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Indian Cabinet Secretary Ajit Seth and other top Indian officials today are laying a framework to begin discussions about intellectual property rights with U.S. drugmakers, a number of whom have lost patent protection in India in recent months. Read More
U.S. Supreme Court Chief Justice John Roberts on Friday denied Teva’s attempt to recall and stay a lower court’s ruling that invalidated a patent on Copaxone, opening the gate for generic versions of the blockbuster multiple sclerosis drug to reach the market as early as next month. Read More
The European Medicines Agency said late last week that additional drugs have been diverted in a still unfolding case of product tampering that began with stolen vials of the cancer drug Herceptin (trastuzumab). Read More
Hospira’s quality struggles continue as the injectable giant voluntarily recalled seven lots of generic anesthetic propofol due a defect that led to metal particles in certain vials. Read More
The FDA has approved GlaxoSmithKline and Genmab’s Arzerra and Leukeran as a first-line combination treatment for the most common form of blood and bone marrow cancer. Read More
Opko Health said Thursday it has signed a definitive agreement to acquire Israeli-based Inspiro Medical, giving the drugmaker a delivery vehicle for its respiratory therapies. Read More
Indian drugmaker Lupin Pharmaceuticals is voluntarily recalling three lots of its flagship cephalosporin oral antibiotic Suprax after the drug failed to meet specification in total impurities at the nine-month stability mark. Read More
Impax said Friday it has refiled an NDA for its Parkinson’s disease drug Rytary after implementing quality systems improvements at the plant where the drug was slated to be made. Read More
The EMA is tightening stability testing requirements for drugmakers submitting applications for significant post-approval manufacturing changes that involve active substances. Read More