The U.S. FDA announced July 18 that it has granted an emergency use authorization (EUA) to Quest Diagnostics Inc. for the company’s real-time, reverse transcriptase polymerase chain reaction test for the SARS-CoV-2 virus in a development that FDA commissioner Stephen Hahn described as “an important step forward.”
The number of clinical trials initiated each year has continued to grow every year over the last decade, sans a slight decrease in 2013, according to data presented in a webcast facilitated by Applied Clinical Trials.
LONDON – There were encouraging results from trials of three COVID-19 vaccines on July 20, with Astrazeneca plc, Biontech SE/Pfizer Inc. and Cansino Biologics Inc. all reporting T-cell responses in ongoing phase I/II studies of their respective products.
DUBLIN – Synairgen plc has detected what appear to be promising efficacy signals in a phase II trial of its inhaled formulation of interferon-beta 1a, SNG-001, in hospitalized COVID-19 patients.
NEW DELHI – Bangalore-based Biocon Ltd. has received the Indian drug regulator's approval for restricted emergency use of its psoriasis biologic, itolizumab, to treat patients with severe cases of COVID-19 in need of ventilator support.
HONG KONG – Incheon, South Korea-based Celltrion Inc. will start manufacturing its COVID-19 treatment for clinical trials and commercial distribution, even though it’s only reached phase I.
LONDON – Glaxosmithkline plc (GSK) is putting £130 million (US$164.3 million) into one of the leading COVID-19 vaccines developers, Curevac AG, acquiring a 10% stake, and will also invest £104 million cash up front to fund research and development of the company’s mRNA vaccines.
Keeping you up to date on recent developments in cardiology, including: COVID-19's influence on broken heart syndrome; Researchers see hope with blood test for advancing heart failure treatment; Antiplatelet med could treat heart attack.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Generex, Immuron, Karyopharm, Molecular Partners, Neoimmunetech, Orchard, Orphazyme, Osmotica, Sanifit, Sorrento.