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.
LONDON – From the start of the pandemic antibodies have been the main focus of attempts to understand the immune response to SARS-CoV-2 and ascertain what it will take for vaccines to be protective.
The U.S. FDA’s interest in harmonizing its regulations for medical devices with an international standard is a matter of record, but the agency has found this to be an enormously complicated task. Kim Trautman, executive vice president for medical device services at NSF International, of Ann Arbor, Mich., told BioWorld that the task of rewriting Part 820 to meet ISO 13485 in the middle is no mean feat, but also that it may be delayed again, this time because of the COVID-19 pandemic.
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