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  • AstraZeneca advances obesity pill to Phase 3 after mid-stage trials show ~11% weight loss
    AstraZeneca announced that its experimental oral GLP-1 drug, elecoglipron, will enter an extensive Phase 3 development program following encouraging data from two mid-stage studies in obesity and d…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • SonoThera secures $125 million to advance ultrasound-based gene therapy for Duchenne and polycystic kidney disease
    SonoThera announced it has raised $125 million in financing to move its ultrasound-based non-viral gene therapy platform toward clinical testing. The funding will support the company’s two lead pr…
    Endpoints · 4mo agoDealPositive↗ source
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  • Ending federally funded animal testing could stall xenotransplantation breakthroughs
    Transplant surgeon Joshua Mezrich argues that recent moves to end federally funded animal testing could impede the development of xenotransplantation, a field that aims to use pig organs for human…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Financing gaps keep $2 million gene therapies out of reach for many patients
    William Padula argues that the United States lacks the financial infrastructure to deliver ultra‑expensive gene therapies, even though they can cure diseases with a single dose. He notes that treat…
    STAT · 4mo agoNegative↗ source
  • Lilly presents safety data on obesity drug retatrutide, noting rare cardiac events
    Eli Lilly reported new safety and tolerability findings for its next-generation obesity therapy retatrutide at the American Diabetes Association annual meeting. In the study, 7 of the 403 particip…
    STAT · 4mo agoNegative readoutNeutral↗ source
  • Pfizer’s monthly obesity drug berobenatide shows up to 12% weight loss in mid-stage VESPER-3 study
    Detailed data from Pfizer's mid‑stage VESPER-3 trial indicate that the company’s monthly‑dosed obesity candidate, berobenatide, continues to demonstrate weight‑loss potential. The drug, originally…
    STAT · 4mo agoPositive readoutNeutral↗ source
  • RevMed’s experimental pancreatic cancer drug available via expanded access as FDA voucher program faces potential changes
    RevMed's experimental pancreatic cancer therapy daraxonrasib has not received FDA approval yet, but the company is offering it through an expanded access (compassionate use) program. Access to the…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Texas attorney general probes energy drink safety as federal research ethics office shrinks dramatically
    The Texas attorney general has opened an inquiry into the safety and marketing claims of popular energy drinks, seeking to determine whether they pose health risks or violate state consumer protect…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Otsuka presents new data to bolster full approval bid for Voyxact in IgA nephropathy
    Otsuka Pharmaceutical announced that new clinical evidence has been generated for its monoclonal antibody Voyxact, aimed at treating IgA nephropathy, a chronic autoimmune kidney disease. The data,…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • Drug makers and patient groups call on FDA to suspend fast‑track voucher program
    The FDA held a town‑hall listening session on its Commissioner’s National Priority Voucher program, hearing from 17 speakers that included patient advocates, pharmaceutical companies and academic r…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Otsuka's Voyxact reduces kidney function decline in IgA nephropathy but falls short of expectations in Phase 3
    Otsuka reported Phase 3 trial results for its drug Voyxact in patients with IgA nephropathy, a chronic autoimmune kidney disease. In the study, patients receiving Voyxact experienced an annualized…
    STAT · 4mo agoNegative readoutNeutral↗ source
  • Otsuka showcases kidney drug data; Pfizer cuts an AI deal
    Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off gen…
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • HHS says Americans with high-risk Ebola exposure can receive experimental antibody MBP-134 from Mapp Biopharma
    HHS announced that U.S. citizens who have had high-risk exposure to Ebola in the ongoing Central African outbreak will be eligible to receive an experimental antibody therapy. The treatment, ident…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Eli Lilly partners with Ascidian Therapeutics on $1.9 b RNA exon-editing collaboration for kidney disease
    Eli Lilly and Boston-based Ascidian Therapeutics announced a research collaboration aimed at discovering medicines for genetically driven kidney diseases. The partnership leverages Ascidian’s RNA e…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Legend Biotech shares jump 40% after promising early CAR-T data in Non-Hodgkin’s lymphoma
    Shares of Legend Biotech rose more than 40% after the company released early results from its in vivo CAR‑T therapy targeting Non‑Hodgkin’s lymphoma. The data showed encouraging activity and a mana…
    STAT · 4mo agoPositive readoutPositive↗ source
  • Eli Lilly signs up to $1.9B deal with Ascidian Therapeutics for RNA editing in kidney disease
    Ascidian Therapeutics recently presented early data indicating that its novel RNA‑editing approach to repair faulty genes appears safe in humans, focusing on kidney disease applications. Eli Lilly…
    Endpoints · 4mo agoDealPositive↗ source
  • Radiopharmaceutical shows promise after Pluvicto; Vera Therapeutics gains FDA agreement to speed IgA nephropathy data analysis
    A new radiopharmaceutical is generating interest for use after patients have completed Pluvicto therapy, suggesting a potential follow‑on treatment option. Abivax reported encouraging results from…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Travere Therapeutics pays $112 million upfront to China’s Everest Medicines to expand rare kidney disease pipeline
    Travere Therapeutics, a San Diego‑based biotech, announced a partnership with China‑based Everest Medicines to strengthen its rare kidney disease portfolio beyond its approved drug Filspari. Under…
    Endpoints · 4mo agoDealPositive↗ source
  • Trump administration releases Medicaid work-requirement rules, prompting state compliance challenges
    The Morning Rounds newsletter highlighted several health‑policy developments, notably new Medicaid work‑requirement rules and fast‑tracked funding for experimental Ebola vaccines. The Trump admini…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Heart transplant patient warns of 'ghost approval' gap that leaves life-saving drugs out of reach
    A heart transplant recipient and patient advocate describes how the medication everolimus (Zortress) is essential to prevent organ rejection, not an optional treatment. The author coins the term "…
    STAT · 5mo agoNegative↗ source
  • FDA approves AstraZeneca’s novel hypertension pill Baxfendy
    The U.S. Food and Drug Administration has cleared AstraZeneca’s new hypertension medication, Baxfendy, marking the first approval of a drug that works by inhibiting a blood‑pressure‑raising enzyme.…
    BioPharma Dive · 5mo agoApprovalPositive↗ source
  • Supreme Court temporarily restores telehealth access to mifepristone amid ongoing legal fight
    The Supreme Court on Thursday reversed a 5th Circuit order and allowed mifepristone to be prescribed and mailed through telehealth for the time being. The reversal follows a lawsuit brought by Lou…
    STAT · 5mo agoRegulatoryNeutral↗ source
  • Dr Croll reviews study linking tumor size changes on scans to pathological outcomes after neoadjuvant therapy in kidney cancer
    Dr Benjamin Croll, MD, presented findings from a recent investigation into the relationship between radiographic size changes and pathological response in renal cell carcinoma patients receiving ne…
    onclive · 5mo agoNeutral↗ source
  • Acting FDA Commissioner Kyle Diamantas Seen as Drama-Free Stabilizer for Biotech
    Kyle Diamantas has been named the acting commissioner of the Food and Drug Administration, stepping into the role after Marty Makary’s resignation. He previously led the FDA’s food safety division,…
    STAT · 5mo agoRegulatoryPositive↗ source
  • Experts discuss combination and sequencing approaches for radiopharmaceuticals in advanced prostate cancer
    Dr. Pedro Barata and Dr. Johann De Bono review the current questions surrounding how best to combine and sequence radiopharmaceutical therapies for patients with metastatic castration‑resistant pro…
    onclive · 5mo agoNeutral↗ source