DUBLIN – The Genentech arm of Roche Holding AG plans to move its interleukin-6 inhibitor, Actemra, into a global phase III trial in patients with severe pneumonia associated with COVID-19 infection.
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.
HONG KONG – Korean biopharma Celltrion Inc. said it’s halfway through the process of creating a super antibody to reign in the COVID-19 novel coronavirus that has claimed almost 13,000 lives globally.
BEIJING – Shanghai Junshi Biosciences Ltd. is developing neutralizing antibodies as a potential treatment for COVID-19, and the program will move on to clinical trials soon. Meanwhile, the biotech is set to launch a pre-revenue IPO on Shanghai’s STAR market.
Despite earlier signs it might meet the primary endpoint of a phase III trial testing its ability to terminate supraventricular tachycardia (SVT) episodes in patients with paroxysmal supraventricular tachycardia (PSVT), a short-acting calcium channel blocker tested by Milestone Pharmaceuticals Inc. failed to do so.
A survey of 149 companies by Tufts Center for the Study of Drug Development found more than two-thirds of clinical trial sponsors were using or piloting at least four different data sources in their clinical trials.
It took less than a week from the publication of Science 37’s whitepaper on March 12 encouraging virtual clinical trials to the FDA’s decision to endorse the idea, tailored to address the COVID-19 pandemic.
It took less than a week from the publication of Science 37’s whitepaper on March 12 encouraging virtual clinical trials to the FDA’s decision to endorse the idea, tailored to address the COVID-19 pandemic.
Stoke Therapeutics Inc. is marching ahead in the second half of this year with its phase I/IIa study with STK-001 in Dravet syndrome (DS), one of the more abysmal forms of epilepsy, although the FDA has temporarily hobbled part B of the test, pending preclinical data that will more fully characterize the safety profile of the antisense oligonucleotide (ASO).
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