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Henlius Reports First Patient Dosing in P-I Trial of HLX15-SC (Biosimilar, Darzalex Faspro) in the US 
    Shots:  Henlius has dosed the first U.S. patient in the global P-I HLX15-SC (HLX15-SC-NDMM-001) trial, a biosimilar version of Darzalex Faspro, as a 1L treatment for newly diagnosed multiple myeloma (NDMM)  The study will compare HLX15-SC vs. US-licensed Darzalex Faspro in transplant-ineligible NDMM patients, evaluating PK similarity, safety, tolerability, immunogenicity, and efficacy in combination with lenalidomide & dexamethasone (Rd)  HLX15 is an anti-CD38 daratumumab biosimilar candidate for…
July 13, 2026
Bayer Receives €3B Equity Capital Through Apollo Investment
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…
July 13, 2026
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…
July 13, 2026
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…
July 13, 2026
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…
July 10, 2026
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…
July 10, 2026
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,…
July 10, 2026
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