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Formycon Partners with OneSource Specialty Pharma for Biosimilars 
Shots:  Formycon and OneSource Specialty Pharma have entered into a strategic manufacturing partnership for biosimilars  As per the deal, OneSource will act as Formycon’s strategic manufacturing partner, providing integrated Drug Substance (DS) and Drug Product (DP) manufacturing from its advanced biologics facility in Bangalore, India  The collaboration combines Formycon’s biosimilar development expertise with OneSource’s end-to-end biologics manufacturing capabilities to advance Formycon’s global biosimilar programs  Ref: Formycon |  Image:…
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…
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…
Universal Brain Reports FDA Clearance of UB ERP System for Rapid Brain-Function Measurement
Shots: The US FDA granted 510(k) clearance to the UB ERP System for electroencephalography & event-related potentials-based brain function assessment, with commercial launch expected later this year To support clinical expansion, the company initiated US & Japan studies in depression to evaluate brain function before & after 1L antidepressant treatment, and develop objective brain function…
GSK
GSK Reports P-II (AZUR-1) Trial Data on Jemperli for dMMR/MSI-H Locally Advanced Rectal Cancer
Shots: GSK has reported global P-II (AZUR-1) trial data assessing Jemperli (dostarlimab) (500mg, IV, Q3W for 9 cycles) in 154 pts with stage II/III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer Trial met its 1EP, with a meaningful & sustained clinical complete response rate at 12mos. Interim AZUR-1 data will be shared with global…
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…
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…