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The FDA has hit two compounding pharmacies with warning letters for quality violations and failure to have prescriptions for products they were compounding. Read More
Pharma companies applying for approval to sell drugs in Canada must submit quality summary documents, certifications of their products’ comparability with monographs of the European Pharmacopoeia and detailed drug master files that comply with the International Conference on Harmonisation’s registration for human use quality standards Read More
Pfizer’s lung cancer drug dacomitinib has failed in two Phase III clinical trials and analysts aren’t holding out much hope for results from a third Phase III study expected next year. Read More
Boehringer Ingelheim and Teva Friday were hit with their fourth class action lawsuit over an alleged $120 million pay-for-delay deal to keep generics of the anti-stroke drug Aggrenox off the market. Read More
A New Jersey federal judge Friday dismissed a pay-for-delay case involving a “no-authorized generic agreement” between GlaxoSmithKline and Teva, saying the Supreme Court’s landmark 2013 ruling in Federal Trade Commission v. Actavis applies antitrust scrutiny only to pay-for-delay deals that involve money. Read More
Japan’s national drug regulator has asked drugmakers to submit information on stability monitoring and water purity, in addition to existing requirements, when they apply for mandatory post-approval GMP inspections. Read More
Generic drugmakers and the biotech industry have drafted a set of rules to govern when and how biosimilars can be substituted for brand-name biologics. Read More
The European Medicines Agency (EMA) on Friday said it will investigate reports that emergency contraceptives such as Teva’s Plan B One-Step lose effectiveness in some women who weigh more than 165 lbs. Read More