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  • Medicare proposes ban on vendor-provided remote patient monitoring services
    Medicare regulators have proposed a rule that would prohibit vendors from delivering remote patient monitoring services on behalf of physicians, marking a significant policy shift. Remote patient…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Senator Lindsey Graham’s death highlights gaps in detecting aortic dissection
    Senator Lindsey Graham, 71, died on Saturday after suffering an aortic dissection, a sudden tear in the body's main blood vessel that can be fatal. A final death certificate has not yet been relea…
    STAT · 1mo agoNegative↗ source
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  • Senate hearing probes CDC nominee Erica Schwartz amid concerns over political pressure from RFK Jr. and Trump
    Senate leaders questioned Erica Schwartz, the administration's nominee to head the CDC, about her ability to resist political pressure during a Wednesday hearing. Lawmakers referenced the earlier…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • FDA acting chief says two journal articles by former commissioner do not represent agency policy
    Acting FDA Commissioner Kyle Diamantas announced that the agency is reversing its earlier position regarding two medical‑journal articles authored by former commissioner Marty Makary. The FDA now…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • New blood-based Alzheimer’s tests promise easier, more detailed diagnosis
    At the recent Alzheimer’s Association International Conference, researchers presented advances that could make Alzheimer’s testing more widely available and informative. Current diagnostic methods…
    STAT · 1mo agoPositive↗ source
  • Senator Cassidy challenges Trump pandemic nominee over anti-vaccine LinkedIn post
    Senate Health Committee Chairman Bill Cassidy confronted Sean Kaufman, President Trump's nominee for a senior pandemic preparedness position, during the confirmation hearing. Cassidy cited a delet…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Johnson & Johnson to spend up to $750 million restructuring pharma manufacturing and closing plants
    Johnson & Johnson announced it will incur up to $750 million as it reshapes its pharmaceutical manufacturing network. The plan involves exiting certain factories and consolidating production, aimi…
    Endpoints · 1mo agoNeutral↗ source
  • Glenmark agrees to $29.6 million settlement over generic drug price-fixing claims
    Glenmark Pharmaceuticals has reached a settlement with dozens of U.S. states, agreeing to pay $29.6 million to resolve accusations that it participated in a scheme to inflate prices of generic medi…
    STAT · 1mo agoDealNegative↗ source
  • Nobel laureate Jennifer Doudna unveils AI-driven platform to design novel gene‑editing enzymes
    Jennifer Doudna, the Nobel laureate who co‑invented CRISPR, announced a new AI‑powered platform for creating gene‑editing proteins in a paper published today in Science. The system uses computation…
    Fierce Biotech · 1mo agoPositive↗ source
  • Lonza urges biotech firms to prioritize early de-risking to streamline IND path
    In a recent interview, Jaime Okray of Lonza highlighted that emerging biotech companies are shifting focus from pure speed to early identification of development risks as they aim for an IND filing…
    Fierce Biotech · 1mo agoPositive↗ source
  • AdvanCell secures $315M Series D to advance lead-based prostate cancer therapy
    AdvanCell announced a $315 million Series D financing round aimed at supporting development of its lead-based prostate cancer agent and expanding U.S. manufacturing capacity for the radioactive tre…
    Endpoints · 1mo agoDealPositive↗ source
  • Agentic AI poised to reshape clinical development by moving beyond tools to autonomous decision-making
    Earlier this year, a colleague argued that clinical leaders should stop asking whether they have an 'AI strategy', because the question often leads to the wrong conversation. Instead, leaders are…
    Fierce Biotech · 1mo agoPositive↗ source
  • J&J reports 18,000 new prescriptions for Icotyde in first full quarter
    Johnson & Johnson gave an update on the launch of its plaque-psoriasis drug Icotyde. The company said that in its first full quarter on the market, Icotyde generated about 18,000 new prescriptions…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Ebola outbreak in Congo tops 2,000 cases as health workers strike over unpaid wages
    The Congo Ministry of Health reported on July 15 that confirmed Ebola cases have risen to 2,011, with 754 deaths, making it the fastest-growing outbreak on record. Health workers at Bunia General…
    STAT · 1mo agoNegative↗ source
  • Biogen’s experimental Alzheimer’s therapy shows comparable slowing of cognitive decline in mid-stage trial, paving way to Phase 3
    Biogen reported that its experimental Alzheimer’s drug slowed cognitive decline in a mid-stage study. The trial showed patients experienced a rate of decline similar to that seen with currently app…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Nava Therapeutics raises $89 million to advance lipid nanoparticle platform targeting bone marrow, immune cells and kidney
    Nava Therapeutics, a stealth-mode biotech, announced it has secured $89 million in financing, according to a statement to Endpoints News. The capital will support development of a next generation…
    Endpoints · 1mo agoDealPositive↗ source
  • Braveheart Bio seeks Nasdaq listing to finance Phase 3 trial of Hengrui rival cardio drug
    Braveheart Bio announced it has filed for an initial public offering on the Nasdaq exchange. The company says the capital raised will be used to fund a Phase 3 study of its cardiovascular candidate…
    Endpoints · 1mo agoNeutral↗ source
  • Insilico Medicine and Bora Pharma launch AI-driven biologics manufacturing venture to challenge Chinese CDMOs
    Insilico Medicine, an AI drug discovery company, and Bora Pharmaceuticals, a Taiwan-based CDMO, announced the formation of a new joint venture. The new company will develop an AI-driven platform t…
    Endpoints · 1mo agoDealPositive↗ source
  • Bipartisan lawmakers demand AI use details from top Medicare Advantage insurers amid care denial concerns
    Senators Richard Blumenthal and Josh Hawley have written to UnitedHealth, Humana, CVS and other large Medicare Advantage insurers asking for internal records that detail how artificial intelligence…
    STAT · 1mo agoRegulatoryNegative↗ source
  • XR Health acquires Swing Therapeutics, adding FDA-cleared fibromyalgia digital therapy to its VR platform
    XR Health announced the acquisition of Swing Therapeutics, a developer of a digital treatment for fibromyalgia. The deal expands XR Health’s portfolio of virtual reality health solutions. Swing Th…
    STAT · 1mo agoDealPositive↗ source
  • FDA acting commissioner says Makary’s journal policies are not official guidance; UK regulator reports rise in drug approvals and AI steps
    The acting commissioner of the U.S. Food and Drug Administration clarified that the policies published in medical journals by former commissioner Marty Makary do not constitute official FDA policy…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Senate HELP Committee probes CDC director nominee over potential political pressure on vaccine decisions
    Senate HELP Committee held a confirmation hearing for the Trump administration's CDC director nominee, Erica Schwartz, and pressed her on the possibility of political interference. Lawmakers asked…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Study reveals how Epstein-Barr virus triggers immune response in multiple sclerosis
    A study published in Science Translational Medicine describes how infection with Epstein-Barr virus (EBV) initiates the immune reactions that lead to inflammation and nerve damage in people with mu…
    STAT · 1mo agoPositive↗ source
  • Bipartisan bill calls for FTC and Treasury to assess U.S. reliance on foreign drug supplies
    A group of bipartisan lawmakers has reintroduced legislation that would require the Federal Trade Commission and the Department of Treasury to examine how heavily the United States depends on forei…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Eli Lilly invests in Oura to aid patients using GLP-1 medicines
    Eli Lilly announced an equity investment in Oura, a startup that makes a wearable health‑monitoring ring. The partnership is intended to support patients who are prescribed Lilly's GLP-1 medicines…
    Endpoints · 1mo agoDealPositive↗ source