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Mylan and Sandoz have filed a legal brief with the U.S. Supreme Court challenging Teva’s appeal to salvage the patent protection on its blockbuster multiple sclerosis drug Copaxone. Read More
Generic versions of Depomed’s shingles drug Gralise are unlikely in the near future after a federal judge sided with the brand manufacturer’s patent infringement suit against a 2012 ANDA filed by Actavis. Read More
Alabama’s Supreme Court Aug. 15 reaffirmed its ruling that a brand drugmaker can be held liable for damages caused by a generic version of its product if the generic carries warning labels that are drafted by the brand company. Read More
1.7 million treatments will be sent to Burkina Faso, the Democratic Republic of Congo, Burundi, Nigeria, Liberia and Niger in the coming months. Read More
Actavis has launched a generic challenge against UCB’s Parkinson’s disease drug Neupro, and is facing a patent infringement lawsuit as a result. Read More
Generic versions of Ferring Pharmaceutical’s menstrual bleeding drug Lysteda can move forward after the brandmaker lost a pair of appeals in patent infringement lawsuits seeking to block ANDAs against the product. Read More
Swiss pharmaceutical company Roche said yesterday it will acquire California-based biotechnology firm InterMune for $8.3 billion, in a deal that allows Roche to strengthen its respiratory therapy portfolio. Read More
European regulators approve new drugs at a faster clip than their Canadian counterparts, but both jurisdictions have the same rate of pulling drugs from the market due to safety reasons, a new study finds. Read More
The FDA has cleared Mylan’s generic version of Upsher-Smith’s potassium drug Klor-Con, and the generics firm has already started shipping the product. Read More
The FDA slapped an Indian manufacturer with a warning letter for creating phony records, falsifying training tests and failing to clean up a moldy and insect-infested facility. Read More