Shots:
Bayer has signed an agreement with Apollo to secure €3B (~$3.4B) in equity capital as part of a strategic financing initiative to strengthen its capital structure
Apollo-managed funds will acquire a minority, non-controlling stake in Bayer’s new long-acting reversible contraceptives entity, while Bayer retains majority ownership, operational control, & full financial consolidation within its…
Shots:
Novo Nordisk has reported P-III (FRONTIER4) extension study data assessing Mim8 (denecimig, SC) prophylaxis in paediatric & adult pts with hemophilia A, with or without inhibitors, across a range of dosing frequencies incl. QM, Q2W, & QW
Interim data (n=426) showed Mim8’s safety was consistent with prior studies, while efficacy EPs demonstrated low mean ABRs…
Shots:
The US has approved Sarclisa Escena (isatuximab-irfc; SC) + SoC for the treatment of pts with MM across all existing indications of Sarclisa IV formulation
Approval was backed by multiple trials, incl. P-III (IRAKLIA) in R/R MM, which showed shorter treatment time & fewer infusion-related reactions with Sarclisa Escena
In IRAKLIA, SC Sarclisa delivered…
Shots:
The US FDA has approved Padcev (enfortumab vedotin) + Keytruda/Keytruda Qlex for neoadj. & adj. treatment for pts with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility
Approval was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs neoadj. SoC + surgery in cisplatin-eligible MIBC…
Shots:
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…
Shots:
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…
Shots:
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…
Shots:
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…
Shots:
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,…
Shots:
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…

