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A European Medicines Agency working group is recommending revisions to a guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins to account for differences between large complex and small, simple-structured proteins and other critical issues. Read More
The FDA needs to hold more pre-submission meetings with generic drugmakers on topics such as stability, batch size and drug release specifications to speed up the ANDA approval process, industry representatives say. Read More
Unlike in the EU, Swiss regulators will not accept marketing authorization applications for biosimilars of low-molecular-weight heparin products already approved in Switzerland. 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
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
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
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