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  • Moderna and Merck’s personalized mRNA cancer vaccine success spurs industry shift to faster, smaller-scale production
    After mastering large‑scale mRNA manufacturing during the COVID‑19 pandemic, the sector is now turning its attention to delivering individualized vaccines to patients quickly. The recent clinical…
    BioSpace · 1d agoPositive↗ source
  • Parkinson's drug pipeline diversifies as firms seek disease-modifying therapies
    Several pharmaceutical companies are shifting away from the traditional alpha-synuclein antibody strategy and exploring alternative mechanisms to treat Parkinson's disease. AC Immune is highlighted…
    BioSpace · 1d agoNeutral↗ source
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Roivant's mosliciguat shows strong Phase 2 results, advancing to Phase 3 for PH-ILD
Mosliciguat, the pulmonary hypertension candidate from Roivant Sciences subsidiary Pulmovant, cut pulmonary vascular resistance by more than 56% in a Phase 2 trial of patients with PH‑ILD, surpassi…
BioSpace · 22h agoPositive readoutPositive↗ source
  • Moonwalk Biosciences raises $70M to move RNAi obesity drug MW101 toward first-in-human trials in 2027
    Moonwalk Biosciences, an obesity drug developer backed by Eli Lilly, announced a $70 million Series B financing. The funding will support its lead RNAi candidate, MW101, which in mouse studies pro…
    BioSpace · 1d agoDealPositive↗ source
  • Novartis' pelacarsen fails Phase 3, casting doubt on Lp(a) lowering strategy
    Novartis announced that its antisense drug pelacarsen failed to meet the primary endpoint in the Phase 3 Lp(a)HORIZON trial. The study was intended to determine whether the drug’s ability to lower…
    BioSpace · 1d agoNegative readoutNegative↗ source
  • Pharvaris reports 83% drop in hereditary angioedema attacks in phase 3 trial, FDA decision pending
    Pharvaris announced that its oral bradykinin B2 receptor antagonist, deucrictibant, met the primary goal in a second phase 3 study. The trial, called CHAPTER-3, enrolled 85 patients with three for…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Benelux’s strong science base eyed for biotech scaling despite funding gaps
    Belgium and the Netherlands have built some of Europe’s strongest life‑science ecosystems, anchored by leading research institutions and a growing pool of biotech talent. Early‑stage capital remai…
    BioSpace · 1d agoPositive↗ source
  • AI can transform drug discovery only when its strengths are properly leveraged
    The article notes a split narrative in the industry, with some headlines promising AI will speed drugs to market while others warn it could waste resources. Thomas M. Kaiser, a medicinal chemist,…
    BioSpace · 1d agoNeutral↗ source
  • Novartis' del-desiran fails primary endpoint in phase 3 Harbor trial for myotonic dystrophy type 1
    Novartis announced that its experimental therapy del-desiran did not meet the primary endpoint in the phase 3 Harbor trial, which evaluated improvement in video hand opening time in patients with m…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • Inhibrx reports 9.6-month median PFS for OX40 agonist combo in phase 2 head-neck cancer trial
    Inhibrx Biosciences presented updated data from its phase‑2 HexAgon study of the hexavalent OX40 agonist INBRX‑106 combined with Merck’s Keytruda in patients with untreated metastatic or unresectab…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • FDA approves AstraZeneca breast cancer drug despite negative advisory committee vote; Novartis faces cholesterol drug setbacks
    The U.S. Food and Drug Administration granted approval to AstraZeneca's breast cancer therapy even though the advisory committee voted against it. The decision underscores the agency's willingness…
    raps · 1d agoRegulatoryNeutral↗ source
  • EMA publishes guidance on voluntary electronic product information submissions for EU MAAs
    The European Medicines Agency released new guidance detailing how companies should provide electronic product information (ePI) when filing marketing authorization applications under the EU's centr…
    raps · 1d agoRegulatoryNeutral↗ source
  • Four CDMOs to watch as biopharma outsourcing grows
    The article lists four contract development and manufacturing organizations (CDMOs) that biopharma companies can partner with as demand for external development and manufacturing rises. Lonza, bas…
    BioSpace · 1d agoNeutral↗ source
  • Schrödinger births new immunology and inflammation biotech, Tectora Therapeutics
    Schrödinger announced the launch of new immune disease-focused Tectora Therapeutics, which comes online with a $55 million series A financing round.
    Fierce Biotech · 21h ago↗ source
  • Novo Nordisk abandons two phase 3 trials of ziltivekimab, dimming blockbuster hopes
    Novo Nordisk announced it is terminating two late‑stage phase 3 studies of its IL‑6 ligand antibody ziltivekimab. The Hermes and Athena trials enrolled about 4,900 and 673 patients with heart fail…
    Fierce Biotech · 2d agoNegative readoutNegative↗ source
  • Boston Scientific warns cyberattack will likely hit Q3 and full-year 2026 results
    Boston Scientific disclosed in a September 7 SEC filing that a cyberattack it suffered last month is expected to have a material impact on its third‑quarter and full‑year 2026 financial results. T…
    Fierce Biotech · 2d agoNegative↗ source
  • Guardant Health receives FDA clearance for Guardant360 CDx to guide AstraZeneca's Etcamah in breast cancer
    Guardant Health announced that the FDA has cleared its Guardant360 CDx test, which is designed to identify patients who may benefit from AstraZeneca's newly approved breast cancer therapy Etcamah.…
    Fierce Biotech · 2d agoApprovalPositive↗ source
  • BrainChild Bio masterminds $116M series A for CAR-T's pivotal push in pediatric brain cancer
    A startup spawned from Seattle Children’s Hospital has raised a $116 million series A to advance cell therapies for devastating childhood brain tumors.
    Fierce Biotech · 1d agoNeutral↗ source
  • ADARx, backed by AbbVie, files for IPO to fund clinical-stage siRNA programs
    ADARx Pharmaceuticals, a San Diego biotech supported by AbbVie, announced plans to pursue an initial public offering. The company says most of the IPO proceeds will be used to advance three clinic…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Roivant’s inhaled pulmonary hypertension drug mosliciguat shows strong Phase 2 results
    Roivant invested $14 million in Bayer's inhaled soluble guanylate cyclase activator mosliciguat after a $294 million biobucks agreement in 2024, and promptly advanced the candidate into a Phase 2 s…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • AbbVie’s etentamig shows strong survival and response gains in Phase 3 multiple myeloma trial
    AbbVie reported that its investigational bispecific T‑cell engager, etentamig, significantly reduced the risk of disease progression or death in a Phase 3 study of patients with relapsed or refract…
    BioSpace · 5d agoPositive readoutPositive↗ source
  • Ionis secures FDA approval for zilganersen, a first treatment for Alexander disease
    Ionis Pharmaceuticals announced that the U.S. Food and Drug Administration has approved its antisense drug zilganersen for the treatment of Alexander disease, an ultra‑rare neurodegenerative disord…
    Fierce Biotech · 5d agoApprovalPositive↗ source
  • Menarini to launch Gan & Lee’s GLP-1 drug bofanglutide across Europe in $771 M partnership
    Italian firm Menarini Group has entered a licensing agreement with Chinese insulin producer Gan & Lee Pharmaceuticals to bring the GLP-1 compound bofanglutide to Europe. The deal includes an upfro…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Novartis' Lp(a) drug pelacarsen fails to cut heart attack or stroke risk in phase 3 trial
    Novartis, in partnership with Ionis, completed the phase 3 Lp(a)Horizon trial of pelacarsen, an antisense oligonucleotide designed to lower lipoprotein(a) levels. The study enrolled more than 8,30…
    Fierce Biotech · 4d agoNegative readoutNegative↗ source
  • Truist sees biotech rebound as M&A hits $136B and XBI climbs 34% in H1
    Truist Securities says the biotech sector is regaining momentum after a prolonged post‑pandemic slowdown, driven by rising merger activity, returning venture capital and easing policy risks. The S…
    BioSpace · 4d agoPositive↗ source