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  • 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
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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
  • Premium subscribers invited to exclusive post-hoc Q1 earnings recap live event
    A live, post‑hoc session will be held for premium subscribers that reviews first‑quarter earnings across the pharmaceutical sector, with a particular focus on the deal activity reported in the call…
    Endpoints · 4mo agoNeutral↗ 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
  • BMS's Krazati fails confirmatory colorectal cancer trial, jeopardizing its accelerated approval
    Bristol Myers Squibb said its drug Krazati did not meet the primary endpoint in a confirmatory study for second‑line colorectal cancer. The trial was required to verify the benefit that earned the…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • House panel urges FDA to bar Chinese clinical trial data from drug applications
    A House spending committee introduced language urging the FDA to prohibit the use of clinical trial data generated in China when reviewing new drug applications. The proposal reflects concerns abo…
    Endpoints · 4mo agoRegulatoryNegative↗ 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 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
  • 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