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  • EMA leaders say single pivotal trial should not be default, decision must match evidence needed
    EMA chief Emer Cooke and other officials weighed in on the ongoing debate about the number of pivotal trials required for drug approval. They argued that requiring a single pivotal trial as a rigi…
    raps · 27d agoRegulatoryNeutral↗ source
  • Senators Question FDA Nominee Overton as Agency Issues New Rule to Cut Animal Testing
    Senators on the Senate Health Committee interrogated President Trump's nominee to lead the FDA, Dr. Janet Overton, during her confirmation hearing. Lawmakers focused on her views about the agency's…
    raps · 27d agoRegulatoryNeutral↗ source
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  • Senate grills Trump’s FDA nominee Heidi Overton on agency priorities
    Heidi Overton, President Trump’s nominee to lead the U.S. Food and Drug Administration, appeared before the Senate for a confirmation hearing on September 24, 2026. Senators from both parties aske…
    raps · 27d agoRegulatoryNeutral↗ source
  • Roche reports phase 3 success for sefaxersen in IgA nephropathy, eyes accelerated approval
    Roche announced that its experimental drug sefaxersen met the primary endpoint in a phase 3 trial for IgA nephropathy, showing reduced proteinuria versus placebo. The interim analysis at week 37 d…
    Fierce Biotech · 28d agoPositive readoutPositive↗ source
  • Boston biotech seed funding drops 40% as investors favor later-stage firms
    Boston remains the world’s largest biotech hub, but early‑stage startups are feeling a sharp squeeze in capital. The average seed round for a pre‑clinical company in Massachusetts fell to $4.65 mi…
    Fierce Biotech · 28d agoNegative↗ source
  • Enveda Biosciences raises $311 million in Series E to accelerate nature-derived drug development
    Enveda Biosciences announced a $311 million Series E financing round, adding to the more than $500 million it has raised in previous rounds. The new capital follows a $130 million Series C in Nove…
    Fierce Biotech · 28d agoDealPositive↗ source
  • Kyverna reports year-long efficacy and clean safety for miv-cel CAR-T in autoimmune trials
    Kyverna Therapeutics released one-year data for its CAR-T candidate miv-cel in stiff person syndrome and 18-month data in generalized myasthenia gravis. The single dose showed durable clinical ben…
    Fierce Biotech · 28d agoPositive readoutPositive↗ source
  • Boehringer Ingelheim boosts Variant Bio partnership with $250 million for cardiovascular research
    Boehringer Ingelheim announced an expansion of its collaboration with Variant Bio. The partnership will now include cardiovascular disease research, broadening its original scope. The deal value…
    Fierce Biotech · 28d agoDealPositive↗ source
  • Human‑centric testing methods promise safer, cheaper drug development but repeatability remains a key obstacle
    Regulators such as the FDA, EMA and ICH are urging drug developers to replace animal safety studies with New Approach Methodologies that use human‑relevant models. Early research shows these models…
    Fierce Biotech · 28d agoNeutral↗ source
  • Immunovant halts cutaneous lupus program after phase 2 failure
    Immunovant announced it is discontinuing development of its anti-FcRn antibody IMVT-1402 for cutaneous lupus erythematosus. The decision follows a mid-phase trial that did not meet its primary end…
    Fierce Biotech · 28d agoNegative readoutNegative↗ source
  • Industry groups back FDA’s proposed distributed manufacturing rule, seek clarification on implementation
    Industry trade groups have expressed overall support for the FDA’s draft rule that would allow drugs to be produced using distributed manufacturing models. The proposal aims to modernize the supply…
    raps · 28d agoRegulatoryNeutral↗ source
  • Federal Court Issues Consent Decree Halting Gold Star Distribution's FDA-Regulated Shipments Over Unsanitary Warehouse
    The U.S. District Court for the District of Minnesota entered a consent decree on Sept. 21, 2026 that permanently enjoins Gold Star Distribution, Inc. and its owner Bassam Abu Samrah from distribut…
    fda press · 27d agoRegulatoryNegative↗ source
  • Trump's Department of War bets $47M on Flagship biotechs to develop countermeasures
    The Department of War has awarded Flagship Pioneering $47 million to develop medical countermeasure technologies against emerging threats.
    Fierce Biotech · 28d agoNeutral↗ source
  • Roche’s dual GLP-1/GIP drug enicepatide lowers HbA1c in phase 2 trial, sparking best-in-disease hopes
    Roche reported that its dual GLP-1/GIP receptor agonist, enicepatide, met the primary goals of a phase 2 study in patients with type 2 diabetes. The top 24‑mg weekly dose reduced HbA1c by 2.65% ove…
    Fierce Biotech · 29d agoPositive readoutPositive↗ source
  • GSK pursues China-centric growth after successful Hansoh licensing deals show promise
    GSK says it is following a "balance West and East" strategy, increasingly looking to China for drug licensing opportunities. In 2023 the company paid a combined $270 million upfront to Hansoh Phar…
    Fierce Biotech · 29d agoDealPositive↗ source
  • Celldex reports dual Phase 3 successes for barzolvolimab in refractory chronic spontaneous urticaria
    Celldex Therapeutics announced that its monoclonal antibody barzolvolimab achieved positive results in two Phase 3 studies of patients with treatment-refractory chronic spontaneous urticaria. The E…
    Fierce Biotech · 29d agoPositive readoutPositive↗ source
  • Otsuka and Ionis report ALS drug ulefnersen meets primary endpoint in phase 3 trial
    Otsuka and Ionis have completed the Fusion phase 3 trial of ulefnersen, an RNA‑targeted therapy for ALS patients with mutations in the FUS gene. The study enrolled 89 participants, with 73 forming…
    Fierce Biotech · 29d agoPositive readoutPositive↗ source
  • Novartis licenses preclinical radioligand from China's BoomRay in up to $900 million deal
    Novartis has expanded its radiopharmaceutical pipeline by signing a licensing agreement with Chinese biotech BoomRay Therapeutics. The deal could be worth up to $900 million, including an upfront…
    Fierce Biotech · 29d agoDealPositive↗ source
  • Amgen’s Horizon-acquired drug dazodalibep meets primary endpoint in phase 3 Sjögren’s trial
    Amgen announced that its investigational fusion protein dazodalibep, acquired through Horizon Therapeutics, achieved its primary goal in a phase 3 study of patients with moderate to severe Sjögren’…
    Fierce Biotech · 29d agoPositive readoutPositive↗ source
  • Vertex reports positive Phase 2b results for inaxaplin in APOL1-mediated kidney disease
    Vertex Pharmaceuticals announced positive Phase 2b data for its kidney disease candidate inaxaplin, which targets APOL1-mediated kidney disease (AMKD). The Amplified trial enrolled two cohorts: 2…
    Fierce Biotech · 29d agoPositive readoutPositive↗ source
  • Consumer groups call on FDA to strengthen generic drug testing and safety reporting under GDUFA IV
    Consumer health organizations used a public meeting on the reauthorization of the Generic Drug User Fee Amendments to press the FDA for more resources dedicated to testing generic medicines. The g…
    raps · 29d agoRegulatoryNegative↗ source
  • Boston life-science lab vacancy climbs to 31% as new spaces sit empty
    Vacancy rates for laboratory and manufacturing space in Massachusetts have surged dramatically, rising from around 3% in 2021 to roughly 31% by mid-2026, according to recent data. One high-profile…
    Fierce Biotech · 29d agoNegative↗ source
  • Siemens Healthineers partners with Novo to raise awareness and testing for fatty liver disease
    Siemens Healthineers and Novo have announced a collaboration aimed at increasing awareness and improving diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD) and its progre…
    Fierce Biotech · 29d agoDealPositive↗ source
  • Cordis receives FDA approval for first sirolimus drug-coated balloon for coronary in-stent restenosis
    The U.S. Food and Drug Administration has approved a new device from Cordis that delivers sirolimus via a drug-coated balloon. This is the first sirolimus-eluting balloon cleared for use in treatin…
    Fierce Biotech · 29d agoApprovalPositive↗ source
  • Iambic Therapeutics eyes IPO as it pushes HER2 inhibitor IAM1363 into early trials
    Iambic Therapeutics, a San Diego AI‑driven biotech, said it is preparing for an initial public offering after securing several large‑scale partnerships with major pharmaceutical companies. In its…
    Fierce Biotech · 29d agoPositive↗ source