Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apeiron, Athira, Boehringer Ingelheim, Clover, Eiger, Eli Lilly, Hutchmed, Innate, Longeveron, Marker, Trillium, Ysopia.
PERTH, Australia – Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Ltd. completed a A$63 million (US$47.44 million) initial public offering (IPO) on the Australian Securities Exchange (ASX) on July 5. “The funds raised will support U.S. commercialization of Febridx, to build our pipeline and to expand our operations so that we have the facilities and infrastructure in place to do automated assembly and manufacturing,” Lumos Diagnostics CEO Rob Sambursky told BioWorld.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advicenne, Agenus, Bristol Myers Squibb, Cytodyn, Diurnal, Hangzhou Chance, Iterum, Moderna, Recipharm, Zydus Cadila.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 4D, Agenus, Arbutus, Auris, BMS, Cellgenix, Defence, Destiny, Denovo, Lipidor, Lundbeck, Mandos, Merck, Regeneron, Sartorius, SK Chemicals, Standigm, Vaccitech, Vtesse.
The U.S. National Institutes of Health (NIH) has waded into the controversial question of the respective roles of rapid antigen and polymerase chain reaction (PCR) tests for detection of the SARS-CoV-2 virus, a question that roiled relations between the FDA and public health experts. According to NIH, three rapid antigen tests administered at three-day intervals offer the same level of sensitivity as PCR, a finding that will likely make itself felt in future communicable disease outbreaks.
Zydus Cadila Ltd. has applied for emergency use authorization in India for its DNA plasmid COVID-19 vaccine, potentially the first shot of its kind to be approved in humans. The filing for the vaccine called ZyCoV-D will be based on a phase III study showing efficacy of 66.6% for symptomatic disease and 100% efficacy for moderate disease.