Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genmark Dx.
With the number of COVID-19 cases continuing to rise and with people social distancing and quarantining, at-home diagnostics and telehealth offer the means for doctors and patients to get vital answers and care without meeting face to face. Now, Los Angeles-based Scanwell Health has gained exclusive rights to license and distribute a rapid serology test from Innovita Biological Technology Co. Ltd., of Hebei, China, for at-home testing of SARS-CoV-2, the coronavirus that causes COVID-19.
DUBLIN—Can high-dose inhaled nitric oxide (NO) make a meaningful contribution to patients with COVID-19 infection? The FDA was sufficiently persuaded by the data presented by Bellerophon Therapeutics Inc. to grant it expanded access approval for its iNOpulse system for pulmonary delivery of NO.
BEIJING – China was the first country to face serious disruptions in clinical trials caused by COVID-19, and policy advocates in the country moved quickly to identify lessons for future outbreaks and address the concerns of a biotech industry in dismay.
BioWorld looks at translational medicine, including: Heparan sulfate DAMPens acetaminophen toxicity; Study links GABA, mitochondria, social defects; Recruiting NK cells to the antitumor battle; Potassium channel blocker improves motor learning in fetal alcohol syndrome; A20s inflammation-fighting properties decoded; Brown fat activity without fat browning; Agonists selectively wake up melatonin receptor subtypes; Multistep method wrests causality from GWAS; BET on BD1 for cancer, BD2 for inflammation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agex, Bellerophon, Imstem, Oncology Ventures, Viiv.