Cabaletta Bio shares CAR-T results in three autoimmune conditions
Cabaletta Bio reported that its CAR-T therapy led to clinical improvements and in some cases remission in three different autoimmune diseases, and the biotech is now planning the pivotal trials that ...
View ArticleEndpoints Livestream: What happens when AI thinks in ways we can’t understand?
We’re back for the second time this week! Tomorrow on Post-Hoc Live, we’re going to bring in a guest I’ve wanted to have on for a long time, to talk about how biotech models of ...
View ArticleNuvation Bio scores first FDA approval for new lung cancer drug
Nuvation Bio on Wednesday won FDA approval with its first commercialized drug, Ibtrozi, for advanced ROS1-positive non-small cell lung cancer (NSCLC). The approval of Ibtrozi, known generically as...
View ArticleHouse appropriators call for FDA tweaks on accelerated approvals, biosimilars
House appropriators are calling on the FDA to boost biosimilar access and better align its accelerated approval pathway across its drug and biologics centers. A House Appropriations Committee report...
View ArticleOrganoid startup raises $21M to test drugs and vaccines in human lymph...
Parallel Bio, a startup that figured out how to grow miniature human lymph nodes in a dish, has raised $21 million in Series A funding for its alternative to animal models, the company told ...
View ArticleFederal officials plan listening sessions to address drug competition
The Federal Trade Commission and Department of Justice plan to have three listening sessions focused on how to lower drug prices through enhanced market competition. The sessions will center on pharma...
View ArticleHHS urges against reviving Chamber of Commerce’s IRA suit
The Trump administration is defending another Biden-era court win in a case challenging Medicare price negotiations under the Inflation Reduction Act. The government on Wednesday urged the US Court of...
View ArticleTrump officials seek price details as they assess most favored nation plan
Officials in President Donald Trump's administration have spent the month since his “most favored nation” drug price announcement trying to learn more about how pharma companies price their products...
View ArticleRFK Jr. names eight new ACIP members
Two days after firing all 17 members of the CDC’s vaccine advisory committee, HHS Secretary Robert F. Kennedy Jr. announced a new panel roughly half the size. Some of the new eight ...
View Article#EHA25: Schrödinger reports early Phase 1 data for MALT1 inhibitor
Schrödinger said its experimental MALT1 inhibitor showed early signs of safety and efficacy in an ongoing Phase 1 trial. The company also said the data support its broader computational discovery...
View ArticleBioNTech to acquire CureVac in all-stock deal valued at $1.25B
BioNTech plans to buy mRNA-based cancer immunotherapy and infectious disease vaccine company CureVac in an all-stock deal, the companies said Thursday. The acquisition gives an implied equity value of...
View ArticleCommons Clinic raises $26M Series B to offer preventive testing
Commons Clinic, a Los Angeles-based clinic chain focused on musculoskeletal care, has raised $26 million to test for and treat more conditions, Endpoints News learned exclusively. The startup is using...
View ArticleCapricor gets Form 483 from FDA; WuXi Biologics' new China factory
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Capricor Therapeutics has received a Form 483 from the FDA after an...
View ArticleADC Therapeutics reveals layoffs, $100M PIPE; Third Harmonic seeks buyer for...
Plus, news about Blue Water, Enterome and BeOne Medicines: ADC Therapeutics launches $100M PIPE, discontinues some cancer work: The money is expected to help the company focus on its preclinical PSMA ...
View Article#EHA25: Kura, Kyowa say Phase 1 update supports menin inhibitor combos
As Kura Oncology and Kyowa Kirin await an FDA decision for their oral menin inhibitor in acute myeloid leukemia, the partners are highlighting another early cut of data for a combo with the drug in ...
View ArticleInsmed aims to raise $750M in one of the largest stock offerings this year
Insmed announced Thursday morning that it expects to raise $750 million in a stock sale, marking one of the largest public offerings by a biopharma company this year. The public offering ...
View ArticleTwo new ACIP picks were paid experts against Merck in court
Two of HHS Secretary Robert F. Kennedy Jr.’s new appointees to the CDC’s vaccine advisory board have previously served as paid expert witnesses for plaintiffs suing Merck over its HPV and MMR shots....
View ArticleFDA approves UroGen's bladder cancer hydrogel after negative adcomm vote
The FDA on Thursday approved UroGen’s application for its bladder cancer drug, despite a negative vote from an advisory committee last month. The drug, which UroGen will brand as Zusduri, is ...
View ArticleAnother care navigation deal
Capital Rx’s acquisition of Amino Health is the latest in a wave of consolidation in the care navigation space among companies that work with employers to connect their health plan ...
View ArticleCureVac CEO on the $1.25B BioNTech deal
After 25 years of trying to lead biopharma's mRNA revolution across infectious diseases and cancer, German biotech CureVac made the surprise announcement Thursday morning that it would exit to its...
View ArticleKennedy's doubts over vaccine placebos don't align with science, experts say
Much of HHS Secretary Robert F. Kennedy Jr.'s recent stated skepticism about vaccines is based on claims that many of the shots have never been tested against “inert” placebos. But experts interviewed...
View ArticleNovo Nordisk plans Phase 3 trials of oral, injectable amycretin
Novo Nordisk plans to go straight to Phase 3 with its experimental weight loss drug amycretin in the first quarter of 2026, the Danish drug giant said Thursday. The rush to late-stage testing signals...
View ArticleAppeals court upholds halt on Minnesota generic drug pricing law
A Minnesota drug pricing law violates the Constitution by allowing the state to essentially control prices outside of its borders, an appeals court ruled on Thursday. The US Court of Appeals for the...
View ArticleModerna wins FDA approval for expanded use of RSV shot in more adults
A little more than a week after Moderna’s new Covid-19 vaccine was approved, the FDA has expanded who can receive the company’s RSV shot. The agency approved mRESVIA on Thursday for at-risk adults 18...
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