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Samsung Bioepis and Harrow Relaunch Byooviz (Biosimilar, Lucentis) in the US
Shots: Samsung Bioepis, in partnership with Harrow, has relaunched Byooviz, a biosimilar to Lucentis (ranibizumab), in the US Byooviz was initially commercialized by Biogen beginning in Jun 2022, before Biogen returned the US commercial rights to Samsung Bioepis at the end of 2025 Approved by the FDA in 2021 as the first ophthalmology biosimilar, Byooviz…
July 1, 2026
RefleXion Seeks FDA Clearance for Anchor Point Tumor Tracking
Shots: The US FDA has received a 510(k) premarket notification for Anchor Point Tracking, a tumor tracking technology designed for use with its new RefleXion X2 radiotherapy platform Filing is backed by extensive system validation & phantom testing, with additional data from academic investigators demonstrating improved target tracking, dose conformity, motion management, & organ-at-risk sparing…
July 1, 2026
Orca Bio’s Tregzi Wins FDA Approval for Allogeneic Transplant in Adults with Hematological Malignancies
Shots: The US FDA has approved Tregzi (Orca-T) for use in a stem cell transplant to improve survival free of chronic graft versus host disease (GVHD) in adults with hematological malignancies  Approval was backed by the P-III (Precision-T) trial assessing Orca-T + TAC vs conventional alloHSCT in pts (n=187) with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, &…
July 1, 2026
Ipsen to Acquire Memo Therapeutics for >€700M
Shots: Ipsen has entered into a definitive share purchase agreement to acquire all issued & outstanding shares of Memo Therapeutics, with closing expected in Q3’26 As per the deal, Memo shareholders will receive €200M upfront at closing, with total consideration exceeding €700M upon achieving development, regulatory, & sales milestones. Assets & employees unrelated to potravitug…
July 1, 2026
Boulevard Bio Inks ~$1.62B Licensing Deal with METiS TechBio for MTS-128
Shots: METiS TechBio has granted Boulevard worldwide development, manufacturing, and commercialization rights to MTS-128, a trispecific T-cell engager (TCE) program As per the deal, METiS TechBio will receive a $20M upfront payment & ~$1.6B in development, regulatory, & commercial milestone payments, in addition to tiered royalties on product sales MTS-128 is a trispecific T-cell engager…
June 30, 2026
Sanofi
Sanofi Reports P-III (Baby-COMET) Trial Data on Nexviazyme for Infantile-Onset Pompe Disease (IOPD)
Shots: Sanofi has reported the P-III (Baby-COMET) trial results assessing Nexviazyme (avalglucosidase alfa; 40mg/kg, Q2W, IV) in 17 treatment-naïve pediatric pts (≤12mos.) with IOPD Trial met its 1EP, with more treatment-naïve pts (≤6mos.) alive & free of invasive ventilation at 52wks., and achieved all 2EPs, including higher survival without invasive ventilation in pts at 12…
June 30, 2026
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