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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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Another 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 ...

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CureVac 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...

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Kennedy'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...

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Novo 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...

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Appeals 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...

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Moderna 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 aged...

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AstraZeneca, CSPC ink AI drug development deal for $110M upfront 

AstraZeneca is further tightening its relationship with China, announcing a new research partnership with CSPC Pharmaceuticals on Friday. CSPC will receive $110 million upfront for the partners to...

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Bristol Myers gets a key strategist with 'Team Shibs'; Idorsia to change CEOs...

Just a few months ago, Chris Shibutani was asking Bristol Myers Squibb executives about their strategy during the drugmaker's quarterly earnings calls. As of Monday, the recently departed Goldman Sachs...

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Rein Therapeutics study on clinical hold; Beam updates sickle cell therapy data

Plus, news about Enliven Therapeutics, Merck's Keytruda and Celldex: FDA places hold on Rein study: The agency has “non-clinical requests” for Rein Therapeutics’ Phase 2 trial in idiopathic pulmonary...

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With HIV prevention under attack, how might Gilead’s new PrEP injection fare?

A groundbreaking new therapy that can almost entirely prevent HIV is days away from an FDA decision — but a mix of recent federal politics and historically slow launches may get in its way. At stake ...

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FDA Commissioner Marty Makary calls for more consolidation

FDA Commissioner Martin Makary sent an email to staff this week announcing plans to further consolidate the agency’s operations outside of medical product reviews and inspections. Human resources,...

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FDA's oncology adcomm to review GSK's Blenrep relaunch plans

The FDA’s Oncologic Drugs Advisory Committee will meet on July 17 to discuss a potential relaunch of GSK’s multiple myeloma drug Blenrep. The committee will consider GSK's application to bring Blenrep ...

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KalVista says FDA delayed decision on HAE drug, citing ‘heavy workload’ 

KalVista Pharmaceuticals said Friday that the FDA pushed back its decision on whether to approve its on-demand oral drug for hereditary angioedema, citing “heavy workload and limited resources” at the...

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Former CEO Anne Wojcicki wins bid for 23andMe

23andMe said it agreed to sell itself to co-founder and former CEO Anne Wojcicki for $305 million, ending a bidding war for the struggling consumer genetic testing company. Wojcicki’s price of ...

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RFK removes all ACIP members, names new ones; National Resilience to close...

Welcome back to Endpoints Weekly! It was another busy news week, so let’s dive in. Our reporters tracked a number of updates from DC, including the removal of all 17 members of the CDC’s vaccine ...

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