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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
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 European Medicines Agency (EMA) has launched a new pilot program intended to speed new therapies to patients via a process that authorizes products for use by targeted populations in stages. Read More
Japanese drugmakers Astellas Pharma and Daiichi Sankyo are planning to form the first-ever large-scale compound library, through which they plan to share 400,000 compounds. Read More
Manufacturers of stem cell and cell-based products (SCCPs) should perform stability tests during early phases of clinical trials to establish the products are sufficiently stable for the period required by the study, a draft guidance by India’s Central Drugs Standard Control Organization advises. Read More
The studies evaluated the humanized monoclonal antibody in patients with severe eosinophilic asthma who continued to have exacerbations on current medication. Read More