UCB and Amgen have ended patient testing of romosozumab, for accelerated healing of bone fractures. UCB cited recent and stricter regulations for approval of drugs in the area. Citibank Analyst Yaron Weber saw the decision as motivated “by lack of efficacy in a one-year study with patients with fractures of the tibia,” in addition to heightened approval standards. Regulatory bodies would now require two late-stage patient studies for each fracture site, and mandate that they follow patients for two years. Werber noted that increased development costs are not worthy of the “relatively small market opportunity,” suggesting that the companies' move was based more on business than science considerations.
Five days after the FDA issued a rejection of Novo Nordisk's new long-acting insulin, the Danish drug maker received approval for Tresiba in Japanese markets. Novo will launch commercially shortly after the drug hits Japan's National Health Insurance price list on February 22nd.
DiabeticConnect.com topped comScore's list of top diabetes sites by unique monthly visitors, with 1.4 million unique visitors for January. Diabetes.org, the American Diabetes Association website, was the runner-up.