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GlycoNex Reports the P-III Trial Data on SPD8 (Biosimilar, Denosumab)
Shots: GlycoNex has reported the P-III trial results assessing SPD8 (SC, Q6M), a biosimilar version of denosumab co-developed with Mitsubishi Gas Chemical, vs Prolia in 266 Japanese subjects with osteoporosis Trial met its 1EP, with SPD8 demonstrating therapeutic equivalence to Prolia. The between-group difference in the 1EP & its 95% confidence interval fell within the pre-specified…
June 11, 2026
XtalPi Secures Over $400M Partnership to Develop GPCR-Targeted Small Molecule Therapy
Shots: XtalPi has entered into a strategic partnership with a biopharmaceutical company to develop an oral small molecule against G protein-coupled receptor XtalPi will leverage its structure-based drug design platform, combining quantum physics, generative AI, large-scale automated chemical synthesis orchestrated by a multi-agent system to accelerate Design-Make-Test-Analyze (DMTA) cycles As per the deal, XtalPi will receive…
June 11, 2026
Novartis Inks a ~$1.44B Deal with Orionis to Advance Molecular Glue Therapies for Multiple Targets
Shots: Orionis Biosciences has entered into a multi-year collaboration with Novartis to discover & design molecular glue drugs for challenging therapeutic targets across multiple disease areas As per the deal, the companies will leverage Orionis’s Allo-Glue platform & AI-powered discovery engine to accelerate target & ligase profiling, as well as molecular glue optimization, enabling the…
June 10, 2026
NMPA Accepts IND Application for Harbour BioMed’s HBM7004 to Treat Advanced Solid Tumors
Shots: The NMPA has accepted IND application for HBM7004 for the treatment of advanced solid tumors HBM7004, developed using Harbour’s HBICE platform, is a novel B7H4×CD3 bispecific antibody that is designed to enhance cancer immunotherapy, aiming to improve both efficacy & safety through targeted immune activation In preclinical studies, HBM7004 induced B7H4-dependent T-cell activation within…
June 10, 2026
Oncolys BioPharma Reports MHLW Approval of Telomelysin for Esophageal Cancer
Shots: The Japanese MHLW has granted full marketing approval to Telomelysin Injection (suratadenoturev/OBP-301) for the treatment of esophageal cancer pts ineligible for curative resection or CT, based on a Japanese pivotal trial conducted at 17 sites Approval triggered a milestone payment to Oncolys under its deal with FUJIFILM Toyama Chemical, which granted FUJIFILM commercialization rights…
June 10, 2026
Vara Secures CE Mark for AI-Powered Tomosynthesis Solution
Shots: Vara has received CE Class IIb marking under the EU MDR for its tomosynthesis (3D mammography) AI solution, expanding its offerings for breast cancer screening programs across the EU Vara is validated for national-scale breast cancer screening, with its scale demonstrated through PRAIM, a large prospective screening study published in Nature Medicine in 2025, supporting…
June 10, 2026
Eli lilly
Eli Lilly Receives the US FDA Approval for Ebglyss as a Q8W Maintenance Therapy for Atopic Dermatitis
Shots: The US FDA has approved Ebglyss (lebrikizumab-lbkz; 250mg/2mL, Q8W, SC) maintenance therapy for the treatment of pts (≥12yrs.; ≥40kg) with mod. to sev. atopic dermatitis Approval was supported by longitudinal exposure-response modeling & Q8W dosing data from an extension of the P-III (Adjoin) long-term trial, which assessed Ebglyss maintenance dosing for Q4W or Q8W over…
June 10, 2026
Xenix Medical Reports the US FDA Clearance for Lux Expandable Lumbar Fusion System
Shots: Xenix Medical has received the US FDA 510(k) clearance & initiated the full commercial launch of its Lux Expandable Lumbar Interbody Fusion System Lux features up to 4.5mm of controlled post-implant expansion, enables bone graft delivery through the inserter into a large endplate-to-endplate graft window after expansion, & incorporates NanoACTIV surface tech. to support fusion…
June 9, 2026
Novanta to Acquire Riverpoint Medical in ~$1.45B Deal
Shots: Novanta has entered into a definitive agreement to acquire Riverpoint Medical from Arlington Capital Partners, expanding Novanta’s presence in the minimally invasive surgery market As per the deal, Novanta will acquire Riverpoint for $1.2B upfront, with $250M in milestone payments expected in Q1’27, representing the total deal value of $1.45B; closing is anticipated in…
June 9, 2026
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