Altimmune posts mixed results for incretin drug in MASH; stock is halved
Altimmune said its experimental therapy for a serious fatty liver disease hit one key endpoint but not the other in a Phase 2b study. The biotech’s shares {$ALT} tanked after the ...
View ArticleCDC vaccine panel votes to remove thimerosal from flu shots
Clinicians and infectious disease specialists clashed with the majority of the CDC’s remade vaccine advisory committee on Thursday, arguing that the panel’s debate over an ingredient in a small number...
View ArticleJudge says CVS Caremark owes $95M in false claims case
A Pennsylvania federal judge ruled that CVS Caremark owes the federal government $95 million in a case that accused the pharmacy benefit manager of conduct that caused Medicare to overpay for...
View ArticleAI scribes are evolving
For so long, AI scribes pitched healthcare providers on the promise of reducing burnout. But lately, we’ve been hearing a different pitch: that scribes can be used to make billing easier. Take Abridge,...
View ArticleGilead ends RSV antiviral trials after low incidence rates
Gilead Sciences has terminated two Phase 2 studies of an RSV treatment candidate called obeldesivir. The California biotech ended a trial of the oral tablet in non-hospitalized adults and another study...
View ArticleA dinner in Paris revived talks for Sanofi's $9.5B deal for Blueprint
For Blueprint Medicines, a monumental meal in the City of Bridges helped bring back to life Sanofi's interest in acquiring the commercial-stage drugmaker. Blueprint had almost lost out on a $9.5...
View ArticleBill Meury brings new perspective to Incyte as Hoppenot retires; Ex-MorphoSys...
→ Hervé Hoppenot is handing the CEO post at Incyte to Bill Meury after 11 years leading the Delaware drugmaker. Endpoints News caught up with Hoppenot and Meury on their last and first days on ...
View ArticleAlphabet’s Calico inks $25M licensing deal for Mabwell’s IL-11 programs
Longevity biotech Calico is spending $25 million in cash to license therapeutic candidates targeting the interleukin-11 protein from China’s Mabwell. Calico will get exclusive global rights to a...
View ArticleFDA head Makary's intervention attempt on KalVista raises concerns
FDA Commissioner Marty Makary’s unsuccessful attempt to intervene in an ongoing drug review, as described by multiple agency sources, raises further concerns about the regulator under its new...
View ArticleInnovent brings a new mechanism to obesity market with China approval
Innovent said on Friday that its obesity medicine mazdutide has been approved in China, becoming the first dual GLP-1/glucagon agonist to be greenlit for the disease anywhere in the world. ...
View ArticleBioCryst sells Orladeyo business in Europe; UCB gets a Phase 3 win for Fintepla
Plus, news about XOMA Royalty, Turnstone Biologics, CorMedix, the Novo Nordisk Foundation, Achieve Life Sciences and Cidara Therapeutics: BioCryst sells Orladeyo business in Europe: The company will...
View ArticleCEOs push EU for cell, gene therapy incentives in Biotech Act
Upcoming European legislative changes should include new incentives to boost early capital for developing cell and gene therapies, more than 30 biotech CEOs urged this week to EU lawmakers. Several...
View ArticleFDA loosens safety requirements for CAR-Ts in move to boost access
The FDA is eliminating a safety monitoring program for all CAR-T therapies, saying the cell therapies can be used safely and effectively without it. The agency said Thursday it determined the ...
View ArticleFDA extends impurity data submission deadline for drugmakers
It's been more than six years since the FDA found potentially cancer-causing impurities, known as nitrosamines, in drugs to treat high blood pressure and heart failure. And yet, the agency announced...
View ArticleJ&J dealt blow in fight over its 340B rebate model
A federal judge said the government did not run afoul of the law when it required Johnson & Johnson to seek approval before implementing its proposed 340B rebate model. The Friday decision marks...
View ArticleSources say FDA commissioner sought rejection of KalVista’s rare disease...
Welcome back to Endpoints Weekly! Thanks for spending your Saturday with us. We start this week’s recap with reporting from Endpoints News’ senior biopharma correspondent Andrew Dunn on the FDA’s...
View ArticleUnicycive gets a CRL for chronic kidney disease pill as third-party...
Unicycive Therapeutics’ phosphate binder drug has failed to secure FDA approval for certain chronic kidney disease (CKD) patients, marking another hitch in its goal to shift into a commercial-stage...
View ArticleHikma pledges $1B to expand US manufacturing presence
Hikma Pharmaceuticals has promised to spend $1 billion on growing its US manufacturing and R&D footprint by 2030. The drugmaker said its latest investment — which it refers to as “America Leans on...
View ArticleAbbVie bags Capstan’s in vivo CAR-T work with $2.1B buyout deal
Almost three years ago, longtime biotech vet Laura Shawver cheerfully heralded the arrival of her latest startup with a colorful observation on the confluence of its mRNA and CAR-T tech. “To me, it’s...
View ArticleINmune Bio’s Alzheimer’s drug fails Phase 2; BridgeBio sells some ATTR-CM...
Plus, news about Laverock Therapeutics, Bristol Myers Squibb, Sobi, Pliant Therapeutics, Bayer and Takeda: INmune Bio’s Alzheimer’s disease drug fails Phase 2 study: The company was testing XPro, a TNF...
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