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Vaxart shares rise after reporting norovirus vaccine data

A small vaccine maker's stock price shot up Wednesday after releasing new data in the same week that vaccine R&D is the focus of attention. Vaxart {$VXRT} saw its shares surge 45% at market open ...

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Lilly pledges more than $650M to muscle health biotech; Cogent gets $50M

Plus, news about Cellectar Biosciences, Bausch + Lomb, Elkedonia, Pharmazz and Roche: Eli Lilly turns to muscle health biotech: The drugmaker and Juvena Therapeutics will work on treatments for ...

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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 ...

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Endpoints 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 ...

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Nuvation 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...

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House 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...

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Organoid 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 ...

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Federal 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...

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HHS 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...

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Trump 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...

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RFK 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 ...

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#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...

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BioNTech 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...

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Commons 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...

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Capricor 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...

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ADC 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 ...

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#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 ...

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Insmed 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 ...

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Two 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....

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FDA 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 ...

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