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  • FDA signals need for GCP compliance to accept foreign clinical trial data for regulatory review
    The U.S. Food and Drug Administration says it will only consider clinical evidence generated outside the United States if the studies were conducted according to good clinical practice standards.…
    raps · 1mo agoRegulatoryNeutral↗ source
  • China NewCo model pioneer sued in US over alleged trade secret theft and double-dealing
    A lawsuit filed in New York and later moved to federal court accuses Su Zhang, a consultant known for shaping the China "NewCo" dealmaking model, of misusing trade secrets and engaging in double-de…
    Fierce Biotech · 1mo agoNegative↗ source
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  • FDA nominee Heidi Overton affirms safety of vaccines and mifepristone in Senate hearing
    Heidi Overton, the Trump administration’s pick for FDA commissioner, appeared before the Senate Health, Education, Labor and Pensions Committee to answer questions about her views on key public‑hea…
    Fierce Biotech · 1mo agoRegulatoryNeutral↗ source
  • Travere appoints former Amicus CEO Bradley Campbell as new chief executive
    Travere Therapeutics CEO Eric Dube is stepping down after overseeing the launch of the rare kidney disease drug Filspari. Bradley Campbell will assume the role on Dec 1, bringing experience from l…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Merck sees pivotal victory for $3B eye disease prospect
    Merck & Co.’s Brunello trial has hit its primary endpoint, shedding light on the effects of a trispecific diabetic macular edema (DME) drug candidate that the Big Pharma bought in a $3 billion take…
    Fierce Biotech · 1mo agoRegulatoryNeutral↗ source
  • 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 · 1mo 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 · 1mo agoRegulatoryNeutral↗ source
  • 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 · 1mo agoRegulatoryNeutral↗ source
  • Galil Importing Corp recalls Lior ground cinnamon over elevated lead levels
    Galil Importing Corp of Hauppauge, New York announced a recall of its Lior Cinnamon Ground Seasoning because of potential elevated lead contamination. The product, distributed to retail outlets in…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Deano’s Pasta recalls 20 lbs of ravioli over undeclared lobster allergen
    Deano’s Pasta of Somerville, Massachusetts announced a recall of its Pear and Pecorino Triangoli Ravioli after discovering the product may contain undeclared lobster, a crustacean shellfish allerge…
    fda recalls · 1mo agoRegulatoryNegative↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoRegulatoryNeutral↗ source
  • Berlin Seeds recalls 950 lbs of alfalfa sprouting seed over possible STEC and Salmonella contamination
    Berlin Seeds of Millersburg, Ohio announced a recall of 950 pounds of its alfalfa sprouting seed. The recall was triggered because the seed could be contaminated with Shiga toxin‑producing Escheri…
    fda recalls · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoDealPositive↗ source