Axsome reports Phase 3 win for Sunosi in adults with ADHD
Axsome Therapeutics said the lower dose of its sleep disorder drug Sunosi met the primary endpoint in a late-stage test of adults with ADHD. But Wall Street analysts noted that less impressive results...
View ArticleCalculating healthcare's real costs
As you probably know by now, my ears perk up when I hear of a new way to vet the claims health tech companies make. So when Lantern released a
View ArticleIllumina adds activist investor to board, taps ex-FDA head as chair
Illumina on Tuesday added activist investor Keith Meister to its board and named director Scott Gottlieb, a former FDA commissioner, as board chair. The DNA sequencing company's stock has fallen about...
View ArticleDOGE reverses three FDA lease closures on its 'Wall of Receipts'
Elon Musk's Department of Government Efficiency has reversed its termination of three of 30 FDA site leases over the past month, including a 52,000 square-foot St. Louis-based lab that operates under...
View ArticleRevvity wins $37.8M contract to screen UK newborns for rare diseases
Diagnostics company Revvity will sequence the DNA of newborns to help identify rare genetic conditions as part of Genomic England's efforts to bolster early disease detection. Last year, Genomics...
View ArticleSenate committee backs Dr. Oz for CMS nomination
Mehmet Oz’s nomination to lead CMS will advance to the full Senate after clearing the Finance Committee on Tuesday. The committee voted 14 to 13 in Oz’s favor. Oz faced a roughly three-hour
View ArticleEisai cuts Leqembi 2027 sales projections by half
Eisai has slashed 2027 sales projections for its Biogen-partnered Alzheimer’s treatment Leqembi by roughly half. The Japanese drugmaker said it expects annual Leqembi sales to reach $1.7 billion to...
View ArticleLyndra Therapeutics to shut down after funding challenges
A company that sought to make long-acting forms of commonly used drugs, with backing from some of the biggest names in biotech, will shut down after running short on money to advance its pipeline. ...
View ArticleBhattacharya is confirmed by Senate as NIH chief
Stanford researcher Jay Bhattacharya has been confirmed as the new head of the NIH, taking over the once-stable science agency that’s at the center of the new administration’s sweeping cost-cutting...
View ArticleSenate confirms Marty Makary as 27th FDA commissioner
The Senate on Tuesday voted 56-44 to confirm Johns Hopkins researcher Marty Makary as FDA commissioner, putting him in charge of the agency amid ongoing staffing cuts and a broader Trump administration...
View ArticleTrump tariffs would increase biopharma costs — industry survey
The Trump administration's threatened tariffs on Europe would be painful for the biotech industry, according to data from a survey conducted by the industry's main lobbying group. Of every company...
View ArticleEpicrispr raises $68M, will start clinical trial of epigenetic editing for FSHD
Decades ago, Amber Salzman remembers feeling like there was nothing she could do to help her cousin-in-law with a progressive muscle disease called facioscapulohumeral muscular dystrophy, or FSHD. She...
View ArticleEndpoints Slack interview: Duke's Chatterjee on AI bio, NIH cuts
The Endpoints News Slack chat is back for 2025, and we're starting with a 32-year-old computational biology professor who isn’t afraid to share a hot take or two. Pranam Chatterjee opened his Duke...
View ArticleHumacyte to raise $50M; Acrivon to focus on prexasertib in endometrial cancer
Plus, news about Tribune Therapeutics and Leap Therapeutics: Humacyte’s $50M offering: The North Carolina biotech is selling 25 million shares at $2.00 apiece, which is nearly 30% lower than its...
View ArticleElevateBio trims workforce by 17%
One of the biotech industry's most well-funded cell and gene therapy companies has laid off employees for the third year in a row. ElevateBio, which raised biotech's largest private funding round in ...
View ArticleWave 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
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