Biohaven stock sinks on three-month delay for neuro drug's FDA approval decision
Biohaven said late Wednesday that the FDA would be delaying the PDUFA date for its neurodegenerative disease therapy troriluzole and will also require an advisory committee meeting to review the drug....
View ArticleMerck KGaA Q1 earnings: Tariff surcharge for US customers will continue
Despite pausing a tariff surcharge for China-based clients, Merck KGaA will carry on with adding an extra charge for US customers to account for President Donald Trump’s levies. “What we're doing is we...
View ArticleExclusive: Datavant will acquire Aetion, double life sciences team
The health tech company Datavant is acquiring Aetion, a rival in the real-world data space, Endpoints News exclusively reports. Datavant on Thursday plans to announce the deal, which will double the...
View ArticleAbundant Venture Partners teams up with 17 health systems to develop tech
Seventeen health systems have signed up for a venture firm to help them vet which health tech companies to adopt and invest in, as more hospitals look towards a more concierge-style approach to...
View ArticleEmpower Pharmacy allegedly used low-quality ingredients, skirted rules
A company that calls itself the US’ “largest and most advanced” compounding pharmacy — and whose business has exploded thanks to demand for popular weight loss drugs — has used poor-quality...
View ArticleAGC Bio secures lentiviral contract; Thermo Fisher to make Cybin asset
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. AGC Biologics is partnering with Quell Therapeutics, the companies...
View ArticlePathos AI collects $365M to fuel data-driven oncology studies
Pathos AI, seeking to upend cancer drug development with artificial intelligence and large multimodal models, has raised the third-largest private funding round in biotech so far this year. In the...
View ArticleBristol Myers CEO says America’s biopharma pole position is not guaranteed
NEW YORK — Bristol Myers Squibb CEO Chris Boerner said America’s role as the global biopharma leader is at a “pivot point” as the Trump administration aims to remake the country’s institutions and...
View ArticleFDA warns Mayne Pharma over 'misleading' birth control pill claims
The FDA’s drug promotion office is calling out Australia's Mayne Pharma for making “false or misleading claims” about the benefits and risks of its birth control pill Nextstellis. The agency's
View ArticlePhiladelphia doctors treat infant with first custom CRISPR therapy that fixes...
PHILADELPHIA — Soon after Kyle Patrick Muldoon, Jr. was born in August 2024, his doctors knew something was wrong. KJ, as his parents call him, was too tired to feed, his ...
View ArticleEli Lilly teams up with RNA editing biotech for hearing loss
Eli Lilly is building out its gene therapy pipeline for hearing loss through a new deal with RNA-focused startup Rznomics. The Indianapolis drug giant and Seongnam-based biotech will work together on...
View ArticleNew CBER chief is readying 'massive framework' for vaccines, Makary says
Vinay Prasad may have just started as the new director of the FDA's biologics center, but he's "planning to unleash a massive framework" on vaccines in the "coming days," FDA Commissioner Marty Makary...
View ArticleEisai says Leqembi sales are expanding steadily in US
Eisai executives said on Thursday that Leqembi sales and shipments in the US are showing “steady growth and expansion,” just a couple months after the company slashed its 2027 sales expectations for ...
View ArticleRegeneron gets $400M+ jury win in Amgen cholesterol drug case
A Delaware jury on Thursday said Regeneron should get more than $400 million in damages in its long-running antitrust case against Amgen. Regeneron brought the case almost three years ago alleging ...
View ArticleTop RFK Jr. advisor dares drugmakers over threats to drop manufacturing promises
NEW YORK — Calley Means, a special White House employee and top advisor to HHS Secretary Robert F. Kennedy Jr., effectively dared Roche to pull its US investment after the company said it would...
View ArticleNovo Nordisk’s global obesity leader is moving on; Flagship biotech gets CEO...
→ Leo Pharma is doing an extensive revamp of its leadership team as it splits product strategy and international operations into two separate divisions. Frederik Kier, the head of the global obesity...
View ArticleIt's been three months without a biotech IPO
The last time a biotech went public on a US stock exchange, people were buying flowers for Valentine's Day. Those petals withered long ago. It's been 13 weeks since Aardvark Therapeutics' $94 million...
View ArticleNovo Nordisk CEO to step down, timeline for successor unknown
In a startling decision, Novo Nordisk CEO Lars Fruergaard Jørgensen will step down as the company deals with pressures on its stock price and GLP-1 business. Novo said Friday it started a search for J ...
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