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Visit 1www.ThePinkSheetDAILY.com for coverage of the latest developments in the pharmaceutical industry, including FDA's "approvable" letter for Merck's COX-2 inhibitor Arcoxia, remarks by FDA's Janet Woodcock on the safety of Pfizer's COX-2 Celebrex and Bristol-Myers Squibb's third quarter earnings conference call. To sign up for a free trial of "The Pink Sheet" DAILY, visit our website or call customer service at 800-332-2181...
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Biocon’s itolizumab gets clearance in India for restricted emergency use in COVID-19 patients, amid some concerns around small study numbers. But company says data are compelling and cites compassionate use substantiation, while partner Equillium expects to pursue a global study under US IND.
Clinical Trials: Industry Navigating Alternative Ways Of Delivering Investigational Drugs During Pandemic
New approaches include delivering study drug from a clinical site directly to a patient’s house through a courier service, as well as use of drones and automated dispensing units; future trials could see a mix of delivery approaches.
Benefits of the BCMA-directed antibody-drug conjugate outweigh its ocular risks in heavily pretreated multiple myeloma patients, Oncologic Drugs Advisory Committee says at the conclusion of a virtual meeting beset by technical problems.