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  • Texas lawmaker warns Chinese biotech firms gaining early-stage advantage over U.S. industry
    Rep. Nathaniel Moran, a Republican from Texas and member of the House Select Committee on China, told Fierce that the United States is overlooking how Chinese biotech companies are outpacing Americ…
    Fierce Biotech · 2mo agoNeutral↗ source
  • Lilly leads GLP-1 weight-loss market while Novo Nordisk’s Wegovy exceeds expectations but falls short of forecasts
    Eli Lilly and Novo Nordisk are intensifying their battle for dominance in the multibillion‑dollar GLP‑1 weight‑loss market, with each company promoting its own set of injectable therapies and pipel…
    BioPharma Dive · 2mo agoEarningsNeutral↗ source
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  • Cure for HIV must protect long-term survivors from loss of benefits
    The authors, a postdoctoral researcher, a long‑term HIV survivor, and the head of a survivor alliance, argue that a future HIV cure should not jeopardize the support systems that have kept many pat…
    STAT · 2mo agoNeutral↗ source
  • Roche's Genentech to invest $750 million to double Oregon manufacturing site
    Roche's Genentech announced a $750 million investment to expand its existing production facility in Oregon, with the goal of doubling its capacity. The expanded site is expected to boost manufactu…
    STAT · 2mo agoDealNeutral↗ source
  • Takeda wins FDA nod for orexin drug oveporexton, first treatment for narcolepsy type 1 and potential broader uses
    Takeda received FDA approval for oveporexton (brand Orzeyful), an orexin receptor agonist, marking the first approved therapy that targets the orexin system for narcolepsy type 1. The drug mimics…
    Fierce Biotech · 2mo agoApprovalPositive↗ source
  • HHS seeks public input on new vaccine recommendation categories under Trump and Kennedy
    A request for information was posted by the Department of Health and Human Services, giving the public a 30‑day window to comment on potential changes to the U.S. vaccine recommendation framework.…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Study suggests cancer patients may be receiving higher doses and longer treatment courses than needed
    Recent analysis highlighted that many cancer patients are being treated with larger drug doses and extended therapy durations than may be medically necessary. The pattern raises concerns about unn…
    STAT · 2mo agoNegative↗ source
  • Merck’s Ebola vaccine rolled out in the Democratic Republic of Congo
    Scientists have begun administering Merck’s Ebola vaccine in the Democratic Republic of Congo as part of ongoing outbreak response efforts. The vaccine, previously used in emergency settings, is b…
    STAT · 2mo agoPositive↗ source
  • Ambros Therapeutics merges with Werewolf, raises $150M to fund phase 3 trial of rare disease drug
    Ambros Therapeutics announced an all‑stock reverse merger with Werewolf Therapeutics, accompanied by a $150 million private placement. The transaction will see the combined company operate under th…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • New study shows focal therapy matches surgery and radiation survival while reducing side effects in localized prostate cancer
    Physicians remain split over focal therapy for localized prostate cancer, a technique that targets MRI‑visible lesions with heat, cold, or other energy sources instead of removing the entire gland.…
    STAT · 2mo agoPositive readoutNeutral↗ source
  • Activist Kaos Capital pushes governance overhaul at Capricor ahead of FDA Duchenne decision
    Activist investor Kaos Capital has sent a letter to Capricor Therapeutics shareholders demanding a “governance reset.” The firm asks for a meeting to nominate two independent directors, create an M…
    BioPharma Dive · 2mo agoNegative↗ source
  • Spruce Biosciences appoints former Zevra Therapeutics CMO Adrian Quartel
    Spruce Biosciences announced the hiring of Adrian Quartel as its new chief medical officer. Quartel joins Spruce after serving as CMO at Zevra Therapeutics, where he oversaw clinical development.…
    STAT · 2mo agoNeutral↗ source
  • Lil Nas X’s bipolar diagnosis highlights the fear many high achievers have of mental-health treatment
    Lil Nas X recently revealed that he has been diagnosed with bipolar disorder. The article notes that he had suspected something was wrong for years but delayed seeking help because he was worried a…
    STAT · 2mo agoNeutral↗ source
  • Moderna’s melanoma vaccine trial success sparks $45 billion market value surge
    Moderna’s shares jumped more than 170% after the company announced that its experimental melanoma vaccine, intismeran, met its primary goals in a Phase 3 trial. The surge added roughly $45 billion…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Regeneron’s ultra-rare bone disorder drug receives U.S. approval after 30-year development
    Regeneron Pharmaceuticals announced that its therapy for an ultra-rare condition in which bone forms in soft tissue has been approved by the U.S. Food and Drug Administration. The disease, sometim…
    STAT · 2mo agoApprovalPositive↗ source
  • Merck and Moderna report positive late-stage melanoma vaccine results, adding to 2026 cancer breakthrough year
    Merck and Moderna announced that their personalized mRNA neoantigen vaccine achieved positive outcomes in a late-stage trial for melanoma patients. The data suggest the vaccine can stimulate an imm…
    STAT · 2mo agoPositive readoutPositive↗ source
  • Moderna's cancer vaccine boost lifts stock, sparks talk of Keytruda-like reach
    Moderna’s shares surged 177% after a phase 3 topline win for its Merck‑partnered cancer vaccine, intismeran autogene, was disclosed. The data, released on Wednesday, added roughly $45 billion to Mo…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • FDA approves Ultragenyx gene therapy and Regeneron ultra-rare disease drug
    The Food and Drug Administration gave the green light to a gene‑therapy product from Ultragenyx, marking a new treatment option in the company’s pipeline. In a separate decision, Regeneron secured…
    STAT · 2mo agoApprovalPositive↗ source
  • FDA clears Vitestro's Aletta, first robotic blood draw device for U.S. clinics
    The U.S. Food and Drug Administration has granted clearance to Vitestro's Aletta, making it the first standalone robotic system approved to draw blood without direct human handling. Aletta can per…
    Fierce Biotech · 2mo agoApprovalPositive↗ source
  • Ultragenyx secures FDA approval for Glenglycos, first gene therapy for GSD Ia
    Ultragenyx announced FDA approval of Glenglycos, a one-time gene therapy for glycogen storage disease type Ia, a rare genetic disorder. The therapy delivers a functional gene to the liver to resto…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • Capricor Therapeutics likely faces FDA rejection of its Duchenne cell therapy
    Capricor Therapeutics is working to avoid an imminent FDA rejection of its cell‑based treatment for Duchenne muscular dystrophy. The company says it remains confident in the drug, but the regulator…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Medigen partners with Charles River to advance multivalent enterovirus vaccine globally
    Charles River Laboratories and Taiwan's Medigen Vaccine Biologics announced a collaboration to prepare Medigen’s multivalent enterovirus vaccine for worldwide use. The partnership will focus on ch…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Chai Discovery partners with Bristol Myers Squibb to use AI for antibody discovery
    Chai Discovery, an AI-driven drug discovery company, announced a collaboration with Bristol Myers Squibb to apply its artificial-intelligence models to therapeutic antibody research. The partnershi…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Eli Lilly partners with Amplitude Therapeutics to develop trans-amplifying RNA vaccines for infectious diseases
    Eli Lilly announced a collaboration with Boston-based Amplitude Therapeutics, a company that emerged from Lilly’s Gateway Labs incubator. The partnership will focus on developing trans-amplifying…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Capricor’s Duchenne drug deramiocel receives negative FDA advisory vote on heart outcome
    Mindy Leffler, a parent of a young man with Duchenne muscular dystrophy, writes an opinion piece about Capricor’s phase 3 study of its drug deramiocel. She describes her son’s experience living ind…
    STAT · 2mo agoRegulatoryNegative↗ source