FDA approves Ionis’ treatment for a rare metabolic disorder
Ionis’ antisense oligonucleotide olezarsen is now the first approved treatment for familial chylomicronemia syndrome, a rare metabolic disorder that prevents the body from breaking down fats called...
View ArticleUpdated: Novo’s 23% weight loss with CagriSema falls short of high...
Novo Nordisk said its highly anticipated Phase 3 readout showed that CagriSema only managed 22.7% weight loss at 68 weeks, failing to hit the 25% benchmark the company, investors and analysts were...
View ArticleFlorida cancer biotech Syncromune raises $100M Series A
Syncromune, a biotech startup working on combination immunotherapies, has put together a $100 million Series A, the company told Endpoints News. The round was led by a new, undisclosed institutional...
View ArticleAadi starts from scratch as it sells assets, licenses ADCs and raises new funds
In a major reset to round off the year, Aadi Bioscience is divesting its only marketed product and in-licensing a trio of ADCs developed by WuXi Biologics and another Chinese biotech. Aadi has inked an...
View ArticleDaiichi Sankyo finds successor to late R&D exec; Versant, Novartis' kidney...
→ Yuki Abe will step in to replace the late Toshinori Agatsuma on Jan. 1 as head of the R&D division at Daiichi Sankyo and VP of its ...
View ArticleTracer Biotechnologies raises $10M, partners with AstraZeneca
Tracer Biotechnologies has raised a $10 million Series A round to advance its technology that's designed to monitor circulating tumor DNA in cancer patients over lengthy periods. The company uses...
View ArticleCommure's latest acquisition sends follow-up texts to patients
General Catalyst-backed Commure is buying another General Catalyst-backed startup that sends follow-up texts to patients. Commure, which was valued at over $6 billion after merging with General...
View ArticleIdorsia’s Tryvio deal delay; Galectin’s liver drug disappoints
Plus, news about Pyxis, Epitopea and Genevant: Idorsia’s deal for blood pressure drug hits snag: The Swiss company said negotiations with an unnamed party for
View ArticleApplied Therapeutics CEO steps down after rare disease drug rejection
Applied Therapeutics is making changes to its leadership less than a month after the FDA rejected its rare disease drug. Shoshana Shendelman is stepping down from her roles as CEO and chair of the...
View ArticleSofinnova outlines $550M fund after IPOs and M&A deals
Sofinnova Investments, one of the longest-standing biotech investment firms, has penciled in plans for a new $550 million fund, Endpoints News has learned. The Menlo Park, CA-based firm disclosed the...
View ArticleGSK's Zejula-Jemperli combo in ovarian cancer hits primary endpoint, misses...
GSK’s Zejula-Jemperli combo met its primary endpoint in a trial investigating the drugs in first-line advanced ovarian cancer, but missed on a key secondary endpoint. The company shared topline results...
View ArticleFDA approves Humacyte’s lab-grown blood vessels
Twenty years ago, Laura Niklason founded a company that sounded like something out of science fiction. The Duke University bioengineer and anesthesiologist was working in the budding field of...
View ArticleRhythm receives expanded approval for genetic obesity drug
Rhythm Pharmaceuticals received FDA approval to market its genetic obesity drug Imcivree for children as young as 2 years old. Friday's action will let the drug be used to treat excess body weight and...
View ArticleFDA's Califf predicts Ramaswamy-RFK battle over agency
FDA Commissioner Rob Califf has only a few weeks left before he steps down with the change in administrations. But he recently predicted that the next person to head the agency will face a ...
View ArticleAccelerated approval brings Pfizer's BRAF inhibitor to first-line patients
Pfizer scored an accelerated approval Friday to bring its BRAF inhibitor to first-line colorectal cancer patients. Braftovi was approved in combination with cetuximab, also known as Eli Lilly’s...
View ArticlePBM changes unlikely to join spending bill as shutdown looms
With the federal government staring down a midnight deadline that could lead to the furlough more than 40,000 staff at the Department of Health and Human Services, several significant healthcare...
View Article2024's biopharma winners and losers; CagriSema falls short; Merck swings...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
View ArticleVertex gets 'vanza triple' approval and Trikafta expansion
The FDA on Friday issued two simultaneous cystic fibrosis approvals for Vertex Pharmaceuticals but included high-level safety warnings for both. The first approval is for Vertex’s “vanza triple”...
View ArticleNovo Nordisk’s once-daily hemophilia drug Alhemo is approved
Novo Nordisk finally won US approval for its hemophilia drug Alhemo following the product’s rejection by the FDA last year. The once-daily shot may now be used to reduce the frequency of ...
View ArticleFDA approves Lilly weight loss drug Zepbound for sleep apnea
Eli Lilly’s weight loss juggernaut Zepbound has been approved in the US to treat sleep apnea, and the label expansion could open the door to Medicare coverage for the drug for the first time. ...
View Article