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  • 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 · 15d 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 · 15d agoNegative↗ source
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  • 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 16d 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 · 15d 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 · 15d 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 · 15d agoNeutral↗ source
  • Argenx to buy Forte Biosciences for up to $2.2 billion, adding experimental CD122 drug FB102
    Argenx announced it will acquire Forte Biosciences in a transaction valued at up to $2.2 billion. The purchase price is set at $77 per Forte share, roughly a 41% premium to the previous closing pr…
    BioPharma Dive · 16d agoDealPositive↗ source
  • Otsuka receives FDA approval for Simtriyo, first norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD
    Otsuka Pharmaceutical announced that the FDA has approved its daily pill centanafadine, branded as Simtriyo, for the treatment of attention-deficit hyperactivity disorder in patients six years and…
    BioSpace · 16d agoApprovalPositive↗ source
  • FDA clears Freenome's SimpleScreen CRC blood test, Abbott to market it in U.S.
    The U.S. Food and Drug Administration has given clearance to Freenome’s SimpleScreen CRC, a blood-based test for colorectal cancer. Abbott will be the exclusive U.S. marketer and will pay Freenome…
    Fierce Biotech · 16d agoApprovalPositive↗ source
  • Global HIV funding drops 18%, raising fears of epidemic resurgence
    A new UNAIDS report warns that the world could see a rebound of HIV infections after donor financing fell sharply last year. Government contributions dropped by more than $1.5 billion to $7.3 bill…
    STAT · 16d agoNegative↗ source
  • Claris Biotherapeutics raises $118M Series B to advance corneal stem-cell eye drop
    Claris Biotherapeutics announced a $118 million Series B financing round led by Novo Holdings and supported by several venture firms. The funding will be used to move its lead candidate, CSB-001, i…
    Fierce Biotech · 16d agoDealPositive↗ source
  • RA Capital backs Oak Hill Bio's Nasdaq debut via $175 million SPAC merger
    RA Capital announced that its SPAC, Research Alliance Corporation III, will merge with Oak Hill Bio, creating a new Nasdaq-listed rare-disease company. The combined entity will start with $175 mil…
    Fierce Biotech · 16d agoDealPositive↗ source
  • Argenx to acquire Forte Biosciences for $2.2 billion, securing phase-2 vitiligo antibody FB102
    Argenx announced it will buy Forte Biosciences for $2.2 billion, gaining access to FB102, an anti‑CD122 antibody currently in phase‑2 trials for vitiligo and celiac disease. In a recent phase 1b s…
    Fierce Biotech · 16d agoDealPositive↗ source
  • PhRMA pushes back as prescription drug spending continues to rise, according to STAT+ newsletter
    STAT+ Health Care Inc. newsletter author Bob Herman reports on the growing concern that prescription drug spending is rising despite industry attempts to downplay it. The piece appears in the July…
    STAT · 16d agoNegative↗ source
  • MapLight shares plunge 66% after mid-stage schizophrenia trial shows modest benefit but raises competitive concerns
    MapLight Therapeutics announced results from its mid‑stage trial of an experimental schizophrenia drug. The study enrolled adults experiencing an acute exacerbation of psychotic symptoms. The twic…
    BioPharma Dive · 16d agoPositive readoutNegative↗ source
  • FDA says Capricor's DMD cell therapy failed to meet Phase 3 endpoints
    The FDA briefing documents released before an advisory committee meeting state that the Phase 3 trial of Capricor's deramiocel did not achieve its pre-specified primary and secondary efficacy endpo…
    BioSpace · 16d agoRegulatoryNegative↗ source
  • FDA staff raise concerns over Capricor’s Duchenne cell therapy as shares plunge; Legend CEO resigns, AstraZeneca reports pipeline woes
    Capricor Therapeutics saw its shares tumble by nearly two‑thirds after FDA reviewers highlighted serious concerns about the data supporting its experimental Duchenne muscular dystrophy cell therapy…
    BioPharma Dive · 16d agoRegulatoryNegative↗ source
  • Sarepta appoints former AbbVie R&D chief Michael Severino as new CEO amid DMD regulatory outlook
    Sarepta Therapeutics announced that Michael Severino, who previously led Tessera Therapeutics and served as AbbVie’s head of research and development, will become the company’s chief executive. Sev…
    BioSpace · 16d agoPositive↗ source
  • Sarepta appoints former AbbVie executive Michael Severino as new CEO to drive turnaround
    Sarepta Therapeutics announced that Michael Severino will become its chief executive officer on July 28, succeeding Doug Ingram who plans to retire. Severino brings more than two decades of experi…
    BioPharma Dive · 16d agoNeutral↗ source
  • FDA doubts efficacy of Capricor’s Duchenne stem-cell therapy after Phase 3 miss
    The U.S. Food and Drug Administration said Monday that Capricor Therapeutics’ stem‑cell treatment for Duchenne muscular dystrophy failed to meet the primary goals of its Phase 3 trial, contradictin…
    STAT · 16d agoRegulatoryNegative↗ source