Merck ends two Phase 3 studies of Keytruda, including an early-stage...
Merck said Thursday morning it is discontinuing two Phase 3 trials of Keytruda, the world’s top-selling medicine, after independent data monitoring committees determined they weren’t going to succeed....
View ArticleJ&J heads to FDA for Vyvgart competitor; Tokyo conglomerate launches venture...
Johnson & Johnson submits FDA application for Vyvgart competitor: The pharma company is seeking approval of nipocalimab in the autoimmune disease generalized myasthenia gravis, where argenx’s...
View ArticleRecursion nears ‘moment of truth’ with first key data, kicking off 18-month...
After years of talking up artificial intelligence’s potential to help make drugs, Recursion will finally bring data to the table — and lots of it. Sometime next month, the Salt Lake City-based biotech...
View ArticleAhead of acquisition by Novo Holdings, are Catalent’s dark days behind it?
In the months leading up to its pending acquisition by Novo Holdings, Catalent has meaningfully boosted its revenue for the first time in over a year, making headway while other contract manufacturers...
View ArticleAfrigen, CEPI to speed up mRNA vaccine manufacturing; Bora Pharma invests in...
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. The Coalition for Epidemic Preparedness Innovations (CEPI) is...
View ArticleFDA hints at what Chevron's elimination means in new SCOTUS filing
Earlier this summer, when the Supreme Court eliminated a longstanding legal doctrine that deferred to federal agencies on interpreting federal law, many legal observers said the move could spell the...
View ArticlePennsylvania judge sides with drugmakers on first steps for growing GLP-1...
A Pennsylvania federal judge has agreed to prioritize two main arguments at issue in a growing number of lawsuits over the alleged side effects of GLP-1s, a legal decision that developers of the drugs...
View ArticleFDA’s drug evaluation wing launches new AI oversight panel
The FDA is hoping that rapidly-advancing artificial intelligence capabilities will not pass it by. The agency’s Center for Drug Evaluation and Research (CDER) has launched its own AI Council, according...
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Updated: Alnylam’s new Phase 3 ATTR data bring uncertainty to standard of...
Alnylam Pharmaceuticals is continuing to make its case for vutrisiran to become the drug of choice for a heart muscle disease, and while the company reported positive results at a major medical meeting...
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J&J's human resources leader to retire; Amgen becomes the newest pharma with...
Kristen Mulholland → Kristen Mulholland will take over for the retiring Peter Fasolo as chief human resources officer at J&J on Oct. 1. “Peter has led J&J’s talent strategy for the past 16...
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NuCana stops Phase 2 as chemotherapy derivative 'unlikely' to meet primary...
Chemotherapy biotech NuCana’s stock $NCNA tanked nearly 50% in premarket trading Friday following a Thursday announcement that it had stopped a Phase 2 trial due to disappointing data. The company said...
View ArticleNovo offers detailed look at semaglutide’s cardiac outcomes in Phase 3 trial...
LONDON — After a recent spate of setbacks, Novo Nordisk has raised the curtain on data detailing semaglutide’s ability to cut the risk of heart failure and cardiovascular death in a late-phase test of...
View ArticleJacobio's China rights deal; Reneuron off the London exchange
Stem cell biotech Reneuron Group leaves the London Stock Exchange’s AIM: The company plans to stop trading on the exchange amid financial struggles, as it continues to look for investors. Reneuron...
View ArticleMerck opens London lab as it makes push into immunology and the UK
Merck has opened the doors to a new lab in London, part of the US drugmaker’s plans to grow its footprint in the UK and leverage its scientific expertise as it works to refill its pipeline. Merck, also...
View ArticleFDA approves Emergent vaccine for mpox as company plans to donate 50,000 doses
Emergent BioSolutions scored an expanded FDA approval for its single-dose vaccine, ACAM2000, to now include the prevention of mpox disease in people at high risk for an infection of the virus. The...
View ArticleIpsen sells priority review voucher for highest price since 2016
Ipsen Pharmaceuticals sold its priority review voucher to an unidentified “large global pharmaceutical company” for $158 million, it said this week, the highest publicly announced price for one of the...
View ArticleBiosecure vote slated for September
The House is planning to vote on the closely-watched Biosecure Act at the start of next month, the latest progression in efforts to rein in the influence of key China-based drug manufacturers. The...
View ArticleNovo Nordisk reveals post-hoc cardiovascular data for semaglutide
Novo Nordisk bolstered its heart disease data for semaglutide on Friday with additional analyses from a handful of trials. In a pooled analysis of certain heart failure patients from four studies,...
View ArticleFDA authorizes Novavax's updated Covid booster
The FDA has authorized emergency use of Novavax’s updated Covid booster, just over a week after clearing updated versions of mRNA boosters from Pfizer and Moderna. Novavax’s shot is the only...
View ArticleFDA authorizes Novavax Covid booster; Recursion nears key data readouts;...
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...
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