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The European Medicines Agency is pairing up with various governments’ policy review boards to streamline consultations with drug companies following a successful test run of the effort. Read More
Johnson & Johnson and Novartis each scored a victory in the UK, with the National Institute for Health and Care Excellence backing their respective treatments for prostate cancer and heart failure. Read More
Spain’s Agency of Medicines and Medical Devices has suspended the manufacturing authorization for finished processing of Madrid-based Inmunotek over GMP deficiencies. Read More
The World Health Organization is calling for stricter enforcement of private vaccine management regulations in China to mirror the tight controls the country has over its public vaccine distribution system. Read More
In the latest of a string of manufacturing snafus plaguing Indian drugmakers, the French National Agency for Medicines and Health Products Safety is calling for the withdrawal of Anuh Pharma’s GMP certificate. Read More
European regulators have signed off on Teva Pharmaceutical Industries’ planned $40.5 billion purchase of Allergan’s generics unit, provided the company sells off numerous overlapping product areas to address anti-competitive concerns. Read More
Comments to the European Commission on proposed changes to orphan drug policy show much agreement on the need for change, but little agreement on how to make those changes. Read More
France’s National Agency for Medicines and Health Products Safety has ordered vaccine maker Theravectys to halt production at its Villejuif plant for seven months after finding numerous GMP deficiencies. Read More
To provide a more unified approach in evaluating biosimilars, India’s Central Drugs Standard Control Organization is requiring sponsors to conduct equivalence, non-inferiority or comparability Phase 3 clinical trials. Read More
The European Medicines Agency is recommending that sponsors use clinical trial information from adults to support the development of therapies for children. Read More