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India appears to be working somewhat on its reputation as being unfriendly to foreign drug patents, with a court temporarily blocking Cipla from marketing its own generic version of Novartis’ COPD therapy Onbrez. Read More
Hikma Pharmaceuticals will launch its gout treatment, Mitigare, after a federal court rejected Takeda’s arguments to block the product, which would compete with Takeda’s drug Colcrys. Read More
The Federal Trade Commission counted 29 pay-for-delay deals in fiscal year 2013 out of a total of 145 patent litigation settlements between brand and generic drugmakers — a slight decline from 2012, but in line with the two previous years. Read More
The FDA this year aims to answer key questions on which quality metrics it will collect from drugmakers, how to develop biosimilars and how to use social media to promote products. Read More
The FDA has named Kathleen Uhl permanent director of the Office of Generic Drugs (OGD), where she has served as acting director since March 2013. Read More
The UK’s healthcare cost watchdog has updated its methods for reviewing biosimilar applications in anticipation of the products’ increasing availability in the country. Read More
Hospira has submitted a BLA for anemia drug Retacrit, a proposed biosimilar to Amgen’s Epogen and Janssen’s Procrit — making it the fourth company to announce submission of a biosimilar application to the FDA. Read More
The European Medicines Agency wants biosimilars makers to use pharmacodynamic markers alongside pharmacokinetic data to demonstrate biosimilarity. Read More
In a closely watched case, a federal judge has denied Celgene’s motion to dismiss a lawsuit alleging the brandmaker engaged in anticompetitive conduct by refusing to turn over product samples for ANDA bioequivalence testing. Read More
Generics makers are pressing the FDA to expand its criteria for granting first-generic status to ANDAs, a move that would put more drugs in line for expedited review. Read More
TWi Pharmaceuticals’ bid to market a generic version of Par Pharmaceutical’s AIDS drug Megace ES was dealt a major blow last month after a federal appeals court overturned a lower court’s ruling that had cleared the way for the product. Read More