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3,893 stories matching this filter · ← front page

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  • SK pharmteco commits over $200 million to expand CDMO infrastructure, adding 100 jobs over five years
    SK pharmteco announced a plan to invest at least $200 million in building out its development and manufacturing infrastructure over the next five years. The funding is aimed at expanding the compa…
    Endpoints · 1mo agoPositive↗ source
  • Swedish biotech AnaCardio secures $70.9M Series B to advance heart failure drug
    Swedish biotech AnaCardio announced a Series B financing round that raised €62.5 million ($70.9 million). The capital will be used to move its chronic advanced heart failure drug toward registrati…
    Endpoints · 1mo agoDealPositive↗ source
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fda medwatch109
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Psychiatry & CNS1197
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Nephrology758
  • BioNTech to shut three German manufacturing sites after sale talks fall through
    BioNTech announced it will close three of its manufacturing facilities in Germany. The decision follows months of searching for buyers for the sites. The company said it was unable to secure a dea…
    Endpoints · 1mo agoDealNegative↗ source
  • MAHA Summit Shows Grassroots Health Movement Aligning with Industry Leaders
    The recent MAHA Summit brought together federal officials and health‑care executives, marking a shift from the movement’s original grassroots stance. At a panel on affordability, leaders from Unit…
    STAT · 1mo agoNegative↗ source
  • Study finds blocking T cells entry into brain slows neurodegeneration in mice
    Researchers at Washington University in St. Louis reported that preventing certain immune cells, specifically T cells, from entering the brain reduced signs of neurodegeneration in a mouse model.…
    STAT · 1mo agoPositive↗ source
  • Child health crisis threatens US national security, authors warn
    The authors argue that chronic illness, anxiety, depression and other health problems among children undermine future military readiness, the workforce and the nation’s global competitiveness. The…
    STAT · 1mo agoNegative↗ source
  • FDA nominee Heidi Overton’s confirmation won’t be voted on before the midterm elections
    The Senate health committee is set to vote on three HHS leadership nominees on Wednesday, but the nomination for FDA commissioner Heidi Overton is not among them. Overton’s confirmation has been p…
    STAT · 1mo agoNeutral↗ source
  • Sociologist finds vaccine-hesitant parents make logical choices, not anti-science
    Jennifer Reich, a sociologist at the University of Colorado, has spent about twenty years interviewing families who choose not to vaccinate their children. Reich, who herself follows the CDC sched…
    STAT · 1mo agoNeutral↗ source
  • SNAP cuts risk increasing child separations, advocates warn
    The latest round of SNAP reductions, the biggest in the program’s history, has already left roughly 1.5 million children without food assistance. Studies cited by the authors suggest that losing t…
    STAT · 1mo agoNegative↗ source
  • Oura cancels planned IPO citing market uncertainty despite strong demand
    Oura, known for its smart ring, announced it is withdrawing its initial public offering. The company said the decision was driven by ongoing uncertainty in the IPO market, even though it continues…
    Endpoints · 1mo agoDealNeutral↗ source
  • STAT+: PhRMA taps Eric Cantor as new CEO
    Eric Cantor, a former GOP House majority leader, is taking the helm of PhRMA at a challenging time for the industry.
    STAT · 1mo ago↗ source
  • UniQure tumbles with latest data for Huntington’s gene therapy
    Analysts guessed that investors wanted to see stronger durability results at a four-year check-in of the key trial supporting a potential approval of "AMT-130."
    BioPharma Dive · 1mo ago↗ source
  • FDA approves Emcitate for peripheral thyrotoxicosis in patients with MCT8 deficiency
    The U.S. Food and Drug Administration announced approval of Emcitate (tiratricol) tablets formulated for oral suspension to treat peripheral thyrotoxicosis in patients with MCT8 deficiency, also ca…
    fda press · 1mo agoApprovalPositive↗ source
  • Merck pulls Recarbrio antibiotic from U.S. market, raising concerns over superbug resistance
    Merck announced it has stopped supplying Recarbrio in the United States earlier this month. Recarbrio, a three‑drug combination injection approved seven years ago, is used for severe infections su…
    STAT · 1mo agoNegative↗ source
  • Kodiak Sciences' Phase 3 eye drug data beats Regeneron’s Eylea, shares double
    Kodiak Sciences reported that its two experimental treatments for macular degeneration met the primary endpoints in a Phase 3 trial that directly compared them with Regeneron’s Eylea. The data show…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Kodiak Sciences reports Phase 3 success for Zenkuda, matching Eylea in wet AMD
    Kodiak Sciences announced that its experimental therapy Zenkuda achieved comparable efficacy to the market‑leading anti‑VEGF drug Eylea in a late‑stage trial for wet age‑related macular degeneratio…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Merck, Daiichi end plans to seek speedy approval of lung cancer ADC
    The FDA indicated that the data generated so far wouldn’t support an accelerated clearance of “I-DXd,” a setback that erases an edge Merck and Daiichi had over multiple fast-moving competitors.
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • Novo Nordisk rebrands GLP-1 therapy Wegovy as weight-loss product, positioning it as lifestyle drug
    GLP-1 drugs have transformed the lives of millions and were originally promoted as medicines for obesity, a medical condition. Recent advertising campaigns are now presenting these drugs as genera…
    STAT · 1mo agoNeutral↗ source
  • Adicet's off-the-shelf CAR-T shows 50% kidney response in early lupus trial
    An early-stage study of Adicet Bio's off-the-shelf gamma-delta CAR-T cell therapy reported encouraging results in patients with lupus nephritis. After a year of follow-up, half of the evaluable pa…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Nonprofits launch ultra-rare immune disease gene therapy Waskyra at $3.25 million price
    Two nonprofit organizations have received FDA approval for a gene therapy that targets an ultra-rare immune disorder. The therapy, called Waskyra, is now being launched with a list price of $3.25…
    Endpoints · 1mo agoApprovalNeutral↗ source
  • Rising health insurance premiums and a private equity hospital chain's shift to nonprofit highlight bleak outlook for US healthcare costs
    Bob Herman's latest Health Care Inc. newsletter warns that employer-sponsored health insurance is becoming increasingly unaffordable, with premiums climbing sharply. The piece cites a series called…
    STAT · 1mo agoNegative↗ source
  • AstraZeneca invests $2 billion for stake in Summit Therapeutics to back its cancer drug
    AstraZeneca announced on Monday that it will invest $2 billion to acquire a minority equity stake in Summit Therapeutics. The investment gives AstraZeneca a slice of the biotech as the companies mo…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA to review and potentially overhaul PMTA rules amid lawsuit and illicit market concerns
    FDA announced it is reviewing its experience with the Premarket Tobacco Product Application (PMTA) rule and recent court actions. The agency cites the growth of an illicit market and rapid introdu…
    fda press · 1mo agoRegulatoryNeutral↗ source
  • Mirum reports Phase 3 success for its acquired hepatitis D therapy
    Mirum Pharmaceuticals announced that its recently acquired chronic hepatitis delta drug met its primary endpoint in a Phase 3 trial. The study tested a once-weekly 300 mg injection, and more than…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • White House seeks data on U.S. manufacturing of 86 essential medicines
    The White House Office of Management and Budget has launched a review of domestic production for a list of 86 medicines deemed essential. The request asks manufacturers to provide information on w…
    Endpoints · 1mo agoRegulatoryNeutral↗ source