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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phases of clinical trials to establish the products are sufficiently stable for the period required by the study, a draft guidance by India’s Central Drugs Standard Control Organization advises.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
Bayer and Onyx’s drug Nexavar joins a growing list of drug candidates targeting liver cancer that have failed in Phase III. The drugmakers revealed Tuesday the product did not meet its primary endpoint. Read More
The partnership will bring together researchers to discover and develop new drugs for autoimmune diseases currently treated with small-molecule biologics. Read More
Beginning with the 2015/2016 flu season, drugmakers producing vaccines in the EU to protect against annual flu strains will not need to conduct preapproval clinical studies to support vaccine applications. Read More
The Scottish Medicines Consortium plans to launch a new initiative on patient-centered research, giving patient groups and clinicians a stronger voice in how drugs for life-threatening and rare diseases are developed and approved. Read More
Sponsors of new drugs and biologics for chronic pain may have to submit more safety data than they would to support acute pain candidates, an FDA draft guidance says. Read More
Sponsors should gather supportive data from two definitive clinical trials to establish efficacy for drugs proposed to treat chronic fatigue syndrome/myalgic encephalomyelitis, the FDA says. Read More