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  • 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 · 3d 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 · 3d agoNeutral↗ source
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  • 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 · 3d 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 · 3d agoNeutral↗ source
  • FDA reduces required analytical tests for emergency-use diagnostic devices
    The FDA finalized new guidance aimed at streamlining validation for in-vitro diagnostic (IVD) devices that detect emerging pathogens during public-health emergencies. The guidance lowers the numbe…
    raps · 3d agoRegulatoryNeutral↗ 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 · 3d 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 · 3d 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 · 3d 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 · 3d agoDealNeutral↗ 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 · 3d 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 · 3d 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 · 3d ago↗ source
  • Recon: FDA orders new eye risk warnings for Ozempic, Zepbound; FDA launches investigation of Novartis’ Zolgensma after cancer ca...
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 3d 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 · 4d agoNegative readoutNegative↗ source
  • Study finds training bystanders and responders does not boost survival after sudden cardiac arrest
    Sudden cardiac arrest kills about 350,000 people in the United States each year, and only one in ten victims survive. Survival depends heavily on rapid CPR and defibrillation by nearby bystanders o…
    STAT · 3d agoNegative↗ source
  • Fresh & Ready Foods recalls 2,414 Fresh To You sausage, egg & cheese biscuit sandwiches over possible Listeria contamination
    Fresh & Ready Foods LLC of Renton, Washington announced a recall of 2,414 Fresh To You sausage, egg and cheese biscuit sandwiches after testing indicated a potential contamination with Listeria mon…
    fda recalls · 4d agoNegative↗ source
  • Biotech Trade Group BIO Sues Over Medicare GLOBE Pricing Pilot
    BIO and two California biotech trade groups have filed a lawsuit in federal court to stop the Medicare GLOBE pilot that would tie US drug prices to those in peer nations. The complaint argues the…
    STAT · 5d agoRegulatoryNegative↗ source
  • Novo Nordisk’s anti-inflammatory drug ziltivekimab fails to cut heart events, but cardiologists still eye inflammation pathway
    Novo Nordisk reported that its experimental monoclonal antibody ziltivekimab lowered interleukin‑6 levels in the ZEUS trial but did not reduce heart attacks, strokes or cardiovascular deaths compar…
    STAT · 5d agoNegative readoutNegative↗ source
  • Chinese biotech CEOs target creation of up to ten global Big Pharma firms within a decade
    Chinese drug developers have shifted from generic manufacturing to aiming for a seat at the global Big Pharma table, according to recent interviews. The country now ranks second after the United S…
    Fierce Biotech · 5d agoPositive↗ source
  • New studies highlight hurdles in lowering blood pressure after stroke or in diabetes patients
    Researchers presented three new studies at the American Heart Association scientific sessions that examined how to lower blood pressure in patients who have had a stroke or who live with type 2 dia…
    STAT · 4d agoNegative readoutNeutral↗ source
  • STAT+: Failure of Novartis Lp(a) drug raises questions about cardiovascular strategy
    Medical mystery at the AHA conference: A Novartis drug lowered a risk marker for cardiovascular disease but did not lower chance of heart attack or stroke.
    STAT · 5d agoRegulatoryNeutral↗ source
  • Merck and Moderna report 99% manufacturing success and 42% lower recurrence risk for personalized melanoma vaccine in Phase 3 trial
    Merck and Moderna announced that their personalized mRNA cancer vaccine, combined with Keytruda, was successfully manufactured for 99% of patients enrolled in a large Phase 3 study. The trial, call…
    BioSpace · 6d agoPositive readoutPositive↗ source
  • Democrats’ Midterm Win Promises Medicaid Reversal and ACA Subsidy Restoration for Hospitals
    The November midterm election gave Democrats control of both the House and Senate, a result analysts describe as a landslide. The shift is expected to create a more favorable environment for hospit…
    STAT · 6d agoRegulatoryPositive↗ source
  • Moderna reports 29% revenue rise as COVID vaccine sales stay steady amid global uptake
    Moderna said its quarterly revenue jumped 29% to $1.3 billion, driven by continued demand for its COVID-19 shots. The company has generated $1.8 billion in revenue so far this year, according to CF…
    BioSpace · 6d agoEarningsPositive↗ source
  • New evidence links AAV gene therapies to tumor risk, raising safety concerns
    Recent cases reported this year provide strong evidence that adeno-associated viruses (AAVs), the vectors used to deliver therapeutic genes, can trigger tumor formation. The findings settle a two‑d…
    STAT · 6d agoRegulatoryNegative↗ source