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  • Zuckerberg’s Biohub secures $1.8 billion to expand AI-driven virtual cell platform with Meta and Google
    Mark Zuckerberg and Priscilla Chan's nonprofit Biohub announced an expansion of its virtual cell initiative, now backed by $1.8 billion in funding. The new capital comes from a coalition that incl…
    Endpoints · 13d agoPositive↗ source
  • Cadrenal Therapeutics launches strategic review to explore sale or partnership for its late-stage cardiology pipeline
    Cadrenal Therapeutics, a heart-focused biotech, announced a strategic review of its late-stage cardiology pipeline, seeking to offload assets or the entire company. The board is evaluating options…
    Fierce Biotech · 13d agoDealNegative↗ source
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  • Matchpoint Therapeutics raises $150M Series B to advance oral covalent therapies for autoimmune disease
    Matchpoint Therapeutics announced a $150 million Series B financing round. The round was co-led by Nextech Invest and Norwest, with participation from Sanofi Ventures, Digitalis Ventures, Invus, BB…
    Fierce Biotech · 13d agoDealPositive↗ source
  • EMA to revise pharmacogenomics guideline as MHRA adopts AI framework for medical devices
    The European Medicines Agency’s Committee for Medicinal Products for Human Use is preparing a major revision of its 2018 guideline on good pharmacogenomic practices. Regulators say the rapid advan…
    raps · 13d agoRegulatoryNeutral↗ source
  • PhRMA files lawsuit against Trump administration over GLOBE drug pricing demonstration program
    PhRMA, the leading trade association for the pharmaceutical industry, has filed a lawsuit against the U.S. government challenging the Centers for Medicare & Medicaid Services' GLOBE drug pricing de…
    Endpoints · 13d agoRegulatoryNegative↗ source
  • Ultragenyx sells priority review voucher for $210 million, retains another to monetize
    Ultragenyx Pharmaceutical announced it has sold a priority review voucher to an undisclosed buyer for $210 million. The transaction is among the highest-priced voucher sales this year, providing a…
    Endpoints · 13d agoDealPositive↗ source
  • WHO advises against GLP-1 obesity drugs for children under 10, limits use in teens
    The World Health Organization issued guidance recommending that GLP-1 drugs not be used to treat obesity in children younger than ten years old. For adolescents aged 10 to 19, the WHO says these m…
    Endpoints · 13d agoRegulatoryNegative↗ source
  • Novartis-partnered Matchpoint Therapeutics raises $150 million Series B to fund clinical entry
    Matchpoint Therapeutics, a biotech company working with Novartis, announced the close of a new financing round. The round raised $150 million in Series B funding. The capital will be used to advan…
    Endpoints · 13d agoDealPositive↗ source
  • TCGX launches $600 million Asia-focused biotech fund to back life-science companies in China and the region
    TCGX, a biotech investment firm led by Chen Yu and Dandan Dong, announced a new $600 million fund aimed at the Asian market. The fund will make direct investments in life-science companies located…
    Endpoints · 13d agoDealPositive↗ source
  • ARPA-H launches Surpass program to speed and broaden clinical trials
    The U.S. Department of Health and Human Services announced a new initiative called Surpass, aimed at removing obstacles that slow clinical development and changing how trials are designed and run.…
    Fierce Biotech · 13d agoPositive↗ source
  • CAR-T biotech Caribou Biosciences halts two programs and seeks exit after funding shortfall
    Caribou Biosciences announced it is suspending two of its allogeneic CAR-T cell therapy projects. The company said it could not obtain the financing needed to keep the programs alive and is now lo…
    Endpoints · 13d agoNegative↗ source
  • TCGX raises $600 million to fund Asian biotech startups
    Investment firm TCGX announced a new $600 million Asia Life Sciences Fund I aimed at supporting biotech companies across the region. The fund will operate separately but in close coordination with…
    Fierce Biotech · 13d agoDealPositive↗ source
  • Atsena reports early efficacy signals for gene therapy ATSN-201 in X-linked retinoschisis trial
    Atsena Therapeutics presented data from the early parts of its Lighthouse gene therapy trial for X-linked retinoschisis (XLRS) at the American Academy of Ophthalmology meeting. The trial administe…
    Fierce Biotech · 13d agoPositive readoutPositive↗ source
  • Stryker appoints Spencer Stiles as CEO, Kevin Lobo to become Executive Chair
    Stryker announced a leadership change, naming Spencer Stiles as the new chief executive officer. Stiles, who has been president and COO, will also join the board. Kevin Lobo, who has led the compa…
    Fierce Biotech · 13d agoNeutral↗ source
  • Bexorg receives $28 million ARPA-H grant to extend testing of revived human brain tissue
    Bexorg, a biotech focused on brain research, was awarded $28 million by the U.S. Advanced Research Projects Agency for Health (ARPA-H). The funding will support longer-duration experiments on human…
    Endpoints · 13d agoDealPositive↗ source
  • Nuvig Therapeutics halts Phase 2 trial of NVG-2089 in chronic inflammatory demyelinating polyneuropathy
    Nuvig Therapeutics announced it is terminating one of its two ongoing clinical programs, a Phase 2 study of its candidate NVG-2089. The trial was designed to evaluate NVG-2089 in patients with chr…
    Endpoints · 13d agoCRLNegative↗ source
  • MimiVax's glioblastoma vaccine falls short of Phase 2b primary endpoint
    MimiVax reported that its investigational vaccine for glioblastoma did not achieve the primary efficacy goal in a Phase 2b trial. The study, more than a decade in development, compared the vaccine…
    Endpoints · 13d agoNegative readoutNegative↗ source
  • iRegene Therapeutics’s NouvSight001 Cleared for Clinical Trials in the U.S. and China for Retinitis Pigmentosa
    Following its Parkinson’s disease program, iRegene advances another off-the-shelf cell therapy into clinical development in the U.S. and China.
    Fierce Biotech · 13d agoNeutral↗ source
  • Eden Brothers recalls Calabrese broccoli seeds over possible Salmonella contamination
    Eden Brothers LLC announced a recall of its Calabrese broccoli seeds after being informed by its supplier that the product may be contaminated with Salmonella. The recall includes 1‑ounce and 1‑po…
    fda recalls · 13d agoCRLNegative↗ source
  • AbbVie and Genmab's Epkinly succeeds in late-stage first-line DLBCL trial, challenging Roche's Polivy
    AbbVie and Genmab announced that their T‑cell engager Epkinly met its primary endpoints in a late‑stage study evaluating first‑line treatment for diffuse large B‑cell lymphoma (DLBCL). The trial de…
    Endpoints · 14d agoPositive readoutPositive↗ source
  • MimiVax’s cancer vaccine fails phase 2 glioblastoma study, but CEO still sees data as ‘inspiring’
    MimiVax has reports a phase 2b miss in newly diagnosed glioblastoma patients, but remains positive about a significant survival benefit in a subset of patients 65 years and under.
    Fierce Biotech · 14d agoNegative readoutNegative↗ source
  • Forbion raises €2.3 billion with Lilly backing, launches largest Dutch VC fund to back ~30 life-science firms
    Forbion, a Netherlands-based life-science investor, announced it has closed two new funds totaling €2.3 billion ($2.6 billion), the largest capital raise in Dutch venture-capital history. The fund…
    Endpoints · 14d agoDealPositive↗ source
  • Forbion raises record €2.3 billion to back 30 European biotech firms
    Forbion Capital Partners announced it has closed two new funds, the Growth Opportunities Fund IV and Ventures Fund VIII, together raising €2.3 billion, a record for the European life‑sciences ventu…
    Fierce Biotech · 14d agoDealPositive↗ source
  • TRex Bio targets $111M IPO as Retension and Lycia also prepare public listings
    TRex Bio, backed by Eli Lilly, filed with the SEC to raise about $111.3 million by offering 8.3 million shares priced between $14 and $16. If the midpoint price is achieved, the company expects net…
    Fierce Biotech · 14d agoDealNeutral↗ source
  • UK regulator to shift from one-off checks to continuous monitoring of AI medical devices
    The UK’s Medicines and Healthcare products Regulatory Agency announced a new policy that will require continuous monitoring of AI‑driven medical devices, replacing the current one‑time review model…
    Fierce Biotech · 14d agoRegulatoryPositive↗ source