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  • Bicara CEO Claire Mazumdar to step down, COO Ryan Cohlhepp to assume leadership in 2027
    Claire Mazumdar, who co‑founded Bicara and has served as its chief executive for almost seven years, announced she will step down at the end of the year. She will take parental leave and then move…
    BioSpace · 1mo agoPositive↗ source
  • Industry groups back FDA draft guidance on single‑trial approvals but seek clearer flexibility rules
    Industry associations and other stakeholders have expressed overall support for the FDA's draft guidance that outlines when a single pivotal trial, supplemented by confirmatory evidence, can be suf…
    raps · 1mo agoRegulatoryNeutral↗ source
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  • Researchers create mouse with human-derived brain cortex, sparking ethical and scientific debate
    A research team led by Stanford professor Sergiu Pașca has reported in Nature the creation of a laboratory mouse whose cerebral cortex is built from human brain cells derived from stem cells. The s…
    STAT · 1mo agoNeutral↗ source
  • Experts call for regulation of kratom and potent 7-OH products, debate over specific rules
    Kratom leaf products have been sold in the United States for many years without formal regulatory oversight. Users often turn to them for chronic pain, anxiety, or to ease opioid withdrawal, despit…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Women-led biotech M&A drops sharply in 2026, only two major deals recorded so far
    Last year saw an unprecedented wave of women-led biotech transactions, with eleven high‑value deals out of 72 total biopharma mergers in 2025. In 2026 the pace has slowed dramatically, with just…
    BioSpace · 1mo agoDealNegative↗ source
  • Biopharma must incentivize scientists to make early go-no-go decisions
    The article argues that simply urging scientists to think like entrepreneurs is not enough; biopharma firms need to align rewards with that mindset. Because only about one in ten drug candidates t…
    BioSpace · 1mo agoNeutral↗ source
  • Pennsylvania reports four measles deaths this year, CDC records only two
    Pennsylvania health officials say four people have died from measles so far in 2026. The Centers for Disease Control and Prevention, however, lists only two measles deaths in its national count. T…
    STAT · 1mo agoNeutral↗ source
  • STAT releases AI Prognosis newsletter on health tech leaders' policy discussions in Washington
    STAT's AI Prognosis newsletter issued a new edition that looks at what health technology executives are saying about policy issues in Washington. The piece was authored by Brittany Trang, a Ph.D.…
    STAT · 1mo agoNeutral↗ source
  • Biopharma needs to reward scientists' judgment
    It’s not enough for organizations to want scientists to think like entrepreneurs. They have to incentivize and reward for that behavior.
    BioSpace · 1mo ago↗ source
  • AstraZeneca invests $2 billion in Summit Therapeutics to advance PD-1xVEGF bispecific ivonescimab with ADC combos
    AstraZeneca is committing $2 billion to Summit Therapeutics, acquiring a 12% equity stake at a premium to the biotech's closing price. The funding is aimed at accelerating development of the PD‑1xV…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • FDA approves Egetis’ Emcitate for rare genetic disease as Novo secures Chinese weight-loss pill in $2.6 billion deal
    The U.S. Food and Drug Administration has granted approval to Egetis' Emcitate, a therapy targeting a rare genetic disorder. This marks a regulatory milestone for the company and patients awaiting…
    raps · 1mo agoDealPositive↗ source
  • AstraZeneca invests $2 billion in Summit Therapeutics to fund Phase 3 trials of ivonescimab
    AstraZeneca has agreed to a $2 billion all‑stock investment in Summit Therapeutics. The deal involves the purchase of preferred shares that can be converted into common stock, but it does not inclu…
    BioSpace · 1mo agoDealPositive↗ source
  • Novo Nordisk signs $2.6 billion deal with China's Hengrui for oral GLP-1/GIP candidate
    Novo Nordisk announced a licensing agreement with Chinese drugmaker Hengrui Pharmaceuticals, paying $300 million upfront for rights to a preclinical GLP-1/GIP dual-receptor agonist. The candidate,…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • UniQure’s gene therapy still slows Huntington’s disease after four years, but benefit declines
    UniQure reported that its one‑time gene therapy, AMT‑130, continues to decelerate the progression of Huntington’s disease four years after being surgically delivered into patients' brains. A new a…
    STAT · 1mo agoNegative readoutNegative↗ source
  • Curium gains FDA nod for Bexlutry as it eyes challenge to Novartis radioligand therapies
    Curium recently received FDA approval for its radiopharmaceutical Bexlutry, positioning it as a direct competitor to Novartis’ Lutathera. The biotech is also in discussions with the FDA about fili…
    BioSpace · 1mo agoApprovalNeutral↗ source
  • US charges two Indian nationals in counterfeit Ozempic distribution scheme
    The U.S. Attorney’s Office for the Middle District of Florida and the DOJ’s Criminal Division announced federal charges against Swapnadip Roy, 33, and Vicky Ramancha, 37, both Indian nationals, for…
    fda press · 1mo agoRegulatoryNegative↗ source
  • Lawmakers ask Trump to reconsider rule that would tighten import of prescription drugs from Canada
    Congressional members are pressing the Trump administration to revisit a federal rule slated to take effect on Oct. 22 that would tighten how prescription medicines are imported from Canada and oth…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Anthropic joins ARPA‑H clinical AI moonshot and will host a closed‑door health‑care event
    Anthropic, an artificial‑intelligence firm, announced it is joining a new clinical‑AI initiative launched by the U.S. Biomedical Advanced Research Projects Agency‑Health (ARPA‑H). The partnership…
    STAT · 1mo agoNeutral↗ source
  • Roche drops anti-myostatin obesity drug after mid-stage trial shows limited weight loss
    Roche announced it will stop development of its anti-myostatin obesity candidate emugrobart after an interim analysis of the Phase 2 GYMINDA trial showed it is unlikely to produce meaningful weight…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • AstraZeneca commits $2 billion to partner Summit Therapeutics on bispecific cancer antibody
    AstraZeneca has announced a $2 billion investment to work with Summit Therapeutics. The deal will fund the testing of Summit’s bispecific antibody, ivonescimab, which targets both PD‑1 and VEGF pat…
    STAT · 1mo agoDealPositive↗ source
  • Novo to pay up to $2.6 billion for rights to Hengrui’s experimental weekly obesity pill
    Novo Pharmaceuticals has signed a licensing agreement with China's Hengrui Pharma to acquire an experimental oral weight‑loss drug that is administered once a week. Under the deal, Novo could pay…
    STAT · 1mo agoDealNeutral↗ source
  • Novo Nordisk licenses weekly oral obesity peptide from Hengrui in up to $2.6 billion deal
    Novo Nordisk has signed a licensing agreement with China's Hengrui Pharma for a once‑weekly oral peptide, HRS‑1596, aimed at obesity and other metabolic conditions. Novo will pay $300 million upfr…
    BioSpace · 1mo agoDealNeutral↗ source
  • Highlight Therapeutics reports positive Phase 2b results for BO-112 in high‑risk head and neck basal cell carcinoma
    Highlight Therapeutics announced that its Phase 2b study of BO-112 met the primary endpoint of visual and pathological response at week 24 in patients with localized high‑risk head and neck basal c…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • uniQure shares tumble 41% after Huntington’s gene therapy misses primary endpoint
    uniQure reported updated 48‑month data from its phase 1/2 trial of AMT‑130 in Huntington’s disease. The therapy showed a 44% slowing of disease progression on the composite Unified Huntington’s Dis…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Midterm elections could reshape drug pricing, Medicaid funding and research support, industry leaders warn
    The November midterm elections are set to influence major health-care policy debates in Washington, according to STAT+. Industry leaders say the outcome could affect Medicaid funding levels, the p…
    STAT · 1mo agoRegulatoryNeutral↗ source