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The drug lobby's lawsuit against the IRA finds a sign of life after appeals...

The US Court of Appeals for the Fifth Circuit is reviving PhRMA’s legal attack on Medicare drug price negotiations. On Friday, the appeals court reversed a lower court’s ruling from earlier this year...

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Sanofi's Sarclisa gets approved as a first-line option for some patients...

Despite largely exiting oncology, Sanofi continues to reap the benefit of its multiple myeloma treatment Sarclisa. The FDA on Friday approved the anti-CD38 treatment as a first-line option for patients...

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A VC-backed genetic testing startup to 'consider' making an offer to buy 23andMe

A small genetic testing startup backed by Peter Thiel’s Founders Fund and Reddit co-founder Alexis Ohanian’s 776 Fund is “considering the possibility of making a public offer to acquire 23andMe,...

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Regulatory RNA startup CAMP4 files for IPO as more biotechs line up listings

Another biotech startup revealed plans Friday evening for an initial public offering, making it the sixth startup to list new shares or file for an IPO in the last two weeks. CAMP4 Therapeutics, a...

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J&J subsidiary files for third bankruptcy to settle talc claims

A Johnson & Johnson subsidiary filed for bankruptcy in its third attempt to settle a vast majority of cases alleging its talc products caused cancer. The $8 billion settlement plan would resolve...

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A small startup is challenging Epic's control over patient health records

A software startup has sued Epic on antitrust grounds, arguing that the electronic health records giant has orchestrated a scheme to destroy the startup’s business and maintain its monopoly over...

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Biogen, UCB declare Phase 3 lupus win and prep a second trial, but details...

Biogen and UCB said Tuesday morning that data from a Phase 3 study for the lupus program dapirolizumab pegol were strong enough to convince it to launch a second pivotal trial to confirm the benefit...

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Flagship’s AI biotech Generate lands $65M upfront in Novartis deal, as first...

The AI-focused biotech Generate:Biomedicines announced another pharma partnership Tuesday, agreeing to work on several protein therapies with the Swiss drugmaking giant Novartis. Novartis will pay $50...

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Constructive Bio raises $58M for synbio work, and Nobel laureate joins board

A UK-based synthetic biology startup has brought in $58 million from private investors to fund its work engineering cell systems that can manufacture new and existing molecules. The company, called...

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Clive Meanwell's new obesity biotech, Metsera, unveils early GLP-1 data with...

Metsera, the well-funded obesity biotech from Population Health Partners and ARCH Venture Partners, has unveiled its first clinical data just a few months after emerging with $290 million and a broad...

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House passes reauthorization of rare pediatric voucher program

The US House of Representatives on Monday afternoon unanimously passed a wide-ranging bill via voice vote that will reauthorize the rare pediatric priority review voucher program through 2029, among...

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Updated: Gene therapy maker bluebird bio cuts costs again, lays off staff

Bluebird bio is cutting more jobs and expenses in the latest bid to manage its fragile finances as it supports the launch of its sickle cell gene therapy Lyfgenia. The company announced earlier Tuesday...

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Health plan startup Centivo raises $75M

Centivo, a startup that sells health insurance to employers, raised $75 million in fresh funds months after it bought a virtual primary care startup to use in its offerings. The startup’s goal is to...

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Sanofi hires Mike Quigley as next chief scientist, internal memo says

Sanofi has appointed Mike Quigley, a former executive at Gilead and Bristol Myers Squibb, as the French pharma’s next chief scientific officer, Endpoints News has learned. Quigley will replace Frank...

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Samsara adds three venture partners to help steer and advise portfolio companies

Biotech investment firm Samsara BioCapital has added three new venture partners in recent months to expand its network, support first-time CEOs in its portfolio and guide more companies by way of board...

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Checking up on past Endpoints 11 winners: Who went public, who got bought and...

You win some, you lose some — that’s the risk of trying to predict the next hot biotechs. Since 2018, the Endpoints 11 awards have identified startups with the right ingredients to become a great drug...

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PCI Pharma earmarks $356M to expand injectable device capacity in US and Ireland

PCI Pharma Services is pouring $365 million to expand its US and Irish footprint for commercial and clinical packaging of drug-device products to meet “evolving” market needs. The CDMO, which...

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Capricor to begin filing DMD drug with FDA next month; Surrozen’s $10M milestone

Plus, news about Adaptimmune, Roche, LIfT BioSciences, VerImmune, and Revance Therapeutics: Capricor Therapeutics to file Duchenne cardiomyopathy treatment with the FDA: The San Diego-based biotech in...

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Wave rides new Phase 2 DMD data as it sets sights on accelerated approval

Wave Life Sciences said new Phase 2 biomarker data for its exon-skipping therapy are promising for certain patients with Duchenne muscular dystrophy, and it plans to discuss accelerated approval plans...

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Regeneron hits setback in Eylea patent battle with Amgen

Regeneron’s stock $REGN dipped about 4% on Tuesday following a loss in its legal battle with Amgen over competitors to its blockbuster eye treatment Eylea. While Regeneron previously defended itself in...

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