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2,811 stories matching this filter · ← front page

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  • Lilly’s ‘triple-G’ drug tops Novo’s Ozempic in diabetes trial
    The highest dose of retatrutide beat Ozempic on measures of blood sugar and weight loss, but was also associated with higher side effect rates and treatment discontinuations.
    BioPharma Dive · 13d ago↗ source
  • STAT+: Lilly’s triple-G drug beats Ozempic in head-to-head study
    Eli Lilly announced that its investigational drug retatrutide was more effective at lowering blood sugar and cutting weight than Novo Nordisk’s Ozempic in a large diabetes study.
    STAT · 13d ago↗ source
  • Phase 3 trial shows cancer vaccine intismeran autogene cuts recurrence risk by 42% versus Keytruda
    At the European Society for Medical Oncology Congress, a Phase 3 trial of the personalized cancer vaccine intismeran autogene reported a 42% reduction in risk of recurrence or death compared with p…
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Nephrology760
STAT · 14d ago
Positive readoutPositive
↗ source
  • FDA releases draft guidance on oversight of individualized gene-editing products
    The U.S. Food and Drug Administration issued draft guidance that outlines a proposed regulatory framework for individualized gene‑editing products, including cases where multiple product variants a…
    raps · 15d agoRegulatoryNeutral↗ source
  • FDA releases details on accelerated approval process for personalized gene therapies
    The U.S. Food and Drug Administration has issued additional guidance on a faster approval pathway designed for personalized gene therapies. The new details outline how sponsors can seek expedited r…
    STAT · 14d agoRegulatoryPositive↗ source
  • Federal judge denies Novo's attempt to block Eli Lilly obesity drug ads
    A federal judge in the U.S. District Court denied Novo Nordisk's request to halt an Eli Lilly advertising campaign that compared the two companies' obesity treatments, Wegovy and Zepbound. Novo ar…
    BioPharma Dive · 14d agoRegulatoryNeutral↗ source
  • U.S. judge denies effort to block Eli Lilly's weight-loss ad; GSK reports oncology drug approval
    A U.S. district judge rejected a request to halt Eli Lilly's advertising campaign that Novo Nordisk alleges is deceptive in promoting its weight‑loss medicines. Novo Nordisk argued the ads could m…
    STAT · 14d agoRegulatoryNeutral↗ source
  • Pennsylvania Mennonite community creates its own biotech firm after successful gene therapy in a calf with maple syrup urine disease
    A tight‑knit Mennonite community in Lancaster County, Pennsylvania, has long faced a high rate of maple syrup urine disease (MSUD), a rare genetic disorder that can be fatal. With few external biot…
    STAT · 14d agoPositive↗ source
  • Missouri AG orders Eli Lilly to stop demanding hospital data for 340B discounts
    Missouri Attorney General Catherine Hanaway sent a cease‑and‑desist letter to Eli Lilly on Oct 26, demanding the company stop requiring hospitals to submit claims data as a condition for receiving…
    STAT · 14d agoRegulatoryNegative↗ source
  • Nonprofit revives gene therapy program after UK startup closure
    Bloomsbury Genetic Therapies, a U.K.-based gene‑therapy startup, announced it was shutting its doors after treating only a single patient. The company’s closure left its lead experimental therapy w…
    STAT · 14d agoPositive↗ source
  • Researchers isolate marine compound that may halt deadly brain-eating amoeba infections
    Brain-eating amoebas are notoriously difficult to treat and have a mortality rate that is almost 100%. The article notes that researchers have now isolated a compound from the sea that could potent…
    STAT · 14d agoPositive↗ source
  • Pediatric emergency departments remain in chronic crisis after 2022 tripledemic, says opinion piece
    The authors argue that the surge in pediatric patients that peaked in 2022 has become a routine reality, leaving emergency departments across the country in a state of permanent crisis. A rural ho…
    STAT · 14d agoNegative↗ source
  • FDA issues early alert on B. Braun Streamline Bloodline Set recall due to connector leak risk
    The FDA's Center for Devices and Radiological Health issued an Early Alert about B. Braun's Streamline Bloodline Set for Dialog+ after discovering a potential high risk issue. The problem is trace…
    fda medwatch · 14d agoCRLNegative↗ source
  • FDA approves prostate cancer and Crohn’s disease therapies as judge rejects effort to block Lilly weight‑loss ads
    The U.S. Food and Drug Administration announced approvals for new treatments targeting prostate cancer and Crohn’s disease. The decisions expand therapeutic options for patients with these conditio…
    raps · 15d agoRegulatoryNeutral↗ source
  • RFK Jr. campaigns in Iowa as healthcare companies prepare earnings reports
    Robert F. Kennedy Jr. appeared in Iowa to support GOP gubernatorial candidate Zach Lahn, marking his final push on the campaign trail. The week’s agenda also includes earnings calls from major hea…
    STAT · 14d agoNeutral↗ source
  • FDA officials share guidance on de novo device classifications and upcoming MDUFA VI changes at MedTech Conference
    At the MedTech Conference in Boston, FDA officials and industry experts discussed de novo classification requests. They offered practical tips for companies seeking de novo designation, stressing…
    raps · 15d agoRegulatoryNeutral↗ source
  • Ferring to acquire next-gen IVF startup Gameto for up to $1.4B
    The buyout hands Ferring rights to a technology capable of simplifying the lengthy and burdensome process of in vitro fertilization.
    BioPharma Dive · 14d ago↗ source
  • STAT+: After two deaths in autoimmune cell therapy trial, Artiva is shutting down
    Recent deaths are setbacks in drug companies’ interest in applying cancer therapy strategies to autoimmune diseases.
    STAT · 14d ago↗ source
  • Artiva to quit autoimmune cell therapy work, cut staff after patient deaths
    The disclosure makes Artiva the third company to recently report fatal events in an autoimmune cell therapy trial, following announcements from Novartis and Bristol Myers Squibb.
    BioPharma Dive · 14d ago↗ source
  • Roche's KRAS inhibitor divarasib shows strong results in second-line lung cancer trial at ESMO
    Roche presented data from a trial of its KRAS G12C inhibitor divarasib at the European Society for Medical Oncology meeting. The study evaluated divarasib in patients with advanced non-small cell…
    STAT · 15d agoPositive readoutPositive↗ source
  • Moderna and Merck aim to file personalized cancer vaccine for FDA approval after Phase 3 success
    Moderna CEO Stéphane Bancel said the company’s personalized cancer vaccine, intismeran, met its primary goals in a pivotal Phase 3 trial. The success was disclosed during an interview at the ESMO m…
    STAT · 15d agoPositive readoutPositive↗ source
  • Melanoma vaccine shows 42% risk reduction at ESMO 2026, but shares tumble on early data release
    Moderna and Merck presented Phase 3 results for their melanoma vaccine intismeran autogene at the European Society for Medical Oncology meeting. The trial reported a 42% reduction in the relative r…
    BioPharma Dive · 15d agoPositive readoutNeutral↗ source
  • Merck/Kelun ADC sac-TMT cuts death risk by one-third in advanced endometrial cancer
    A randomized Phase 3 trial showed that the antibody‑drug conjugate sacituzumab tirumotecan (sac‑TMT) reduced the risk of death by about one‑third in patients with advanced endometrial cancer. The…
    STAT · 15d agoPositive readoutPositive↗ source
  • GSK gains another cancer drug approval and unveils promising chemo data as it prepares for lung cancer approval
    GSK received regulatory approval this week for one of its cancer medicines in an additional tumor indication, expanding the portfolio that has grown since the company re-entered oncology a decade a…
    STAT · 15d agoApprovalPositive↗ source
  • Incyte reports lasting tumor responses in pancreatic cancer patients using targeted drug plus chemotherapy
    Incyte announced at the European Society for Medical Oncology meeting that its targeted therapy, when combined with standard chemotherapy, produced durable tumor responses in a subset of pancreatic…
    STAT · 15d agoPositive readoutPositive↗ source