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  • Bayer's Sunharbo becomes first FDA-approved factor XIa inhibitor blood thinner
    Bayer's oral anticoagulant Sunharbo, known as asundexian, has received FDA approval, making it the first factor XIa inhibitor cleared for use in the United States. The drug is intended to lower th…
    BioSpace · 1h agoApprovalPositive↗ source
  • Beam Therapeutics' base-edited risto-cel shows 12-month pain-crisis freedom in sickle cell trial, paving way for FDA filing
    Beam Therapeutics reported that its base-edited cell therapy, risto-cel, achieved at least 12 consecutive months without severe vaso-occlusive crises in patients with sickle cell disease during a m…
    BioSpace · 1h agoPositive readoutPositive
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  • BIO proposes seven-point plan to keep US biotech ahead of China
    BIO, a major biotech lobbying organization, released a seven‑part “BioAdvance” action plan aimed at preserving U.S. leadership in biotechnology as China rolls out its own five‑year strategy. The p…
    BioPharma Dive · 11h agoRegulatoryPositive↗ source
  • London biotech Oyster raises $60 million to develop tau-targeting protein degraders
    Oyster Therapeutics, a London-based biotech, announced it has secured $60 million in an extension of its Series A financing round. The funding will support its lead program that uses a modified pr…
    BioPharma Dive · 9h agoDealPositive↗ source
  • BIO urges US to create White House biotech office and streamline trials to stay ahead of China
    The Biotechnology Innovation Organization (BIO) released a seven-point "Bio Advance" plan aimed at strengthening the United States' biotech sector. The proposals call for easing the start-up of cli…
    BioSpace · 1h agoRegulatoryNeutral↗ source
  • Altimmune to discuss Phase 3 design for alcohol use disorder drug with FDA
    Altimmune is preparing to meet the FDA in December to discuss the design of a pivotal Phase 3 trial for its glucagon/GLP-1 dual receptor agonist pemvidutide. The Phase 2 RECLAIM study enrolled abo…
    BioSpace · 3h agoRegulatoryNeutral↗ source
  • Delix raises $100M to advance at-home psychedelic without hallucinatory effects
    The series C raise, co-led by Johnson & Johnson’s venture capital arm, will help Delix Therapeutics push its novel psychedelic asset into mid-stage development for major depressive disorder.
    BioSpace · 2h agoRegulatoryNeutral↗ source
  • Amneal and BridgeBio top BioSpace 2027 Best Places to Work list
    BioSpace released its 2027 Best Places to Work list, recognizing 50 life‑science employers with U.S. operations. Amneal Pharmaceuticals, based in Bridgewater, New Jersey, took the top spot among l…
    BioSpace · 11h agoPositive↗ source
  • Delix raises $100M to advance at-home psychedelic without hallucinogenic effects
    The series C raise, co-led by Johnson & Johnson’s venture capital arm, will help Delix Therapeutics push its novel psychedelic asset into mid-stage development for major depressive disorder.
    BioSpace · 2h ago↗ source
  • FDA Approves First Factor Xla Inhibitor to Help Prevent Stroke in Certain Adults at High Risk
    FDA today approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa (FXIa) inhibitor for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a rec…
    fda press · 18h agoApprovalPositive↗ source
  • Lilly's oral GLP-1 Foundayo cuts sleep apnea severity in Phase 3, paving way for second FDA filing
    Lilly said it will submit its oral GLP-1 drug Foundayo for FDA approval in obstructive sleep apnea after a late‑stage trial showed strong efficacy. The Phase 3 ATTAIN-OSA study enrolled about 712…
    BioSpace · 22h agoPositive readoutPositive↗ source
  • Argenx to acquire peptide specialist Unnatural Products in deal worth up to $1.15 billion
    Argenx announced it will purchase Unnatural Products, a peptide discovery biotech, in a transaction that could total up to $1.15 billion. The deal provides $550 million upfront, with additional co…
    BioSpace · 1d agoDealPositive↗ source
  • Bayer's Sunharbo receives FDA approval as first Factor XIa blood thinner
    FDA approved Bayer's new oral anticoagulant Sunharbo, marking the first U.S. approval of a Factor XIa inhibitor. The drug blocks Factor XIa, a protein that helps clots grow while playing a minor r…
    BioPharma Dive · 18h agoApprovalPositive↗ source
  • Novartis' Phase 3 HORIZON trial shows pelacarsen lowers Lp(a) but fails to cut cardiovascular events
    Novartis and Ionis reported that the Phase 3 HORIZON trial of the antisense drug pelacarsen did not improve major adverse cardiovascular events despite markedly lowering lipoprotein(a) levels. The…
    BioSpace · 1d agoNegative readoutNegative↗ source
  • Vir Biotechnology reports 44% undetectable hepatitis delta virus in Phase 3 trial, eyes mid-2027 filing
    Vir Biotechnology announced results from its Phase 3 Eclipse 1 trial of a monthly subcutaneous combination of siRNA therapy elebsiran and monoclonal antibody tobevibart for chronic hepatitis delta.…
    BioSpace · 23h agoPositive readoutPositive↗ source
  • Argenx to acquire Unnatural Products' macrocyclic peptide platform for $550 million upfront
    Argenx announced that it will acquire the California-based protein specialist Unnatural Products, paying $550 million upfront for its macrocyclic peptide platform. The deal could rise to more than…
    BioPharma Dive · 1d agoDealPositive↗ source
  • AbbVie and BMS each secure FDA approval, but impact of their neuro‑drug acquisitions remains uncertain
    AbbVie and Bristol Myers Squibb have both received FDA clearance for new Parkinson's treatments, prompting a fresh look at the large neuro‑focused deals they completed last year. AbbVie bought Cere…
    BioSpace · 1d agoDealNeutral↗ source
  • FDA launches Rare Disease Framework to embed patient input early in drug development
    FDA's Center for Biologics Research and Evaluation (CBER) director Karim Mikhail announced a new Rare Disease Framework Initiative aimed at moving patient perspectives from an optional, late‑stage…
    BioSpace · 1d agoRegulatoryPositive↗ source
  • India moves to suspend licenses of firms making substandard medicines
    The Indian government has proposed a rule that would immediately suspend the manufacturing licence of any company whose drug fails to meet quality standards. The initiative is intended to boost dr…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA mandates label update for all GLP-1 drugs to warn of rare eye disease risk
    The FDA issued a class‑wide labeling requirement for all approved GLP‑1 receptor agonists, adding a warning about non‑arteritic anterior ischemic optic neuropathy (NAION), a rare eye condition that…
    BioSpace · 22h agoRegulatoryNeutral↗ source
  • Compass Pathways to file FDA approval for psilocybin depression therapy within weeks
    Compass Pathways announced it will complete its FDA filing for the psilocybin‑based depression treatment COMP360 in the next two weeks. The company expects the rolling submission to enable a drug…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • J&J/Protagonist’s oral Icotyde shows Phase 3 benefit in psoriatic arthritis but trails AbbVie’s Skyrizi
    A Phase 3 study of Johnson & Johnson and Protagonist Therapeutics’ oral IL‑23 receptor antagonist Icotyde met its primary endpoint, demonstrating improvement in psoriatic arthritis symptoms. In th…
    BioSpace · 1d agoPositive readoutNeutral↗ source
  • Novo’s IL-6 inhibitor ziltivekimab may target milder cardio-renal patients after Phase 3 miss
    At the American Heart Association meeting, investigators discussed new data on Novo Nordisk’s IL-6 inhibitor ziltivekimab, suggesting it could be studied in patients with less severe cardiovascular…
    BioSpace · 1d agoNegative readoutNeutral↗ source
  • Phase II success does not guarantee easy Phase III launch, says Thermo Fisher
    Positive Phase II data often signals the start of Phase III planning, but the transition involves far more than simply adding patients and sites. When a trial expands into new countries, differenc…
    BioPharma Dive · 1d agoNeutral↗ source
  • State incentives can shape site decisions for commercial-stage life sciences firms
    The article advises commercial-stage life-science companies to consider state and local incentives early in expansion planning to improve site selection and preserve capital. Incentives most relev…
    BioPharma Dive · 1d agoNeutral↗ source