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Sanofi
The US FDA Approves Sanofi’s Sarclisa Escena to Treat Multiple Myeloma (MM)
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…
Merck, Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Cisplatin-Eligible MIBC Patients
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…
Viz.ai Partners with Cortechs.ai to Expand AI Platform into Neurodegenerative Disease Care
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…
Rani Therapeutics Partners with PegBio to Expand Obesity Pipeline Across Multiple Novel Candidates
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…
Polpharma and Teva Sign Exclusive Licensing Deal for a Biosimilar Candidate to Ocrevus
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,…
The US FDA Approves Accord BioPharma’s Ennumo (Biosimilar, Neulasta)
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…