Wave strengthens case for accelerated approval, with more positive Duchenne data
Wave Life Sciences shared updated results from a Phase 2 trial of its exon-skipping oligonucleotide candidate in Duchenne muscular dystrophy, bolstering its plans to file for accelerated approval next...
View ArticleJ&J touts new survival data for lung cancer combo
Johnson & Johnson released new data suggesting its lung cancer combination Rybrevant and Lazcluze beat AstraZeneca’s Tagrisso on overall survival. In a Phase 3 trial, 56% of patients who took...
View ArticleWhy did radiopharma biotech Actinium hold an investor event at Mar-a-Lago?
Plenty of companies and CEOs have made the pilgrimage to Donald Trump's Mar-a-Lago resort to meet with the president. But small-cap biotech Actinium Pharmaceuticals is one of the few to hold a public...
View ArticleExelixis’ cancer drug wins approval for neuroendocrine tumors
The FDA has approved Exelixis' cancer drug Cabometyx to treat advanced neuroendocrine tumors inside and outside of the pancreas, marking two new indications for the company’s primary source of revenue....
View ArticleFDA critiques 'misleading' Taiho promotion of bile duct cancer drug
The FDA is taking issue with a promotional website from Taiho Oncology, alleging it misleadingly describes the benefits of its bile duct cancer drug Lytgobi, which won accelerated approval in 2022. The
View ArticleFDA approves Soleno’s rare disease drug for Prader-Willi syndrome
The FDA on Wednesday approved Soleno Therapeutics' new drug designed to treat the worst symptom of a debilitating rare disease known as Prader-Willi syndrome. Regulators approved diazoxide choline...
View ArticleAlcon takes majority stake in Aurion, changes CEOs
Eye giant Alcon said Wednesday it acquired a majority stake in cell therapy startup Aurion and replaced CEO Greg Kunst, the latest twist in a struggle for power between the two companies. The...
View ArticleGalatea Bio gets $25M to map genetic diversity of 10 million people, help...
A Miami startup looking to sequence the genetic diversity of 10 million people this decade has pulled in $25 million in total funding. Galatea Bio wants to create a global biobank that can be used ...
View ArticleCandel to focus on non-squamous lung cancer following new survival data
Candel Therapeutics said Wednesday that new data on its viral immunotherapy showed only a marginal improvement in survival of progressive lung cancer patients compared with an earlier cut from the same...
View ArticleAI scribes reduce burnout, but financial returns unclear — report
Despite cutting down on burnout, AI scribes have yet to clearly prove they save clinicians time and show financial returns, a new report found. For the report, the Peterson Health Technology Institute...
View ArticleMiga Health co-founder shares why he turned down new funding
Last year, Miga Health, a virtual cardiovascular care company, told investors it wasn't going to raise more money and would stop running a central part of its business, transitioning its thousands of...
View ArticleHHS plans to cut 10,000 more staffers in major downsizing
The Department of Health and Human Services on Thursday announced major plans to downsize the department as part of a major reorganization built around Secretary Robert F. Kennedy Jr.'s "Make America...
View ArticleNkarta to lay off 34% of staff; Savara’s debt financing deal
Plus, news about Bicycle Therapeutics, Kelso Pharma, Arbutus Biopharma, Ascletis Pharma, Alvotech and Xbrane: Nkarta axes 34% of staff: The cell therapy maker said the layoffs of 53 workers would help ...
View ArticleWhat happened to Miga Health
My latest story is one I don’t get the chance to write often — maybe ever. When I first heard some murmurs that Miga Health, a virtual cardiovascular care company, had stopped taking patients, I...
View ArticleEquillium says graft-versus-host drug fails Phase 3, stock dives
A penny stock biotech reported that its acute graft-versus-host disease drug failed a late-stage trial, but it still plans to seek accelerated approval. Equillium said Thursday that itolizumab did not...
View ArticleChiesi pours €430 into new Italy site; Bharat’s first CGT site in India
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Chiesi is investing €430 million ($358 million) over the next five...
View ArticleNew pharma tariffs could put generic drugmakers under pressure
President Donald Trump’s threatened tariffs on pharmaceuticals are incentivizing drugmakers to build more manufacturing capacity in the US. But makers of generics likely won’t have the resources to...
View ArticleExclusive: Metsera CEO on what it takes to build an obesity biotech in 2025
Metsera, one of the few biotechs to complete an IPO this year, is making its best effort to catch up to the obesity drug giants: Eli Lilly and Novo Nordisk. The startup landed a ...
View ArticleMerck details injectable Keytruda data as it awaits FDA decision
Merck shared Phase 3 data showing that an injectable version of its blockbuster cancer drug Keytruda is comparable to the approved intravenous infusion in lung cancer patients. And it said it' ...
View ArticleFDA’s policy, communications staff likely to be among agency’s 3,500 staff cuts
HHS’ plans to eliminate almost 20% of the FDA’s staff will likely take a major toll on policy, communications and other administrative staff at the agency, according to agency veterans and other...
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