The COVID-19 pandemic has demanded much of the FDA, and commissioner Stephen Hahn said on a June 1 conference call that “there have been hiccups along the way” as the enormity of the threat came into view. The agency’s use of emergency use authorizations (EUAs) has drawn criticism, but Hahn defended those EUAs and other regulatory flexibilities even has he declared that the FDA is not “walking away from” randomized, controlled clinical trials as the gold standard for premarket review.
Keeping you up to date on recent developments in cardiology, including: iPSC microtissue gives clues to heart disease; Two paths for helping patients with heart stents; COVID-19 hits stroke patients.
Eli Lilly and Co. said June 1 the first patients have been dosed in a phase I test of LY-CoV555, a potential antibody treatment for COVID-19, with results expected by June 30. Should it prove safe, the candidate could quickly move into a phase II trial to assess its efficacy, Ajay Nirula, vice president of immunology at Lilly, told BioWorld.
Gone from the American Society of Clinical Oncology (ASCO) meeting were the packed halls of McCormick Place in Chicago and the excited bustle of scientists reacquainting with each other at the always data-rich event. ASCO’s annual confab, held online because of the COVID-19 pandemic, still managed to pull off what former president Howard Burris called a “resounding success,” with about 40,000 registrants, similar to previous years.
Blue chip public biopharmaceutical companies continued their positive trajectory in May, with the BioWorld Biopharmaceutical index recording an 8% jump in valuation and contributing to its year-to-date performance of approximately 17%.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3nt Medical, Abiomed, Healgen Scientific, Meditech Spine, Rhaeos, Siemens Healthineers, Tissue Regenix.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allergan Aesthetics, Atron Group Avista Capital Partners, Celonova Biosciences, Clarion Medical Technologies, Designplex Biomedical, Evo Design, Ibuttonlink, Ideal Medical, Jet Propulsion Laboratory, Labcorp, Mvent, Minnetronix, Nanovibronix, Pro-Dex, Quanta, Richards Packaging Income Fund, Stark Industries, University of New Mexico, Vacumed, Vacumetrics, Vision Healthcare, Visionquest.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Accord, Altimmune, ANI, Astrazeneca, Aveo, Compugen, Cytodyn, Eli Lilly, Genentech, Henlius, Hutchison China (Chi-Med), J&J, Longeveron, Merck, Mundipharma, Myovant, Myr, Opko.
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