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Novo and Viking present new MASH data, but analysts remain confident in...

Novo Nordisk and Viking Therapeutics took to the annual Liver Meeting to make the case for their experimental MASH drugs as they chase Madrigal Pharmaceuticals' first-ever approved treatment for the...

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When generative AI meets the FDA: First digital health adcomm kicks off...

How to regulate generative AI was the central topic of the inaugural two-day meeting of the FDA’s new digital health advisory committee that began on Wednesday. FDA Commissioner Rob Califf opened the...

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FDA updates label of 33-year-old cancer drug with new dose and warning

The FDA on Wednesday updated the label for Sandoz's decades-old leukemia drug fludarabine phosphate, as part of a wider initiative to revamp the labels for cancer drugs approved long ago. Fludarabine...

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Venrock adds $500M to healthcare investing strategy after outlining 10th fund...

Venrock has added half a billion dollars to its healthcare investing strategy, the firm confirmed to Endpoints News on Wednesday. It comes on top of its $650 million 10th fund — which goes toward

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NewAmsterdam aces Phase 3 trial, but investors are skeptical

NewAmsterdam Pharma’s lead cardio program obicetrapib passed another Phase 3 trial, demonstrating its ability to lower “bad cholesterol” in combination with a drug called ezetimibe. The TANDEM study...

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Kyowa Kirin buys into Kura leukemia treatment rights for $330M+

Japanese drugmaker Kyowa Kirin is acquiring most of the commercial rights for Kura Oncology’s targeted leukemia treatment, paying $330 million upfront and almost $1.2 billion in possible milestones....

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Amgen names geneticist and biotech founder to CSO post

Amgen is joining the chorus of large pharmas naming new science leaders. The company said Wednesday that Stanford physician-scientist Howard Chang will be its new chief scientific officer and senior...

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Novartis buys Kate Therapeutics in $1.1B deal, eyes more bolt-on M&A

Novartis is buying gene therapy and neuroscience biotech Kate Therapeutics in a deal worth $1.1 billion in upfront and milestone payments, the Swiss pharma confirmed to Endpoints News on Thursday. And...

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Aizen debuts with AI-driven 'mirror peptide' platform

Aizen Therapeutics has left stealth with $13 million in seed funding and a mission to advance “mirror peptide” drug candidates, with an initial focus on solid tumors and neuroscience. The San...

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FDA vaccine chief Peter Marks pledges to stay as long as he's welcome

LONDON — The FDA's top leader of vaccines and biologics said Thursday he is not planning to leave his role in light of the incoming Trump administration and the potential for Robert F. Kennedy Jr ...

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Cidara's $100M PIPE; Pyxis Oncology's stock falls on Phase 1 data

Plus, news about argenx, Forte Biosciences, Verrica, Pep2Tango Therapeutics, Eli Lilly, Laekna, Lineage Cell Therapeutics and OneCell Diagnostics: Cidara Therapeutics nabs $105M: The immunotherapy...

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Samsung Bio's new $668M client; Sanofi expands a factory in France

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Samsung Biologics has secured a number of ...

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Trump and RFK Jr. want to ban pharma ads. History isn't on their side

As the healthcare priorities of President-elect Donald Trump and his HHS pick Robert F. Kennedy Jr. take shape, one idea gaining steam is a ban on direct-to-consumer pharmaceutical advertising. Both...

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At Jefferies, all that manufacturers want to talk about is GLP-1s

LONDON — Thousands of delegates flooded into the narrow corridors of the Waldorf Hilton this week to attend the Jefferies London Healthcare Conference. It was so busy that at one point, security had to...

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Jazz wins approval for bispecific in biliary tract cancer

Jazz Pharmaceuticals earned an FDA approval on Wednesday for zanidatamab, the HER2-targeted bispecific antibody it picked up from Zymeworks for $50 million upfront. The drug, to be marketed as Ziihera,...

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AstraZeneca culls Phase 2 opioid use disorder drug

AstraZeneca ended a Phase 2 trial of an experimental opioid use disorder treatment, the UK pharma confirmed to Endpoints News. The termination was due to “discontinuation of the AZD4041 clinical...

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FDA adcomm raises risk questions on AstraZeneca’s Andexxa

Members of an FDA advisory committee were not asked to vote Thursday on AstraZeneca’s anticoagulant reversal drug Andexxa, but they did raise several safety and efficacy concerns. Last year,...

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With yearslong reorganization behind it, Novartis increases its sales guidance

Novartis’ reorganization is paying off, CEO Vas Narasimhan told investors at an event Thursday in London. The company raised its sales guidance through 2028 and now expects to grow sales at a 6% annual...

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Patient dies in Neurogene's Rett syndrome study

A female Rett syndrome patient died Wednesday after receiving Neurogene's gene therapy in a clinical trial, the company disclosed in a new regulatory filing, after saying earlier this week that she ...

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Enveda raises $130M for drugs in I&I, obesity and other areas

Biotech startup Enveda has raised a $130 million Series C, the Colorado company said Thursday morning. Founded and led by early Recursion employee Viswa Colluru, the startup will use the funds ...

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