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In a reversal of its 2010 guidance, the UK's cost-benefit watchdog now recommends coverage of Novartis' cancer drug Glivec in some patients following surgery for gastro-intestinal stromal tumours (GIST).
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The U.S. Patent and Trademark Office's recently established patent review board has received what appears to be its first challenge to a drug patent covering a business practice rather than a drug's attributes. Read More
Bills introduced in four states would grant terminally ill patients access to post-Phase-I experimental drugs without having to go through the FDA. Read More
Regulators pushing for greater international cooperation cautioned that relying on other countries’ inspections would require overcoming crucial hurdles such as incompatible technology, language barriers and keeping trade secrets secret. Read More
Teva is pointing to the Supreme Court’s recent ruling in a soft drink labeling case to claim immunity from GlaxoSmithKline’s lawsuit alleging the Israeli firm falsely advertised its generic antidepressant budeprion XL as bioequivalent to GSK’s Wellbutrin XL. Read More
A federal judge tossed out Novartis’ lawsuit against generic firm Alvogen’s challenge to its dementia treatment Exelon Patch, claiming the brand firm failed to show the generic product contained a patented antioxidant. Read More
A federal judge has dismissed conspiracy claims against four generic drugmakers and a brand firm in a class-action lawsuit that alleges the companies colluded to keep generic versions of Cephalon’s wakefulness drug Provigil off the market. Read More
Avanir Pharmaceuticals has settled with generic firm Ranbaxy over its bid to produce a version of the brand manufacturer’s Nuedexta, the first drug approved in the U.S. to treat pseudobulbar affect (PBA). Read More