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  • STAT+: Failure of Novartis Lp(a) drug raises questions about cardiovascular strategy
    Medical mystery at the AHA conference: A Novartis drug lowered a risk marker for cardiovascular disease but did not lower chance of heart attack or stroke.
    STAT · 3d agoRegulatoryNeutral↗ source
  • Novartis reports nine cancer cases in patients treated with Zolgensma gene therapy
    Novartis disclosed that nine individuals with spinal muscular atrophy who received its gene therapy Zolgensma later developed tumors. Two of the cases showed evidence that the adeno-associated vir…
    BioPharma Dive · 3d agoRegulatoryNegative↗ source
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  • Democrats’ Midterm Win Promises Medicaid Reversal and ACA Subsidy Restoration for Hospitals
    The November midterm election gave Democrats control of both the House and Senate, a result analysts describe as a landslide. The shift is expected to create a more favorable environment for hospit…
    STAT · 3d agoRegulatoryPositive↗ source
  • New evidence links AAV gene therapies to tumor risk, raising safety concerns
    Recent cases reported this year provide strong evidence that adeno-associated viruses (AAVs), the vectors used to deliver therapeutic genes, can trigger tumor formation. The findings settle a two‑d…
    STAT · 3d agoRegulatoryNegative↗ source
  • Novartis reports seven tumor cases in children treated with Zolgensma
    Novartis has disclosed that seven children who received its gene therapy Zolgensma for spinal muscular atrophy were later found to have tumors. The company said the cases were identified during po…
    STAT · 4d agoRegulatoryNegative↗ source
  • Eli Lilly partners with Hims & Hers to sell Zepbound and Foundayo via telehealth platform
    Eli Lilly announced a partnership with Hims & Hers to make its obesity treatments Zepbound and Foundayo available through the telehealth service. The arrangement lets patients with a prescription…
    BioPharma Dive · 4d agoDealNeutral↗ source
  • Novo Nordisk’s oral Wegovy sales beat forecasts, boosting shares over 5%
    BioPharma Dive’s latest visualization series examines how investors reacted to three drug launches highlighted in recent quarterly earnings. Novo Nordisk reported that its oral Wegovy generated 5.…
    BioPharma Dive · 4d agoPositive readoutPositive↗ source
  • Marea Therapeutics reports promising Phase 2b results for MAR001 in hypertriglyceridemia
    Marea Therapeutics, which recently merged with oncology firm Lisata Therapeutics, disclosed data from the first part of its phase 2b trial of the drug candidate MAR001. The study enrolled patients…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • Boehringer targets 2027 submission of obesity drug survodutide after positive cardiovascular trial
    Boehringer Ingelheim announced that its experimental obesity therapy survodutide is moving toward regulatory filing. The move follows the drug's successful phase 3 cardiovascular outcomes study, w…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • Experts warn US Treasury's biotech investment ban on China could backfire
    The U.S. Treasury released a draft policy to implement the Comprehensive Outbound Investment National Security (COINS) Act, proposing to add pharmaceutical compounds to an outbound investment black…
    Fierce Biotech · 3d agoRegulatoryNegative↗ source
  • States sue Trump administration to halt Medicaid work-requirement rollout
    Four states filed a lawsuit in the U.S. District Court in Oregon challenging the Trump administration's Medicaid work-requirement changes. The complaint alleges the overhaul would cause sovereign,…
    STAT · 3d agoRegulatoryNegative↗ source
  • Newly elected scientists aim to restore health equity programs cut by Trump administration
    Two newly elected officials with scientific credentials, Michigan Senator-elect Abdul El-Sayed, an epidemiologist, and Georgia Rep-elect Jasmine Clark, a microbiologist, are preparing to join Congr…
    STAT · 3d agoPositive↗ source
  • Amgen’s Repatha linked to fewer heart attacks while Novartis reports seven new tumor cases in Zolgensma patients
    Amgen reported that its cholesterol‑lowering drug Repatha was associated with a lower incidence of heart attacks in a recent analysis. The data suggest the therapy may provide cardiovascular benefi…
    STAT · 4d agoNeutral↗ source
  • Moderna pauses norovirus vaccine trial after missing interim analysis
    Moderna announced it will not enroll a new cohort in the phase 3 trial of its mRNA-1403 norovirus vaccine. The decision follows a July interim analysis that showed the vaccine missed its predefine…
    Fierce Biotech · 4d agoNegative readoutNegative↗ source
  • Faeth Therapeutics reports 33% response rate in phase 2 endometrial cancer combo trial
    Faeth Therapeutics presented topline results from its phase 2 study of an oral combination targeting the PI3K/AKT/mTOR pathway in patients with advanced or recurrent endometrial cancer. The regimen…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • Merck ends Sutro partnership on IL-2 agonist MK-1484 amid routine pipeline prioritization
    Merck announced it is discontinuing development of MK-1484, an interleukin-2 agonist created in partnership with Sutro Biopharma. The drug entered clinical testing in 2022 as a monotherapy and in…
    Fierce Biotech · 4d agoNegative↗ source
  • Siemens Healthineers to spin off in‑vitro diagnostics unit as Olyrian Diagnostics, rebranding to Healthineers
    Siemens Healthineers announced it will separate its in‑vitro diagnostics division into a new standalone company called Olyrian Diagnostics. The carve‑out will run in parallel with a corporate name…
    Fierce Biotech · 4d agoDealNeutral↗ source
  • Onchilles reports that direct tumor injection of N17350 clears distant lesions in solid tumor models
    Onchilles, a San Diego biotech, presented data on its therapeutic elastase N17350, a vaccine‑like agent injected directly into solid tumors. In preclinical studies the intratumoral injection not o…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • China offers pharma firms large patient pools and early efficacy signals for global drug development
    The podcast examines how China can be woven into global clinical development strategies. It highlights that China provides access to large patient populations, early efficacy signals and a potenti…
    Fierce Biotech · 4d agoPositive↗ source
  • Podcast examines Democrats' midterm win and concerns over a costly, questionable fertility genetic procedure
    Stat's weekly biotech podcast "The Readout LOUD" released an episode featuring Washington correspondent Daniel Payne to discuss how the Democrats' sweeping midterm victory could shape drug pricing…
    STAT · 3d agoNeutral↗ source
  • MetaVia appoints Sarah Browne as chief medical officer
    MetaVia announced the hiring of Sarah Browne as its new chief medical officer. Browne previously worked as a clinical development consultant for Souffle Therapeutics and before that served as vice…
    STAT · 3d agoPositive↗ source
  • Former MAHA official Calley Means blames White House for yielding to industry pressure
    Calley Means, a leader of the Make America Healthy Again (MAHA) group and former senior official in the Trump administration, announced his resignation and criticized the White House for being sway…
    STAT · 3d agoNegative↗ source
  • Axiom Biosciences pursues Hong Kong IPO and novel stem cell platform amid funding challenges
    Axiom Biosciences is charting an unconventional financing path by targeting a public listing in Hong Kong, with a long‑term goal of listing on the Nasdaq. The company is developing multiple drug d…
    Fierce Biotech · 4d agoPositive↗ source
  • Medical records often miss women's health experiences, limiting AI's potential
    Ann Hirsch and Jennifer Silva argue that artificial intelligence cannot reach its full promise in women's health until medical records capture the complete picture of patients' lives. They cite a r…
    STAT · 4d agoNegative↗ source
  • Medicare delays controversial remote patient monitoring ban to 2029, opening window for provider pushback
    Medicare regulators advanced a plan to prohibit hospitals and other providers from using third‑party companies for remote patient monitoring (RPM) services, despite strong opposition from health‑te…
    STAT · 4d agoRegulatoryNeutral↗ source