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European regulators have approved AstraZeneca and Nektar Therapeutics’ opioid-induced constipation drug Moventig for adults that have not responded to laxatives. Read More
Manufacturers of therapies in Japan that combine drugs with either a medical device or a cellular or tissue-based product must determine which category it falls under before filing a marketing application, according to a revised regulation. Read More
Ebola vaccine manufacturers Janssen, GlaxoSmithKline and NewLink Genetics will be sheltered from legal liability under a law that protects companies that produce treatments to combat public health emergencies, HHS said yesterday. Read More
Starting next year, pharmaceutical wholesale distributors must submit annual reports that include detailed contact and state licensure information as well as any significant disciplinary actions taken by state or federal officials, the FDA says. Read More
Brand drugmakers in Europe are calling on the European Commission to implement a system to help resolve patent disputes before the launch of a generic drug, a move they say would address inefficiencies in the current patent litigation system. Read More
Sponsors submitting pediatric study plans for a drug have several options to determine optimal dosing for children when no standard dosing information exists, according to an FDA draft guidance on clinical pharmacology in pediatric studies. Read More
Lax procedural documentation in quality control units topped the list of reasons why drugmakers received Form 483s in fiscal 2014, its ninth consecutive year at the top, while poor laboratory controls jumped to second place from fourth in the annual rankings of inspection observations. Read More
Several EU member countries have suspended marketing authorization for therapies that underwent bioequivalence testing at contract research organization GVK Biosciences’ facility in Hyderabad, India over serious concerns with good clinical practice. Read More
Sandoz’s bid to invalidate two patents protecting Amgen’s biologic rheumatoid arthritis therapy Enbrel was dealt a major blow last week, after a federal appeals court affirmed that a patent challenge prior to submission of a biosimilar application is premature. Read More