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766 stories matching this filter · ← front page

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  • Beam Therapeutics sues YolTech and Serapha Bio over alleged theft of base editing trade secrets
    Beam Therapeutics has filed a lawsuit in U.S. District Court in Massachusetts accusing Chinese biotech YolTech Therapeutics and its U.S. partner Serapha Bio of using confidential information to dev…
    BioPharma Dive · 20d agoNegative↗ source
  • Novo to pay Hengrui up to $2.6 billion for rights to weekly obesity pill HRS-1596
    Novo announced a deal with China-based Hengrui Pharma, paying $300 million up front for rights to HRS-1596, a once‑weekly obesity pill. The agreement could rise to $2.6 billion if the candidate me…
    BioPharma Dive · 20d agoDealNeutral↗ source
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Nephrology627
  • ai3Bio raises $48 million to develop T-helper cell-targeted immune-reset therapies
    ai3Bio, a new biotech startup formed from Corner Therapeutics and Novasenta, announced it has secured $48 million in an early-stage venture capital round. The company aims to create treatments for…
    BioPharma Dive · 20d agoDealPositive↗ source
  • UniQure tumbles with latest data for Huntington’s gene therapy
    Analysts guessed that investors wanted to see stronger durability results at a four-year check-in of the key trial supporting a potential approval of "AMT-130."
    BioPharma Dive · 20d ago↗ source
  • FDA approves Emcitate for peripheral thyrotoxicosis in patients with MCT8 deficiency
    The U.S. Food and Drug Administration announced approval of Emcitate (tiratricol) tablets formulated for oral suspension to treat peripheral thyrotoxicosis in patients with MCT8 deficiency, also ca…
    fda press · 21d agoApprovalPositive↗ source
  • Kodiak Sciences' Phase 3 eye drug data beats Regeneron’s Eylea, shares double
    Kodiak Sciences reported that its two experimental treatments for macular degeneration met the primary endpoints in a Phase 3 trial that directly compared them with Regeneron’s Eylea. The data show…
    BioPharma Dive · 21d agoPositive readoutPositive↗ source
  • Merck, Daiichi end plans to seek speedy approval of lung cancer ADC
    The FDA indicated that the data generated so far wouldn’t support an accelerated clearance of “I-DXd,” a setback that erases an edge Merck and Daiichi had over multiple fast-moving competitors.
    BioPharma Dive · 21d agoApprovalPositive↗ source
  • Adicet's off-the-shelf CAR-T shows 50% kidney response in early lupus trial
    An early-stage study of Adicet Bio's off-the-shelf gamma-delta CAR-T cell therapy reported encouraging results in patients with lupus nephritis. After a year of follow-up, half of the evaluable pa…
    BioPharma Dive · 21d agoPositive readoutPositive↗ source
  • FDA to review and potentially overhaul PMTA rules amid lawsuit and illicit market concerns
    FDA announced it is reviewing its experience with the Premarket Tobacco Product Application (PMTA) rule and recent court actions. The agency cites the growth of an illicit market and rapid introdu…
    fda press · 21d agoRegulatoryNeutral↗ source
  • Operational talent, not just science, will drive next biopharma breakthroughs
    The piece points out that while breakthrough science, founders and venture funding are typical markers of progress, the real test is moving a promising therapy through GMP production, quality syste…
    BioPharma Dive · 21d agoNeutral↗ source
  • Azurity urges simpler medicines for children to reduce daily burdens on families
    Azurity Pharmaceuticals published a sponsored article that looks at how chronic medicines can shape a child's daily routine. The piece points out that while clinical trials test drugs under strict…
    BioPharma Dive · 21d agoPositive↗ source
  • Novo’s stock tumbles after two-year GLP-1 boom as AI drug-discovery startups land huge funding rounds
    Novo’s shares, which peaked above $140 in June 2024 during a surge in demand for its GLP-1 drugs Ozempic and Wegovy, have fallen sharply over the past two years. The decline reflects a broader mark…
    BioPharma Dive · 24d agoNegative↗ source
  • 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 · 25d 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 · 24d agoDealNeutral↗ 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 · 25d agoCRLNegative↗ 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 · 25d agoRegulatoryPositive↗ 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 · 25d 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 · 25d agoDealNeutral↗ 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 · 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 · 25d 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 · 26d ago↗ source
  • Roche and Ionis report positive Phase 3 interim results for IgA nephropathy drug sefaxersen
    Roche and Ionis announced that their experimental RNA therapy sefaxersen met its primary endpoint in an interim analysis of a Phase 3 trial for IgA nephropathy. The trial showed statistically sign…
    BioPharma Dive · 26d agoPositive readoutPositive↗ source
  • European pharma CEOs warn of biotech decline as R&D share drops to 31% and call for faster trials and stronger IP protection
    Nine leading European pharma board chairs issued an open letter warning that Europe is losing its biotech edge. They note that Europe's share of global pharma R&D fell from 43% in 1990 to 31% toda…
    BioPharma Dive · 26d agoNegative↗ source
  • FDA issues early alert on React Health VOCSN ventilators over connector fault
    The FDA's Center for Devices and Radiological Health has posted an early alert about a potential high‑risk problem with certain VOCSN ventilator units made by Ventec Life Systems, operating as Reac…
    fda medwatch · 27d agoRegulatoryNeutral↗ source
  • AI-driven biotech Enveda secures $311 million Series E to advance plant-derived drug candidates
    Enveda Biosciences, a Colorado AI drug discovery company, announced a $311 million Series E financing round, one of the larger biotech raises this year. The firm uses artificial intelligence to sc…
    BioPharma Dive · 26d agoDealPositive↗ source