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377 stories matching this filter · ← front page

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  • Sanofi’s new CEO vows deeper review of late-stage pipeline after series of trial failures
    Sanofi appointed Belén Garijo as chief executive in February with a clear mandate to tighten R&D governance and boost productivity. The board tasked her with bringing more rigor to the company’s st…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • Biogen’s early Phase 2 data supports tau-targeting Alzheimer’s approach
    Biogen has released early Phase 2 results for its experimental Alzheimer’s therapy diranersen, indicating that reducing tau protein levels may lead to cognitive benefits. The findings add to a lon…
    BioSpace · 1d agoPositive readoutPositive↗ source
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Nephrology239
  • Argon Medical issues correction for convenience kits containing lidocaine ampules after FDA safety alert
    Argon Medical has sent a correction notice to customers about certain convenience kits that include lidocaine HCl ampules supplied by Spectra Medical Devices. The FDA has classified this correctio…
    fda medwatch · 1d agoCRLNegative↗ source
  • Boston Scientific lowers full-year revenue outlook as restructuring plan targets slowing growth
    Boston Scientific announced on July 29 that it is cutting its 2026 full-year organic revenue growth forecast to 5-6%, down from the prior 6.5-8% range. The revision follows a second consecutive qu…
    Fierce Biotech · 1d agoEarningsNegative↗ source
  • Arvinas CEO outlines strategy to rebuild pipeline after lead asset departure
    In a recent episode of the Denatured podcast, Arvinas President and CEO Randy Teel discussed how the company is shifting focus to an early‑stage pipeline after its lead asset was out‑licensed or di…
    BioSpace · 1d agoPositive↗ source
  • Attovia, Braveheart Bio, and Vogenx aim to raise over $500M through combined IPOs
    Attovia Therapeutics, Braveheart Bio and Vogenx have each filed IPO paperwork, setting price ranges that together target more than $500 million in gross proceeds from public investors. Braveheart…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • Four biotech firms secure Series B funding and open new hiring opportunities
    Biotech companies that closed Series B financing rounds this year are actively recruiting as they expand their operations. Atavistik Bio, based in Cambridge, Massachusetts, announced a $40 million…
    BioSpace · 1d agoDealPositive↗ source
  • Legend Biotech CEO Ying Huang resigns abruptly, board taps interim leader
    Legend Biotech announced that its chief executive, Dr. Ying Huang, has stepped down unexpectedly, leaving the role vacant. Huang, who moved from chief financial officer to CEO in 2020 after a cust…
    Fierce Biotech · 1d agoNeutral↗ source
  • FDA advisory panel votes 9-3 against Capricor's Duchenne therapy deramiocel
    During an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting, reviewers focused on the Phase 3 HOPE-3 trial's secondary cardiac endpoint and described the data as very fragile. The…
    BioSpace · 1d agoApprovalNegative↗ source
  • Caldera and Vidya secure $478M via reverse mergers to go public
    Caldera Therapeutics, a U.S. bispecific antibody biotech, announced a reverse merger with Nasdaq-listed Synlogic to become a public company. The deal includes a $278 million private placement from…
    BioSpace · 2d agoDealPositive↗ source
  • FDA advisory panel rejects Capricor’s Duchenne cardiomyopathy cell therapy
    A FDA advisory committee voted against Capricor’s cell therapy for Duchenne muscular dystrophy cardiomyopathy, with nine members opposing and three supporting the product. The therapy, called dera…
    Fierce Biotech · 2d agoRegulatoryNegative↗ source
  • Biogen's $5.6B Apellis Purchase Boosts Q2 Revenue Above Forecasts
    Biogen began reporting revenue from its $5.6 billion acquisition of Apellis in the second quarter, pushing earnings above analysts' consensus estimates. CEO Chris Viehbacher said the company will…
    BioSpace · 2d agoDealPositive↗ source
  • Novo Nordisk faces shareholder fraud lawsuit over undisclosed dosing changes in CagriSema Phase 3 trial
    New Jersey federal judge Robert Kirsch ruled that shareholders can pursue claims that Novo Nordisk misled investors about its Phase 3 study of the weight‑loss drug CagriSema. The plaintiffs allege…
    BioSpace · 2d agoRegulatoryNegative↗ source
  • FDA briefing hints tough road for Capricor and Replimune ahead of advisory committee meetings
    The FDA released briefing documents for upcoming advisory committee meetings concerning Capricor Therapeutics' Duchenne muscular dystrophy cell therapy and Replimune's advanced melanoma candidate.…
    BioSpace · 2d agoRegulatoryNeutral↗ source
  • FDA advisory panel votes 9-3 against approval of Capricor’s Duchenne muscular dystrophy therapy deramiocel
    The FDA Cellular, Tissue, and Gene Therapies Advisory Committee focused heavily on the Phase 3 HOPE-3 trial’s secondary endpoint of cardiac function, describing the data as very fragile. Committee…
    BioSpace · 1d agoRegulatoryNegative↗ source
  • Kyverna partners with ElevateBio to supply its autologous CAR-T therapy for autoimmune launches
    Kyverna Therapeutics has signed a five‑year manufacturing agreement with contract development and manufacturing organization ElevateBio. The deal makes ElevateBio the primary supplier of Kyverna's…
    BioSpace · 2d agoDealPositive↗ source
  • Incyte drops early-stage JAK2 inhibitor to prioritize next-generation pipeline
    Incyte announced it is terminating development of its early-stage oral JAK2 inhibitor, INCB160058, after a Phase 1 study in myeloproliferative neoplasms. The company said the decision reflects the…
    BioSpace · 2d agoNegative↗ source
  • Novo Nordisk loses bid to dismiss lawsuit over CagriSema trial readout
    U.S. District Judge Robert Kirsch in New Jersey refused to dismiss most of the securities lawsuit filed by investors after Novo Nordisk’s CagriSema readout. While the judge found the plaintiffs’ cl…
    Fierce Biotech · 2d agoNegative readoutNegative↗ source
  • Processa Pharma acquires Vidya Therapeutics, gaining oral BTK inhibitor VT-7208
    Processa Pharmaceuticals announced an all‑stock acquisition of Vidya Therapeutics, a Florida biotech developing an oral BTK inhibitor called VT‑7208. VT‑7208 is being positioned as a next‑generati…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Caldera Therapeutics completes reverse merger with Synlogic, secures $278 million financing
    Caldera Therapeutics, a Massachusetts biotech founded last year, announced a reverse merger with Nasdaq-listed Synlogic, giving it a public listing. The transaction includes a $278 million financi…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Biotech earnings season kicks off as Agios reports Phase 2 setback for sickle-cell drug
    The second‑quarter earnings window has begun, and analysts are zeroing in on a handful of biotech companies with high‑profile catalysts. Smaller biotechs are increasingly opting to launch their pr…
    BioSpace · 2d agoNegative readoutNeutral↗ source
  • Nanoparticle-loaded chemotherapy crosses blood-brain barrier in mice after glioblastoma surgery, study shows
    Researchers at the University of Manchester have demonstrated that a standard chemotherapy drug can reach the brain when packaged in liposome nanoparticles and given shortly after tumor removal in…
    Fierce Biotech · 2d agoPositive↗ source
  • Biogen CEO says company will pause new acquisitions and focus on developing existing pipeline
    Biogen's chief executive Christopher Viehbacher told analysts during the second-quarter earnings call that the company will slow its merger and acquisition activity for the foreseeable future. Aft…
    Fierce Biotech · 2d agoDealNeutral↗ source
  • BioSpace launches dashboard to track performance of U.S. biotech IPOs in 2026
    BioSpace introduced a new IPO dashboard that monitors U.S. biotech companies that went public in 2026. The tool will be refreshed weekly with the latest closing prices and will add any newly liste…
    BioSpace · 2d agoNeutral↗ source
  • Vertex pays $28 million upfront to AbCellera for autoimmune T-cell engager collaboration
    Vertex Pharmaceuticals has entered a collaboration with AbCellera, paying an upfront sum of $28 million to access the latter’s T-cell engager platform for autoimmune disease programs. Under the ag…
    Fierce Biotech · 2d agoDealNeutral↗ source