FDA warning letter targets doctor who worked on a Takeda Phase 3 study
Back in January, Takeda won approval for a new indication for its primary immunodeficiency drug HyQvia, this time as a treatment for a rare autoimmune disorder called chronic inflammatory demyelinating...
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Incyte gets another graft-versus-host disease drug approval, this time with...
Incyte and partner Syndax Pharmaceuticals on Tuesday secured regulatory clearance to market a third-line chronic graft-versus-host disease treatment, or cGVHD. The agency greenlit the duo’s axatilimab,...
View ArticleZealand joins next-gen club aiming to ‘accelerate’ obesity drug development
As next-generation contenders in the obesity treatment space communicate plans to speed up their drug programs, Zealand Pharma appears to have gotten the memo. The Danish biotech is raising its...
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Biden administration says IRA negotiations will result in $6B in 2026...
The first round of negotiations under the Inflation Reduction Act will save Medicare $6 billion in 2026, the Biden administration announced Thursday. The final prices will be released later today for...
View ArticleIn a reality check for the field, AI underwhelms in Leash Bio's binding...
Artificial intelligence models may be doing a lot more memorizing and a lot less reasoning when it comes to predicting biology, results from a new competition suggest. Shortly after launching in April,...
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Federal government reveals negotiated prices under Inflation Reduction Act
The government announced final prices on Thursday for the first 10 drugs negotiated by Medicare under the Inflation Reduction Act, following months of back-and-forth between pharma companies and the...
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Updated: NIH says SIGA’s antiviral didn’t improve resolution in mpox lesions...
A day after the World Health Organization again declared mpox a public health emergency, more bad news came out about the virus. On Thursday, the National Institutes of Health said that SIGA...
View ArticleMerck signs MoU with Indian CDMO; Scorpius delays public offering
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Merck and Indian CDMO Aragen have signed a memorandum of...
View ArticleLyra pauses work on sinusitis drug; Pathos AI licenses a new asset
Plus, news about Convergent Therapeutics, Turnstone Biologics and Sonnet BioTherapeutics: Lyra Therapeutics pauses development of chronic rhinosinusitis drug: The company now plans to focus on two...
View ArticleBavarian Nordic returns to the spotlight as mpox outbreak reaches emergency...
Bavarian Nordic is capable of supplying around three million doses of its mpox vaccine Jynneos this year, the WHO said following its global health emergency declaration. WHO Director-General Tedros...
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Lykos cutting most of staff less than a week after FDA rejection
Lykos Therapeutics is cutting 75% of its staff following the FDA’s rejection last week of its MDMA-assisted therapy, the company said Thursday. Rick Doblin Rick Doblin, founder and president of the...
View ArticleMedicare price negotiation: Which drugs did the government get the best deals...
LARGO, MD — President Joe Biden and Vice President Kamala Harris rallied around the government’s release of the negotiated prices for the first 10 drugs impacted by a historic drug pricing law. But the...
View ArticleGenentech dissolves cancer immunology group, and research executive Ira...
Genentech is dismantling its cancer immunology team in a reorganization of its work in the field, and its VP of cancer immunology, Ira Mellman, will leave, the company confirmed to Endpoints News. The...
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Esperion's CMO hits the exit; Pfizer appoints Nvidia alum as AI chief
JoAnne Foody Esperion CMO JoAnne Foody has departed, the company disclosed in an Aug. 5 SEC filing. “We are grateful for her significant contributions to the company through the years and wish her the...
View ArticlePfizer, BioNTech review next steps as Covid and flu combo vaccine delivers...
In the Covid-19 and influenza combo vaccine race, Pfizer and BioNTech reported a hiccup on Friday with uneven results in a Phase 3 test. The companies’ Covid-flu vaccine didn’t meet the Phase 3 primary...
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Incyte plans label expansion for cancer drug Monjuvi following positive...
Incyte will go to the FDA by the end of the year with a supplemental BLA for its cancer drug Monjuvi after it hit all the endpoints in a Phase 3 study in follicular lymphoma. The Phase 3 inMIND trial...
View ArticleNovo Nordisk subsidiary to build $220M API facility for chronic disease drugs
Novo Nordisk Pharmatech is building a new facility in Denmark to expand capacity for raw material production due to “significantly higher demand” from its parent company. “This is the largest...
View ArticleAN2’s poison pill; Pfizer shares promising mid-stage data for flu shot
Plus, news about Vericel: AN2 Therapeutics adopts poison pill: The small molecule drugmaker put forth the stockholder rights plan for a year after one of its investors — BML Investment Partners —...
View ArticleQ&A: Lykos just cut 75% of its workforce after an FDA rejection. Here’s what...
In the span of a week, Lykos Therapeutics has been rejected by the FDA, had three published papers retracted, dealt with a boardroom shakeup and, yesterday, cut 75% of its roughly 100 employees. It’s a...
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Avantor sells off CRO for $650M to private equity firm
Audax Private Equity is buying Avantor’s CRO business for about $650 million. The deal, announced Friday, is for Avantor’s clinical services business, which includes kitting, biorepository and related...
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