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CDER Director Patrizia Cavazzoni to step down

Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, will step down, the agency confirmed Friday. An email was sent to employees announcing the departure. "Leaving CDER...

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Four biotechs emerge with $800M and in-licensed assets on Friday

Four new biotechs launched Friday with megarounds and in-licensed treatment candidates, giving the industry an $800 million boost ahead of the year's biggest dealmaking event in San Francisco. Three of...

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City Therapeutics, Bausch + Lomb partner on preclinical RNAi eye drug

With its new CEO installed this week, City Therapeutics is aiming to capitalize on the momentum in signing a new deal. The startup is partnering with Bausch + Lomb on an experimental ...

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Stemson Therapeutics shutters; Insilico teams up again with Menarini

Plus, news about Crinetics, Compass Pathways, Amylyx Pharmaceuticals, Sciwind Biosciences, 4D Molecular Therapeutics, Barinthus Bio, Y-mAbs Therapeutics and Meiji Seika Pharma: Hair growth biotech...

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Endpoints at JPM 2025: China, Trump 2.0, markets and more

When we started putting together this year’s JPM agenda, we had three major focus areas: The transition to Trump 2.0; the on-again, off-again market recovery, and the evolving US-China dynamic. These...

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Moderna's former top scientist Moore has a new mRNA startup

Melissa Moore helped usher in the first mRNA medicines, but the former Moderna executive thinks there’s still a lot of room for improvement. The rapid success of the first mRNA vaccines during the...

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AbbVie writes off $3.5B on Cerevel drug after Phase 2 failures

AbbVie is taking a major loss in the wake of its Cerevel buyout. AbbVie said it will write off $3.5 billion following two mid-stage failures for emraclidine, the experimental schizophrenia drug that...

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Dyne details pivotal plans for myotonic dystrophy RNA drug, though data blip...

Dyne Therapeutics touted an early-stage study of its RNA treatment for myotonic dystrophy type 1 and has selected the dose it plans to move forward into pivotal studies. However, the company’s shares...

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Lilly finances new $500M biotech fund managed by a16z

Eli Lilly is expanding its private financing ambitions, partnering with venture capital firm Andreessen Horowitz on a new $500 million biotech fund. The pharma company is providing all the capital for...

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Pfizer touts bladder cancer results as first advancement for some patients...

Pfizer said its experimental anti-PD-1 drug bested the current standard of care in a type of bladder cancer where progress has been limited. Its therapy, called sasanlimab, significantly prolonged...

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Lawmakers ask administration to tighten China trial rules

Members of Congress working on anti-China legislation have asked the US Commerce Department to harden its policies around who can run clinical trials at sites operated by the People’s Liberation Army....

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FDA adcomm votes to support Seikagaku's herniated disc injection

Despite some safety concerns, an FDA advisory committee on Friday voted 8 to 4 in favor of Japan-based Seikagaku's condoliase injection for the treatment of radicular leg pain associated with lumbar...

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Obesity drug startup Metsera files for IPO

Metsera has filed to go public less than a year after its launch, capitalizing on the fervent investor interest — and intense competition — for all things obesity. The startup's sprint toward an IPO...

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Biogen offers to buy Sage Therapeutics for $469M

Biogen has made an offer to acquire its partner Sage Therapeutics, according to a Friday evening regulatory disclosure, following months of setbacks by the smaller company that have led to a long slide...

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DNA edit leads to apparent cure in infant; CDER director to step down; More...

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...

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Pharma is losing the AI talent war against startups: Analysis

Last month, NeurIPS, the biggest AI research conference, turned Vancouver’s convention center into a battleground for wooing AI talent. The recruiting trenches of the expo floor featured hundreds of...

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Tune Therapeutics raises $175M Series B for epigenetic editing

In genetic medicine, a drumbeat of layoffs and pipeline cuts has replaced the excitement of just a few years ago, when fresh financing rounds were coming almost as often as new editing technologies and...

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The embryo editing debate is back, revived by Nature article

Six years ago, Chinese researcher He Jiankui stunned the world by announcing the birth of the first two babies whose genes were edited as embryos. An ethical red line was crossed and condemnation from...

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J&J looks at potential bid for Intra-Cellular — report

Johnson & Johnson is considering an acquisition of CNS drugmaker Intra-Cellular Therapies, according to anonymous sources cited in a Bloomberg News report on Sunday. If J&J follows through with...

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Lantheus to buy Life Molecular Imaging for $350M, netting Alzheimer's diagnostic

Radiopharmaceutical maker Lantheus Holdings plans to acquire Life Molecular Imaging for $350 million in a bid to build up its commercial Alzheimer’s diagnostics business. In addition to the $350...

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