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The European Commission says it does not have the power to issue compulsory licenses to allow the manufacture of generic drugs during a health emergency, noting those decisions are made by member states on an individual basis. Read More
Swiss drugmaker Novartis is upping its stakes in the chronic pain market with the purchase of U.S.-Australian drugmaker Spinifex Pharmaceuticals for $200 million plus undisclosed milestone payments. Read More
The UK’s healthcare watchdog says it needs more evidence before it can determine if off-label use of Alexion’s Soliris is effective in preventing the recurrence of a rare kidney disease in patients who have undergone transplants. Read More
The FDA Monday published dozens of product-specific draft guidance documents offering recommendations on the design of bioequivalence studies to support ANDAs. Read More
Dr. Reddy’s Laboratories is recalling drugs used to treat seizures and high blood pressure from the U.S. market due to dissolution and potency issues. All of the affected products were manufactured at DRL’s Bachupally, Hyderabad, India, facility, FDA enforcement reports show. Read More