The U.S. FDA detailed which kinds of SARS-CoV-2 tests are getting top priority, with access to rolling, rapid reviews for emergency use authorization (EUA) during the unfolding pandemic. The agency is aiming to authorize point-of-care and at-home tests to better distribute the use of testing in various locations. It also is looking at automated and high-throughput tests that can offer analysis of larger batches of tests at one time.
PERTH, Australia – Sydney-based Speedx Pty. Ltd. has signed a global distribution deal with Roche Holding AG, through which the latter will sell Speedx’s Resistanceplus MG and Resistanceplus GC molecular tests for detecting antimicrobial resistance to Mycoplasma genitalium (Mgen) and gonorrhea, respectively.
TORONTO – What do agricultural pesticides and concealed weapons have to do with med-tech advances in fighting COVID-19? Plenty, according to Canada’s science and industry ministry.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: BGI, BioIQ, Cigna, DNA Genotek, Illumina, Inspire Medical Systems, Lantheus, Metabolon, Nanostring, Orasure, Ortho, Phosphorous, Progenics, Respira, Sd Biosensor, Truvian, Yuyu Pharma.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Biocode, Cae, Candela, Enexor Health, Foundation Medicine, Tandem Diabetes Care.
Keeping you up to date on recent developments in orthopedics, including: Osteoporosis treatment also may protect against pneumonia; Study finds similar short-term outcomes after common MI spine procedures; New biomaterial has potential to repair damaged bone with lower risk of inflammation; Diabetics face greater risk of bone fractures.
BEIJING – Chinese state-backed vaccine developer China National Biotec Group (CNBG), of Beijing, said on Tuesday night that its inactivated COVID-19 vaccine candidate produced a seroconversion rate of up to 100% in a phase I/II trial that enrolled 1,120 healthy subjects.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aclaris, Curevac, Foundation Medicine, Hookipa, Ipsen, Kamada, Merck, Nanobiotix, Novartis, PTC, Reneuron, TG.
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