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Henlius Receives the NMPA IND Clearance for HLX319 (Biosimilar, Phesgo)
Shots: The Chinese NMPA has granted IND clearance to HLX319, a biosimilar version of Phesgo (pertuzumab, trastuzumab & hyaluronidase), for neoadj./adj. treatment of HER2+ early or locally advanced breast cancer, as well as for the treatment of metastatic breast cancer  Pertuzumab & trastuzumab in HLX319 are Henlius’ HLX11 & Hanquyou, respectively, with HLX11 under review…
12 hours ago
restor3d Reports Full Commercial Launch of Aeros Modular Stem System for Total Ankle Replacement
Shots: restor3d has reported the full commercial availability of the Aeros Modular Stem System, a next-generation total ankle replacement platform designed to enhance implant stability, preserve bone, & improve surgical efficiency  Launched with a limited market release, the system enables flexible implant configurations and introduces a modular stem tibial implant that can be placed via…
14 hours ago
Zeto Receives US FDA 510(k) Clearance for Zeto New Wave to Advance Outpatient EEG
Shots: The US FDA has granted 510(k) clearance to Zeto New Wave to perform EEG efficiently in outpatient clinics & homes Zeto New Wave is an easy-to-use outpatient EEG system with 21 soft-tip electrodes (10–20 system), offering full head coverage & paired with a compact device capturing synchronized video/audio  Designed for short-term recordings up to 2.5hrs., the…
15 hours ago
Merck new
Merck Initiates P-IIb/III (MALBEC) Trial of MK-8748 for Neovascular Age-Related Macular Degeneration
Shots: Merck initiates the P-IIb/III (MALBEC) trial assessing MK-8748 (Tiespectus/EYE201) for the treatment of neovascular (wet) age-related macular degeneration (NVAMD) The trial will assess the safety & efficacy of two intravitreal dose levels of MK-8748 vs aflibercept (2mg), with Q4W dosing initially for 3mos., then Q8W through Wk. 48, followed by individualized dosing intervals, with…
16 hours ago
Biocytogen and Sihuan Pharmaceutical Partner to Discover Novel Therapeutics in Multiple Indications
Shots: Biocytogen has partnered with Sihuan Pharmaceutical to discover innovative therapies across multiple areas, incl. weight loss As per the deal, Biocytogen and Sihuan will combine Biocytogen’s fully human antibody discovery platform with Sihuan’s development, manufacturing, & commercialization capabilities In this collaboration, Biocytogen will leverage its integrated platforms, incl. target-humanized mouse models, in vivo efficacy…
1 day ago
Astrazeneca
AstraZeneca Reports the P-III (EMERALD-3) Trial Data on Imfinzi Combination + TACE in Unresectable Hepatocellular Carcinoma
Shots: The P-III (EMERALD-3) trial assessed single priming dose of Imjudo (300mg) + Imfinzi (1500mg) followed by Imfinzi (Q4W) + transarterial chemoembolisation (TACE) ± lenvatinib vs TACE alone in 760 pts unresectable HCC eligible for embolization Imjudo + Imfinzi + Lenvatinib & TACE showed improved PFS (1EP) vs TACE alone, with OS (2EP) demonstrating a favorable trend in the…
2 days ago
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