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GPhA is putting forward a compromise naming scheme for biosimilars that it hopes will quell the dispute over how to assign international nonproprietary names (INN) to follow-on biologics. Read More
The European Medicines Agency (EMA) on Mar. 11 launched its latest transparency effort, publishing the first of many summaries of drugmakers’ risk management plans (RMP) that it plans to make available throughout 2014. Read More
PhRMA is seeking substantial changes to the FDA’s proposed generic drug safety labeling rule, saying the agency should pre-approve all safety labeling changes for drugs with more than one manufacturer. Read More
FDA plans to crack down on generic drugmakers initiating patent litigation early by sending premature Paragraph IV certification notices to innovators, though it’s not yet clear what actions the agency intends to take. Read More
The database is part of the directorate’s anti-counterfeiting efforts and comes at a time of heightened concern over trafficking of illegal and falsified medicines. Read More
The EU’s primary biotech lobbying group is pushing back against same-name biosimilars, arguing that physicians would find such a system confusing. Read More
Influenza vaccine manufacturers in the EU must file strain variation applications for next year’s flu season with the European Medicines Agency (EMA) by June 16. Read More
Japanese regulators have approved Otsuka Pharmaceutical’s Samsca to treat autosomal dominant polycystic kidney disease, or ADPKD — an expanded indication that the FDA rejected last year. Read More
Labeling on drugs and biologics approved under the FDA’s accelerated approval pathway should clearly state that the product was approved based on limited data so that healthcare providers are acutely aware of the product’s potential limitations, the agency says. Read More
EU drug regulators Friday recommended Endocyte’s vintafolide for approval as an ovarian cancer treatment, providing the drugmaker with a major milestone in its attempt to market its first product. Read More
Forest Laboratories and Gedeon Richter on Friday touted positive topline results from a mid-stage trial of their investigational antipsychotic cariprazine to treat major depressive disorder (MDD), renewing hope for the candidate recently rejected by the FDA in another indication. Read More