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Before wasting time and money on a clinical trial, sponsors should determine whether additional preclinical studies are needed to rule out a drug candidate’s potential for endocrine-related adverse effects, the FDA says. Read More
The European Medicines Agency is seeking feedback on the International Conference on Harmonization’s revised E6 guideline, which adds new recommendations for sponsors on developing risk-based quality management systems for clinical trials. Read More
The China State Council is calling for sweeping reforms of the country’s drug regulatory system, including accelerated approvals of novel drugs, specified timelines for deciding applications and increased public access to applications and information. Read More
The FDA on Friday approved Wellstat Therapeutics’s Xuriden to treat a rare metabolic disorder known as hereditary orotic aciduria, landing the company a rare pediatric disease priority review voucher. Read More
Yet another Indian drugmaker has been dinged for serious data integrity and GMP issues — this time during a June 4 to 7 inspection by the World Health Organization. Read More
GlaxoSmithKline is recalling more than 427,000 tubes of mupirocin calcium 2% creams and ointments in various sizes due to penicillin cross contamination and the presence of particulates. Read More
The FDA has granted breakthrough therapy designation to Roche’s investigational ACE910 for the prophylactic treatment of patients 12 years and older with hemophilia A with factor VIII inhibitors. Read More
The FDA has delayed by three months its decision on Alexion Pharmaceuticals‘s metabolic disorder drug Kanuma to review new chemical manufacturing and controls information. Read More