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Hansoh has reported the P-III (ARTEMIS-008) trial results assessing risvutatug rezetecan (Ris-Rez/HS-20093) vs topotecan in pts with advanced or relapsed SCLC after prior Pt-based therapy
Trial met its 1EP of improved OS in the interim analysis, with consistent benefit also observed across 2EPs, incl. PFS; data will be presented at an upcoming conference
Based on…
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Viz.ai has partnered with Cortechs.ai to integrate its NeuroQuant & NeuroQuant MS into its AI-powered care coordination platform, expanding into neurodegenerative diseases
The collaboration will initially focus on multiple sclerosis by integrating Cortechs.ai’s quantitative MRI analysis into Viz.ai’s clinical workflow & care coordination platform to improve MS identification, characterization, & management
The company plans…
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The Chinese NMPA has accepted the BLA & granted priority review to Opamtistomig (LBL-024) as a monotx. for the treatment of advanced extrapulmonary neuroendocrine carcinoma (EP-NEC)
BLA was supported by the registrational trial data, designed to assess the efficacy & safety of Opamtistomig in pts with advanced EP-NEC whose disease had progressed following ≥2…
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Rani Therapeutics has entered into a research and development collaboration with PegBio to evaluate delivery of multiple obesity & metabolic disease candidates using its proprietary RaniPill platform
As per the deal, Rani and PegBio will collaborate on the preclinical development of RaniPill formulations for selected obesity & metabolic disease candidates, aiming to advance the…
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Polpharma has granted Teva exclusive rights to commercialize both IV & SC formulations of Polpharma’s proposed biosimilar to Ocrevus (ocrelizumab) for multiple sclerosis, upon regulatory approval
As per the deal, Polpharma will lead biosimilar development & manufacturing, while Teva will oversee regulatory filings & commercialization across the US, EU, Brazil, Canada, Australia, New Zealand,…
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The US FDA has approved Ennumo, a biosimilar to Neulasta (pegfilgrastim), expanding Accord’s biosimilar portfolio & supporting its goal to launch 20 biosimilars in the US by 2030
Ennumo is approved for adults & pediatric pts (newborn & older) to reduce incidence of infection in febrile neutropenia in non-myeloid malignancies receiving myelosuppressive anti-cancer drugs…
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CervoMed has completed enrollment in the P-IIa study of neflamapimod for the treatment of nonfluent variant primary progressive aphasia (nfvPPA), a type of frontotemporal dementia, with interim results to be presented at CTAD 2026
The study will evaluate the safety, PK, & clinical effects of neflamapimod (40mg, PO, TID; n=19 and 80mg, BID; n=6)…
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Ipsen has reported topline P-III (E-BEOND & C-BEOND) trial results assessing Dysport (abobotulinumtoxinA) vs PBO in a total of 1,510 adults with episodic & chronic migraine, respectively
Both trials met their 1EP, with a reduction in monthly migraine days vs PBO & demonstrated a favorable safety profile; detailed results will be presented at a future…
Shots:
Roche has received a CE Mark for its Elecsys IGRA TB test, a blood-based assay for detecting tuberculosis infection (latent TB) in routine laboratory settings
Test delivers results in <24hrs., with IGRA assay completed in 19min., & automates result calculation, interpretation, & reporting on Roche immunoassay platforms while integrating with third-party liquid handlers to…
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The US FDA has approved Dual Energy THERMOCOOL SMARTTOUCH SF (DE STSF) Platform, an integrated catheter ablation system that enables delivery of both radiofrequency (RF) & pulsed field (PF) energy through a single catheter
Built on the THERMOCOOL SMARTTOUCH SF Platform, used in >1M US pts, the dual-energy system integrates with the CARTO ecosystem…

