Feng Zhang’s protein nanoparticle startup Aera Therapeutics turns to lipid...
When CRISPR pioneer Feng Zhang met with investors to discuss his new drug delivery technology over dinner in the summer of 2021, it didn’t take long to pitch the idea.
View ArticleFDA withdraws compliance deadlines for makers of bone allografts
The FDA on Friday said it's pulling two final guidance documents published earlier this year that sought to help entities manufacturing cell- and tissue-based medical products to make better donor...
View ArticleWhite House budget proposes billions in cuts at NIH, CDC
The White House’s budget request proposes nearly $18 billion in cuts to NIH spending, and more than $3.5 billion slashed at the CDC. And the changes would include major consolidation at both agencies....
View ArticleAfter FDA firings, drug reviewers are asked to volunteer for administrative work
Leadership in the FDA's Office of New Drugs sent an email to staff Friday afternoon asking if anyone would volunteer to take on more administrative work, following the firing of many of the agency's...
View ArticleVertex drops AAV gene therapy research, tRNA therapy partnership
Vertex is pulling back on its genetic medicine research, ending all work related to adeno-associated viruses, or AAVs — the viral vectors commonly used to deliver gene therapies into the body, the...
View ArticleEarnings season continues; FDA delays PDUFA date; AACR recap; and more
Welcome back to Endpoints Weekly, our roundup of the top headlines in biopharma. Earnings season continued this week, with more comments from pharma executives on the potential impact of tariffs, new...
View ArticleTopas claims success in early test of 'immune tolerance' celiac therapy
Topas Therapeutics, a small German biotech company attempting to quell overactive immune systems, has revealed the first data from a study of its “tolerance induction” therapy for celiac disease. The...
View ArticleEarly in vivo CAR-T human data emerge from biotech trials in China
The first shards of human data on in vivo CAR-T cell therapy look promising, based on recent separate reports from two biotech companies’ academic-led studies in China. Last week, a Chinese startup...
View ArticleThe big question for the FDA after Stealth’s PDUFA delay
Is the PDUFA delay for Stealth BioTherapeutics a canary-in-the-coalmine moment? Or is it an overblown one-off that signals little about disruption at the FDA? That’s the question seemingly on...
View ArticleDeerfield secures $600M+ for third healthcare venture fund to seed new companies
Deerfield Management is back with its third healthcare venture fund, this time securing more than $600 million to create new drug development outfits, medical technology startups and adjacent...
View ArticleAI biotech Iambic debuts next-gen model Enchant for drug R&D
Iambic Therapeutics claims that it has improved the predictive power of its AI model Enchant by scaling it up, in what one of the company’s co-founders says is a “material shift” for its drug discovery...
View ArticleJ&J eye disease gene therapy bota-vec fails Phase 3
Johnson & Johnson’s gene therapy for a genetic disease that leads to vision loss called X-linked retinitis pigmentosa (XLRP) failed a pivotal trial, according to an update to a J&J healthcare...
View ArticleUnity lays off 'all' workers; Novo to get FDA decision on oral Wegovy this year
Plus, news about ImmunityBio and Inventiva: Unity Biotechnology shelves work: The anti-aging drug developer plans to evaluate strategic alternatives and conduct layoffs that affect “all of its...
View ArticleAI biotech Recursion cuts pipeline to 'sharpen focus'
Recursion's leaders tried to make the case last year that the company had avoided the fate of some of its AI-focused peers, which had seen their first clinical programs fizzle out. The Salt Lake City ...
View ArticleFunction buys Ezra, combining preventive testing and scans
Function Health is buying Ezra in a bid to create a haven for people who want copious amounts of data on their bodies. The combined company will be a one-stop shop for preventive lab testing ...
View ArticleBioNTech doesn't see ‘near-term’ impact from RFK Jr.'s vaccine policy proposal
A proposal by HHS Secretary Robert F. Kennedy Jr. to change the approval standard of new vaccines shouldn't affect BioNTech's Covid-19 franchise, the company told investors Monday. Biotech and pharma...
View ArticleBristol Myers to lay off over 500 workers in New Jersey
Bristol Myers Squibb is letting go of 516 workers in New Jersey as part of a wide-reaching cost-cutting plan aimed at making the drugmaker more efficient. The company, based in Princeton, NJ, first...
View ArticlePTC's Huntington’s study succeeds, but accelerated approval uncertain
PTC Therapeutics announced Monday that its splicing drug for Huntington’s disease met the primary endpoint of a Phase 2 study, but stopped short of spelling out the important data that could ...
View ArticleFDA adcomm to review Capricor's Duchenne cell therapy
Capricor Therapeutics' cell therapy for Duchenne muscular dystrophy will face an FDA advisory committee ahead of an approval decision that's expected Aug. 31, the company disclosed on Monday. The San...
View ArticleNew opioid data may not be generalizable, FDA adcomm says
Several members of an FDA advisory committee warned on Monday that new data from studies on long-term use of opioids might underestimate the harms from their misuse and abuse. The committee reviewed...
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