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A judge dismissed claims that the FDA is precluded from approving generic versions of Otsuka’s blockbuster antipsychotic until its orphan exclusivity expires. Read More
Novartis has filed a complaint in federal court alleging Apotex infringed on its patent by seeking to manufacture, market and sell a generic version of cancer drug Zometa. Read More
The UK’s National Institute for Health and Care Excellence confirmed its recommendations for Bayer’s Eylea and Allergan’s Ozurdex for some patients with diabetic macular edema in separate final draft guidances. Read More
The decision lets stand a lower court ruling upholding a California county ordinance requiring drugmakers to collect and dispose of unwanted drugs. Read More
The U.S. Supreme Court has turned down a request to overturn an appellate court’s decision that vacated a federal district court’s ruling dismissing a case claiming that Purdue Pharma overstated the potency of its painkiller OxyContin. Read More
A House subcommittee chairman wants the FDA to explain its practices relating to publication and distribution of untitled letters, after hearing complaints from companies that the agency’s policies are inconsistent and, in some cases, unfair. Read More
While nearly three-quarters of generic drugs saw prices fall in 2013, the 27 percent that saw price increases led to the smallest average annual decline in seven years, a new report finds. Read More