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  • FDA CDER appoints veteran GLP-1 reviewer Lisa Yanoff as acting deputy director
    Acting FDA CDER director Michael Davis promoted Lisa Yanoff to the role of acting deputy director of the Center for Drug Evaluation and Research. Yanoff is a long‑time FDA employee with deep exper…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • GOP lawmakers urge FDA under Trump to enforce diversity in clinical trial enrollment
    Republican members of Congress have asked the Food and Drug Administration, now led by President Trump, to adopt policies that require clinical trials to enroll participants who reflect the diversi…
    STAT · 1mo agoRegulatoryNeutral↗ source
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  • Salk Institute President Warns of NIH Funding Cuts While Embracing AI and Brain Research Initiatives
    Gerald Joyce, president of the Salk Institute, highlighted recent reductions in NIH funding and their impact on research institutions. He said the institute is fully committing resources to artifi…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Physicians overuse diagnostic tests, urging structural changes to curb waste and antibiotic resistance
    American medicine orders more than 14 billion diagnostic tests each year, but many are performed at the wrong time or on patients who will not benefit. The author argues that while the industry ha…
    STAT · 1mo agoNegative↗ source
  • Vidcon highlights mental-health challenges faced by social video creators
    Vidcon this year devoted a significant portion of its programming to the mental health of content creators, reflecting growing concern about the pressures of online fame. In a STATus Report interv…
    STAT · 1mo agoNeutral↗ source
  • Anthropic unveils Claude Science platform as US House panel investigates Chinese clinical trial sites
    Anthropic, an artificial‑intelligence startup, announced the launch of Claude Science, a version of its Claude model built for scientific research. The new platform offers tools to help researchers…
    Endpoints · 1mo agoNeutral↗ 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↗ 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
  • 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
  • Sandoz launches direct-to-consumer platform with growth disorder drug
    Sandoz unveiled a direct-to-consumer platform, starting off with a single medication for now as the generic drugmaker adopts a system that several brand-name manufacturers are using to cut out-of-p…
    Endpoints · 1mo ago↗ source
  • STAT+: Up and down the ladder: The latest comings and goings
    Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.
    STAT · 1mo ago↗ source
  • After landmark deal, AstraZeneca goes to CSPC again in up to $1.7B pact
    Less than six months after lining up one of the largest biobucks packages in industry history, AstraZeneca is returning to the same Chinese partner for another drug R&D collaboration. The UK pharma…
    Endpoints · 1mo ago↗ source
  • STAT+: What does DeGette’s loss mean for pharma?
    Colorado Democratic Rep. Diana DeGette, who lost her primary, was knowledgeable about biopharma, if not always a friend to the industry.
    STAT · 1mo ago↗ source
  • Court halts Colorado price cap on Amgen's blockbuster Enbrel
    US District Court Judge Daniel Domenico in Colorado granted Amgen's preliminary injunction to stop a 70% price cap on its blockbuster autoimmune drug Enbrel, arguing that the cap could cause "econo…
    Endpoints · 1mo ago↗ source
  • Revolution Medicines shares promising data around KRAS drug combination
    Revolution Medicines on Thursday gave a first look at the early-stage data that led it to plan a Phase 3 trial combining two KRAS drugs in pancreatic cancer. One of the two drugs is a ...
    Endpoints · 1mo ago↗ source
  • Otsuka reports long-term kidney data key to Voyxact's bid for full approval
    Otsuka on Thursday reported new long-term data that it hopes will convert an accelerated approval to a full green light in kidney disease. The company said the Phase 3 study showed Voyxact stabiliz…
    Endpoints · 1mo ago↗ source
  • IPF biotech Celea gets $180M to follow paths of PureTech's Karuna, Seaport
    With major backing from new investors, Celea Therapeutics hopes to follow in the footsteps of its siblings Seaport Therapeutics and Karuna Therapeutics. Celea has corralled $180 million to see if
    Endpoints · 1mo ago↗ 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