Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Circa Scientific, KSL Diagnostics, SQI Diagnostics.
The FDA continues its tight surveillance of rapid antigen tests for the COVID-19 pandemic and has issued three safety communications advising against the use of these tests thus far in the month of March. In each instance, the test is made by the manufacturer of name, but was not authorized in the U.S., making these misbranded products despite their legal use in other nations.
PERTH, Australia – The independent data safety monitoring board of the global REMAP-CAP COVID-19 study has uncovered a concerning safety signal in treatment arms that include an angiotensin converting enzyme inhibitor and an angiotensin receptor blocker in patients with severe COVID-19, and it has recommended that recruitment be suspended for those treatment arms.
LONDON – The U.K. Recovery trial has added a fourth drug to the list of therapies it has shown are effective in treating hospitalized COVID-19 patients, demonstrating the JAK inhibitor Olumiant (baricitinib) reduces the risk of death by 13% in seriously ill patients. That effect is in addition to treatment with dexamethasone, which became standard of care after the Recovery trial showed it reduced mortality by one-third in patients on ventilators.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: A2, Aquestive, Athira, Autolus, Avenge, Haisco, Inspirevax, Oragenics, Sorrento, Spexis.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dexcom, Gleamer, Intrivo, J&J Vision, Valencia Technologies.
New drug and device regulations going into effect in Canada are serving as a reminder of the extended life of the COVID-19 pandemic. After two years of interim orders regulating the importation and sale of drugs and devices for COVID-19 clinical trials and the conduct of those trials, Canada is issuing long-term regulations that will incorporate most of the provisions of the temporary orders.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 9 Meters, Accure, Affinivax, Akeso, Astellas, Blue Willow, BMS, Dragonfly, Gemini, Medigen, Oculis, Prokarium, Promis, Shenzhen Chipscreen.
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