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  • FDA advisory panel backs Moderna seasonal mRNA flu vaccine after earlier controversy
    A Food and Drug Administration advisory committee unanimously endorsed Moderna’s seasonal mRNA flu vaccine on Thursday, after the product became the focus of controversy earlier this year when a se…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Eli Lilly stops 340B discounts for hospitals that did not submit required claims data
    Eli Lilly has begun withdrawing the federally mandated 340B price discounts from a handful of hospitals that have failed to provide the comprehensive claims data the company requires. The move fol…
    STAT · 4mo agoRegulatoryNegative↗ source
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  • FDA lifts opposition to Huntington’s disease gene therapy, clearing path for development
    The Readout Loud podcast this week highlighted a regulatory shift for a gene therapy aimed at Huntington’s disease. The Food and Drug Administration reversed its earlier opposition, removing a key…
    STAT · 4mo agoRegulatoryPositive↗ source
  • FDA advisory panel unanimously backs Moderna’s flu vaccine
    The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend Moderna’s seasonal influenza vaccine. The vote overturns earlier hesitations from previous agen…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • U.S. Treasury Considers New Screening Rules for Investments in Chinese Biotech
    Treasury Department officials are reviewing possible measures to screen U.S. capital flowing into Chinese biotechnology firms, according to multiple sources familiar with the discussions. The revi…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Pfizer CFO to leave in August as GSK secures approval for urinary-tract infection drug
    Pfizer announced that its chief financial officer, Dave Denton, will step down in August, ending his tenure at the company. GSK reported that it has received regulatory approval for a new treatmen…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Shingles vaccine linked to 24% lower dementia risk in nursing home residents, study shows
    A new study of elderly nursing home residents examined the effect of receiving at least one dose of the shingles vaccine Shingrix on dementia incidence over a four year period. The analysis found…
    STAT · 4mo agoPositive readoutPositive↗ source
  • Biogen to acquire RayThera for up to $1 billion as J&J shifts focus away from obesity to cancer
    Biogen announced an agreement to purchase RayThera for as much as $1 billion, marking the company's second takeover this year. The deal expands Biogen's portfolio into RayThera's pipeline, though s…
    STAT · 4mo agoDealNeutral↗ source
  • Novocure's electric field therapy fails Phase 3 glioblastoma trial, not extending patient survival
    Novocure announced on Thursday that its electric fields device, used together with standard chemoradiation, did not improve overall survival for patients with glioblastoma in a Phase 3 trial. The…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • New poll shows only half of U.S. adults can afford quality health care, with record-high concerns for next year
    A recent West Health-Gallup Affordability Index found that roughly 50% of American adults said they could pay for health care and still access quality services in the past year. The survey also re…
    STAT · 4mo agoNegative↗ source
  • Moderna appoints Ester Banque as chief commercial officer and expands Stephen Hoge's responsibilities
    Moderna announced a leadership reshuffle as it readies for upcoming product launches. The company named Ester Banque, who previously led U.S. operations at animal health firm Zoetis, as its new ch…
    Endpoints · 4mo agoNeutral↗ source
  • Eli Lilly's TuneLab AI platform reaches 100 members and integrates Chai's models
    Eli Lilly has built TuneLab, an AI initiative that gives biotech companies free access to a range of artificial‑intelligence tools to support drug discovery and development. The program recently a…
    Endpoints · 4mo agoPositive↗ source
  • Super-potent nitazene opioids linked to sharp rise in U.S. overdose deaths
    Synthetic opioids known as nitazenes, which can be up to forty times stronger than fentanyl, are increasingly being found mixed into other street drugs across the United States. The Centers for Di…
    STAT · 4mo agoNegative↗ source
  • Senate Democrats subpoena HHS for records on Trump-era vaccine policy overhaul
    Senate Democrats have launched an inquiry into the Trump administration’s overhaul of U.S. vaccine policy, asking the Department of Health and Human Services to turn over records by the following w…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Pfizer and Amgen target GLP-1 weight-loss market to rival Novo Nordisk and Eli Lilly
    The STATus Report video hosted by Alex Hogan discusses the growing GLP-1 weight-loss drug market. Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound have been on the market for a few years and are pop…
    STAT · 4mo agoNeutral↗ source
  • F2G and Shionogi report positive Phase 3 results for antifungal candidate olorofim
    F2G and Shionogi announced that their joint antifungal candidate, olorofim, met the primary endpoints in a Phase 3 trial. The data were released Thursday morning and showed the drug performed compa…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Kardigan secures $400 million IPO to fund three clinical-stage cardiovascular candidates
    Kardigan, a New Jersey biotech focused on heart disease, announced it raised $400 million in a Nasdaq initial public offering. The capital will be directed toward advancing three clinical-stage dr…
    Endpoints · 4mo agoDealPositive↗ source
  • Biogen to acquire San Diego biotech RayThera in up to $1 billion deal
    Biogen announced it will acquire RayThera, a San Diego-based biotech, in a transaction valued at up to $1 billion. The agreement specifies that most of the payment will be made through milestone-b…
    Endpoints · 4mo agoDealPositive↗ source
  • Eli Lilly stops 340B discounts for dozens of hospitals that did not submit claims data
    Eli Lilly has begun removing the federally mandated 340B price discounts for a few dozen hospitals that have not provided the required claims data. The company said the step follows a warning it is…
    STAT · 4mo agoRegulatoryNegative↗ source
  • RA Capital, Forbion and Sanofi Ventures back Korean eye-drug startup
    RA Capital, Forbion and Sanofi Ventures are reported to be providing financing for a new eye-drug company that is developing its product in Korea. The investment follows a growing pattern where la…
    Endpoints · 4mo agoDealNeutral↗ source
  • Former Senators Urge Congress to Prioritize Global Health as Strategic Diplomacy
    The authors, former U.S. senators, argue that improving global health must become a top priority for the United States, especially in light of recent outbreaks such as hantavirus and Ebola, which l…
    STAT · 4mo agoPositive↗ source
  • Patrick Soon-Shiong's pancreatic cancer claims lag behind reality, STAT reports
    STAT's Adam Feuerstein notes a wide gap between the outcomes promised by Patrick Soon-Shiong's pancreatic cancer therapies and the results that have actually been delivered. The columnist highlight…
    STAT · 4mo agoNegative↗ source
  • AI's rising electricity and water demand poses a public health risk, authors warn
    Two public-health scholars argue that the expanding use of artificial intelligence is creating a hidden strain on essential services such as electricity and water. They note that the massive data c…
    STAT · 4mo agoNegative↗ source
  • STAT Health Tech examines whether wearables benefit cardiovascular patients
    Mario Aguilar writes in a STAT Health Tech newsletter that the issue of wearables for people with cardiovascular disease is under review. The piece notes that researchers have been studying whether…
    STAT · 4mo agoNeutral↗ source
  • Cambrian’s experimental longevity drug shown to mimic exercise effects
    Cambrian Therapeutics reported early data on a new compound aimed at extending healthy lifespan by reproducing some benefits of physical activity. The preclinical studies described in the newslett…
    STAT · 4mo agoNeutral↗ source