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Saya Biologics and Kashiv BioSciences Partner to Introduce a Biosimilar Supportive Oncology Therapy in Mexico and the CAC Region 
Shots:  Saya Biologics has signed a strategic partnership with Kashiv BioSciences to register and commercialize a supportive oncology therapy in Mexico and the CAC region  As per the deal, the agreement spans 11 countries across Mexico and the CAC region. Saya Biologics will handle regulatory registration, commercialization, and distribution, while Kashiv BioSciences will oversee manufacturing and supply.   Saya has already submitted the regulatory dossier in Mexico,…
February 4, 2026
Quanterix Seeks US FDA Approval for Multi-Analyte Algorithmic Blood Test to Diagnose Alzheimer’s Disease
Shots: The US FDA has received 510(k) premarket notification for the multi-analyte algorithmic blood test to diagnose Alzheimer’s disease Submission was backed by data across three independent cohorts & 1,800+ pts, published in the Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring The blood test uses Quanterix’s Simoa tech to integrate five AD biomarkers (p-Tau217,…
February 4, 2026
Zonsen PepLib Biotech and Eli Lilly Partner to Advance Peptide-Based Therapies
Shots: Zonsen PepLib Biotech has entered into a worldwide R&D and license agreement with Eli Lilly to jointly advance peptide-based drug candidates using PepLib’s robust & diverse peptide libraries & discovery platforms As per the deal, PepLib will screen & identify optimal peptide molecules using its in-house platform, while Lilly will oversee IND-enabling activities, clinical…
February 4, 2026
Exelixis Reports the US FDA’s NDA Acceptance of Zanzalintinib + Tecentriq for Metastatic Colorectal Cancer (mCRC)
Shots: The US FDA has accepted NDA of zanzalintinib + Tecentriq (atezolizumab) for the treatment of adults with mCRC who have been previously treated with fluoropyrimidine, oxaliplatin & irinotecan-based CT, &, if RAS wild-type, an anti-EGFR therapy (PDUFA: Dec 03, 2026) NDA was based on P-III (STELLAR-303) trial assessing zanzalintinib in combination with atezolizumab (n=451)…
February 3, 2026
Astrazeneca and Daiichi-Sankyo New
Daiichi Sankyo and AstraZeneca Report the US FDA Priority Review for Datroway to Treat Metastatic Triple Negative Breast Cancer
Shots: FDA has accepted sBLA & granted priority review to Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy (PDUFA: Q2’26) sBLA was backed by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644 above-mentioned pts, which showed 5mos. improvement in…
February 3, 2026
Bio-Thera Partners with Avalon Pharma to Commercialize BAT3306 (Biosimilar, Keytruda) in Saudi Arabia and MENA 
Shots:  Bio-Thera and Avalon Pharma have signed commercialization and licensing agreements for BAT3306, a biosimilar version of Keytruda (Pembrolizumab)  As per the deal, Bio-Thera will oversee development, manufacturing, and supply of BAT3306, while Avalon Pharma will handle regulatory approvals and commercialization across Saudi Arabia and the MENA region  BAT3306 is a humanized monoclonal antibody and immune checkpoint inhibitor…
February 3, 2026
Genentech to Advance RNAi Therapeutics with SanegeneBio in a ~$1.7B Deal
Shots: SanegeneBio has entered into a global licensing agreement with Genentech (Roche) to advance one of its RNAi programs, using SanegeneBio's RNAi platform As per the deal, Genentech will receive exclusive worldwide rights to develop & commercialize the program, with SanegeneBio handling early development activities, after which Genentech will lead subsequent development & commercialization efforts …
February 3, 2026
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