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  • OpenLoop Health says it can launch a virtual GLP-1 prescribing service in 24 hours
    OpenLoop Health says it can set up a telehealth operation that can prescribe GLP-1 medicines within a day. The company provides the medical‑group infrastructure that powers multiple virtual care p…
    Endpoints · 2mo agoNeutral↗ source
  • Alzheimer specialist admits she missed early signs in her own father, urging earlier detection
    A neurologist at the University of California, San Diego writes about her personal experience when her father began showing subtle cognitive changes that were missed. She recounts small mistakes a…
    STAT · 2mo agoNegative↗ source
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Medicare to cover GLP-1 weight-loss drugs for seniors under temporary Trump-backed program
Starting July 1, Medicare will make GLP-1 weight-loss drugs available to adults 65 and older at a cost of $50 per prescription through a new demonstration program. The initiative, called Bridge, i…
STAT · 2mo agoRegulatoryNeutral↗ source
  • Medicare rule could bring subcutaneous Keytruda and Opdivo under price negotiations
    A federal rule proposed for 2029 aims to close a loophole that currently shields medicines moving from intravenous to subcutaneous administration from Medicare price negotiations. The Centers for M…
    BioPharma Dive · 2mo agoRegulatoryNegative↗ source
  • J&J's Talvey plus Darzalex Faspro cuts death risk by up to 53% in relapsed multiple myeloma
    Johnson & Johnson reported that a combination of its immunotherapy Talvey with Darzalex Faspro, with or without Pomalyst, significantly lowered the risk of death in patients with relapsed or refrac…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Newborn contracts preventable syphilis amid Pfizer emergency penicillin shortage and procedural delays
    In March 2026 a pregnant woman in Gila County, Arizona tested positive for syphilis. Doctors said she needed an injectable penicillin dose at least 30 days before delivery to avoid severe fetal com…
    STAT · 2mo agoRegulatoryNegative↗ source
  • CMS proposes rule to close Medicare negotiation loophole for biologics
    CMS announced a proposed policy change that would clarify how the Centers for Medicare & Medicaid Services groups products for price negotiations under the Inflation Reduction Act. The rule target…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • FDA says it will maintain Makary’s focus on clinical trials, rare diseases and China despite leadership exits
    The Food and Drug Administration announced that, even after the recent resignations of Commissioner Marty Makary and the heads of its drug and biologics centers, it will keep pursuing the policy ag…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • FDA greenlights Colorado's plan to import prescription drugs from Canada to lower costs
    The FDA announced Monday that Colorado will be allowed to bring in certain prescription medicines from Canada, aiming to reduce drug prices for state residents. This decision makes Colorado the se…
    STAT · 2mo agoApprovalPositive↗ source
  • FDA greenlights Colorado plan to import prescription drugs from Canada to lower prices
    FDA announced Monday that Colorado will be allowed to import certain prescription medicines from Canada, making it the second state to receive such authorization after Florida. The move is intende…
    STAT · 2mo agoApprovalPositive↗ source
  • Takeda releases additional Phase 3 data to bolster its orexin program amid new competition
    Takeda announced new results from its two Phase 3 trials of an orexin‑targeting therapy. The data are intended to demonstrate the drug’s efficacy and safety, reinforcing Takeda’s claim of market‑l…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Elicio Therapeutics’ KRAS pancreatic cancer vaccine fails in Phase 2, stock drops sharply
    Elicio Therapeutics reported that its KRAS‑targeted vaccine for pancreatic cancer did not improve patient outcomes in a mid‑stage (Phase 2) trial. The study results were released in a company state…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • Gan & Lee reports positive Phase 3 obesity trial results; J&J shares multiple myeloma data
    Gan & Lee Pharmaceuticals, a China‑based insulin specialist, announced topline results from its Phase 3 obesity trial, indicating a successful outcome. The company said the study met its primary e…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • European trial registry shows under half of studies missing timely results, analysis says
    A new analysis of a major European clinical trial database found that fewer than half of the studies reported results within the legally required timeframe, and only 42% provided complete data. Th…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Covid vaccine linked to 24% drop in overall cardiac events, study of 1 million veterans shows
    A new analysis of more than one million U.S. veterans indicates that receiving a Covid‑19 vaccine is associated with a substantial reduction in heart‑related problems. Researchers observed a roughl…
    STAT · 2mo agoPositive readoutPositive↗ source
  • Neumora Therapeutics halts lead depression drug after two more Phase 3 failures, plans 35% staff cuts
    Neumora Therapeutics announced that its lead depression candidate will be discontinued after it did not meet primary endpoints in two additional Phase 3 trials. The company said the data were consi…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • Lilly reports early positive results for new JAK2 inhibitor in hard-to-treat myelofibrosis
    Lilly has incorporated a JAK2‑targeting drug originally discovered by Ajax Therapeutics after its recent acquisition. The experimental pill is intended for patients with myelofibrosis, a difficult‑…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Sanofi’s Tzield approved amid review dispute as Bicillin shortage hampers syphilis treatment
    An Arizona woman pregnant with syphilis could not receive timely treatment because of a worsening shortage of Bicillin, the injectable penicillin made by Pfizer. The shortage has raised concerns ab…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • US sees 800% rise in congenital syphilis births amid penicillin shortage, officials warn of preventable "never event"
    The article notes a dramatic surge in congenital syphilis cases in the United States, with births affected rising about 800% between 2012 and 2024. This increase is described as a "never event" bec…
    STAT · 2mo agoNegative↗ source
  • Celiac disease faces new therapeutic possibilities as companies target underlying inflammation
    Celiac disease affects roughly one in every hundred people worldwide, imposing a daily burden that goes far beyond dietary restrictions. Currently, patients have no approved medicines and must rel…
    BioPharma Dive · 2mo agoPositive↗ source
  • HMNC Brain Health raises $50M Series B to advance two depression drugs
    HMNC Brain Health announced it has closed a $50 million Series B financing round. The capital will be used to move two depression drug candidates into mid-stage clinical trials. The round was led…
    Endpoints · 2mo agoDealNeutral↗ source
  • Pfizer fails to provide emergency penicillin donations as Trump administration seeks policy change to curb drugmaker price avoidance
    Pfizer has not complied with a request from state health agencies to donate emergency penicillin, a measure intended to act as a backstop against congenital syphilis. The shortfall underscores ong…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Lilly showcases Jaypirca combination data in CLL at EHA26, debuting results from Ajax acquisition
    Eli Lilly highlighted new blood‑cancer data at the European Hematology Association meeting in Stockholm. The company presented early clinical results for its Jaypirca therapy combined with the stan…
    Endpoints · 2mo agoNeutral↗ source
  • Medicaid fraud crackdown threatens home care for disabled, risking loss of essential services
    States are adopting a Medicaid fraud enforcement strategy modeled on the Trump administration, tightening regulations and cutting funding that many disability advocates say will strain the home‑car…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Strategic steps for moving sterile injectables from lab to clinical trials
    The article, sponsored by Vetter, discusses how drug owners of sterile injectable candidates face a key question when a molecule is ready for first‑in‑human studies: how fast can a clinical batch b…
    BioPharma Dive · 2mo agoPositive↗ source