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  • FDA approves Arvinas' PROTAC drug Veppanu for specific metastatic breast cancer
    U.S. regulators have granted approval for Veppanu, a protein-degrading therapy developed by biotech firm Arvinas, to treat a defined group of patients with metastatic, estrogen-receptor-positive, H…
    BioPharma Dive · 4mo agoApprovalPositive↗ source
  • Summit Therapeutics' ivonescimab misses interim goal, shares tumble 27% as trial setback raises doubts
    Summit Therapeutics reported that its experimental immunotherapy ivonescimab failed to achieve statistical significance at an interim analysis of the late-stage HARMONi-3 trial in frontline non‑sma…
    BioPharma Dive · 4mo agoNegative readoutNegative↗ source
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  • Two biotech firms raise $556 million in combined IPOs
    Seaport Therapeutics and Hemab Therapeutics launched initial public offerings on Thursday, together bringing in $556.4 million to fund further development of their drug pipelines. Hemab Therapeuti…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Moderna reports Q1 revenue surge driven by international COVID vaccine sales despite larger net loss
    Moderna posted first‑quarter revenue of $389 million, more than triple the same period a year earlier, primarily from overseas COVID‑19 vaccine sales. The company recorded a net loss of $1.3 billi…
    BioPharma Dive · 4mo agoEarningsNeutral↗ source
  • Axsome receives FDA nod for Alzheimer’s agitation treatment
    Axsome announced that the U.S. Food and Drug Administration granted it a nod for a therapy aimed at agitation associated with Alzheimer’s disease, according to the STAT+ report. The decision marks…
    STAT · 4mo agoApprovalPositive↗ source
  • FDA proposes removing obesity and diabetes drug ingredients from compounding substances list
    The U.S. Food and Drug Administration has issued a proposal to remove the active ingredients of widely used obesity and diabetes medicines from the list of substances that can be compounded. The ch…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Psychedelic boom risks sidelining people of color despite new federal push and AbbVie's billion-dollar deal
    The piece highlights that psychedelics are being praised for their therapeutic potential but still face scientific uncertainty and political debate. President Trump signed an executive order aimed…
    STAT · 4mo agoDealNegative↗ source
  • FDA drops Casey Means as surgeon general nominee, naming Fox News radiologist Nicole Saphier instead
    FDA withdrew the nomination of Casey Means for surgeon general and appointed Nicole Saphier, a radiologist and Fox News commentator. The switch underscores the administration’s limited sway in the…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Founder launches new biotech to scale personalized medicines after prior venture folded
    Julia Vitarello’s daughter Mila received a custom‑designed therapy for her rare mutation eight years ago, sparking Vitarello’s interest in individualized treatments. Her first company, EveryONE Me…
    STAT · 4mo agoNeutral↗ source
  • Ailux appoints former AstraZeneca executive Maria Belvisi as chief scientific officer
    Ailux announced the hiring of Maria Belvisi as its new chief scientific officer. Belvisi comes from AstraZeneca where she served as senior vice president of research and development for respirator…
    STAT · 4mo agoPositive↗ source
  • US fertility decline sparks debate over policy motives and family support
    The piece highlights growing alarm in the United States about a sustained drop in birth rates, pointing to factors such as costly childcare, unaffordable housing, shaky health‑care access, and the…
    STAT · 4mo agoNegative↗ source
  • FDA finds low levels of PFAS in most U.S. baby formulas, says supply remains largely safe
    The FDA recently tested 312 infant formula samples from 16 brands and released its findings. The agency detected five types of PFAS, with PFOS appearing in about half of the samples, but 95% of th…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Eli Lilly beats forecasts with 56% revenue jump, lifts full-year outlook
    Eli Lilly reported first‑quarter revenue of $19.8 billion, up 56% year over year, and net income of $7.4 billion, or $8.26 a share. Non‑GAAP earnings were $8.55 a share, well above the $6.77 consen…
    BioPharma Dive · 4mo agoEarningsPositive↗ source
  • Merck remains optimistic on Terns leukemia drug despite new data
    Merck said Thursday that it still sees a compelling outlook for Terns' leukemia drug even after updated study data suggested it may be less differentiated. The updated data came from a trial of TE…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • UniQure to submit UK marketing application for Huntington's gene therapy AMT-130
    UniQure announced it will file a marketing application in the United Kingdom later this year for its gene therapy AMT-130 aimed at Huntington's disease. The filing follows a positive meeting with…
    BioPharma Dive · 4mo agoRegulatoryPositive↗ source
  • Elevance blocks deposition of former Medicare Advantage chief as DOJ seeks testimony
    Elevance Health told the Justice Department it would not make Peter Haytaian, an outgoing executive who oversaw its Medicare Advantage plans, available for a deposition, the agency said in a letter…
    STAT · 4mo agoRegulatoryNegative↗ source
  • J. Craig Venter, pioneering genomics scientist, dies at 79 after cancer treatment
    J. Craig Venter, a leading figure in genomics, passed away at age 79. The cause was complications from a cancer treatment. Venter’s work helped turn genetics from a craft into an industrial inform…
    STAT · 4mo agoPositive↗ source
  • 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
  • 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
  • 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
  • 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
  • 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