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1,826 stories matching this filter · ← front page

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  • Arrowhead's RNAi drug Redemplo shows safety advantage over Ionis in late-stage triglyceride trials
    At the European Society of Cardiology meeting in Munich, Arrowhead Pharmaceuticals presented new data on its RNA interference candidate Redemplo. Redemplo was evaluated in two late-stage studies i…
    Endpoints · 15d agoPositive readoutPositive↗ source
  • FDA grants approval to Revolution Medicines' Rasonque for pancreatic cancer
    The U.S. Food and Drug Administration has approved Rasonque, a new therapy from Revolution Medicines, for the treatment of pancreatic cancer. The decision follows data that showed the drug nearly…
    Endpoints · 16d agoApprovalPositive↗ source
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  • Novartis launches Phase 3 trial of IL-6 antibody to test cardiovascular benefit despite Novo's setback
    Novartis announced it will begin a Phase 3 study evaluating its anti-IL-6 monoclonal antibody in patients at high cardiovascular risk. The trial aims to determine whether reducing inflammation thr…
    Endpoints · 16d agoNeutral↗ source
  • Eli Lilly’s Mounjaro receives FDA approval to lower cardiovascular risk; Teva announces acquisition of approved drug
    Eli Lilly’s once‑a‑diabetes blockbuster tirzepatide, marketed as Mounjaro, was granted FDA approval on Friday for an indication that reduces the risk of major cardiovascular events. The approval e…
    Endpoints · 17d agoApprovalPositive↗ source
  • Eli Lilly's Mounjaro gets FDA approval to cut heart attack, stroke risk in type 2 diabetes
    The U.S. Food and Drug Administration has approved Eli Lilly's Mounjaro for reducing the risk of heart attack, stroke, or cardiovascular death in adults with type 2 diabetes who are at high risk fo…
    BioSpace · 17d agoApprovalPositive↗ source
  • Phase 3 trial shows Wainua fails to improve outcomes in ATTR-CM, hazard ratio 1.14
    AstraZeneca and Ionis Pharmaceuticals presented detailed results from the Phase 3 trial of their antisense oligonucleotide Wainua (eplontersen) in patients with transthyretin-mediated amyloid cardi…
    BioSpace · 17d agoNegative readoutNegative↗ source
  • Priovant's Lisraya receives first FDA approval as oral therapy for dermatomyositis
    The U.S. Food and Drug Administration has cleared Priovant Therapeutics' daily TYK2/JAK1 inhibitor tablet, marketed under the name Lisraya, for the treatment of dermatomyositis in adults. Lisraya…
    BioSpace · 17d agoApprovalPositive↗ source
  • AstraZeneca and Ionis gene silencer Wainua fails trial after patients also took Pfizer heart drug
    At the ESC Congress in Munich, a high‑profile trial of the gene‑silencing therapy Wainua, developed by AstraZeneca and Ionis, was reported to have failed. The failure was linked to participants co…
    Endpoints · 17d agoNegative readoutNegative↗ source
  • BioNTech stops Phase 2 colorectal cancer mRNA vaccine trial after futility findings
    BioNTech announced that it is ending its Phase 2 study of a personalized mRNA vaccine for resected colorectal cancer after the trial failed to show the needed benefit. The news sent the company’s s…
    BioSpace · 16d agoNegative readoutNegative↗ source
  • BioXcel files for Chapter 11 bankruptcy, selling assets to Teva for up to $125 M
    BioXcel Therapeutics announced it has filed for Chapter 11 bankruptcy and plans to sell all of its assets. Teva Pharmaceuticals will serve as the stalking horse bidder, proposing an upfront paymen…
    BioSpace · 17d agoDealNegative↗ source
  • AstraZeneca and Amgen’s Tezspire eyes Dupixent’s EoE stronghold after late-stage trial win
    Analysts note that AstraZeneca and Amgen have secured a late‑stage trial win for Tezspire, positioning the drug as a possible challenger to Dupixent in eosinophilic esophagitis (EoE). Dupixent re…
    BioSpace · 17d agoPositive readoutPositive↗ source
  • AusperBio secures $120 million Series C to push hepatitis B antisense therapy into Phase 3
    AusperBio Therapeutics announced it has closed a $120 million Series C financing round aimed at moving its hepatitis B antisense oligonucleotide candidate toward late‑stage trials and eventual mark…
    Fierce Biotech · 17d agoDealPositive↗ source
  • Roche pays $190 million for rights to Hanmi's UCN2 analog targeting obesity with muscle-preserving effects
    Roche's Genentech unit has agreed to pay $190 million upfront for rights to HM17321, a urocortin‑2 analog developed by South Korea’s Hanmi Pharmaceutical, covering markets outside South Korea. The…
    Fierce Biotech · 17d agoDealPositive↗ source
  • Genentech pays $45M upfront to DualityBio for ADC platform targeting resistant cancers
    Genentech has agreed to pay DualityBio $45 million upfront for rights to its antibody‑drug conjugate (ADC) technology, with the agreement offering more than $1 billion in potential milestone paymen…
    Fierce Biotech · 17d agoDealPositive↗ source
  • FDA greenlights Takeda and Protagonist's rusfertide (Mimrylo) for polycythemia vera
    The U.S. Food and Drug Administration has granted approval to rusfertide, a therapy developed jointly by Takeda Pharmaceutical and Protagonist Therapeutics. The drug, to be marketed under the name…
    Endpoints · 16d agoApprovalPositive↗ source
  • BioNTech and Genentech halt Phase 2 trial of personalized mRNA cancer vaccine
    BioNTech and its partner Genentech announced the termination of a Phase 2 study evaluating a personalized mRNA cancer vaccine. The decision was made shortly after the trial had entered its second s…
    Endpoints · 17d agoNegative↗ source
  • CRISPR Therapeutics to test highest dose of lipid‑lowering gene editing therapy after mixed durability data
    CRISPR Therapeutics presented early‑stage data at the European Society of Cardiology meeting showing that its lipid‑lowering gene editing candidate produced mixed durability results a year after pa…
    Endpoints · 17d agoNegative readoutNeutral↗ source
  • BioNTech-Genentech halts colorectal cancer vaccine trial after higher death rate in vaccine arm
    BioNTech and Genentech stopped a phase 2 trial of their personalized mRNA vaccine BNT122 in patients with stage 2 or 3 colorectal cancer after an independent data safety monitoring board found more…
    Fierce Biotech · 17d agoNegative readoutNegative↗ source
  • Roche commits over $1 billion to DualityBio for ADC development targeting TOP1 resistance
    Roche's Genentech unit announced a major investment in DualityBio to advance antibody-drug conjugate (ADC) technology. Under the agreement DualityBio will receive an upfront payment of $45 million…
    Endpoints · 17d agoDealPositive↗ source
  • Cytokinetics aims for broader Myqorzo approval next year after supportive trial data
    Cytokinetics reported new data on its cardiac therapy Myqorzo, presented at a European scientific meeting. The results reinforce the drug’s efficacy in a specific heart muscle disorder. The compan…
    Endpoints · 17d agoApprovalPositive↗ source
  • Multispecific antibodies push CDMOs to redesign development platforms
    Manufacturers are moving beyond traditional monoclonal-antibody platforms as multispecific therapeutics gain traction. The new design model relies on molecular engineering, advanced analytics, and…
    BioSpace · 17d agoNeutral↗ source
  • FDA alerts on possible Aspergillus contamination in Avid Medical IV start kits
    The FDA’s Center for Devices and Radiological Health has issued an Early Alert warning that certain IV start kits from Avid Medical may be contaminated with the fungus Aspergillus penicillioides, a…
    fda medwatch · 17d agoRegulatoryNegative↗ source
  • Boston Scientific recalls Imager II angiographic catheters over tip detachment risk
    FDA's CDRH issued an Early Alert about Boston Scientific's Imager II angiographic catheters due to a manufacturing problem that can cause the catheter tip to detach. The company sent a letter on A…
    fda medwatch · 17d agoRegulatoryNegative↗ source
  • CAR T therapy moves from cancer to autoimmune disease, leveraging oncology safety lessons
    Cell therapy that transformed treatment of blood cancers is now being tested for autoimmune disorders, according to a recent opinion piece. Early cancer trials showed high complete response rates…
    BioSpace · 17d agoPositive↗ source
  • Genentech strikes second Asia deal in a week, betting up to $1B in oncology ADC alliance with DualityBio
    Through its DualityBio deal, Roche's Genentech hopes to create antibody-drug conjugates with payloads that can circumvent growing cancer drug resistance.
    BioSpace · 17d agoDealNeutral↗ source