an appeal of a lower court ruling that invalidated the brandmaker’s patent on the drug. Read More
Bristol-Myers Squibb has submitted a new NDA for its hepatitis C drug Daklinza, this time in combination with Gilead Sciences’ Sovaldi for patients with genotype 3 disease. Read More
China’s drug approval backlog ballooned to nearly 18,600 applications by the end of 2014, up more than 30 percent from December 2013, with generics applications representing most of the increase. Read More