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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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SIGA fires former NYC Covid advisor after secret recordings detail...

Biotech company SIGA Technologies has fired chief medical officer Jay Varma, days after the publication of secret recordings of the former New York City public health advisor talking about how he...

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Novo Nordisk CEO skeptical of PBM promises in Senate hearing on weight loss...

Sen. Bernie Sanders (I-VT) told Novo Nordisk CEO Lars Fruergaard Jørgensen that three major pharmacy benefit managers have agreed not to penalize the company for lowering the list prices of its popular...

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FDA adcomm will reexamine approval of checkpoint inhibitors in two cancers...

The FDA’s Oncologic Drugs Advisory Committee will meet Thursday to discuss whether several immune checkpoint inhibitor drugs should come with narrower indications in two cancers, based on emerging data...

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Amgen reports dual Phase 3 wins in atopic dermatitis and myasthenia gravis

Amgen released data from two pivotal trials on Tuesday that showed its experimental drug rocatinlimab succeeded in a Phase 3 test in atopic dermatitis, while its approved drug Uplizna also yielded...

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Italian gene therapy startup nabs $52M for rare genetic disease that Moderna...

Genespire patched together a €46.6 million (about $52 million) funding round to get its lead gene therapy into the clinic in a few years. The Milan-based biotech, which employs nine people, said...

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2seventy bio, Bristol Myers end late-stage Abecma study in multiple myeloma

2seventy bio and its partner Bristol Myers Squibb said Wednesday that they are discontinuing enrollment in the Phase 3 KarMMa-9 study investigating Abecma in patients with newly diagnosed multiple...

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FDA OKs IntraBio's drug less than a week after rare disease's first-ever...

Within the span of a week, the FDA gave the green light to another drug for the rare condition Niemann-Pick disease type C in the form of IntraBio’s levacetylleucine. On Friday, the FDA approved Zevra...

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Merck's LAG-3 plus Keytruda combo fails Phase 3 in colorectal cancer

Merck’s efforts to combine its PD-1 blockbuster Keytruda with an experimental LAG-3 inhibitor hit a stumbling block Wednesday morning. The company said a Phase 3 study testing the LAG-3 program...

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