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1,602 stories matching this filter · ← front page

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  • FDA finds Replimune's melanoma data package uninterpretable, foreshadows tough advisory committee review
    The FDA has deemed the single-arm mid-stage study submitted by Replimune for its oncolytic immunotherapy RP1 as not interpretable, raising concerns ahead of an upcoming advisory committee meeting.…
    BioSpace · 23d agoRegulatoryNegative↗ source
  • Apnimed targets up to $160 million IPO to fund sleep‑apnea drug AD109
    Apnimed, a sleep‑specialist biotech, announced plans for an initial public offering that could raise up to $160 million in gross proceeds. The company will sell 10 million shares at $14‑$16 each,…
    BioSpace · 23d agoDealPositive↗ source
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  • Pharma deals in China face heightened IP risk under U.S. BIOSECURE Act
    Pharma companies are increasing licensing activity in China, but experts say patent attorneys must now factor in the geopolitical implications of the BIOSECURE Act. The legislation seeks to compil…
    BioSpace · 23d agoRegulatoryNegative↗ source
  • GSK launches $2.5 billion restructuring plan to fund late-stage pipeline and offset upcoming HIV drug patent loss
    GSK reported $2.4 billion in impairment charges for the second quarter and unveiled a three‑year restructuring designed to save roughly $2.5 billion. The company says the savings will be redirecte…
    BioSpace · 23d agoPositive↗ source
  • GSK CEO outlines £1.9bn cost-saving drive and aims to launch 20 Phase 3 trials by year-end
    GSK chief executive Luke Miels presented a three‑year plan to make the company more agile and generate significant cost efficiencies. The strategy targets £1.9 billion in annual savings by 2029, wi…
    STAT · 23d agoPositive↗ source
  • FDA staff raise concerns over Replimune's skin cancer drug data
    FDA staff have reiterated concerns that Replimune's investigational skin cancer therapy lacks sufficient data for approval. The agency highlighted the single-arm trial, in which patients previousl…
    STAT · 23d agoRegulatoryNegative↗ source
  • Altimmune's pemvidutide cuts heavy drinking days in Phase 2 trial
    Altimmune reported that its experimental GLP-1/GIP injection pemvidutide achieved its primary and key secondary goals in a Phase 2 study of alcohol use disorder. The double-blind trial enrolled 10…
    BioSpace · 23d agoPositive readoutPositive↗ source
  • 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 · 23d agoDealPositive↗ 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 · 23d agoPositive readoutPositive↗ 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 · 23d 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 · 23d 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 · 23d 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 · 24d 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 · 24d 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 · 23d 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 · 23d 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 · 23d 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 · 23d 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 · 23d agoRegulatoryNeutral↗ 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 · 24d 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 · 23d 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 · 23d agoNeutral↗ source
  • OKYO Pharma CSO Raj Patil boosts stake to 20,030 shares
    OKYO Pharma, a clinical stage biotech focused on neuropathic corneal pain and anterior segment eye diseases, disclosed that its chief scientific officer, Raj Patil, PhD, bought additional shares.…
    globenewswire health · 23d agoDealNeutral↗ 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 · 23d agoNeutral↗ source
  • Danske Bank reports share sell-off by APMH Invest under ongoing buy-back program
    Danske Bank A/S disclosed recent transactions made by persons required to report under the EU Market Abuse Regulation. The notification dated 28 July 2026 notes that APMH Invest A/S has been conti…
    globenewswire health · 23d agoRegulatoryNeutral↗ source