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.
Researchers from Massachusetts General Hospital have identified peripheral neuropathy in more than half of a group of long COVID patients, suggesting that it may be a mechanism that contributes to multiple, seemingly disparate, long COVID symptoms.
Visby Medical Inc. reeled in more than $100 million in a series E round led by Ping An Voyager Partners. The funds will be used to scale production capacity of Visby’s instrument-free, single-use real-time polymerase chain reaction (RT-PCR) platform from tens to hundreds of thousands of tests per month.
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