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  • FDA oncology panel votes against AstraZeneca's camizestrant trial, citing lack of meaningful benefit
    The FDA's oncology advisory committee convened for the first time in about nine months and evaluated AstraZeneca's late-stage trial of its oral selective estrogen receptor degrader, camizestrant.…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Supreme Court hints at ruling in case over generics' use of skinny-label drugs
    Supreme Court justices have offered preliminary signals about how they may decide a contentious lawsuit that could reshape the way generic drug makers market products with "skinny labels". The cas…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
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  • FDA proposes removing semaglutide, tirzepatide, liraglutide from 503B compounding list
    The FDA has proposed removing the active ingredients of several popular GLP‑1 drugs from the 503B compounding list. The agency says there is no clinical need for large compounding facilities to pr…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Avalyn Pharma launches $300M IPO, selling 16.5 million shares at $18 each
    Avalyn Pharma, a Boston-based biotech, announced an initial public offering that aims to raise roughly $300 million. The company will sell more than 16.5 million shares at $18 per share and is set…
    Endpoints · 4mo agoDealNeutral↗ source
  • Analysts zero in on three Bristol Myers programs as company gears up for multiple data readouts through 2026
    Analysts are closely watching Bristol Myers Squibb's pipeline, focusing on three key programs that could drive growth in the coming years. Wall Street expects a flurry of data readouts, with at le…
    Endpoints · 4mo agoNeutral↗ source
  • Democrats unveil plan to lower health care costs across the board
    Senate Minority Leader Chuck Schumer presented a health policy outline that calls for reducing patient costs for all services and treatments. The proposal emphasizes lowering expenses universally,…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Lilly’s obesity pill Foundayo sees slower early uptake than Novo’s, with only about 20,000 users in first 20 days
    Eli Lilly launched its obesity medication Foundayo recently, and the company reported that roughly 20,000 patients have started the treatment within the first 20 days. CEO David Ricks said this ea…
    Endpoints · 4mo agoNegative↗ source
  • Novartis announces new North Carolina manufacturing plant, completing its $23 billion U.S. expansion
    Novartis disclosed plans to construct another manufacturing facility in the United States, adding to its ongoing expansion program. The new plant will be located in North Carolina and represents t…
    Endpoints · 4mo agoPositive↗ source
  • NIH grant success rates hit historic low, pushing researchers to seek alternative funding
    NIH grant success rates have fallen to historic lows, with only about 13% of applications receiving funding in the most recent fiscal year. Researchers are responding by dedicating more time to wr…
    STAT · 4mo agoNegative↗ source
  • Avalyn Pharma raises $300M in IPO to fund inhalable lung-fibrosis drugs
    Avalyn Pharma completed a $300 million initial public offering, pricing 16.7 million shares at $18 each and exceeding its original $200 million target. The proceeds will be used to develop inhalab…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Study finds OpenAI large language model outperforms doctors in diagnostic and clinical reasoning tasks
    Researchers from Boston published a paper in Science describing a series of experiments that tested an OpenAI large language model on real‑world diagnostic and clinical reasoning cases drawn from a…
    STAT · 4mo agoPositive readoutPositive↗ source
  • New quintuple-agonist obesity drug shows strong weight loss results in mice
    A preclinical study reported that a novel "quintuple agonist" compound, designed to activate five metabolic pathways, produced marked weight loss in mice. The researchers said the drug outperformed…
    STAT · 4mo agoPositive readoutPositive↗ source
  • XTL Bio to acquire Psyga Bio, adding psychedelic manufacturing capability
    XTL Bio announced it will acquire all outstanding shares of Psyga Bio, a biotech focused on psychedelic therapies. The transaction gives XTL access to Psyga’s manufacturing facility, expanding its…
    Endpoints · 4mo agoDealNeutral↗ source
  • Cigna to Leave ACA Individual Market in 2027, Shifting Focus to Core Business
    Cigna announced it will withdraw from the Affordable Care Act’s individual exchanges starting in 2027, a move revealed on its first‑quarter earnings call. The insurer currently covers about 369,00…
    STAT · 4mo agoRegulatoryNegative↗ source
  • AstraZeneca to Resume Expansion of Cambridge R&D Site After US-UK Trade Deal Boosts UK Drug Spending
    AstraZeneca announced it will restart the expansion of its research and development facility in Cambridge, United Kingdom. The move marks the first R&D project to be revived since the recent United…
    STAT · 4mo agoPositive↗ source
  • New OBSCORE tool predicts risk of 18 obesity-related complications to guide GLP-1 therapy
    A new predictive model called OBSCORE has been introduced to identify individuals at risk for a range of obesity‑related health problems. The tool expands on the traditional body‑mass index metric…
    STAT · 4mo agoPositive↗ source
  • Congress urged to hold RFK Jr. accountable after health policy hearings
    Former Republican congressmen and physicians Michael Burgess and Larry Bucshon wrote an opinion piece calling on lawmakers to keep pressure on Health and Human Services Secretary Robert F. Kennedy…
    STAT · 4mo agoNegative↗ source
  • FDA appoints Katherine Szarama as acting director of vaccines and biologics center
    The FDA announced that Katherine Szarama will serve as the acting director of the Center for Biologics Evaluation and Research (CBER), the agency's unit that oversees vaccines, gene therapies and t…
    STAT · 4mo agoNeutral↗ source
  • Trump nominates radiologist Nicole Saphier as third surgeon general candidate, emphasizes vaccine schedule questions
    The White House announced Dr. Nicole Saphier as its third nominee for surgeon general, replacing the previously considered candidate whose medical license had lapsed. Saphier is a board‑certified…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • STAT podcast highlights investor buzz around hair loss drugs, AI in trials, and Servier's M&A ambitions
    The latest episode of STAT’s “The Readout LOUD” podcast explored why investors are increasingly focused on treatments for hair loss, noting recent trial data that has generated notable market inter…
    STAT · 4mo agoNeutral↗ source
  • Akeso‑Summit’s ivonescimab lands a prime ASCO plenary slot despite unclear survival data
    The upcoming American Society of Clinical Oncology meeting will feature a plenary presentation from Akeso and Summit Therapeutics on their lung‑cancer candidate ivodescimab. Industry observers note…
    STAT · 4mo agoNeutral↗ source
  • HHS Appeals Court Ruling Blocking Health Secretary Kennedy’s Vaccine Policy Changes
    The Department of Health and Human Services has filed an appeal to a federal circuit court challenging a judge’s preliminary ruling that halted several of Health Secretary Robert F. Kennedy Jr.’s p…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Court dismisses portion of Eli Lilly lawsuit against Empower Pharmacy, leaves some claims alive
    A federal judge ruled that part of Eli Lilly's lawsuit against Empower Pharmacy is dismissed. The suit alleged that Empower misled patients about its compounded versions of tirzepatide, an obesity…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Hinge receives FDA clearance for new migraine device
    Hinge announced that its migraine treatment device has received clearance from the U.S. Food and Drug Administration. The clearance allows the company to market the device in the United States and…
    STAT · 4mo agoApprovalPositive↗ source
  • CVS Health explores clinical AI but cites barriers to broader use
    CVS Health's President of Health Care Delivery Sree Chaguturu discussed the company's ongoing experiments with artificial intelligence tools aimed at delivering clinical services. The testing has…
    Endpoints · 4mo agoNeutral↗ source