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HistoSonics Reports CE Mark Approval of Edison System for Unresectable Liver Tumors
Shots: HistoSonics has reported CE Mark approval of its Edison System for the non-invasive mechanical destruction of liver tumors, incl. the partial or complete destruction of unresectable liver tumors using histotripsy Approval was supported by clinical evidence, incl. HOPE4LIVER trial, which demonstrated a 90% local tumor control rate at 12mos. across liver tumor types with…
4 days ago
Dizal Inks ~$1.5B Global Exclusive License Agreement with AstraZeneca for Zegfrovy
Shots: Dizal has entered into a global exclusive license agreement with AstraZeneca for Zegfrovy (sunvozertinib) for the treatment of pts with lung cancer; closing is expected in H2’26 As per the deal, AstraZeneca will acquire worldwide rights to develop & commercialise Zegfrovy in exchange for $600M upfront, & ~$900M in development, regulatory & sales milestones, with tiered royalties…
4 days ago
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…
5 days ago
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…
5 days ago
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…
5 days ago
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