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NEWS

Daiichi Sankyo
Daiichi Sankyo Reports the First Patient Dosing in P-III (DESTINY-Gastric05) Trial of Enhertu Regimen to Treat G/GEJ Cancer
Shots: Daiichi has reported first pts dosing in its P-III (DESTINY-Gastric05) trial assessing Enhertu regimen in 1L, inoperable, locally advanced or metastatic HER2+ (IHC 3+ or IHC 2+/ISH+) G/GEJ cancer pts, with PD-L1 CPS ≥1 Trial will assess efficacy & safety of Enhertu (5.4mg/kg) + Keytruda + fluoropyrimidine-based CT vs trastuzumab + Keytruda + Pt-based…
Axsome
Axsome Therapeutics Reports Topline Data of P-III (PARADIGM) Trial of Solriamfetol for Major Depressive Disorder (MDD) regardless of Excessive Daytime Sleepiness (EDS)
Shots: Axsome reported topline data of PoC P-III (PARADIGM) trial assessing solriamfetol (300mg) vs PBO in MDD pts with severe EDS (ESS ≥16; n=51) & those without severe EDS (n=295) Trial showed no significant MADRS total score change (1EP) in the overall population. However, EDS pts saw depressive symptom improvements across MADRS total score, MADRS…
Lexicon & Novo Nordisk
Lexicon Enters a Global Licensing Agreement with Novo Nordisk for LX9851
Shots: Lexicon has granted Novo Nordisk exclusive global rights to develop, manufacture & commercialize LX9851 (oral ACSL5 inhibitor) in all indications As per the deal, Lexicon will receive $45M upfront, ~$485M in regulatory & launch milestones, ~$475M in sales milestones, & tiered royalties from single to low-double-digit % of annual net sales. Lexicon will complete…
Pfizer New
Pfizer Secures the EC’s Approval for Abrysvo (Respiratory Syncytial Virus Vaccine) for RSV Lower Respiratory Tract Disease
Shots: The EC has approved Abrysvo to prevent lower respiratory tract disease (LRTD) caused by RSV in individuals (aged 18-59yrs.) across all EU states including Iceland, Liechtenstein, and Norway. Approval was based on a pivotal P-III (MONeT) study that assesses the safety, tolerability & immunogenicity of Abrysvo vs PBO in adults (aged 18-59yrs.) at risk…
EchoIq, Sciimage & Medaxiom
Echo IQ Enters into Strategic Partnership And Integration Agreements With ScImage And MedAxiom for EchoSolv AS
Shots: This collaboration will broaden the availability of EchoSolv AS, integrating its AI cardiology technology into a wide network of US hospitals and cardiology practices As per the agreement, EchoSolv AS will be deployed across 36 MedAxiom/ScImage-affiliated hospitals and cardiology practices, providing physicians access to AI-driven diagnostics via ScImage's image management and workflow platform. By leveraging…
Ono & Reborna Biosciences 
Ono Enters into an Option Agreement with Reborna Biosciences for RNA-Targeting Small Molecule to treat CNS Disorders
Shots: Ono Pharmaceutical entered into an option agreement to obtain exclusive rights for identified small-molecule compounds developed by leveraging Reborna’s proprietary RNA-targeting drug discovery platform Furthermore, the companies will collaborate to discover small molecule drug candidates for mutually selected rare neurological disorders Upon exercising the option, Ono will gain exclusive worldwide rights to develop, manufacture, and…