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European regulators are looking to industry for suggestions on the best ways to get generic versions of topical drugs approved without having to conduct time-consuming and expensive clinical trials to prove bioequivalence. 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
The European Commission has updated its GMP guideline on process validation to reflect the EU’s current risk-based approach to managing quality systems over the entire lifecycle of a drug. Read More
The European Medicines Agency has rejected calls from industry to use biosimilar reference products from outside the EU unless they are justified using pharmacokinetic tests. 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