Makary's new voucher program seeks 'most favored nation' pricing
The FDA on Tuesday opened up its new voucher program for submissions, explaining more of the details behind the first year of the pilot that will speed up drug reviews by ...
View ArticleApnimed's sleep apnea pill clears second Phase 3, setting up FDA filing
The first pill for obstructive sleep apnea is getting closer to market. Apnimed's AD109 has now passed the bar in its second Phase 3 study, the Cambridge, MA-based biotech said Wednesday morning. The...
View ArticleParker Institute, ARCH unveil CAR-T biotech with $216M to crack solid tumors
Solid tumors make up about 90% of cancer globally, but so far have faced little threat from cell therapies that have revolutionized treatments for blood cancers. A new startup that's operated quietly...
View ArticleAbivax shares up over 400% as ulcerative colitis drug scores two Phase 3 wins
Abivax soared on the Nasdaq Tuesday evening after the French biotech reported positive late-stage data from its inflammatory bowel disease drug candidate. The biotech’s miR-124 enhancer, dubbed...
View ArticleArrowhead’s multibillion-dollar deal with Sarepta is still in place;...
Plus, news about ANI, Genentech, Telix and Madrigal: Arrowhead’s partnership with Sarepta Therapeutics is business as usual: Amid the blistering pace of updates from Sarepta over the past week,...
View ArticleCDMOs beat earnings expectations as clients navigate funding cuts and tariffs
Three CDMOs unveiled their latest earnings reports on Wednesday – and they all seem to be singing the same tune. Lonza, Thermo Fisher and Samsung Biologics all noted revenue upticks in Q2 despite the...
View ArticleRFK Jr. adopts ACIP guidance to remove thimerosal from flu shots
The CDC now recommends that seasonal flu shots do not include thimerosal, a preservative that vaccine critics say is linked to autism, the HHS announced Wednesday. HHS Secretary Robert F. Kennedy Jr....
View ArticleRoche halts Elevidys shipments in six countries as Europe mulls approval
Roche has temporarily stopped shipping Elevidys to certain countries as of Wednesday morning. The Swiss pharma said Wednesday in a statement that it will pause new orders of Elevidys for ambulatory...
View ArticleNovo Nordisk loses Wegovy patent fight against generics maker Viatris
Novo Nordisk faced a setback in its bid to stave off Wegovy generics after a federal court held that Viatris’ proposed product doesn’t infringe a GLP-1-related patent. The ruling deals a ...
View ArticleFDA delays review date for GSK's multiple myeloma drug Blenrep
The FDA on Wednesday extended its review of GSK’s multiple myeloma drug Blenrep by three months as the company seeks a relaunch after it was pulled from the US almost three years ago. The agency' ...
View ArticlePolitical or professional? Makary's overhaul of CDER, CBER may reshape...
The FDA's replacement of top officials at its drugs and biologics centers may have far-reaching implications not just for current policy, but for how the agency is run in future years and under...
View ArticleAustralia-based life sciences VC firm nabs $287M for sixth fund
Brandon Capital, an Australian life sciences investor, has collected AUD 439 million (about $287 million) for the final close of its sixth fund. It's the largest batch of capital in the firm's nearly...
View ArticleStill in flux, Galapagos hires new execs, adjusts deal with Gilead, and...
Galapagos, the Belgian biotech that has gone great lengths to reshape itself in recent years, is overhauling its business once again. The drug developer said Wednesday that it added two executives ...
View ArticleFlagship’s Generate:Biomedicines and Tessera lay off employees
Generate:Biomedicines and Tessera Therapeutics, two massively funded darlings in the Flagship Pioneering ecosystem, have recently laid off employees, a spokesperson confirmed to Endpoints News....
View ArticleRoche looks at direct-to-patient sales in the US, drops preclinical obesity...
Roche is in talks with the US government about potentially offering certain drugs directly to patients in the US, sidestepping “middlemen” such as pharmacy benefit managers, CEO Thomas Schinecker said....
View ArticleTCG Labs Soleil gets another $400M for single-asset biotechs, expands to China
TCG Labs Soleil is firing on all cylinders, with the venture firm and biotech R&D operator doubling its initial pool of capital to $800 million and opening a Shanghai unit, it said Thursday...
View ArticleAstraZeneca’s self-administered myasthenia gravis drug clears Phase 3 trial
AstraZeneca on Thursday said its patient-administered drug candidate with blockbuster potential has passed a registrational test in the rare autoimmune disorder myasthenia gravis. The Phase 3 PREVAIL...
View ArticleNovo Nordisk to discontinue three insulin products; Thermo Fisher CFO to retire
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Novo Nordisk is discontinuing three of its insulin injections,...
View ArticleNovartis inks deal with covalent medicines biotech Matchpoint for $60M upfront
Novartis is teaming up with a private biotech that’s laid low in recent years on a preclinical platform for inflammation. The Swiss pharma is paying Matchpoint Therapeutics $60 million upfront for oral...
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