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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
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
The goal of the ICMRA would not be to develop identical standards, but to provide the public with “high-level, strategic advocacy” around quality, Hamburg said at a recent conference in London hosted by the UK’s Medicines and Healthcare products Regulatory Agency. Read More
University of Iowa Pharmaceuticals, a contract manufacturer affiliated with the school, received a Form 483 for deficient training materials and poor investigations into quality issues. Read More
The FDA March 12 banned imports to the U.S. from two more Indian manufacturers, ratcheting up the pressure on the country’s domestic drugmakers to improve product quality. Read More
The FDA, working through the International Society for Pharmaceutical Engineering (ISPE), is launching a one-year pilot program examining the feasibility of collecting manufacturers’ quality metrics, a pivotal piece of the agency’s evolving risk-based inspection program. Read More