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Exero Medical Reports the Trial Data on xBar Monitoring System for Early Detection of Colorectal Surgery Complications
Shots: Exero Medical has reported clinical trial data assessing xBar monitoring system to detect post-operative anastomotic leaks in colorectal resection surgery pts (n=222) Study showed that the xBar system detected post-operative anastomotic leaks in colorectal resection pts earlier than standard clinical practice, achieving 100% sensitivity & 88% specificity by post-operative day 3 & identifying leaks…
Roche
Roche’ Elecsys pTau217 Test Receives the European CE Mark Approval to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology
Shots: Roche has received CE Mark for Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology CE Mark was backed by retrospective real-world studies in early-stage Alzheimer’s pts, incl. Subjective Cognitive Decline, Mild Cognitive Impairment, & Mild Dementia, where individuals experience memory changes but…
BMS Partners with Hengrui Pharma in a Potential ~$15.2B Deal to Advance 13 Early-Stage Programs Across Oncology, Hematology, and Immunology
Shots: BMS has partnered with Hengrui to advance 13 early-stage programs, incl. 4 Hengrui onco/hemo assets, 4 BMS immunology assets, and 5 jointly discovered & developed candidates; expected to close in Q3’26 Hengrui will lead early clinical development, while BMS gains ex-China rights to Hengrui-originated assets & Hengrui will secure exclusive Greater China rights to…
Partner Therapeutics Reports the US FDA Approval of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma
Shots: The FDA has approved Partner Therapeutics' Bizengri (zenocutuzumab-zbco) under CNPV, for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring an NRG1 gene fusion who progressed on or after prior systemic therapy Approval was supported by eNRGy study assessing Bizengri in pts with NRG1 fusion-positive advanced solid tumors, incl. cholangiocarcinoma (n=22, where 19 were…
Henlius Receives US FDA IND Clearance for HLX05-N (Biosimilar, Erbitux)
Shots: The US FDA has granted IND clearance to HLX05-N, a biosimilar version of Erbitux (cetuximab) for the treatment of metastatic colorectal cancer (mCRC) HLX05-N is developed by Henlius in accordance with biosimilar guidelines in China, the EU, & the US, and showed high similarity to reference cetuximab in analytical & non-clinical comparative studies Cetuximab…
GSK Collaborates with Sino Biopharmaceutical to Accelerate Bepirovirsen at Launch
Shots: GSK has entered an exclusive strategic collaboration with Sino Biopharmaceutical, via its subsidiary CTTQ, to support the launch & commercialization of bepirovirsen (under NMPA’s priority review) in mainland China CTTQ will manage importation, distribution, hospital access, and promotional & non-promotional activities in China under a 5.5yr. supply deal with GSK On the other hand,…
The US FDA Grants IND Clearance to Harbour BioMed’s HBM7004 to Initiate P-I Trial in Advanced Solid Tumors
Shots: The US FDA has granted IND clearance to initiate the P-I trial assessing the safety, tolerability, PK, & anti-tumor activity of Harbour Biomed's HBM7004 in advanced solid tumors  Preclinical studies showed that HBM7004 induced B7H4-dependent intratumoral T-cell activation, strong anti-tumor activity, in vivo stability, & reduced systemic toxicity, while combination with a B7H4x4-1BB BsAb…