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1,379 stories matching this filter · ← front page

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  • RNAi biotech ADARx raises $446 million in IPO, secures $89 million from AbbVie
    ADARx Pharmaceuticals priced its initial public offering at $17 per share, selling more than 26 million shares to raise about $446.3 million. The company also received an additional $89 million th…
    BioPharma Dive · 26d agoDealPositive↗ source
  • Novo signs €1.2 bn deal with Nanexa for long-acting injectables as Acadia’s Alzheimer trial misses target
    Novo has agreed to pay Nanexa up to about €1.165 bn for its PharmaShell delivery platform, which enables long-acting injectable medicines. The partnership will apply the technology to up to five c…
    BioPharma Dive · 25d agoDealNeutral↗ source
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  • 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 · 26d 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 · 27d agoNegative readoutNegative↗ source
  • FDA advisory panel finds Grail's Galleri multicancer blood test benefits outweigh risks
    A Food and Drug Administration advisory panel voted 7-2, with one abstention, to conclude that the probable benefits of Grail's Galleri multicancer blood test outweigh its risks. The panel unanimou…
    BioPharma Dive · 26d agoRegulatoryPositive↗ 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 · 27d 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 · 27d 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
  • Merck's remigromig meets visual acuity goal in diabetic macular edema trial, safety signals noted
    Merck announced that its experimental eye drug remigromig achieved non‑inferiority to Roche’s Lucentis in a late‑stage trial for diabetic macular edema. The trial, called Brunello, measured visual…
    BioPharma Dive · 26d agoPositive readoutNeutral↗ source
  • Eli Lilly inks $3.35 B China partnership as Immunovant halts lupus drug trial
    Eli Lilly announced a new alliance with Beijing‑based InnoCare Pharma that could be worth up to $3.35 billion. The deal includes an upfront payment of $100 million and up to five target programs fo…
    BioPharma Dive · 26d agoDealNeutral↗ 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 · 27d 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
  • 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 · 26d 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 · 26d 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 · 27d 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 · 26d 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 · 26d agoRegulatoryNegative↗ source
  • FDA nominee Overton parries vaccine questions at Senate hearing
    Pressed by lawmakers on Thursday, Trump’s pick as the next FDA chief said she’d “follow the law” on key decisions and work to speed early drug research.
    BioPharma Dive · 26d ago↗ source
  • Convenience Kit Correction: Becton Dickinson Issues Correction for Kits and Procedure Trays Containing Recalled Sodium Chloride Ampules
    BD is correcting convenience kits and procedural trays containing recalled Huons Co. sodium chloride ampules
    fda medwatch · 27d ago↗ source