A New Direction For Alzheimer’s R&D: FDA Outlines Early Disease Pathway
Alzheimer’s R&D has suffered multiple failures over the last decade, with no drug found to slow or halt the underlying progression of the disease. Industry’s focus is now on patients at the very earliest stages of the disease, and FDA is meeting sponsors halfway, with a draft guidance outlining approval requirements.
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In addition to a spate of FDA approvals closing out the year, Roche contended with trial failures and Actavis received a “complete response” letter for its nebivolol/valsartan combination.
Alzheimer’s R&D In Brief: Roche’s Crenezumab Misses Endpoints, Novartis Plans Large New Genetic Study
In data presented at the Alzheimer's Association International Conference in Copenhagen, held July 12-17, Roche’s anti-amyloid beta antibody misses endpoints in two Phase II studies, but there were some promising signs of efficacy.
Alzheimer’s disease science is in disarray and the risk associated with developing disease-modifying agents has driven many players from the field. But venturesome biotechs are finding backers to support efforts to look for a way forward: we profile Alzheon Inc., Neurotrack Inc., Rodin Therapeutics Inc., and Tetra Discovery Partners LLC.