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802 stories matching this filter · ← front page

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  • ai3Bio raises $48 million to develop T-cell targeting therapy for autoimmune disease
    ai3Bio announced its emergence from stealth mode after securing $48 million in Series A funding. The round was led by UPMC Enterprises and Ziff Capital Partners and combines technology from Corner…
    Fierce Biotech · 22d agoDealPositive↗ source
  • Roche halts obesity antibody emugrobart after negative phase 2 interim readout
    Roche has stopped development of its obesity antibody emugrobart after an interim analysis of a phase 2 trial indicated a low chance of meeting the study endpoints. The antibody, designed to block…
    Fierce Biotech · 22d agoNegative readoutNegative↗ source
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Nephrology634
  • Mirum's Phase 3 Trial Shows Brelovitug Achieves Primary Endpoint in Hepatitis D Study
    Mirum Pharmaceuticals reported that its phase 3 Azure-1 trial in chronic hepatitis delta met its primary efficacy goal, marking a significant step toward market entry in a field dominated by Gilead…
    Fierce Biotech · 22d agoPositive readoutPositive↗ source
  • Kodiak Sciences' eye disease drug matches Eylea in Phase 3, sending stock soaring
    Kodiak Sciences reported that two of its eye‑disease candidates performed on par with aflibercept (Eylea) in a pivotal Phase 3 trial. The data suggest comparable efficacy in treating the targeted r…
    Fierce Biotech · 22d agoPositive readoutPositive↗ source
  • Merck signs $400 million deal with China’s SciBrunch for KRAS G12D preclinical candidate
    Merck & Co. announced a new partnership with Chinese biotech SciBrunch. The agreement includes a $400 million payment for a preclinical candidate that targets the KRAS G12D mutation. The KRAS G12D…
    Fierce Biotech · 22d agoDealNeutral↗ source
  • Sofinnova Partners raises €82 million to expand medtech creation strategy in Europe and U.S.
    Sofinnova Partners announced that it has secured €82 million ($93.3 million) in an oversubscribed financing round. The capital will be used to broaden the firm’s medtech creation strategy across Eu…
    Fierce Biotech · 22d agoDealPositive↗ source
  • Merck and Daiichi withdraw lung cancer ADC filing after FDA says data insufficient
    Merck and Daiichi Sankyo have pulled their application for accelerated approval of a B7-H3-directed antibody-drug conjugate aimed at extensive-stage small cell lung cancer. The FDA indicated that…
    Fierce Biotech · 23d agoRegulatoryNegative↗ source
  • Sierra Nevada Cheese Company recalls all Graziers raw milk cheeses over possible E. coli O26:H11 contamination
    Sierra Nevada Cheese Company of Willows, California, announced a voluntary recall of its Graziers Raw Milk Cheese line, which includes Monterey Jack, Jalapeno Jack, Medium Cheddar and Sharp Cheddar…
    fda recalls · 22d agoNegative↗ source
  • Mezzetta voluntarily recalls 32-oz Golden Greek Peperoncini after pest contaminant found in jar
    G. L. Mezzetta Inc. announced a voluntary recall of its 32‑oz Golden Greek Peperoncini after a video showed a pest contaminant in a jar. The recall is limited to lot 720106 (SKU 10106328). The com…
    fda recalls · 24d agoRegulatoryNeutral↗ source
  • Adicet Bio's off-the-shelf CAR-T therapy shows lupus remission in early Phase 1 trial
    Adicet Bio reported that its off-the-shelf CAR-T product prula-cel induced remission in more than half of lupus patients enrolled in a small Phase 1 study. One year after a single infusion, 12 of…
    Fierce Biotech · 25d agoPositive readoutPositive↗ source
  • Novo signs $1.3 billion deal with Nanexa to add long-acting injectables for obesity and diabetes
    Novo has entered a licensing agreement with Nanexa, valued at about 1.17 billion euros, to use Nanexa’s PharmaShell platform for its obesity and type‑2 diabetes medicines. The PharmaShell technolo…
    Fierce Biotech · 26d agoDealPositive↗ source
  • Genentech signs $1.5 billion bispecific antibody deal with Earendil Labs
    Genentech, Roche's US subsidiary, announced a licensing agreement with Earendil Labs to discover and develop multiple bispecific antibodies aimed at oncology. The agreement provides a $55 million…
    Fierce Biotech · 26d agoDealPositive↗ source
  • ADARx upsizes Nasdaq IPO to $446M as City Therapeutics eyes public listing
    ADARx Pharmaceuticals, a San Diego-based RNA biotech, completed a Nasdaq initial public offering this morning, selling 26.3 million shares at $17 each. The offering generated gross proceeds of abo…
    Fierce Biotech · 26d agoDealPositive↗ source
  • Lundbeck plans US headquarters move to Boston to boost neuroscience R&D
    Lundbeck, a Danish pharmaceutical company focused on neuroscience, announced it will relocate its U.S. operations to Boston. The move is part of a broader strategy to concentrate R&D on increasing…
    Fierce Biotech · 25d agoNeutral↗ source
  • Boston Scientific recalls Imager II angiographic catheters over tip detachment risk
    Boston Scientific has issued a recall of its Imager II Angiographic Catheters after a manufacturing problem that can cause the catheter tip to detach during use. The FDA classified the recall as t…
    fda medwatch · 26d agoCRLNegative↗ source
  • NIH deputy director Nicole Kleinstreuer leads push to cut animal testing with new policies
    NIH has spent the past 18 months accelerating policies aimed at reducing the use of animals in research. The effort is being directed by Dr. Nicole Kleinstreuer, the agency’s deputy director for p…
    Fierce Biotech · 25d agoRegulatoryPositive↗ source
  • Indivior ends Addex PAM collaboration as it prepares for Supernus merger
    Indivior Pharmaceuticals has terminated its long‑standing partnership with Addex Therapeutics that focused on developing positive allosteric modulators (PAMs) for addiction treatment. The collabor…
    Fierce Biotech · 26d agoDealNeutral↗ source
  • Acadia misses mark in Alzheimer’s but concludes phase 3 ‘absolutely worth’ pursuing
    Acadia Pharmaceuticals’ phase 2 Alzheimer’s disease trial has missed its primary endpoint, but the company and analysts alike saw enough encouraging signals to support the continuation of a phase 3…
    Fierce Biotech · 26d agoNegative readoutNegative↗ source
  • Henlius Biotech signs $440 million deal with Amberstone to develop T-cell engagers
    Henlius Biotech, a subsidiary of Fosun Pharma, announced a licensing agreement with California‑based Amberstone Biosciences valued at up to $440 million. The partnership will focus on creating anti…
    Fierce Biotech · 26d agoDealPositive↗ source
  • Roche signs $2 billion deal with Atavistik to discover allosteric cardiovascular-renal-metabolic drugs
    Roche announced a partnership with Cambridge-based biotech Atavistik Bio to develop allosteric small-molecule therapies for cardiovascular, renal and metabolic diseases. The agreement includes an u…
    Fierce Biotech · 26d agoDealPositive↗ source
  • Eli Lilly commits $100M upfront in new five-target partnership with China's InnoCare
    Eli Lilly has agreed to pay $100 million upfront and in the near term to Chinese biotech InnoCare Pharma as part of a five‑target drug discovery partnership. The agreement also provides for up to $…
    Fierce Biotech · 27d agoDealPositive↗ source
  • Adagio Medical begins strategic review and cuts over half its workforce amid Nasdaq delisting risk
    Adagio Medical, a maker of cryoablation devices, announced it is launching a strategic review of its operations. As part of the review, the company will lay off more than half of its full‑time sta…
    Fierce Biotech · 26d agoLayoffsNegative↗ source
  • Abiomed issues recall of Automated Impella Controllers over purge cassette detection issue
    Abiomed has announced a recall of its Automated Impella Controllers after identifying failures in the purge cassette recognition system, which could lead to prolonged delays in mechanical circulato…
    fda medwatch · 27d agoRegulatoryNegative↗ source
  • Grail's Galleri blood test receives positive FDA advisory panel vote, moving closer to approval
    Grail's multi‑cancer blood test Galleri earned a favorable recommendation from the FDA's medical devices advisory committee, bringing the test one step nearer to U.S. market clearance. The panel v…
    Fierce Biotech · 27d agoRegulatoryPositive↗ 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 · 26d agoNegative↗ source