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Teva’s zero-hour attempt to prevent generic competition to its blockbuster multiple sclerosis drug Copaxone was halted Wednesday when a federal judge threw out its lawsuit calling for ANDA applicants to meet additional requirements. Read More
Beleaguered Indian generics maker Wockhardt is recalling 109,744 bottles of the hypertension drug metoprolol due to problems with how the product dissolves in the body. Read More
Investigators looking to develop new therapies for children with Gaucher disease may use either multi-company, multi-arm clinical trials or data extrapolation techniques, according the FDA and European Medicines Agency. Read More
A federal appellate court has ruled in favor of Sanofi-Aventis’s defense of its combination hypertension drug Tarka, finding that there was nothing “obvious” about its patent on the product. Read More
Generic manufacturers are unlikely to be pleased with final draft guidance from the FDA on ANDA stability testing that continues to insist on six months of long-term stability data. Read More
Two Johnson & Johnson divisions have sued generic firm Mylan over its bid to market a version of the attention deficit hyperactivity disorder drug Concerta. Read More
The National Institute for Health and Care Excellence says the UK government should not reimburse for Johnson & Johnson’s prostate cancer drug Zytiga because it is not cost effective. Read More
An FDA study of postmarket reports shows that Boehringer Ingelheim’s blood thinner Pradaxa presents an increased risk of major gastrointestinal bleeding but a lower risk of strokes and deaths compared with warfarin. Read More
Manufacturers of biosimilars should take great care in designing clinical trials and other steps needed to demonstrate exactly how their products line up with the reference drugs, according to key FDA draft guidance on creating versions of the complex therapies. Read More