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2,408 stories matching this filter · ← front page

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  • 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 · 27d agoRegulatoryNeutral↗ source
  • AI-driven interviews risk alienating biotech and pharma job seekers, experts warn
    AI interview tools are being introduced by biotech and pharma firms to speed up candidate screening, but they can create negative experiences for applicants. Candidates described frustrations such…
    BioSpace · 28d agoNegative↗ source
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  • Sarepta Therapeutics agrees to pay $39 million to settle gene therapy dispute with Regenxbio
    Sarepta Therapeutics has agreed to resolve a dispute with Regenxbio by paying $39 million. The payment settles claims related to gene therapy technology that both companies have been developing.…
    Endpoints · 27d agoDealNeutral↗ source
  • Heidi Overton, Trump’s FDA commissioner nominee, to face Senate confirmation hearing
    Heidi Overton has been nominated by President Donald Trump to serve as the next commissioner of the U.S. Food and Drug Administration. She is scheduled to appear before the Senate Health, Educatio…
    Endpoints · 27d agoRegulatoryNeutral↗ source
  • US senators grill FDA nominee Overton on ability to ‘stand up’ to Trump
    In Thursday’s Senate committee meeting, FDA commissioner nominee Heidi Overton was repeatedly questioned about her ability to retain the FDA’s independence under President Donald Trump, as well as…
    BioSpace · 27d ago↗ source
  • FDA approves Eli Lilly's once-weekly insulin pen, setting up rivalry with Novo
    Eli Lilly’s once-weekly basal insulin shot Onswik has been approved by the FDA for patients with type 2 diabetes. Lilly has touted Onswik as a longer-acting alternative to daily basal insulin injec…
    Endpoints · 27d ago↗ source
  • Backed by NVIDIA, Basecamp bags $140M to advance AI-designed drugs
    Basecamp Research joins the growing group of AI-forward biotechs that in recent months have brought in notable sums from investors, including Isomorphic Labs and Enveda.
    BioSpace · 27d ago↗ source
  • Roche and Ionis report Phase 3 success for RNA therapy sefaxersen in IgA nephropathy
    A late‑stage Phase 3 trial of the Roche‑Ionis RNA‑targeted drug sefaxersen met its primary endpoint, showing a statistically significant reduction in proteinuria for patients with primary IgA nephr…
    BioSpace · 28d agoPositive readoutPositive↗ source
  • Ionis and Otsuka's RNA therapy Ulefnersen shows functional and survival gains in rare FUS-ALS in Phase 3 trial
    Ionis Pharmaceuticals and Otsuka Pharmaceutical reported that their antisense oligonucleotide drug Ulefnersen improved both functional impairment scores and overall survival in a Phase 3 study of p…
    BioSpace · 28d agoPositive readoutPositive↗ 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 · 29d agoPositive readoutPositive↗ source
  • China’s $522 bn biotech push fuels US competition and partnership opportunities
    Chinese biotech is entering a rapid growth phase, with the government’s new five-year plan targeting about $522 billion in revenue by 2030 and aiming for at least 25% of first-in-class drugs worldw…
    BioSpace · 29d agoDealPositive↗ source
  • Amgen's Sjögren's drug dazodalibep meets primary endpoint in Phase 3 trial
    Amgen reported that its experimental therapy for Sjögren's disease, dazodalibep, achieved the primary goal in a late‑stage study. The Phase 3 OASIZ 301 trial enrolled roughly 621 patients with mod…
    BioSpace · 28d agoPositive readoutPositive↗ source
  • Novartis signs up to $900 million deal with China's BoomRay for preclinical radioligand therapy
    Novartis has licensed a preclinical radioligand therapy from BoomRay Pharmaceuticals, a Suzhou‑based biotech, in a deal that could be worth up to $900 million. The agreement includes an undisclose…
    BioSpace · 28d agoDealPositive↗ source
  • FDA panel questions effectiveness of Grail's early-cancer detection test
    FDA's Molecular and Clinical Genetics Panel and agency officials raised concerns about Grail's next-generation sequencing test designed to detect multiple cancers early in adults over 50. The advi…
    Endpoints · 28d agoRegulatoryNegative↗ source
  • World's first personalized gene-editing therapy costs $1.65 million per patient, project director says
    At a rare disease conference in Oxford, Fyodor Urnov disclosed that the world's first therapy designed to correct an individual’s unique genetic mutation cost $1.65 million to produce. The treatme…
    Endpoints · 28d agoNeutral↗ 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
  • Former Changsheng biotech chair sentenced to life in prison over Chinese rabies vaccine scandal
    Chinese authorities sentenced Gao Junfang, the former chairwoman of Changsheng Biotechnology, to life imprisonment after a court found her guilty of wrongdoing in a rabies vaccine scandal. The cas…
    Endpoints · 28d agoRegulatoryNegative↗ source
  • Enveda secures $311 million in third consecutive megaround to advance discovery and weight-maintenance programs
    Enveda, a biotech startup operating out of Colorado and India, announced a new financing round on September 23, 2026. The company raised $311 million, marking its third large-scale funding round i…
    Endpoints · 28d agoDealPositive↗ source
  • AI startup Basecamp Research secures $140 million Series C funding and outlines six-program AI pipeline
    Basecamp Research, an AI-driven biotech founded in 2019, announced a $140 million Series C financing round. The company said the new capital will support its ambitious six-program pipeline that ap…
    Endpoints · 28d agoDealPositive↗ source
  • Roche reports positive interim Phase 3 results for kidney drug, paving way for accelerated approval
    Roche announced interim results from its Phase 3 trial of a kidney disease therapy, indicating the study met its primary endpoints. The data, released on Wednesday, suggest the drug could qualify…
    Endpoints · 28d agoPositive readoutPositive↗ source
  • Novo outlines $23B revenue goal, cuts 4,000 jobs and expands Wegovy manufacturing amid investor skepticism
    Novo held its Capital Markets Day to detail a plan to reach $23 billion in sales by 2035. The company announced another round of layoffs, trimming its workforce by 4,000 people and leaving the head…
    BioSpace · 28d agoNeutral↗ 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