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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
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
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
Simcere Zaiming Inks ~$1.53B Licensing Deal with Roche for SIM0660
Shots: Simcere Zaiming has entered into an exclusive global licensing agreement with Roche for the development & commercialization of SIM0660, a potential treatment of B-cell-mediated diseases As per the deal, Roche will acquire exclusive global rights to develop, manufacture, & commercialize SIM0660 in exchange for ~$1.53B in total, incl. $75M in upfront, as well as…
September 2, 2026
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
Hutchmed
HUTCHMED Reports P-III Trial Data on Orpathys + Tagrisso for Previously Untreated MET-Overexpressing EGFRm NSCLC
Shots: The P-III (SANOVO) trial assessed Orpathys (300 or 200mg, BID) + Tagrisso (80mg, QD) vs Tagrisso in 326 treatment-naïvepts with locally advanced or metastatic NSCLC harboring EGFR mutations (exon 19 deletion or L858R) & MET overexpression The combination significantly improved PFS in both high-MET and ITT populations, while also showing encouraging OS benefit; follow-up…
September 1, 2026
Novartis Reports P-III (REMODEL-1/-2) Trial Data on Remibrutinib for Relapsing Multiple Sclerosis
Shots: Novartis has reported topline data from P-III (REMODEL-1/-2) trials assessing remibrutinib (100mg) vs teriflunomide in ~2,000 adults with relapsing multiple sclerosis (RMS)  Remibrutinib met the 1EP, significantly reducing annualized relapse rate (ARR), plus trial showed clinically meaningful reductions in key 2EPs related to disability progression, with a positive trend in 3mCDP & nominally significant…
September 1, 2026
Ascendis Pharma and BioMarin Reach Global Settlement for Yuviwel
Shots: Ascendis Pharma has entered into a binding term sheet with BioMarin for a global settlement & license agreement covering Yuviwel (navepegritide) & related products, resolving ongoing litigation & disputes between the companies As per the deal, BioMarin will grant Ascendis a non-exclusive, worldwide, royalty-bearing license to research, develop, manufacture & commercialize navepegritide-related products without…
September 1, 2026
PharmaEssentia Reports the US FDA Approval of BESREMi (Ropeginterferon Alfa-2b-njft) for Essential Thrombocythemia
Shots: The US FDA has approved BESREMi (ropeginterferon alfa-2b-njft) for the treatment of adults with essential thrombocythemia (ET), expanding BESREMi product label beyond polycythemia vera Approval was supported by durable ELN responses and hematologic control in adults with ET. In P-III (SURPASS-ET) trial, it outperformed anagrelide in durable response rates & reduced thromboembolic events over…
September 1, 2026
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