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Over the past month, Boehringer Ingelheim has sued five manufacturers seeking to produce generic versions of the company’s Gilotrif lung cancer treatment — most recently naming Sandoz and Sun Pharmaceutical. Read More
The system, which mirrors a similar EU program, is designed to foster reporting of side effects, which may not have shown up in clinical trials. Read More
The European Commission formally adopted updated regulations on good manufacturing practices for pharmaceuticals generally and for investigational drugs and clinical trials more specifically. Read More
UK regulators moved to block imports to the European Union from a generic drug manufacturer in India after reporting deficiencies in quality control, processing, laboratory testing and safeguards against contamination. Read More
Pennsylvania became the 38th state to pass a “right-to-try” law earlier this month, enacting legislation that aims to increase access by terminal patients to investigational therapies that have cleared Phase I clinical testing. Read More
The European Medicines Agency launched a new plan to streamline procedures for developing advanced gene and cell therapies, including adapting manufacturing requirements to products’ specific challenges. Read More