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  • CMS recalculates 2026 Medicare Advantage star ratings, increasing program volatility and affecting $16 billion in bonuses
    Federal officials have issued a new memo that recalculates the quality ratings for 2026 Medicare Advantage plans. The change follows another lawsuit from insurers that contest lower star ratings,…
    STAT · 2mo agoRegulatoryNegative↗ source
  • 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 · 2mo agoRegulatoryPositive↗ source
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  • 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 · 2mo agoRegulatoryNegative↗ source
  • 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 · 2mo 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 · 2mo 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 · 2mo agoRegulatoryNegative↗ 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 · 2mo agoRegulatoryNegative↗ 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 · 2mo agoNeutral↗ source
  • Novo Nordisk expands in China and Czech; Cellares boosts Series D by $50M
    Plus more from Eisai and Siegfried. 🧱 Novo Nordisk's expansions: Novo Nordisk has invested around $380 million to expand its manufacturing facility in Bohumil, Central Bohemia, in the Czech Republ…
    Endpoints · 2mo ago↗ source
  • STAT+: Cambrian’s experimental longevity drug mimics exercise
    What Soon-Shiong has delivered, Encanta's RSV antiviral, and other biotech news from The Readout
    STAT · 2mo ago↗ source
  • Biogen adds more immune drugs in $1B buyout of secretive startup RayThera
    The companies didn’t specify the drugs Biogen is acquiring in the deal, though patents RayThera secured provide important clues.
    BioPharma Dive · 2mo ago↗ source
  • IRA's Medicare out-of-pocket cap increased access to drugs, study finds
    Medication usage, particularly for the most expensive drugs, increased significantly shortly after the Medicare annual out-of-pocket cost cap took effect in January 2025, a study published in JAMA…
    Endpoints · 2mo ago↗ source
  • Prepping for peptides
    It wasn’t too many years ago when we were busy theorizing about the market opportunity for GLP-1 weight loss drugs. Now, the big question is the moneymaking potential for other peptides that might…
    Endpoints · 2mo ago↗ source
  • Pfizer CFO to step down; Denali sells a regulatory fast-pass
    A search is underway for a successor to Dave Denton, who took a job outside the pharmaceutical industry. Elsewhere, a new kind of Duchenne gene therapy got venture backing and a GSK deal paid divid…
    BioPharma Dive · 2mo ago↗ source
  • Pfizer CFO to depart; GSK wins approval for UTI drug
    Plus news about Apellis Pharmaceuticals, Servier, TORL BioTherapeutics, Verastem, Corcept Therapeutics, Legend Biotech, COUR Pharmaceuticals, cAMPfield Therapeutics and LabGenius Therapeutics. 👋 P…
    Endpoints · 2mo ago↗ source
  • STAT+: Shingles vaccine may lower dementia risk, new study finds
    Nursing home residents who received at least one dose of shingles vaccine were 24 percent less likely to develop dementia, a new study found.
    STAT · 2mo ago↗ source
  • RA, Forbion and Sanofi Ventures appear to back new eye drug from Korea
    The trend continues in which big-name venture investors band together to back new companies with an experimental medicine developed by another biotech. RA Capital and Forbion — partners on a couple…
    Endpoints · 2mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about an FDA review of Moderna’s flu shot, J&J’s focus on cancer, and more
    Johnson & Johnson has no plans to enter the booming obesity market, opting instead to focus on diseases such as cancer
    STAT · 2mo ago↗ source
  • Novocure’s electric fields therapy fails key glioblastoma study
    Novocure reported Thursday morning that its electric fields device combined with chemoradiation failed to extend glioblastoma patients' lives in a Phase 3 study, dampening the company's hopes of ex…
    Endpoints · 2mo ago↗ source
  • How many Americans can afford high-quality health care? A new poll finds the number has fallen
    A new poll shows only about half of U.S. adults could afford their health care and had access to quality care last year.
    STAT · 2mo ago↗ source
  • Innoviva revives Lyndra's long-acting oral drug platform
    A healthcare asset and royalties holding company is bringing a long-acting oral medicine approach back to life, resurrecting a drug delivery platform that had accumulated more than $380 million in…
    Endpoints · 2mo ago↗ source
  • Six of the biggest health news stories today
    High-end infant formula scrutiny, the spread of synthetic opioids, and more health news from Morning Rounds
    STAT · 2mo ago↗ source
  • Moderna adds commercial chief, expands Stephen Hoge's role; Reunion Neuroscience CEO departs
    → In preparation for potential new product launches, Moderna has selected Ester Banque as chief commercial officer and expanded the role of president Stephen Hoge. Banque was head of US operations…
    Endpoints · 2mo ago↗ source
  • Eli Lilly's TuneLab hits 100 members, adding Chai's AI models
    The leader behind TuneLab, Eli Lilly's first-of-its-kind AI initiative, had no idea what to expect when it launched. Lilly was trying something new by effectively offering biotechs free access to s…
    Endpoints · 2mo ago↗ source
  • STAT+: In pancreatic cancer, Patrick Soon-Shiong makes promises he has not kept
    A wide gap exists between what Patrick Soon-Shiong says his cancer drugs can achieve and what they actually do, STAT's Adam Feuerstein writes.
    STAT · 2mo ago↗ source