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  • Democrats’ Midterm Wins Boost Hospital Prospects as CVS Breakup Looms
    Voters gave Democrats a decisive edge in the recent midterm elections, reshaping the political landscape for the coming year. The shift is expected to favor the hospital sector, which stands to gai…
    STAT · 20h agoPositive↗ source
  • Compass Pathways to file FDA approval for psilocybin depression therapy within weeks
    Compass Pathways announced it will complete its FDA filing for the psilocybin‑based depression treatment COMP360 in the next two weeks. The company expects the rolling submission to enable a drug…
    BioSpace · 22h agoRegulatoryNeutral↗ source
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  • J&J/Protagonist’s oral Icotyde shows Phase 3 benefit in psoriatic arthritis but trails AbbVie’s Skyrizi
    A Phase 3 study of Johnson & Johnson and Protagonist Therapeutics’ oral IL‑23 receptor antagonist Icotyde met its primary endpoint, demonstrating improvement in psoriatic arthritis symptoms. In th…
    BioSpace · 22h agoPositive readoutNeutral↗ source
  • Merck's efinopegdutide shows strong MASH resolution in phase 2b trial
    Merck & Co. reported results from a phase 2b trial (MK-6024-013) evaluating efinopegdutide, a GLP-1 and glucagon receptor co-agonist, in patients with metabolic dysfunction-associated steatohepatit…
    Fierce Biotech · 23h agoPositive readoutPositive↗ source
  • Lilly's oral GLP-1 pill Foundayo reduces sleep apnea events in late-stage trials
    In two late-stage trials, Eli Lilly’s oral GLP‑1 pill Foundayo lowered the apnea‑hypopnea index by an average of 17.8 events per hour, compared with a 4.5‑event reduction for patients on placebo.…
    STAT · 23h agoPositive readoutPositive↗ source
  • Novo’s IL-6 inhibitor ziltivekimab may target milder cardio-renal patients after Phase 3 miss
    At the American Heart Association meeting, investigators discussed new data on Novo Nordisk’s IL-6 inhibitor ziltivekimab, suggesting it could be studied in patients with less severe cardiovascular…
    BioSpace · 1d agoNegative readoutNeutral↗ source
  • Democrats weigh limits of health-care reforms after midterm win
    In the days after their sweeping midterm victories, House and Senate Democrats are debating the scope of possible health-care actions. Party leaders agree on rolling back the Medicaid cuts impleme…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Global liver experts agree on definition of acute-on-chronic liver failure
    Liver doctors from many countries have reached a common definition for acute-on-chronic liver failure, a serious complication that occurs when an existing liver disease is suddenly worsened by an a…
    STAT · 1d agoPositive↗ source
  • CVS split into two entities fails to address core issues in pharmacy benefit management
    CVS Health is one of the largest U.S. companies, serving hundreds of millions of Americans and generating about $400 billion in annual revenue. It touches nearly every step of the drug supply chain…
    STAT · 1d agoNegative↗ source
  • Zura Bio halts hidradenitis suppurativa program after tibulizumab fails phase 2 trial
    Zura Bio announced it is ending development of tibulizumab for hidradenitis suppurativa after the drug did not meet the primary endpoint in a phase 2 study. The trial, called Tibushield, compared t…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • Vir Biotechnology's Phase 3 Trial Shows Primary Endpoint Success in Chronic Hepatitis Delta
    Vir Biotechnology reported that its phase 3 Eclipse 1 trial in chronic hepatitis delta met the primary endpoint. At week 48, 44% of patients who began treatment immediately showed undetectable HDV…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Valneva's Shigella vaccine cuts infection rates in phase 2 trial
    Valneva reported that its Shigella vaccine reduced the number of intestinal infections in a phase 2 controlled human infection model study conducted in the United States. The trial enrolled 120 he…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Phase 3 trial shows Zealand-Boehringer obesity drug survodutide does not raise cardiovascular death risk
    The Phase 3 SYNCHRONIZE-CVOT study found that survodutide, the joint obesity therapy from Zealand and Boehringer Ingelheim, was non‑inferior to placebo for cardiovascular death, indicating no added…
    BioSpace · 19h agoPositive readoutNeutral↗ source
  • American Heart Association meeting reports neutral outcomes for inflammation and Lp(a) trials
    The American Heart Association's scientific sessions in Chicago highlighted a theme of neutral findings across cardiovascular research. Two high profile trials, ZEUS targeting inflammation and HOR…
    STAT · 21h agoNeutral↗ source
  • Kyorin signs $140M deal for Japan rights to Edesa's ARDS antibody
    Kyorin Pharmaceutical will pay $12 million up front and up to $134 million in milestones, plus royalties, for exclusive Japan rights to Edesa Biotech’s anti‑TLR4 antibody, paridiprubart, intended f…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Gene therapy sponsors urged to address six GMP manufacturing considerations early
    SK pharmteco’s chief technical officer Tatiana Nanda explained that gene therapy sponsors need to think about manufacturing issues well before reaching GMP production. She told BioSpace that early…
    BioSpace · 1d agoNeutral↗ source
  • Trump administration issues new guidelines to curb AI-driven bioweapon threats
    The White House announced a set of guidelines aimed at preventing the misuse of artificial intelligence in creating biological weapons. Officials said the rapid advances in AI-driven drug discovery…
    STAT · 1d agoRegulatoryNeutral↗ source
  • AI chatbots may help men share emotions, study suggests
    AI chatbots are not therapists, but they can offer a low‑pressure space where men feel less judged when discussing personal concerns. The article follows Luca, who drove across Europe to be with h…
    STAT · 1d agoNeutral↗ source
  • Bill Ackman Announces Ambitious Initiative to Advance Brain Research
    Billionaire investor Bill Ackman has unveiled a new, bold plan aimed at transforming brain research. The initiative is driven by a personal tragedy that has motivated him to seek breakthroughs in…
    STAT · 19h agoPositive↗ source
  • Spruce Biosciences spins out preclinical endocrinology program into new unit Adrenyx, backed by up to $50 million
    Spruce Biosciences announced it is creating a separate subsidiary to house its preclinical endocrinology research. The new company, named Adrenyx Biosciences, will focus on advancing the early-sta…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 1d agoLayoffsNegative↗ source
  • STAT+: Trump administration removes WuXi AppTec from its Chinese military list
    The Trump administration has removed WuXi AppTec, a key partner for the pharma industry, from its list of “Chinese military companies” operating in the U.S.
    STAT · 17h ago↗ source
  • Update: FDA investigates Novartis' Zolgensma following 9 cases of tumors in treated patients
    After Novartis confirmed the reports of tumors in patients who have been treated with the spinal muscular atrophy gene therapy, the FDA will determine if any regulatory action is needed for Zolgens…
    BioSpace · 23h ago↗ source
  • STAT+: Pharmalittle: We’re reading about a Novartis heart drug, BIO fighting a Trump program, and more
    Novartis is largely abandoning a drug once considered a potential blockbuster after a study found it had little promise for preventing heart attacks and deaths
    STAT · 23h ago↗ source
  • Recent heart-drug trials miss endpoints, raising doubts about AI-driven drug design
    Two large clinical studies presented at the American Heart Association meeting this weekend failed to show any benefit for experimental heart‑attack and stroke therapies, underscoring the difficult…
    STAT · 2d agoNegative readoutNegative↗ source