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Vertex Pharmaceuticals’ Kalydeco/lumacaftor combination therapy may be in danger as regulators question whether it will provide significant improvements in lung function for most cystic fibrosis patients. Read More
Actavis plans to immediately relaunch its generic version of AstraZeneca’s inhaled asthma drug Pulmicort Respules following a federal appeals court decision upholding a lower court ruling that invalidated the brandmaker’s patent on the drug. Read More
Novartis’ Zykadia will soon be available as a second-line treatment for European patients with a specific type of non-small cell lung cancer, following European Medicines Agency approval late last week. Read More
A federal court in Australia Thursday agreed that Pfizer’s proposed settlement in a class action lawsuit over gambling and other addictions caused by its Parkinson’s disease drugs Cabaser and Dostinex is a fair compromise — but delayed accepting the proposal due to procedural matters. Read More
The California Supreme Court Thursday held that a pay-to-delay agreement between Bayer and Barr Laboratories over a generic of the brandmaker’s antibiotic Cipro violates the state antitrust law. Read More
The FDA Friday approved Bayer HealthCare’s Avelox for the treatment of pneumonic and septicemetic plague, under the animal efficacy rule. It also is approved to prevent plague in adults. Read More
Tennessee has joined a growing list of 11 states to pass legislation enabling pharmacists to substitute a biosimilar for a branded biological product, in a move applauded by industry. Read More
Dublin, Ireland-based Amarin Pharmaceuticals is asking a New York federal court to declare its off-label promotion of a cholesterol-lowering drug constitutionally protected free speech, after several FDA rejections of its desire to promote the drug for a wider patient population. Read More
Gilead Sciences is poised to enter the fledgling field of epigenetics after signing a definitive deal to purchase Denmark-based EpiTherapeutics for $65 million. Read More
Drugmakers are getting better at reporting clinical trials results in a timely manner, with only 10 percent of studies on new treatments approved by the European Medicines Agency in 2012 not disclosed within 12 months, a new study shows. Read More