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41 stories matching this filter · ← front page

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  • Vertex unfazed by competitive IgAN space as FDA verdict looms
    Positive two-year follow-up data for Otsuka Pharmaceuticals’ IgA nephropathy drug Voyxact could support the FDA’s ongoing review of Vertex Pharmaceuticals’ povetacicept, CEO Reshma Kewalramani said…
    BioSpace · 18h agoEarningsNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 15h agoLayoffsNegative↗ source
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Infectious Disease266
Pain265
  • Amgen discloses cybersecurity breach affecting patient data
    Amgen reported a cybersecurity incident that resulted in the exfiltration of protected patient health information and other proprietary data stored in cloud services managed by third‑party provider…
    BioSpace · 1d agoRegulatoryNegative↗ source
  • Novo Nordisk's heart drug ziltivekimab fails Phase 3 trial, raising doubts on inflammation-targeted therapies
    Novo Nordisk announced that its experimental cardiovascular drug ziltivekimab did not meet the primary endpoint in a Phase 3 study. The trial was designed to see if the drug could lower the inciden…
    BioPharma Dive · 4d agoNegative readoutNegative↗ source
  • Novo Nordisk’s IL-6 drug ziltivekimab misses Phase 3 cardiovascular endpoint, shares drop 9%
    Novo Nordisk announced that its IL-6 inhibitor ziltivekimab did not meet the primary goal in a late-stage Phase 3 trial aimed at lowering major cardiovascular events. The ZEUS study enrolled patie…
    BioSpace · 4d agoNegative readoutNegative↗ source
  • Novo Nordisk's ziltivekimab fails phase 3 trial, jeopardizing CKD program
    Novo Nordisk reported that its phase 3 Zeus trial of the IL‑6 ligand antibody ziltivekimab did not meet its primary endpoint, a setback for the drug's development. The study enrolled more than 6,3…
    Fierce Biotech · 4d agoNegative readoutNegative↗ 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 · 5d agoDealPositive↗ 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 · 6d agoDealPositive↗ 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 · 6d agoDealNeutral↗ source
  • AstraZeneca says Wainua failure won’t alter M&A plans, stays on track for $80B 2030 goal
    AstraZeneca said during its Q2 earnings presentation that the late‑stage failure of the antisense therapy Wainua in ATTR‑cardiomyopathy does not derail its goal of reaching $80 billion in revenue b…
    BioSpace · 8d agoDealNeutral↗ source
  • Amgen seeks FDA hearing to keep rare kidney drug Tavneos amid safety concerns
    Amgen has asked the U.S. Food and Drug Administration for a hearing to argue against a proposed withdrawal of its rare‑disease drug Tavneos. The company submitted a data package containing real‑wo…
    BioSpace · 11d agoRegulatoryNegative↗ source
  • FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
    The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.
    fda press · 13d ago↗ source
  • Crystalys nets $130M more to push gout drug through late-stage tests
    The startup has a broad global development program underway — and the support of more than 20 investment firms — for a treatment that’s approved in many Asian countries but isn’t yet available in t…
    BioPharma Dive · 13d ago↗ source
  • Bristol Myers to build ‘powerful’ AI factory; Samsung Biologics bids for peptide maker
    Bristol Myers is the third pharmaceutical company to recently seek Nvidia’s help building a large AI data center. Elsewhere, a Novartis kidney drug gained a leg up on competitors.
    BioPharma Dive · 15d ago↗ source
  • Vertex’s IgA nephropathy drug derisked after Novartis, Vera approvals
    The FDA is currently reviewing Vertex Pharmaceuticals’ povetacicept, with a target action date of Nov. 30. If approved, the drug could benefit from campaigns from Novartis and Vera Therapeutics for…
    BioSpace · 15d ago↗ source
  • Kolon’s cell-based gene therapy fails phase 3 osteoarthritis trial
    A phase 3 trial of Kolon TissueGene’s cell-based gene therapy has missed its co-primary endpoints. With a second late-stage study scheduled to report data in October, the biotech is holding off on…
    Fierce Biotech · 15d ago↗ source
  • Jasper gets a lifeline in merger with immune drugmaker Kira
    The acquisition, which involves a concurrent licensing deal with startup Mirador, gives Jasper a chance to rebound from setbacks that have wiped out most of its market value.
    BioPharma Dive · 18d ago↗ source
  • Jasper finds new purpose in merger with Kira, while offloading Tavneos rival to Mirador
    Jasper Therapeutics is being reborn via a merger with Nasdaq-listed immune-mediated disease biotech Kira Pharmaceuticals.
    Fierce Biotech · 18d ago↗ source
  • Dimerix snaps up Mission’s stalled, phase 2-ready kidney disease candidate in $292M deal
    Dimerix has bought an acute kidney injury drug from Mission Therapeutics, paying $5 million upfront and committing up to $287 million in milestones for the phase 2-ready asset.
    Fierce Biotech · 19d ago↗ source
  • Vertex to acquire Crinetics in $10B foray into endocrine disease drugs
    Vertex claimed the two drugs in the deal could eventually bring in more than $5 billion annually. Still, the high price it paid stirred debate among analysts and investors.
    BioPharma Dive · 28d ago↗ source
  • Vera Therapeutics wins FDA nod for closely watched kidney disease drug
    The clearance marks another step forward in treatment for IgA nephropathy and sets up a commercial battle with Otsuka, which brought a similar medication to market last year.
    BioPharma Dive · 28d ago↗ source
  • BridgeBio gets funding for drug launch; United buys into cell therapy
    Elsewhere, Otsuka’s kidney drug hit the goal of a confirmatory trial and Vertex’s CRISPR sickle cell drug secured expanded approval.
    BioPharma Dive · 1mo ago↗ source
  • Ipsen to buy Swiss biotech Memo Therapeutics in potential $800M deal
    The purchase hands Ipsen an experimental medicine in late-stage testing for a virus that often affects kidney transplant patients.
    BioPharma Dive · 1mo ago↗ source
  • 10 clinical trials to watch in the second half of 2026
    The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.
    BioPharma Dive · 1mo ago↗ source
  • AstraZeneca’s ‘extensive’ obesity drug push; $125M for ultrasound-aided genetic medicine
    Newly published data convinced AstraZeneca to conduct a sprawling late-stage program for its GLP-1 pill. Elsewhere, Bausch + Lomb will lay off 119 employees and Cartesian boosted its ‘in vivo’ cell…
    BioPharma Dive · 1mo ago↗ source