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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
Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows. 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
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
The FDA has granted breakthrough therapy designation to AbbVie’s venetoclax to treat relapsed or refractory chronic lymphocytic leukemia in people with a certain genetic abnormality — paving the way for its speedy development and review. Read More
Sponsors seeking Canadian approval of new drugs or indications based on published literature or postmarketing data need to be able to prove that their drug is comparable to its reference product, regulators says. Read More