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Organizations conducting clinical trials will no longer have to submit routine GCP compliance reports that have been used to establish inspections with the UK’s Medicines and Healthcare products Regulatory Agency. Read More
French drug giant Sanofi will terminate its licensing agreement with Auvi-Q developer kaléo later this year, returning U.S. and Canadian rights to the epinephrine injection to the company. Read More
The FDA and Amarin get another month to settle their differences over the drugmaker’s efforts to promote its cholesterol drug Vascepa off-label. Read More
In a case with broad implications for medical patent protection, the U.S. Supreme Court showed little enthusiasm for lowering a strict appellate standard for enhanced damages during oral arguments Tuesday. Read More
The FDA is urging two Florida compounders to reassess their operations after finding significant issues with GMPs and sterile drug practices during inspections. Read More
The FDA has delivered PTC Therapeutics a stinging rebuke, sending the company a refuse to file letter for Translarna, its candidate for the treatment of nonsense mutation Duchenne muscular dystrophy. Read More