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Impax Laboratories said it has begun shipping generic Renvela tablets in the U.S. after securing a license from Genzyme to sell a specified number of bottles. Read More
The European Medicines Agency said Monday it has concluded its investigation into deficient postmarket reporting by Roche and forwarded a report to the European Commission, where penalties will be debated. Read More
A group of generic drugmakers is urging the U.S. Supreme Court to let them introduce generic versions of Teva Pharmaceutical’s Copaxone multiple-sclerosis drug next month. Read More
The UK’s National Institute for Health and Care Excellence has recommended Ferring Pharmaceuticals’ Firmagon as a cost-effective treatment for advanced hormone dependent prostate cancer in people with spinal metastases and signs or symptoms of spinal cord compression. Read More
Drugmakers should include information for all uses of a product — including off-label uses — when preparing periodic benefit-risk evaluation reports, the International Council on Harmonisation says in new Q&A guidance. Read More
The FDA has approved another under-the-tongue hay fever treatment, putting a second product on the market that will replace the routine injections currently prescribed to control symptoms. Read More
U.S. lawmakers are asking the Office of the United States Trade Representative to put Canada back on its priority watch list after the country withdrew a number of patents for drugs sold by American drugmakers. Read More
A federal judge Tuesday overturned Massachusetts’ ban of Zogenix’s controversial painkiller Zohydro ER, saying the state overstepped its authority. Read More
Boehringer Ingelheim and Eli Lilly said Monday that the FDA has accepted their NDA for a first-in-kind drug combination to treat type 2 diabetes. Read More