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The Centers for Medicare & Medicaid Services (CMS) has backed away from its controversial plan that would have removed protected status for antidepressants and immunosuppressants in formularies under Medicare Part D. Read More
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
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
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
An EU panel of drug reviewers Friday urged approval of Boehringer Ingelheim and Eli Lilly’s diabetes drug empagliflozin, lauding the candidate just two weeks after the FDA turned it down. Read More
The FDA has granted a breakthrough therapy designation to Pfizer’s investigational bivalent rLP2086 meningococcal B vaccine, the drug giant said Thursday. Read More