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  • AbbVie and BMS each secure FDA approval, but impact of their neuro‑drug acquisitions remains uncertain
    AbbVie and Bristol Myers Squibb have both received FDA clearance for new Parkinson's treatments, prompting a fresh look at the large neuro‑focused deals they completed last year. AbbVie bought Cere…
    BioSpace · 10h agoDealNeutral↗ source
  • FDA launches Rare Disease Framework to embed patient input early in drug development
    FDA's Center for Biologics Research and Evaluation (CBER) director Karim Mikhail announced a new Rare Disease Framework Initiative aimed at moving patient perspectives from an optional, late‑stage…
    BioSpace · 10h agoRegulatoryPositive↗ source
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  • Argenx acquires Unnatural Products for up to $1.15 billion to boost oral peptide platform
    Argenx announced it will buy biotech Unnatural Products, paying $550 million upfront with the total deal value potentially reaching $1.15 billion through development and regulatory milestones. The…
    Fierce Biotech · 11h agoDealNeutral↗ source
  • Argenx to acquire macrocycle biotech Unnatural Products in up to $1.15 billion deal
    Argenx announced Monday it will acquire Unnatural Products, a biotech focused on macrocycle therapeutics that began as a garage startup. The transaction is structured as an up-to-$1.15 billion dea…
    Endpoints · 3h agoDealNeutral↗ 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 · 5h 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 · 5h 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 · 5h agoNegative↗ 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 · 10h 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 · 11h agoPositive readoutPositive↗ source
  • Zura Bio’s Phase 2 trial of tibulizumab fails, shares plunge
    Zura Bio announced that its experimental drug tibulizumab did not meet efficacy endpoints in a Phase 2 study of a painful skin disorder. The company said that both dose levels performed no better t…
    Endpoints · 1h agoNegative readoutNegative↗ 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 · 7h 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 · 10h 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 · 2h 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 · 5h agoNeutral↗ 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 · 56m agoLayoffsNegative↗ source
  • STAT+: Gene therapy’s long-debated cancer risk materializes
    For years, gene therapy researchers debated whether the viruses they use to ferry replacement genes into cells could cause tumors. A small number of cases now offer strong evidence that…
    STAT · 41m ago↗ source
  • #AHA26: Lilly gets another sleep apnea win, this time with obesity pill
    Eli Lilly plans to seek approval of its obesity med in obstructive sleep apnea after a positive Phase 3 trial, potentially giving it a new way to compete with Novo's far-better-selling Wegovy ...
    Endpoints · 46m ago↗ source
  • STAT+: Eli Lilly’s GLP-1 pill Foundayo helped alleviate sleep apnea in studies
    Eli Lilly’s GLP-1 pill Foundayo helped alleviate sleep apnea in two late-stage studies, but it doesn’t appear as effective as Lilly’s injectable drug Zepbound.
    STAT · 47m 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 · 48m 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 · 48m ago↗ source
  • Novo’s troubled cardio drug could find niche in less sick patients
    At the American Heart Association conference, investigators were supportive of further studying Novo’s IL-6 inhibitor ziltivekimab in patients with less severe cardiovascular and kidney disease.
    BioSpace · 1h ago↗ source
  • #AHA26: Marea’s triglyceride candidate could have an edge in diabetic patients
    Marea Therapeutics' investigational lipid-lowering medicine has shown further promise in cutting triglycerides in patients with dangerously high levels of these fatty molecules in their blood. It a…
    Endpoints · 1h ago↗ source
  • Zura scraps hidradenitis suppurativa program after phase 2 miss, sinking stock
    Zura Bio’s tibulizumab has flunked a phase 2 hidradenitis suppurativa trial, prompting the biotech to end development in the indication while continuing studies in other settings.
    Fierce Biotech · 5h ago↗ source
  • Sanofi-backed Windward breezes toward $204M IPO to fund respiratory pipeline from China
    Windward Bio is sailing toward the public markets with the aim of raising over $200 million in proceeds to fund two respiratory drugs licensed from China.
    Fierce Biotech · 6h ago↗ source
  • Spruce spins out preclinical endocrinology program into newly formed Adrenyx
    Spruce Biosciences is spinning out a preclinical endocrinology program into a newly formed subsidiary called Adrenyx Biosciences, supported with up to $50 million from an unnamed investor.
    Fierce Biotech · 6h ago↗ source