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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phases of clinical trials to establish the products are sufficiently stable for the period required by the study, a draft guidance by India’s Central Drugs Standard Control Organization advises.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
The FDA has placed clinical trials for California-based biotech Geron’s blood cancer candidate, imetelstat, on hold after liver abnormalities were found in study subjects. Read More
The drugmaker says this is the first randomized trial of an angiogenic agent in combination with a vascular disrupting agent, but no chemotherapy. Read More