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  • Inside the Gulf biotech deal model, ahead of RGMBS 2026 in Riyadh
    Sovereign capital, guaranteed offtake, and localization mandates are reshaping how biotech deals get structured in the Gulf, ahead of the Riyadh Global Medical Biotechnology Summit (RGMBS) 2026, 14…
    BioSpace · 20h agoDealNeutral↗ source
  • BioSpace launches dashboard to track performance of U.S. biotech IPOs in 2026
    BioSpace introduced a new IPO dashboard that monitors U.S. biotech companies that went public in 2026. The tool will be refreshed weekly with the latest closing prices and will add any newly liste…
    BioSpace · 13h agoNeutral↗ source
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  • Cellares defends its cell therapy platform after Bristol Myers ends partnership
    Cellares, a cell therapy manufacturing startup, responded to criticism from Bristol Myers Squibb after the drugmaker terminated their agreement. Bristol Myers withdrew, saying Cellares' commercial…
    Endpoints · 7h agoNegative↗ source
  • Calcium scans may guide statin decisions in a few borderline patients, studies find
    Two recent trials evaluated whether coronary artery calcium (CAC) scans, used together with the PREVENT risk calculator, can help decide on statin therapy. The studies compared the imaging results…
    STAT · 10h agoNeutral↗ source
  • FDA reportedly weighing two new deputy commissioner roles, one for health AI and one for drugs
    The Food and Drug Administration is said to be considering the creation of two additional deputy commissioner positions. The proposal is being reported by media outlets but has not been confirmed b…
    BioSpace · 14h agoRegulatoryNeutral↗ source
  • New York law adds recording safeguard to medical aid in dying, sparking ethical debate
    New York has enacted a law that permits terminally ill residents with six months or less to obtain medication for self-directed death. A distinctive feature of the legislation is that patients must…
    STAT · 16h agoRegulatoryNeutral↗ source
  • Many post-Dobbs abortion concerns have not materialized, says expert
    David N. Hackney, a professor of reproductive biology and division chief of maternal‑fetal medicine, reflects on the four years since the Supreme Court overturned Roe v. Wade. He notes that several…
    STAT · 16h agoNeutral↗ source
  • Early Alert: Heart Pump Controller Purge Cassette Issue from Abiomed
    Abiomed is removing Automated Impella Controllers due to purge cassette recognition failures that may lead to prolonged delayed in mechanical circulatory support.
    fda medwatch · 21h ago↗ source
  • Percutaneous Catheter Recall: Boston Scientific Removes ENROUTE Transcarotid Neuroprotection System
    ENROUTE Transcarotid Neuroprotection Systems may have arterial sheath tip separation or partial tip separation during use.
    fda medwatch · 21h ago↗ source
  • FDA expands Jazz's Ziihera use to frontline gastric cancer
    FDA granted approval for Jazz Pharmaceuticals' bispecific antibody Ziihera as a frontline treatment for certain gastric cancer patients. This is the first time Ziihera will be marketed to newly di…
    Endpoints · 1d agoApprovalPositive↗ source
  • J&J’s Imaavy gains first-in-class label for warm autoimmune hemolytic anemia
    J&J announced that its monoclonal antibody Imaavy has received a label expansion in the United States. The expanded indication makes Imaavy the first therapy approved specifically for warm autoimm…
    Endpoints · 1d agoApprovalPositive↗ source
  • Eli Lilly launches oral obesity drug Foundayo in the UK
    Eli Lilly has introduced its oral weight‑loss pill Foundayo to the United Kingdom market, positioning the small‑molecule therapy as a price‑sensitive alternative to injectable options. The UK Medi…
    BioSpace · 1d agoRegulatoryPositive↗ source
  • Sword Health proposes acquisition of mental-health startup Headspace, linking two digital health unicorns
    Sword Health announced a proposal to acquire Headspace, a mental-health startup, according to a filing with Massachusetts state officials. The deal would combine two digital-health companies that…
    Endpoints · 1d agoDealNeutral↗ source
  • Trump-era health funding cuts reshape U.S. health system, prompting Medicaid coverage changes
    STAT’s D.C. Diagnosis newsletter examines how recent Republican health‑care funding cuts are altering the nation’s health‑care safety net. The series, led by Washington correspondent John Wilkerson…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Haisco Pharmaceutical partners with ARCH Venture Partners and Population Health in new China-focused deal
    Haisco Pharmaceutical, a China-based drugmaker, has continued its active summer dealmaking by striking a new partnership. The partnership brings together ARCH Venture Partners, a venture capital f…
    Endpoints · 1d agoDealPositive↗ source
  • Haisco partners with US VCs to launch immunology biotech Sentivera with up to $1.5B funding
    Haisco Pharmaceutical Group announced the creation of a new immunology-focused biotech called Sentivera, backed by two American venture‑capital firms, Population Health Partners and ARCH Venture Pa…
    BioSpace · 1d agoDealPositive↗ source
  • Turkish antitrust regulator launches probe into Teva for alleged patent manipulation and false claims about rivals
    Turkish competition authorities have opened an investigation into Teva Pharmaceutical, the world’s largest generic drugmaker, accusing the company of manipulating the patent system and making misle…
    STAT · 1d agoRegulatoryNegative↗ source
  • OmicsBank secures $2.25M to expand overseas patient data platform for biopharma
    OmicsBank announced it has closed a $2.25 million financing round aimed at scaling its platform that aggregates patient health data from overseas sources for use by biopharma companies. The compan…
    Endpoints · 1d agoDealPositive↗ source
  • Trump’s Medicaid cuts strain rural hospitals in Maine and Louisiana
    President Trump’s administration has slashed about $1 trillion from projected Medicaid funding over the next ten years and let billions in insurance subsidies expire, prompting a rapid reassessment…
    STAT · 1d agoRegulatoryNegative↗ source
  • Curium seeks FDA review of rival radioligand therapy to boost supply resilience against Novartis' Pluvicto
    Curium is preparing to challenge Novartis' dominant prostate cancer radioligand therapy, Pluvicto, by entering discussions with the FDA about reviewing its own PSMA‑directed Lu‑177 candidate. Nova…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Sword Health to acquire mental-health platform Headspace in cash deal slated for September 14
    Sword Health, a digital health firm best known for its AI‑driven virtual physical therapy, has filed to purchase mental‑health service provider Headspace. The regulatory filing indicates the trans…
    STAT · 1d agoDealNeutral↗ source
  • Amgen and academic centers discuss FDA pilot to accelerate first-in-human trials
    The U.S. Food and Drug Administration is working with industry and research institutions on a pilot program aimed at speeding first-in-human studies. The effort is intended to counter the rapid tim…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • Two unvaccinated Pennsylvanians die from measles, marking first US deaths this year
    Two unvaccinated residents of Lancaster County, Pennsylvania have died from measles, the first measles-related deaths reported in the United States this year. State Health Secretary Dr. Debra Boge…
    STAT · 1d agoNegative↗ source
  • Massachusetts biotech workforce rebounds after 2025 decline
    A new report from the Massachusetts Biotechnology Council shows the state’s biopharma employment fell by about 3,600 workers in 2025, marking the first drop since at least 2002. The workforce tota…
    STAT · 1d agoPositive↗ source
  • FDA pledges new guidance for generative AI medical devices as Epic shares updates from its user conference
    The Food and Drug Administration released a discussion paper outlining its plans to regulate generative‑AI‑powered medical devices. The agency said it will issue formal guidance to clarify how exis…
    STAT · 1d agoRegulatoryNeutral↗ source