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NEWS

Novartis and Alteogen Partner for ALT-B4 to Advance SC Formulations of Multiple Products

Shots: Alteogen has entered into an option & license agreement with Novartis for the development & commercialization of SC products leveraging ALT-B4 powered by Alteogen's Hybrozyme tech As per the deal, Novartis can obtain exclusive rights to develop & commercialize SC formulations of multiple products using Alteogen’s ALT-B4, with Alteogen eligible for ~$3.223B in option…
September 3, 2026

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NEWS

Akeso and Summit Report P-III (HARMONi-2) Trial Data on Ivonescimab for PD-L1-Positive Advanced NSCLC

Shots: Akeso and Summit has reported the P-III (HARMONi-2/AK112-303) trial data assessing ivonescimab monotx. vs Keytruda in Chinese pts with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression Trial showed improvement in OS (2EP), with results to be presented in future. In the primary analysis, trial met it 1EP of improved PFS,…
September 3, 2026

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NEWS

uniQure Reports the US FDA BLA Submission for Ifezuntirgene Inilparvovec to Treat Huntington’s Disease

Shots: The US FDA has received a BLA for the accelerated approval of ifezuntirgene inilparvovec (AMT-130) for the treatment of Huntington’s disease, plus a request for Priority Review BLA was supported by the 3yr. data analysis from the P-I/II trial of AMT-130 vs a propensity score-matched external control derived from the Enroll-HD natural history database;…
September 2, 2026

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NEWS

Evotec and Plectonic Partner on Next-Generation T-Cell Engagers for Solid Tumors

Shots: Evotec and Plectonic Biotech have entered a research collaboration to explore a novel immunotherapy approach for solid tumors by combining Plectonic’s programmable Logibody technology with Evotec’s BiTco platform Plectonic’s Logibody uses multi-antigen tumor signatures to selectively activate T cells, while Evotec’s BiTco platform uses a non-blocking CD2 antibody to enhance T-cell activity, tumor killing…
September 2, 2026

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NEWS

Styx Biotechnologies Partner with ZoeNCure Therapeutics to Advance ADC Development

Shots: Styx Biotechnologies has entered into a strategic agreement with ZoeNCure Therapeutics to accelerate selected Styx ADC programs toward first-in-human clinical studies for multiple solid tumor indications The collaboration gives Styx a capital-efficient path to advance selected ADC assets through coordinated preclinical, CMC, regulatory & clinical activities while preserving opportunities for global development & strategic partnering As…
September 2, 2026

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NEWS

Vara Gains CE Certification for Autonomous Breast Cancer Screening AI

Shots: Vara has secured CE certification under the EU Medical Device Regulation (Class IIb) for autonomous triage in organised breast cancer screening, enabling normal examinations to be reported without radiologist review ATMON (Autonomous-Triage Monitoring) is a real-time system that monitors AI performance, mammography hardware, system health, & site-level signals. If predefined limits are exceeded, the…
September 2, 2026

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NEWS

Medibyt Receives FDA 510(k) Clearance for CPETWise

Shots: The US FDA has granted 510(k) clearance to CPETWise (K260242) designed to streamline cardiopulmonary exercise testing (CPET) analysis, interpretation and reporting through a standardized clinical workflow The clearance follows a 100-case proof-of-concept study at the University of Washington, where CPETWise achieved an average user satisfaction score of 4.5/5 & cut interpretation time by more…
September 2, 2026

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NEWS

CorTec Receives Second FDA Breakthrough Device Designation for Brain Interchange system

Shots: The US FDA has granted Breakthrough Device Designation to Brain Interchange system for communication in people with non-progressive quadriplegia, letting users to control a computer cursor through thought alone The new designation builds on Brain Interchange’s April 2026 BDD for stroke motor rehabilitation. The same implant can function therapeutically by stimulating the brain to…
September 1, 2026

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INSIGHTS+

Key Biosimilars Events of August 2026 

Shots:  In August, biosimilar approvals and launches gained strong momentum with Biocon’s Yesafili (Eylea) and Yesintek (Stelara), FDA approval of rituximab from Dr. Reddy’s and Fresenius Kabi, and Celltrion’s European launch of Omlyclo (Xolair).   Global licensing and commercialization partnerships continued to drive biosimilar expansion with collaborations spanning North America, Europe, ASEAN, and MENA markets.   The biosimilar pipeline continued to broaden across key therapeutic…
September 1, 2026

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