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Endpoints Livestream: ACIP and the future of vaccines

Today on Post-Hoc Live, I'll be joined by senior editor Zachary Brennan and pharma reporter Max Bayer for a wide-ranging discussion about the remade Advisory Committee on Immunization Practices and how...

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Novartis strikes cardiovascular discovery deal with Flagship’s ProFound

Novartis has signed up proteomics specialist ProFound Therapeutics to pinpoint “previously unknown” proteins to be investigated as cardiovascular drugs and drug targets in a $25 million upfront deal....

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Vor Bio bounces back with RemeGen autoimmune deal, $175M private placement

In an unexpected turn of events, Vor Bio is back on the fundraising trail and shifting focus to autoimmune disease, less than two months after it seemed to be at the end ...

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Bharat, GSK to cut malaria vaccine price; Emergent's US stockpile deal expands

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Bharat Biotech and GSK said they will reduce the price of their ...

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Handspring Health raises $12M to provide more complex care for youth

Youth virtual mental health startup Handspring Health just raised $12 million, Endpoints News has learned exclusively. Cobalt Ventures led the Series A round, with contributions from NextView Ventures,...

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Why Commure, one of healthcare's most deal-hungry startups, plans to buy more...

Commure, one of the buzziest healthcare startups backed by General Catalyst, is hunting for more startups to buy — AI scribes included. Commure has been on a shopping spree over the past few years,...

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Opus, Viatris say presbyopia drug succeeds in Phase 3

Opus Genetics and Viatris' eye drug hit the primary endpoint in a Phase 3 study, putting them on track for an FDA filing by the end of the year. The phentolamine ophthalmic solution 0.75% program ...

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Edgewise details pivotal plans in Becker muscular dystrophy; Kymera’s $250M...

Plus, news about Hummingbird, Percheron, Pfizer and I-Mab: Edgewise Therapeutics can’t get accelerated approval for muscle disease drug: The biotech said the FDA deemed its Phase 2 CANYON data...

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Altimmune posts mixed results for incretin drug in MASH; stock is halved

Altimmune said its experimental therapy for a serious fatty liver disease hit one key endpoint but not the other in a Phase 2b study. The biotech’s shares {$ALT} tanked after the ...

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CDC vaccine panel votes to remove thimerosal from flu shots

Clinicians and infectious disease specialists clashed with the majority of the CDC’s remade vaccine advisory committee on Thursday, arguing that the panel’s debate over an ingredient in a small number...

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Judge says CVS Caremark owes $95M in false claims case

A Pennsylvania federal judge ruled that CVS Caremark owes the federal government $95 million in a case that accused the pharmacy benefit manager of conduct that caused Medicare to overpay for...

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AI scribes are evolving

For so long, AI scribes pitched healthcare providers on the promise of reducing burnout. But lately, we’ve been hearing a different pitch: that scribes can be used to make billing easier. Take Abridge,...

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Gilead ends RSV antiviral trials after low incidence rates

Gilead Sciences has terminated two Phase 2 studies of an RSV treatment candidate called obeldesivir. The California biotech ended a trial of the oral tablet in non-hospitalized adults and another study...

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A dinner in Paris revived talks for Sanofi's $9.5B deal for Blueprint

For Blueprint Medicines, a monumental meal in the City of Bridges helped bring back to life Sanofi's interest in acquiring the commercial-stage drugmaker. Blueprint had almost lost out on a $9.5...

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Bill Meury brings new perspective to Incyte as Hoppenot retires; Ex-MorphoSys...

→ Hervé Hoppenot is handing the CEO post at Incyte to Bill Meury after 11 years leading the Delaware drugmaker. Endpoints News caught up with Hoppenot and Meury on their last and first days on ...

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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...

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FDA 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...

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Innovent 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. ...

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BioCryst 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...

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CEOs 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...

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FDA 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 ...

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FDA 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...

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J&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...

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Sources 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...

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