Lilly, Eisai and Biogen seek more specifics in FDA guidance on early...
Alzheimer’s drug manufacturers are asking the FDA to give them more clarity on the different stages of the disease in comments they’ve submitted on the agency’s draft guidance for developing drugs for...
View ArticleGilead's M&A appetite is for deals in the 'mid-single-digit billions,' CEO says
Gilead CEO Daniel O’Day says the company will likely look for more deals like its $4.3 billion purchase of CymaBay Therapeutics over the next few years, rather than big buys costing tens of billions of...
View ArticlePfizer’s Duchenne muscular dystrophy gene therapy fails Phase 3 trial
Pfizer’s Duchenne muscular dystrophy gene therapy failed to meet the primary and key secondary endpoints in a Phase 3 study, pointing to a bleak future for the program. The gene therapy failed to...
View ArticleOnly a third of employers and health plans cover GLP-1 drugs for weight loss,...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Companies still aren’t rushing to pay for their workers’ GLP-1 weight loss drugs, despite skyrocketing...
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Former Merck scientists raise $85M to map and drug protein interactions in...
The surfaces of cells are studded with proteins used to communicate with neighbors and visitors. A new method for mapping them and their interactions is revealing clues for making cancer and immune...
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Barinthus Bio to lay off 25% of its workforce and focus on just two programs
Barinthus Bio is shifting its focus to just two investigational candidates and cutting about 25% of its workforce in order to extend cash runway into the second quarter of 2026, the company announced...
View ArticleCara cuts oral pruritus drug after Phase 2/3 disappointment, seeks strategic...
Cara Therapeutics’ drug candidate has flopped in a mid-stage trial in people with moderate-to-severe itch due to a neurological disorder, prompting the company to terminate the program — the last one...
View Article'Speed is everything': Versant-backed immunology startup raises $125M with...
Another Versant Ventures startup announced a big funding round this week, and this one wants to move quickly. Santa Ana Bio said Thursday that it closed a $125 million Series B, bringing its total...
View ArticleAbbVie banks on second-gen TL1A program, licensing antibody from FutureGen
AbbVie is jumping into the TL1A space, inking a new deal with a Beijing-based biotech. The company said Thursday that it’s partnering with FutureGen Biopharmaceutical, licensing an anti-TL1A antibody...
View ArticleIs $13B Devoted Health succeeding where other insurance upstarts have failed?
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) The private health insurance market for seniors has been a brutal business recently, with rising medical...
View ArticleAvidity’s $300M offering; Rapport raises $174M
Plus, news about Replimmune, Novo Nordisk and Biosplice: Avidity Biosciences is looking for $300M in stock sale: The RNA company is planning a $300 million public offering on the heels of an...
View ArticleJ&J returns bispecific T cell engager to Xencor, reducing scope of partnership
Johnson & Johnson is handing back a bispecific T cell engager program to its partner Xencor, ending a significant piece of an agreement between the companies that started in 2021. Once known as...
View ArticleUroGen touts long duration of response for its bladder cancer chemotherapy gel
In a Phase 3 study, patients who saw a complete response at three months after receiving UroGen Pharma’s therapy had an 82% chance of having no cancer progression another year later. UroGen’s...
View ArticleUltragenyx to seek accelerated approval for rare disease gene therapy
Ultragenyx moved one step closer to establishing a new surrogate biomarker for accelerated approval in rare disease gene therapies. The biotech said Wednesday it will seek accelerated approval for its...
View ArticleSiegfried nabs US site from Curia; Merck KGaA pumps €62M more into its HQ
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Siegfried is acquiring a manufacturing facility in Grafton, WI, from...
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Radiopharma execs warn that lutetium could be at risk of shortage
The radioisotope lutetium-177 is at risk of slipping into shortage due to rapidly increasing demand, outdated manufacturing infrastructure and vulnerable supply chains, some radiopharma manufacturer...
View ArticleAlchem faces fines over price-fixing allegation from the European Commission
Alchem International has been accused by the European Commission of being a part of a “cartel” of companies to fix prices for a pharmaceutical ingredient. According to the Commission, Alchem “may have...
View ArticleTelehealth startup Done's execs arrested and charged for alleged Adderall...
Top executives at the telehealth startup Done Global have been arrested and charged for allegedly peddling easy access to Adderall and other potentially addictive stimulants, in many cases when they...
View ArticlePharma industry praises Supreme Court's rejection of abortion pill challenge
The Supreme Court has unanimously rejected an attempt by doctors and anti-abortion groups to limit the use of the abortion pill mifepristone. The Court on Thursday held that the plaintiffs failed to...
View ArticleStakeholders weigh in on potential reforms to FDA advisory committee process
The FDA on Thursday heard feedback from a slew of stakeholders on potential upcoming changes to the advisory committee process — and the reviews were mixed. The meeting was held to glean public input...
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