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  • Chile's Frutas y Hortalizas del Sur recalls frozen organic blueberries over possible E. coli O145 contamination
    Frutas y Hortalizas del Sur S.A., based in San Carlos, Chile, announced a recall of its frozen GreenWise Organic IQF Blueberries (10‑oz) because the product may be contaminated with Escherichia col…
    fda recalls · 1mo agoCRLNegative↗ source
  • Cadence raises $100M Series C to advance clinical AI for autonomous medical care
    Cadence, a health tech startup, announced a $100 million Series C financing round aimed at expanding its artificial intelligence platform. The new capital will support development of AI tools that…
    Endpoints · 1mo agoDealPositive
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Infectious Disease364
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  • Mars Petcare voluntarily recalls two lots of Pedigree high-protein wet dog food over possible metal and plastic contamination
    Mars Petcare US announced a voluntary recall of two lots of Pedigree Can High Protein Chopped Chicken & Duck Flavor wet dog food (13.2 oz) after discovering potential foreign material. The recall…
    fda recalls · 1mo agoCRLNegative↗ source
  • AstraZeneca signs up to $1.7 billion R&D pact with China’s CSPC, marking second deal in six months
    AstraZeneca announced a new research collaboration with Chinese partner CSPC, valued at up to $1.7 billion. The agreement follows a previous large biobucks deal signed less than six months earlier…
    Endpoints · 1mo agoDealPositive↗ source
  • Scribe Therapeutics files for Nasdaq IPO, testing market appetite for early-stage gene-editing firms
    Scribe Therapeutics announced it has filed a registration statement to list its shares on the Nasdaq, marking the company’s first step toward a public offering. The filing highlights the growing i…
    Endpoints · 1mo agoDealNeutral↗ source
  • Medicare proposes 33% cut to 340B drug payments for hospitals
    Medicare has released a proposal to cut payments to hospitals for drugs bought through the 340B discount program by more than a third. Under the plan, Medicare would reimburse hospitals at the aver…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Lawmakers ask HHS to compel Eli Lilly to resume 340B hospital discounts
    A bipartisan group of congressional lawmakers has written to HHS Secretary Robert F. Kennedy Jr., urging the department to require Eli Lilly to restore 340B drug discounts for hospitals. Lilly hal…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Colorado judge blocks 70% price cap on Amgen's Enbrel, citing potential economic injury
    A U.S. District Court in Colorado issued a preliminary injunction that stops a state‑imposed 70% price cap on Amgen's autoimmune drug Enbrel. The ruling was made by Judge Daniel Domenico, who grant…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Revolution Medicines reports promising early data for KRAS drug combo, plans Phase 3 in pancreatic cancer
    Revolution Medicines presented early-stage results that support moving forward with a Phase 3 study of a combination of two KRAS-targeted agents in pancreatic cancer. The data, shown for the first…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Otsuka presents long-term Phase 3 data for Voyxact, aiming to secure full FDA approval for kidney disease
    Otsuka announced new long-term results from the Phase 3 trial of its kidney disease drug Voyxact. The data show that the therapy stabilized kidney function over an extended period, building on ear…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Celea Therapeutics secures $180M financing to advance IPF pipeline
    Celea Therapeutics, an idiopathic pulmonary fibrosis (IPF) biotech, announced it has raised $180 million from a group of new investors. The funding is intended to help the company follow the devel…
    Endpoints · 1mo agoDealNeutral↗ source
  • Sandoz launches direct-to-consumer platform with growth-hormone biosimilar Omnitrope
    Sandoz announced a direct-to-consumer platform, initially offering Omnitrope, a biosimilar growth hormone for growth disorders. The approach follows a trend among brand-name manufacturers to lower…
    Endpoints · 1mo agoPositive↗ source
  • Elevance Health sues CMS, claiming $115 million loss from disputed Medicare Advantage star rating recalculation
    Elevance Health filed a lawsuit in the U.S. District Court for the Southern District of Georgia, alleging that the Centers for Medicare & Medicaid Services (CMS) recalculated its Medicare Advantage…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Protillion Biosciences appoints Robert Hollingsworth as chief scientific officer
    Protillion Biosciences announced the hiring of Robert Hollingsworth as its new chief scientific officer. Hollingsworth joins Protillion after serving as chief scientific officer at Shoreline Therap…
    STAT · 1mo agoNeutral↗ source
  • Loss of Colorado Rep. Diana DeGette removes a knowledgeable voice for biopharma in Congress
    Colorado Democratic Rep. Diana DeGette was defeated in her primary, ending her service in the U.S. House of Representatives. DeGette was widely recognized for her deep understanding of biopharma p…
    STAT · 1mo agoNegative↗ source
  • Gellert Global Group recalls ALDI Fusia Kimchi & Tofu Kimbap over undeclared tuna
    Gellert Global Group of Elizabeth, NJ announced a recall of 8.1-oz packages of ALDI's Fusia Asian Inspirations Kimchi & Tofu Kimbap because they may contain undeclared tuna. The undeclared fish po…
    fda recalls · 1mo agoCRLNegative↗ source
  • STAT+: Roche drug sets new standard for KRAS-driven lung cancer
    Biotech's bull market, Vertex's gene therapy expansion, and more news from The Readout
    STAT · 1mo ago↗ source
  • Vertex's sickle cell therapy approved for kids; United Therapeutics buys startup
    🧬 Vertex’s sickle cell gene therapy approved for kids: Casgevy may now be used to treat either sickle cell disease with recurrent vaso-occlusive crises or transfusion-dependent β-thalassemia patie…
    Endpoints · 1mo ago↗ source
  • Galderma gets CRL for anti-wrinkle drug; Kimball buys CDMO for $103M
    Plus more from Lonza, Icosagen and others. 🟥 Galderma’s CRL: Galderma has received a complete response letter from the FDA for its relabotulinumtoxinA, a drug being reviewed as a neuromodulator to…
    Endpoints · 1mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about a court win for Amgen, Novo seeking supplier discounts, and more
    U.S. judge blocked a Colorado state panel from placing a cap on the price of Amgen's blockbuster drug Enbrel
    STAT · 1mo ago↗ source
  • How Butterfly, once known for its handheld ultrasound device, is growing its chip-making business
    Nvidia got its start as a gaming chip maker before meteoric success selling its chips to nearly every industry. One health tech company is hoping to go down a similar route. Last month, ultrasound…
    Endpoints · 1mo ago↗ source
  • STAT+: U.S. judge blocks Colorado’s first-of-its-kind price cap on an Amgen drug
    A federal judge blocked a Colorado state panel from placing a cap on the price of Enbrel, a blockbuster drug sold by Amgen
    STAT · 1mo ago↗ source
  • STAT+: More frequent, more intense, and longer heat waves pose health risks for Americans
    The presidential fitness test is back, surprising new data on the health risks of obesity, and more Morning Rounds news
    STAT · 1mo ago↗ source
  • Roche’s KRAS G12C inhibitor beats rivals in head-to-head Phase 3 study
    Roche’s lung cancer drug candidate divarasib has beaten marketed drugs from Amgen and Bristol Myers Squibb in a head-to-head trial. Full data haven't yet emerged, but if the drug's survival benefit…
    Endpoints · 1mo ago↗ source
  • Ex-iTeos CEO starts fresh at GSK neuro partner; Genentech loses yet another key scientist
    → Michel Detheux has succeeded Rita Balice-Gordon as CEO of Danish neuro biotech Muna Therapeutics, which is partnering with GSK on Alzheimer’s treatments. Balice-Gordon will slide over to ...
    Endpoints · 1mo ago↗ source