FDAnews Drug Daily Bulletin
Oct. 10, 2012 | Vol. 9 No. 199
Eli Lilly’s Alzheimer’s disease candidate solanezumab may offer potential as a treatment for milder forms of the disease, new detailed data reveal, but the company’s prospects are still flimsy, with odds of failure potentially exceeding more than 50 percent, one analyst says.
Drug sponsors may be able to avoid establishing in vivo bioequivalence as part of safety and efficacy data requirements in situations where in vitro data provides a reasonable estimate of the relative in vivo performance of the two products, according to a new Health Canada draft guidance.
Novo Nordisk has discontinued development of one of its four hemophilia drug candidates following data from a Phase IIIa trial that found anti-drug antibodies and further potential risks for hemophilia patients with inhibitors.
J&J applied for U.S. and European regulatory approval of a new manufacturing process that would provide a short-term fix to the supply shortage of the cancer drug Doxil.
It was a few old boxes of medicine in the back of a pharmacy that got Lee Cantrell thinking.
Scientists are sifting through massive quantities of freely available data scattered across the internet, aiming to catch potentially deadly problems with prescription drugs more quickly — even ahead of federal regulators.
Scientists have been trying for a long time to deliver vaccines without needles.
NuPathe said it would cut half of its workforce to reduce costs and focus on the regulatory approval of its experimental migraine patch.
Cannabis seems to ease the painful muscle stiffness typical of multiple sclerosis, indicate Phase III trial results, published in the Journal of Neurology Neurosurgery and Psychiatry.
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