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Novartis is hoping a federal judge will dismiss a Department of Justice kickback lawsuit against it based on the drugmaker’s argument that the government hasn’t shown a cause-and-effect relationship between the alleged kickbacks to pharmacies and increased sales of its products. Read More
Drugmakers using Twitter to promote their products need to include both product benefit and risk information in every tweet, despite the 140-character limitations that Twitter imposes on each message, the FDA says. Read More
The FDA says drugmakers have no obligation to correct misleading statements or claims made about their products by third-parties on social media, on websites and in online forums – even on websites owned by the drugmaker. Read More
Generic firm Mylan said June 2 that it had reached a settlement with Pfizer to market versions of Celebrex (celecoxib), marking the latest twist in the generic conversion of the blockbuster arthritis pain drug. Read More
Generic-maker Mylan has launched a version of Bristol-Myers Squibb’s advanced ovarian carcinoma drug Paraplatin Injection in 50 mg/5 ml multidose vials. Read More
Teva cleared a major hurdle this month in its bid to launch a generic version of Bristol-Myers Squibb’s hepatitis B drug Baraclude after a federal appellate court upheld a lower court’s decision invalidating the drug’s patent. Read More
A federal judge tossed out claims over a patent in Sandoz’s bid to launch a generic version of United Therapeutics Corporation’s pulmonary arterial hypertension drug Remodulin, but two more patent challenges remain. Read More
Generic firm Glenmark Pharmaceuticals wants a federal appeals court to rehear its case over rights to the combination hypertension drug Tarka, arguing that an April decision was invalid because it incorrectly attributed exclusive patent rights. Read More