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  • Claris Bio secures $118 million to launch pivotal eye-drop trials next year
    Claris Bio announced a financing round that raised $118 million to move its investigational eye‑drop therapy forward. The capital will fund two pivotal Phase 3 studies slated to start next year, f…
    Endpoints · 4d agoDealPositive↗ source
  • GSK launches three-year cost-cutting plan as new CEO targets R&D efficiency
    GSK announced a three-year restructuring program designed to cut costs and sharpen focus on its advanced assets. The plan was presented by CEO Luke Miels, who has been in the role for just over si…
    Endpoints · 4d agoNeutral↗ source
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  • Oak Hill Bio to go public via SPAC merger, securing $175 million for Angelman syndrome program
    Oak Hill Bio announced it will become a publicly traded company through a merger with the special purpose acquisition company Research Alliance Corporation III. The transaction will provide $75 mi…
    BioSpace · 4d agoDealPositive↗ source
  • Altimmune's GLP-1/glucagon shot reduces drinking in Phase 2 alcohol use disorder trial
    Altimmune announced results from its mid‑stage Phase 2 RECLAIM trial evaluating pemvidutide, a GLP‑1/glucagon dual agonist, in patients with moderate‑to‑severe alcohol use disorder. The trial comp…
    Endpoints · 4d agoPositive readoutPositive↗ source
  • ProMIS Neurosciences early trial shows low brain bleeding and no swelling, hinting at safer Alzheimer’s drug
    ProMIS Neurosciences reported interim safety data from a early‑stage trial of its amyloid‑targeting therapy for Alzheimer’s disease. The analysis pooled data from participants receiving the investi…
    STAT · 4d agoPositive readoutPositive↗ source
  • GSK launches three-year £1.9bn savings plan to boost late-stage R&D and relocate research HQ
    GSK announced a three-year cost-saving programme designed to free cash for its late-stage research and development pipeline while moving its research headquarters. The plan targets annual savings…
    Fierce Biotech · 4d agoNeutral↗ source
  • Dementia finally shows a viable business model, AAIC2026 highlights economic shift
    At the Alzheimer’s Association International Conference in London this year, the author observed that dementia now appears to have a clear business model, a shift from earlier meetings where commer…
    STAT · 4d agoPositive↗ source
  • Biotech firms rush to develop gene-editing cure for rare alpha-1 antitrypsin deficiency
    A wave of biotech companies is intensifying efforts to cure alpha-1 antitrypsin deficiency (AATD), a rare liver and lung disorder, using gene-editing approaches. Companies such as Beam, Wave Life…
    STAT · 4d agoNeutral↗ source
  • Trump administration proposes four-year visa cap for foreign PhD students and postdocs, sparking science community concerns
    The Department of Homeland Security announced a new rule that limits the stay of international graduate students and postdoctoral researchers in the United States to four years on nonimmigrant visa…
    STAT · 4d agoRegulatoryNegative↗ source
  • Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selection
    Industry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…
    raps · 4d agoRegulatoryNeutral↗ source
  • FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trials
    Industry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies. The r…
    raps · 4d agoRegulatoryNeutral↗ source
  • FDA advisory panel debates allowing compounding pharmacies to produce seven peptides
    The FDA’s advisory committee spent two days reviewing whether compounding pharmacies should be permitted to manufacture a set of seven peptide products. The discussion involved both committee membe…
    Endpoints · 4d agoRegulatoryNeutral↗ source
  • New name for PCOS aims to boost awareness and diagnosis for Black and Latina women
    Bontle Moka-Moliki, a 32-year-old from Atlanta, was diagnosed with endometriosis in 2019, fibroids a year later, and in 2024 received a diagnosis of a condition now called polyendocrine metabolic o…
    STAT · 4d agoPositive↗ source
  • CMS marks one year of Health Tech Ecosystem, unveils eight new pledge categories
    CMS held an event in Washington to review its Health Tech Ecosystem after a year. Officials highlighted progress toward data interoperability without new federal regulations. A coffin labeled "RI…
    STAT · 4d agoRegulatoryPositive↗ source
  • ADA faces member backlash and calls for CEO and CSO resignations after expert expulsions
    The American Diabetes Association’s 2026 Scientific Sessions in New Orleans ended with the expulsion of five diabetes experts, sparking a wave of criticism. More than 200 members signed an open le…
    STAT · 3d agoNegative↗ source
  • Webinar Explores AI-Driven Intelligence Engine for Optimizing Antibody, ADC and Peptide Candidates
    Drug discovery teams are grappling with an ever‑growing volume of data, and converting that data into actionable insight remains a key hurdle. In a recent BioSpace webinar, Patsnap’s Ben Coverdale…
    BioSpace · 3d agoNeutral↗ source
  • Anthony Fauci scheduled to testify before Senate Homeland Security Committee
    Anthony Fauci has been subpoenaed to appear before the Senate Homeland Security Committee for a new testimony. The hearing is scheduled for tomorrow and will focus on issues related to the federal…
    STAT · 4d agoRegulatoryNeutral↗ source
  • Incyte drops phase-1 JAK2 inhibitor to focus on next-generation candidates
    Incyte announced it is abandoning its phase-1 JAK2V617F inhibitor, INCB160058, which was being tested in patients with myeloproliferative neoplasms. The decision was disclosed in the company's sec…
    Fierce Biotech · 4d agoNegative readoutNegative↗ source
  • Acrosian launches AI-focused biometrics CRO targeting pharma and biotech
    Acrosian has been introduced as a new contract research organization built for the AI era. The firm is founded by Benjamin Jackson, Soumitra Chowdhury and Vladimir Mats, who previously created the…
    Fierce Biotech · 4d agoPositive↗ source
  • Guardant Health partners with Patrick Dempsey for emotional colorectal cancer screening video
    Guardant Health, maker of the Shield blood test for colorectal cancer, released a new video featuring actor Patrick Dempsey to raise awareness of the disease. In the one‑minute clip, Dempsey watch…
    Fierce Biotech · 4d agoPositive↗ source
  • WHO publishes first interim list of 12 medical device regulators eligible for WHO-listed authority status
    The World Health Organization has released its first interim list of medical device regulators that can attain WHO-listed authority status. The list names 12 regulators from different regions that…
    raps · 4d agoRegulatoryNeutral↗ source
  • Senate Republicans, led by Rand Paul, compel Dr. Fauci to testify at hearing on COVID-19 response
    Senate Republicans, especially Rand Paul, have long criticized the government’s handling of the COVID-19 pandemic and are using a Senate hearing to question Dr. Anthony Fauci. Paul, who has accuse…
    STAT · 4d agoRegulatoryNeutral↗ source
  • CDC survey shows racial gaps in diagnosis of endometriosis, PMOS and uterine fibroids among US women
    A recent CDC National Center for Health Statistics report based on a 2022-2023 survey of about 5,000 women ages 20 to 49 provides new insight into how often certain gynecologic conditions are diagn…
    STAT · 4d agoNeutral↗ source
  • Whoop appoints new chief medical officer, discusses health tech plans and CMS initiative
    STAT Health Tech’s latest newsletter features a brief interview with Whoop’s newly appointed chief medical officer. The CMO fielded three questions about the company’s direction, wearable data use…
    STAT · 4d agoNeutral↗ source
  • Otsuka’s ADHD approval opens up new drug class with $615M opportunity
    Otsuka Pharmaceutical plans to launch Simtriyo—the first norepinephrine, dopamine, serotonin reuptake inhibitor—later this year following scheduling by the U.S. Drug Enforcement Agency.
    BioSpace · 5d agoApprovalPositive↗ source