Headlines:
“Novartis wins speedy U.S. review of new leukemia drug,” Reuters
“A new leukemia treatment from Novartis for children and young adults will get priority review from the U.S. Food and Drug Administration (FDA), putting the Swiss drugmaker ahead of rivals working on similar cancer therapies. The FDA’s announcement late Wednesday means the regulator plans to take action within six months on Novartis’s so-called chimeric antigen receptor T cell therapy, or CAR-T, in partnership with University of Pennsylvania researchers…”
“F.D.A. Will Allow 23andMe to Sell Genetic Tests for Disease Risk to Consumers,” The New York Times
“For the first time, the Food and Drug Administration said it would allow a company to sell genetic tests for disease risk directly to consumers, providing people with information about the likelihood that they could develop various conditions, including Parkinson’s and Alzheimer’s…”
“Kite completes FDA CAR-T filing, posts improved data,” Fierce Biotech
“Kite Pharma completed an FDA submission for its CAR-T therapy hours before its self-imposed target passed. Finishing the application on Friday meant Kite met its goal of filing in the first quarter, and put it days behind Novartis in the race to bring a CAR-T therapy to market…”
“Plan to Cut Funding for Biomedical Research Hits Opposition in Congress,” The New York Times
“A proposal by President Trump to cut federal spending for biomedical research by 18 percent — just months after Congress approved bipartisan legislation to increase such spending — has run into a buzz saw on Capitol Hill, with Republicans and Democrats calling it misguided…”
“For Bristol-Myers, A Victory And A Mystery,” Forbes
“New data presented at a medical conference show that combining Bristol-Myers Squibb’s two immune-boosting cancer drug appears to extend the lives of melanoma patients longer than using either alone. But a big question lingers about one of the drugs, Opdivo: why did it fail to extend survival in patients with previously untreated non-small cell lung cancer, when a very similar drug from Merck proved effective? A trial being presentd this afternoon may yield some clues. Both studies are being presented at the annual meeting of the American Association for Cancer Research…”
“Teva wins FDA approval for Huntington’s drug,” Reuters
“Israel-based Teva Pharmaceutical Industries Ltd said the U.S. Food and Drug Administration had approved its drug to treat chorea stemming from Huntington’s disease, a fatal degenerative disorder. Chorea is an abnormal, involuntary writhing movements disorder that occur in 90 percent of Huntington’s disease patients at some point in the course of their illness…”
