Wave, with new data, plots path forward for Huntington’s drug
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…
Novo to spend $4B on US plant, adding to obesity drug production push
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…
Exsilio debuts with $82M, pitching a ‘leap’ forward for genetic medicine
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…
Obesity drugs from Altimmune, Hengrui show potential; Lilly details Zepbound sleep apnea data
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,…
Bridging science and humanity: Systems thinking in clinical trial design
Diseases aren’t just disorders in physiological systems, and it’s not possible to cure them simply by discovering molecules with therapeutic effects on cellular targets. Instead, as research from the National Institutes of Health (NIH) reminds us, diseases affect individuals who…
Amazon expands drug subscription program to Medicare members
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…
Twice-yearly shots of Gilead HIV drug effective in large prevention study
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,…
FDA lifts hold on PTC Huntington’s disease trial
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…
Jazz drug for tremor fails study; Radiopharma drug developer ITM swaps CEOs
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…
Duchenne approval exposes FDA rift over Sarepta gene therapy
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…