Alphabet’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 ArticleOpenAI-backed biotech debuts antibody-making AI models
A San Francisco startup said Monday that its newest AI models produced de novo antibodies in the lab with far greater success rates than other top protein models. In a preprint, Chai Discovery...
View ArticleModerna reports Phase 3 flu data, teeing up new submissions
Moderna said Monday that its flu vaccine was 26.6% effective at preventing illness compared to a licensed comparator — a similar showing to other updated shots — and sets the stage for more FDA...
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...
View ArticleApple Tree Partners' biotechs 'face imminent collapse' as firm battles...
Apple Tree Partners, a venture firm and creator of dozens of biotechs like Akero Therapeutics and Chinook Therapeutics, says multiple portfolio companies are at risk of closure as it fights its main...
View ArticleKhosla Ventures backs ‘therapeutic plasma exchange’ startup Circulate Health
Circulate Health, a startup offering a potential anti-aging procedure, has raised $12 million in seed funding led by Khosla Ventures, the companies told Endpoints News in exclusive interviews. The...
View ArticleCBER chief Prasad details why he overrode Novavax reviewers
CBER Director Vinay Prasad says the benefits of Covid-19 vaccination have depreciated and may no longer outweigh the risks in adults who aren’t prone to more severe illness. “Even rare...
View ArticleArcturus claims Phase 2 success in first data since shift to mRNA therapeutics
Arcturus said a Phase 2 mRNA therapeutic program achieved its goals in a rare disease population, though the results are early and Wall Street appeared skeptical. The biotech touted the new ...
View Article