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  • A-Alpha Bio launches AI antibody data consortium with GSK, Boltz and partners
    A-Alpha Bio, a spin‑out founded by David Baker, announced the creation of a new consortium focused on sharing antibody design data. The group aims to address a shortage of high‑quality data that b…
    Endpoints · 22d agoDealPositive↗ source
  • FDA advisory panel to consider reclassifying several widely used peptides
    An FDA advisory committee is meeting this week to decide whether it will recommend reclassifying a group of popular peptide products. The discussion comes as the industry watches closely for any sh…
    Endpoints · 22d agoRegulatoryNeutral↗ source
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  • EU releases AI Act transparency guidelines, impacting healthcare AI developers
    The European Commission published new guidelines on Monday to help providers and deployers of AI systems meet the transparency obligations set out in the EU AI Act. The guidance includes examples…
    raps · 22d agoRegulatoryNeutral↗ source
  • EU releases AI Act transparency guidelines, affecting health-tech developers
    The European Commission has published new guidelines to help providers and users of artificial intelligence systems meet the transparency obligations set out in the EU AI Act. The document explain…
    raps · 22d agoRegulatoryNeutral↗ source
  • PT Organics recalls select Pumpkin Tree banana‑strawberry puree pouches over possible soft plastic contamination
    PT Organics Limited of Lake Oswego, Oregon announced a voluntary recall of certain Pumpkin Tree Peter Rabbit Organics Banana & Strawberry Fruit Puree pouches. The recall is due to an internal pack…
    fda recalls · 22d agoCRLNeutral↗ source
  • Fresh & Ready Foods recalls Spicy Breakfast Burritos over undeclared soy
    Fresh & Ready Foods LLC announced a recall of its Sprig & Sprout and Fresh and Ready Spicy Breakfast Burritos because they may contain undeclared soy. The problem was traced to inadvertent inclusi…
    fda recalls · 22d agoRegulatoryNegative↗ source
  • Samsung Biologics to acquire Swiss CDMO PolyPeptide for $1.8 billion, entering peptide API market
    Samsung Biologics announced a plan to purchase Swiss contract development and manufacturing organization PolyPeptide for $1.8 billion in cash. The acquisition will extend Samsung Biologics' manufa…
    Endpoints · 23d agoDealPositive↗ source
  • UK regulator reports rise in drug approvals and new AI healthcare regulations
    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) released its 2025-2026 annual report to Parliament. The agency highlighted that it approved more new medicines in the past year…
    raps · 23d agoRegulatoryPositive↗ source
  • Study finds China approved more cancer drugs than US between 2020-2025, but US led in first-in-class and speed
    A new analysis published in Health Affairs compares oncology drug approvals by China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) from 2020 thro…
    raps · 23d agoRegulatoryNeutral↗ source
  • UK regulator reports rise in drug approvals and steps to regulate AI in healthcare
    The Medicines and Healthcare products Regulatory Agency (MHRA) presented its 2025-2026 annual report to Parliament, highlighting a higher number of new drug approvals compared with the previous yea…
    raps · 23d agoRegulatoryPositive↗ source
  • Anthropic ramps up biopharma push with Nobel hires and M&A plans
    Anthropic, known for its artificial‑intelligence models, is expanding its focus to life sciences after a detailed internal memo outlined the move. The memo, released in late 2024, named biology an…
    Endpoints · 23d agoPositive↗ source
  • UK biotech venture capital funding hits record high in Q2 2026, surpassing any full year since 2022
    UK biotech companies secured more venture capital in the second quarter of 2026 than they did in any full calendar year since 2022. The surge reflects a broader fundraising revival, with investors…
    Endpoints · 23d agoDealPositive↗ source
  • Bristol Myers Squibb partners with Nvidia to build pharma's most advanced AI supercomputer
    Bristol Myers Squibb announced it will construct what it calls the most advanced and energy-efficient AI supercomputer system in the biopharma sector. The project will be carried out in partnershi…
    Endpoints · 23d agoDealPositive↗ source
  • UnitedHealth outlines AI rollout as quarterly results beat expectations
    UnitedHealth Group, a major health insurer, announced a substantial investment in artificial intelligence earlier this year. The company recently detailed how the technology is being integrated in…
    Endpoints · 23d agoPositive↗ source
  • House lawmakers support US trade panel's probe into China's biotech sector and pricing practices
    At least ten members of the U.S. House of Representatives have voiced support for a trade investigation targeting China’s biotechnology industry. The investigation, led by a U.S. trade panel, will…
    Endpoints · 23d agoRegulatoryNeutral↗ source
  • J&J and AbbVie also considered AtaiBeckley before Lilly’s $2.8 B acquisition
    Johnson & Johnson and AbbVie were reported to have evaluated AtaiBeckley as a potential target in the psychedelic market. The companies did not submit an offer before Eli Lilly closed its $2.8 bil…
    Endpoints · 23d agoDealNeutral↗ source
  • Scribe targets $96 million from Nasdaq IPO as Scholar Rock awaits site classification for apitegromab
    Scribe, a gene-editing biotech, announced plans for a Nasdaq initial public offering that could raise roughly $96 million. The company said it would price the shares at $14 each, which is the midp…
    Endpoints · 23d agoDealNeutral↗ source
  • Australia's TGA opens consultation to revamp rules for digital mental health tools
    The Therapeutic Goods Administration (TGA) has launched a public consultation aimed at updating the regulatory framework that governs digital mental health tools in Australia. The move seeks to cla…
    raps · 23d agoRegulatoryNeutral↗ source
  • Relay Peak Research LLC Recalls Zen Principle® Moringa Capsules Because of Possible Health Risk
    Relay Peak Research LLC (Zen Principle Naturals) of Incline Village, NV is voluntarily recalling its Zen Principle® brand Moringa Capsules dietary supplement because the product has the potential t…
    fda recalls · 24d ago↗ source
  • Biogen’s mixed Alzheimer’s data; Two new startups launch; and more
    Welcome back to another edition of Endpoints Weekly! We hope you all have been staying safe indoors as the Canadian wildfires blanketed much of the US Northeast this week. Hopefully things calm dow…
    Endpoints · 25d ago↗ source
  • Fayus Inc., dba Yusol International Foods Expands Recall of OLA-OLA POUNDED YAM Due to Undeclared Milk Allergen
    Fayus Inc., doing business as Yusol International Foods (Sacramento, CA) is expanding its recall of OLA-OLA POUNDED YAM to include product sizes 2lbs, 4lbs, 5lbs, and 10lbs due to product labeling…
    fda recalls · 25d ago↗ source
  • Midsized biotechs press White House to drop CMS pricing rules
    A number of midsized biotech companies have met with White House and HHS officials in the last week, presenting their case for why two pending CMS pricing models could hinder their business and sho…
    Endpoints · 26d ago↗ source
  • Celcuity got its cancer drug approved. Then its stock dipped
    The FDA’s approval for Celcuity’s cancer drug Revtorpyk on Tuesday was widely anticipated. What Wall Street didn’t expect was that the drug could take until the end of the quarter to launch. ...
    Endpoints · 26d ago↗ source
  • GSK plans large study to see if shingles vaccine can prevent dementia
    LONDON — Over the past several years, data scientists searching through national health records have noticed something surprising about people who had been vaccinated for shingles: They were less l…
    Endpoints · 26d ago↗ source
  • Dimerix buys a kidney injury drug; Arpeggio appears to be winding down
    Plus, news about Takeda, Novartis and Regenxbio. 🤝 Mission sells kidney injury drug to Dimerix: Dimerix will pay $5 million upfront for Mission’s Phase 2-ready candidate for acute kidney injury, k…
    Endpoints · 26d ago↗ source