Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Arcturus, Chemomab, Genor, Grunenthal, Janone, Mesoblast, Pieris, Seelos.
With the green light for a phase II trial to test a new drug to tackle some of the impacts of COVID-19, clinical-stage antibody developer Sorrento Therapeutics Inc. is going all in on the COVID-19 business.
Royal Philips NV reported a 6% decline in year-to-year sales for the second quarter of 2020. While delays in elective procedures suppressed sales in the Amsterdam-based company’s diagnostics and treatment division, the virus boosted demand for connected care and minimized the impact of the coronavirus for the company compared to many competitors.
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.
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