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1,803 stories matching this filter · ← front page

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  • Alnylam cuts Amvuttra sales guidance as demand shifts, hurting stock
    Alnylam’s second-quarter earnings report Thursday did little to assuage investor concerns in what has already been a difficult year for the company. The drugmaker lowered its full-year sales projec…
    Endpoints · 5h ago↗ source
  • STAT+: Rising oil prices can boost the cost of some medicines. One expert says it’s time to lower reliance on fossil fuels
    Unitaid found the rising price of oil could boost the cost of a widely used HIV medicine it reviewed in a detailed analysis.
    STAT · 5h ago↗ source
  • Relation promises 'transformationally different success rates' in expanded AI pact with GSK
    GSK is set to pay Relation Therapeutics up to $110 million to expand their existing partnership to use AI modeling for drug discovery. Under the Thursday deal, Relation will build a ...
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Endpoints · 7h ago
↗ source
  • BMS CEO Boerner doesn’t ‘feel any compulsion to chase deals’ despite lack of M&A this year
    BMS may have been absent from the dealmaking spree of some of its Big Pharma peers this year, but that might not change anytime soon.
    Fierce Biotech · 8h ago↗ source
  • Bristol Myers delays Cobenfy Alzheimer’s psychosis readout again amid another quarterly beat
    Investors awaiting Bristol Myers Squibb’s key Alzheimer’s psychosis readout for Cobenfy and atrial fibrillation data for milvexian will have to wait a little longer.
    Fierce Biotech · 9h ago↗ source
  • Attovia, Braveheart and Vogenx seek more than $500M across trio of IPOs
    Attovia Therapeutics, Braveheart Bio and Vogenx have set target ranges for their IPOs, positioning the trio to collectively net more than $500 million from public investors.
    Fierce Biotech · 10h ago↗ source
  • Labcorp posts higher Q2 earnings on strength of diagnostics, lab services; adjusts full-year guidance
    Labcorp continues to power along as it posts strong quarterly earnings led by growth in its diagnostics and lab services and triggering the medtech to raise its full-year guidance.
    Fierce Biotech · 10h ago↗ source
  • Takeda scraps another phase 2 celiac disease therapy, narrowing pipeline to one
    Takeda has dropped another celiac disease therapy from its phase 2 pipeline, leaving the company with just one shot at treating the condition.
    Fierce Biotech · 11h ago↗ source
  • GSK pens $110M biological datasets pact with AI biotech Relation
    GSK is boosting its AI chops with a new deal worth up to $110 million with Relation.
    Fierce Biotech · 12h ago↗ source
  • Boston Scientific cuts guidance again after unveiling restructuring plan
    Boston Scientific is cutting its financial guidance for the second quarter in a row as it gears up for a tough six months ahead.
    Fierce Biotech · 15h ago↗ 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 · 1d agoRegulatoryNegative↗ source
  • FDA approves first freeze-dried plasma product for U.S. use
    The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
    fda press · 1d agoApprovalPositive↗ source
  • FDA reviewers doubt Replimune’s melanoma therapy as shares tumble 40%
    Replimune's shares fell nearly 40% after FDA reviewers released briefing documents expressing skepticism about its experimental melanoma drug RP1. RP1 has been rejected twice before; the company l…
    BioPharma Dive · 1d agoRegulatoryNegative↗ source
  • FDA advisory panel rejects Capricor's Duchenne heart-cell therapy deramiocel
    An FDA advisory committee voted 9-3 to reject Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne-related cardiomyopathy. The panel said the data did not provide substantial ev…
    BioPharma Dive · 21h agoRegulatoryNegative↗ source
  • MapLight Therapeutics' mid-stage schizophrenia trial shows modest improvement but shares plunge two-thirds
    MapLight Therapeutics announced that its experimental schizophrenia drug met its primary endpoint in a mid-stage study, delivering an average 4.5‑point reduction on the PANSS symptom scale after fi…
    BioPharma Dive · 21h agoNegative readoutNegative↗ source
  • Latigo's mid-stage trial shows non-opioid pill LTG-001 cuts post-surgery pain, outperforms placebo
    Latigo Biotherapeutics reported positive Phase 2 data for its experimental oral analgesic LTG-001, tested in patients who had undergone tummy-tuck surgery. The study enrolled 343 participants who w…
    STAT · 22h agoPositive readoutPositive↗ source
  • FTC sues Hims & Hers over alleged health data sharing and deceptive billing practices
    The Federal Trade Commission filed a lawsuit against Hims & Hers, a telehealth company based in San Francisco, accusing it of improper handling of patient information. According to the complaint,…
    Endpoints · 23h agoRegulatoryNegative↗ source
  • US releases $600M pledged to global vaccine alliance Gavi after year‑long delay
    The United States has released the $600 million it pledged to Gavi, the global vaccine alliance. The funds had been held in limbo for about a year before the Treasury completed the transfer. Sena…
    Endpoints · 23h agoDealPositive↗ source
  • FDA and Capricor clash over Duchenne cell therapy efficacy at advisory committee
    At an FDA advisory committee meeting, the agency and Capricor Therapeutics presented conflicting views on the efficacy data for the company's experimental cell therapy aimed at Duchenne muscular dy…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • Vertex and AbCellera team up to develop next-generation T-cell engagers for autoimmune diseases
    Vertex Pharmaceuticals has entered a partnership with AbCellera to create next-generation T-cell engagers aimed at autoimmune diseases. AbCellera will receive an upfront payment of $28 million, wit…
    BioPharma Dive · 1d agoDealPositive↗ source
  • Atea's hepatitis C combo therapy shows non-inferior results to Gilead's Epclusa
    Atea Pharmaceuticals announced that its oral combination of bemnifosbuvir and ruzasvir met the predefined non-inferiority criteria when compared with Gilead's Epclusa for treating hepatitis C. The…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • Trump administration ends Medicare drug plan subsidies, raising cost concerns ahead of midterms
    The White House announced that subsidies for private Medicare prescription drug plans will be discontinued, a move expected to increase premiums for many seniors. The policy shift comes as Democra…
    STAT · 1d agoRegulatoryNegative↗ source
  • Benchmarking Clinical LLMs Proves Complex After Recent Nature Medicine Study
    The STAT AI Prognosis newsletter, written by health‑tech reporter Brittany Trang, looks at why evaluating new clinical large language models is difficult. A recent Nature Medicine paper compared s…
    STAT · 1d agoNeutral↗ 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 · 1d 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 · 1d agoDealPositive↗ source