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  • Moderna posts first profit in two years, driven by Covid-19 vaccine sales, as it refocuses on cancer vaccines
    Moderna reported a modest profit for the quarter, marking its first earnings surplus in two years. The turnaround was driven primarily by continued sales of its international Covid-19 vaccine portf…
    Endpoints · 3d agoEarningsPositive↗ 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 · 3d agoNegative readoutNegative↗ source
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  • 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 · 3d 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 · 3d 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 · 3d agoDealNeutral↗ source
  • Sarepta halts enrollment in confirmatory Phase 3 trial of Elevidys gene therapy for Duchenne muscular dystrophy
    Sarepta Therapeutics announced it will no longer enroll additional patients in the Phase 3 confirmatory study of its gene therapy Elevidys for Duchenne muscular dystrophy. The trial was intended t…
    Endpoints · 3d agoCRLNegative↗ 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 · 3d 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 · 3d 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
  • Verdicts for Summit/Akeso, Capricor, Vertex mark FDA’s stacked November
    Also lined up are target action dates for Sanofi’s Gaucher disease therapy, GSK’s lung cancer medicine and BridgeBio’s muscular dystrophy drug.
    BioSpace · 3d agoRegulatoryNeutral↗ 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 · 2d agoNegative↗ source
  • Novo and Pfizer appoint new CFOs while Alnylam sees departure of its chief commercial officer
    Novo announced the appointment of a new chief financial officer as part of its effort to improve financial leadership. The hire follows earlier reports that the company is seeking to turn a corner…
    Endpoints · 3d agoNeutral↗ 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 · 3d 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 · 3d 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 · 3d agoRegulatoryNeutral↗ source
  • Kratom use rises as health officials warn of addiction risk and push emergency bans
    Kratom, a plant‑derived supplement, is becoming more visible in smoke shops and gas stations, yet most Americans remain unfamiliar with the product. Health officials have highlighted the addiction…
    STAT · 3d agoRegulatoryNegative↗ source
  • Opinion: STAT+: What it’s like to live with cognitively unimpaired Alzheimer’s disease
    People with cognitively unimpaired Alzheimer’s “may be asymptomatic, but they do have a disease experience,” writes Jason Karlawish.
    STAT · 3d agoNeutral↗ source
  • Study finds ritual cannabis use in 2,800-year-old Siberian tomb
    Researchers published a paper in Science that presents archaeological evidence of cannabis being used in ritual contexts in a tomb dating back about 2,800 years in Siberia. The analysis of plant re…
    STAT · 3d agoNeutral↗ source
  • Novartis reports seven new tumor cases in children treated with Zolgensma gene therapy
    Novartis has disclosed that seven children who received its SMA gene therapy, Zolgensma, have been found to have tumors that were not previously reported. The cases were brought to light by an adv…
    STAT · 4d agoRegulatoryNegative↗ source
  • RevMed's pancreatic cancer drug Rasonque generates $198M in Q3, far exceeding forecasts
    RevMed reported $198 million in revenue from its newly launched pancreatic cancer therapy Rasonque during the third quarter, roughly ten times the $19 million estimate from Truist Securities. The…
    BioSpace · 4d agoPositive readoutPositive↗ source
  • AstraZeneca reportedly bids $10 billion for metabolic biotech Rhythm Pharmaceuticals
    AstraZeneca is said to have made a $10 billion offer to acquire Rhythm Pharmaceuticals, a biotech that develops treatments for rare neuroendocrine disorders. The proposal values Rhythm at $124 per…
    BioSpace · 4d agoDealPositive↗ source
  • Revolution Medicines' Rasonque generates $198 million in sales within five weeks of U.S. approval
    Revolution Medicines reported that its pancreatic cancer therapy Rasonque has achieved $198 million in revenue in the first five weeks after receiving U.S. approval. The company said more than 5,00…
    STAT · 4d agoApprovalPositive↗ source
  • Novartis reports nine tumor cases in patients treated with Zolgensma gene therapy
    Novartis has confirmed that nine cases of tumors have been reported in patients who received its spinal muscular atrophy gene therapy, Zolgensma. The company says two cases are confirmed and seven…
    BioSpace · 4d agoNegative↗ source
  • British biotech T-Therapeutics raises $133 million Series B to advance bispecific T-cell engagers
    T-Therapeutics, a British biotech, announced a $133 million Series B financing to advance its next-generation T-cell engager therapeutics. The round was co-led by Advent Life Sciences and the Brit…
    BioSpace · 4d agoDealPositive↗ source