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4,211 stories matching this filter · ← front page

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  • AI pioneer Jakob Uszkoreit’s Inceptive Nucleics teams with Alnylam as biotech lobby pushes Congress for DNA safeguards
    Jakob Uszkoreit, one of the architects behind the transformer model that powers ChatGPT, has turned his attention to drug development. His new venture, Inceptive Nucleics, is creating biological fo…
    STAT · 5mo agoRegulatoryNeutral↗ source
  • Grail’s Galleri multi-cancer early detection trial misses primary endpoint, but oncologists note promising signals
    The first randomized trial of a multi-cancer early detection test enrolled about 143,000 English adults aged 50 to 77. Participants were randomly assigned to receive either standard care or the Gal…
    STAT · 5mo agoNegative readoutNeutral↗ source
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  • Promising pancreatic cancer drug daraxonrasib shows near-double survival, patients await expanded access
    Amy Johnston, diagnosed with pancreatic cancer last year, has undergone chemotherapy and surgery and is now in a clinical trial that hopes to delay disease progression. She expects results by the e…
    STAT · 5mo agoPositive readoutNeutral↗ source
  • Lilly and Boehringer cut German investments amid health-spending overhaul
    A proposed overhaul of Germany's health-insurance financing is sparking criticism from industry groups. Eli Lilly and Boehringer Ingelheim announced they will reduce their investment programmes in…
    Endpoints · 5mo agoRegulatoryNegative↗ source
  • Supreme Court unanimously backs Hikma's skinny label fish oil generic
    The U.S. Supreme Court issued a unanimous decision favoring Hikma Pharmaceuticals in a dispute over its skinny label version of a prescription-strength fish oil product. The court ruled that Hikma…
    Endpoints · 5mo agoRegulatoryPositive↗ source
  • Eli Lilly cuts German weight-loss syringe investment by half amid new cost-cutting law
    Eli Lilly said it will cut its planned investment in Germany for the production of weight‑loss syringes. The company had originally earmarked $2.67 billion, but will now invest roughly half that a…
    STAT · 5mo agoDealNegative↗ source
  • Parabilis Medicines targets over $400 million in Nasdaq IPO to fund peptide pipeline
    Parabilis Medicines, a peptide-focused biotech led by former Johnson & Johnson R&D head Mathai Mammen, announced plans for a Nasdaq initial public offering. The company aims to raise more than $40…
    Endpoints · 5mo agoDealPositive↗ source
  • ADC Therapeutics' Zynlonta confirmatory trial shows higher death rates, clouding full approval prospects
    ADC Therapeutics is pursuing full FDA approval for its antibody-drug conjugate Zynlonta in patients with relapsed or refractory diffuse large B-cell lymphoma. In the confirmatory study presented,…
    Endpoints · 5mo agoRegulatoryNegative↗ source
  • Revolution Medicines eyes broader use of daraxonrasib pending FDA submission
    Revolution Medicines' daraxonrasib has not yet been approved for metastatic pancreatic cancer after chemotherapy, but a recent ASCO plenary presentation generated strong interest. Analysts expect…
    STAT · 5mo agoRegulatoryPositive↗ source
  • Lawmakers backtrack on promised Medicaid protections for cancer patients, new CMS rules impose work requirements
    Gwen Nichols, a hematologist/oncologist and chief medical officer of Blood Cancer United, wrote that lawmakers who pledged to protect cancer patients from Medicaid cuts are now backing a policy tha…
    STAT · 5mo agoRegulatoryNegative↗ source
  • Patient-focused AI apps turn smartphones into real-time visit scribes
    More than a quarter of U.S. medical practices now rely on AI-powered ambient scribes that record appointments and draft clinical notes for doctors. The technology, initially deployed for clinicians…
    STAT · 5mo agoDealPositive↗ source
  • ADC biotech Ona Therapeutics raises $86.6M in Series B to move two ADC candidates toward clinic
    Barcelona-based Ona Therapeutics announced a $86.6 million Series B financing round. The capital will be used to move two antibody‑drug conjugate (ADC) programs into early‑stage clinical testing.…
    Endpoints · 5mo agoDealPositive↗ source
  • Spanish biotech Ona Therapeutics secures $86.6 million Series B to advance new ADCs for breast and colorectal cancer
    Ona Therapeutics, a Barcelona‑based biotechnology startup, announced a Series B financing round that raised roughly $86.6 million. The new capital will fund the launch of two antibody‑drug conjuga…
    BioPharma Dive · 5mo agoDealPositive↗ source
  • Trump admin moves to politicize NIH grant officials, stripping job protections
    The White House issued an executive order that reclassifies thousands of civil‑service positions as political appointments under the so‑called Schedule F. The change would allow the administration…
    STAT · 5mo agoRegulatoryNegative↗ source
  • Drug makers and patient groups call on FDA to suspend fast‑track voucher program
    The FDA held a town‑hall listening session on its Commissioner’s National Priority Voucher program, hearing from 17 speakers that included patient advocates, pharmaceutical companies and academic r…
    STAT · 5mo agoRegulatoryNegative↗ source
  • Otsuka's Voyxact reduces kidney function decline in IgA nephropathy but falls short of expectations in Phase 3
    Otsuka reported Phase 3 trial results for its drug Voyxact in patients with IgA nephropathy, a chronic autoimmune kidney disease. In the study, patients receiving Voyxact experienced an annualized…
    STAT · 5mo agoNegative readoutNeutral↗ source
  • Acting FDA Commissioner Kyle Diamantas says he will not seek permanent appointment
    Acting FDA Commissioner Kyle Diamantas has indicated that he does not intend to remain in the role on a permanent basis. Sources close to the administration say that the search for a new permanent…
    Endpoints · 5mo agoRegulatoryNeutral↗ source
  • Acting FDA chief vows to shield rare-disease discussions from political influence
    Acting FDA Commissioner Kyle Diamantas met with executives from fifteen rare‑disease nonprofit groups and senior agency staff. During the gathering he emphasized a new approach that differs from th…
    Endpoints · 5mo agoRegulatoryPositive↗ source
  • Otsuka showcases kidney drug data; Pfizer cuts an AI deal
    Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off gen…
    BioPharma Dive · 5mo agoDealNeutral↗ source
  • Scientists identify previously unknown HIV reservoir in the body
    Scientists have reported the discovery of a new location where HIV can hide within the human body. The finding expands the list of known viral reservoirs and suggests that the virus may persist in…
    STAT · 5mo agoNeutral↗ source
  • Elevance Health’s chief digital officer discusses practical AI applications for insurers
    Elevance Health interviewed its chief digital information officer, Ratnakar Lavu, about how health insurers are adopting artificial intelligence. Lavu, who previously held digital roles at Kohl’s,…
    Endpoints · 5mo agoNeutral↗ source
  • Utah Medical Board Criticized for Unilateral Stance on AI in Healthcare
    The Utah Medical Board faced rebuke after it took an independent approach to criticizing artificial intelligence tools used in medical practice. The criticism came as the state was running a pilot…
    STAT · 5mo agoRegulatoryNegative↗ source
  • HHS says Americans with high-risk Ebola exposure can receive experimental antibody MBP-134 from Mapp Biopharma
    HHS announced that U.S. citizens who have had high-risk exposure to Ebola in the ongoing Central African outbreak will be eligible to receive an experimental antibody therapy. The treatment, ident…
    STAT · 5mo agoRegulatoryPositive↗ source
  • Revolution Medicines' pancreatic cancer drug sparks standing ovation on biotech podcast
    The latest episode of STAT’s "The Readout LOUD" podcast highlighted a recent data presentation on Revolution Medicines’ pancreatic cancer candidate, daraxonrasib. Oncologists in the audience respo…
    STAT · 5mo agoNeutral↗ source
  • Health secretary RFK Jr. faces staffing gaps as top priority over vaccine initiatives
    Robert F. Kennedy Jr., in his second year as the nation’s health secretary, has spent much of the first half of the year traveling to farms, clinics and other sites across the United States. In in…
    STAT · 5mo agoNeutral↗ source