Dive Brief: Wave Life Sciences on Tuesday said it will meet with regulators to discuss what kind of evidence would be needed to support an accelerated approval application for an experimental drug it’s developing for Huntington’s disease. The biotechnology company shared its plans alongside results from a placebo-controlled clinical trial testing the drug, dubbed WVE-003….
Dive Brief: Novo Nordisk will spend $4.1 billion to build a new U.S. factory in North Carolina, the latest multibillion-dollar investment by the Danish drugmaker to expand production of its fast-selling weight loss and diabetes drugs Wegovy and Ozempic. Funding for the planned factory, announced Tuesday, comes as Novo plans to allocate $6.8 billion towards…
Exsilio Therapeutics, a biotechnology startup led by a former Moderna executive, emerged from stealth Tuesday with an approach it claims can solve some of the shortcomings of genetic medicines. The Boston-based company is debuting with $82 million from a group of investors that include Novartis’ venture arm and the gene editing biotech CRISPR Therapeutics. It’s…
Today, a brief rundown of news from Altimmune, Jiangsu Hengrui, Eli Lilly and others that you might have missed from over the weekend, when the American Diabetes Association held its annual meeting. After an early setback for Altimmune’s obesity shot pemvidutide, the biotechnology company appears to be back on track with additional data. The dual-acting drug,…
An experimental medicine helped people with a deadly heart disease stay out of the hospital and live longer in a closely watched clinical trial, a finding that could pave the way for a regulatory approval and help its developer, Alnylam Pharmaceuticals, rebound from a significant setback. Trial data released Monday showed trial participants with the…
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…
