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Genentech, whose scleroderma treatment Actemra recently gained breakthrough therapy status from the FDA, topped the list of drugmakers making payments to physicians and teaching hospitals last year, with at least $274.2 million in general payments and $99.2 million in research payments covering more than 16,000 transactions. Read More
Two patient advocacy groups are suing the FDA to force it to release raw clinical trial data on Gilead Sciences’ groundbreaking hepatitis C drugs Sovaldi and Harvoni. Read More
India’s government has announced plans for a $78 million venture capital fund to offer loans to drug companies that are building or expanding manufacturing facilities. Read More
Celgene and Juno Therapeutics have entered into a 10-year collaboration leveraging their T cell strategies to develop treatments for patients with cancer and autoimmune diseases. Read More
Roche announced positive results from two Phase 3 studies pitting its investigational multiple sclerosis drug ocrelizumab against the standard-of-care in patients with relapsing MS, the most common form of the disease. Read More
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The FDA Monday published dozens of product-specific draft guidance documents offering recommendations on the design of bioequivalence studies to support ANDAs.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