The European Medicines Agency’s pharmacovigilance panel made recommendations for updated label warnings for a variety of products. Source: Drug Industry Daily

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.…

A Texas drugmaker was flagged by the FDA for failing to follow up on a patient’s complaint. Source: Drug Industry Daily

The European Commission formally adopted updated regulations on good manufacturing practices for pharmaceuticals generally and for investigational drugs and clinical trials more specifically. Source: Drug Industry Daily

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.…

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…

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. Source: Drug Industry Daily

The FDA updated its staff manual on Chemistry, Manufacturing and Controls reviews of drug master files for packaging materials. Source: Drug Industry Daily

A group of Iraq War veterans and their families filed a lawsuit this week accusing several drugmakers of contributing to servicemembers’ deaths by indirectly funding militias in Iraq. Source: Drug…

The FDA published new product-specific draft guidances for 30 active ingredients — including cancer therapies, asthma treatments, epinephrine auto-injectors and anti-infectives — outlining the agency’s preferred methods for supporting ANDA…