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UK’s healthcare cost watchdog has recommended against coverage of Celegene’s multiple myeloma drug Imnovid, in combination with dexamethasone, for treating MM patients who have failed on at least two previous treatments and whose disease has progressed on the last therapy. Read More
British drugmaker GlaxoSmithKline must pay a fine of roughly $490 million and change its business practices in China after a Chinese court found the company guilty in a year-old bribery case. Read More
The U.S. Trade Representative’s Office has launched a review of India’s intellectual property regime that will focus in large part on pharmaceutical IP issues, including the country’s policy of providing access to affordable medicines. Read More
Australian doctors and academics are asking their colleagues worldwide to ban all meetings with pharmaceutical sales reps for a year in a bid to reduce concerns over inappropriately pushed medications. Read More
The FDA is turning up the heat on drugmakers who don’t pay their generic drug user fees, warning its tenth manufacturer since the summer for delinquent fees. Read More
The FDA issued a warning letter to injectables giant Hospira after an investigation of its Victoria, Australia, plant uncovered significant good manufacturing practice violations, including a failure to adequately investigate failed batches and determine levels of impurities in distributed products. Read More
Drugmakers Sagent and Baxter Healthcare recently recalled products due to labeling mix-ups, a common quality problem that one expert says can be easily solved through an additional examination by personnel. Read More
Endo International will acquire Auxilium Pharmaceuticals in a move that is expected to bolster Endo’s pipeline of testosterone products, which FDA advisors have recently scrutinized. Read More