The FDA has announced its decision to grant a de novo application submitted by 23andMe for the company’s direct-to-consumer (DTC) Personal Genome Service Genetic Health Risk (“GHR") tests. The GHR test panel currently includes genetic variants…By: DLA Piper http://www.jdsupra.com/legalnews/fda-authorizes-first-direct-to-consumer-40610/
Genentech, Roche’s biotech group, has announced its plans to conduct a second Phase 3 study for crenezumab, its anti-Abeta antibody for the treatment of early Alzheimer’s disease.
The trial is designed to further elucidate earlier traces data on the drug’s efficacy in treating Alzheimer’s; crenezumab failed to meet its primary endpoint of slowing cognitive degeneration in mild-to-moderate forms of the disease in two 2014 Phase 2 studies, but did show promise as a treatment in the earliest stages.
read more http://www.pharmafile.com/news/513609/genentech-plans-second-phase-3-alzheimers-trial-following-endpoint-failures
antibody in rare condition PSP, for which FDA has awarded
fast-track designation http://www.pmlive.com/pharma_news/abbvie_takes_anti-tau_drug_into_phase_ii_for_alzheimers_1185122
INDIANAPOLIS, Dec. 9, 2016 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and AstraZeneca announced a worldwide agreement to co-develop MEDI1814, an antibody selective for amyloid-beta 42 (Aβ42), which is currently in Phase 1 trials as a potential disease-modifying treatment for… http://www.prnewswire.com/news-releases/lilly-and-astrazeneca-to-develop-second-potentially-disease-modifying-treatment-for-alzheimers-disease-300375924.html
(MedPage Today) — Small study shows heart function affected, too http://www.medpagetoday.com/Cardiology/CHF/61708
NewsAlzheimer’s disease is a neurodegenerative disorder for which, despite years of research, there are no effective treatments or cures.Contributed Author: Cornell UniversityTopics: Disease Research http://www.dddmag.com/news/2016/11/study-challenges-model-alzheimers-disease-progression
ArticleThe findings suggest that this therapy would be most effective in the early stages of disease.Staff Author: Ryan BusheyTopics: Biotech http://www.dddmag.com/article/2016/10/gene-therapy-shows-early-signs-preventing-alzheimers-disease