Dive Brief: Amazon has expanded its generic drug savings program to Prime members on Medicare, throwing open the program’s doors to a major population of medication users — if Amazon is able to get them to sign up. The subscription service, called RxPass, is now available to more than 50 million Medicare members in 46…
Dive Brief: Twice-yearly shots of a Gilead Sciences HIV drug were so effective at preventing infections in a large late-stage clinical trial that study monitors recommend the company stop testing early and offer the drug to all participants. The trial, called Purpose 1 and run in South Africa and Uganda, compared Gilead’s medicine lenacapavir to…
Dive Brief: PTC Therapeutics said Thursday it can resume a Phase 2 trial of its Huntington’s disease drug in the U.S., following the Food and Drug Administration’s review of data showing the pill reduced a mutant protein linked to the disorder. The drug, called PTC518, suppressed levels of huntingtin protein in both the blood and…
Today, a brief rundown of news from Jazz Pharma, Vanda Pharmaceuticals, ITM, Ashibio and Novartis that you might have missed from earlier in the week. An experimental medicine that Jazz Pharmaceuticals picked up in 2019 has failed a mid-stage study testing it against essential tremor. Researchers evaluated three doses of the medicine in 420 participants….
Peter Marks is again at the center of a controversial Food and Drug Administration decision on a gene therapy for Duchenne muscular dystrophy. Twice now, the high-ranking FDA leader has pushed aside objections from agency reviewers to grant an approval to Sarepta Therapeutics’ treatment for the muscle-wasting condition. On Thursday, the FDA substantially broadened use…
An experimental weight loss shot developed by Denmark-based Zealand Pharma helped people with obesity lose as much as 9% of their body weight over four months, results the company said support further research on a medicine it hopes could compete with drugs from Novo Nordisk and Eli Lilly. The shot, called petrelintide, is part of…
The Food and Drug Administration has substantially loosened limits on the first gene therapy for Duchenne muscular dystrophy in a decision that could greatly expand its use even as questions remain about its effectiveness. The agency on Thursday made the therapy, called Elevidys and sold by biotechnology company Sarepta Therapeutics, available to people with Duchenne…
Today, a brief rundown of news from Belharra Therapeutics, AstraZeneca, Regenxbio and Tasyha Gene Therapies. Sanofi will work with biotechnology startup Belharra Therapeutics to develop small molecule drugs for inflammatory diseases, the companies announced Tuesday. Belharra will get $40 million in upfront and near-term payments to start the deal, through which it will use what…
Dive Brief: Intra-Cellular Therapies plans to seek clearance to sell its medicine Caplyta for patients with depression after a second-late stage study of the drug succeeded. Caplyta, also known as lumateperone, is currently approved for patients suffering from schizophrenia and depressive episodes associated with bipolar disorder. Intra-Cellular now wants to add major depressive disorder to…
Dive Brief: The Food and Drug Administration on Monday approved a new vaccine from Merck & Co. that protects against 21 types of the bacteria that causes pneumococcal disease. The vaccine, cleared for use in adults 18 and older, will be sold by Merck as Capvaxive. Pneumococcal disease can lead to severe infection in the…
