LONDON – After eight years in development, Memed Diagnostics Ltd. has secured CE marking for its point-of-care blood test, which is able to distinguish between bacterial and viral infections in 15 minutes.
Swept up into a coronavirus whirlwind, the biopharma industry has ramped up development of therapeutics and vaccines and altered business plans to fight the SARS-CoV-2 virus in a way that nobody could have imagined only months ago.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avita Medical, Citius, College Park Industries, Fibralign, Icometrix, Lumendi, Medx, Mölab, Mybio, Myndtec, Maness Veteran Medical, Nuprobe, Ourcrowd, Pathgroup, Protech Home Medical, Qualigen Therapeutics, Respira Technologies, Steeper Group, Surgery Exchange, Technopath Clinical Diagnostics, Terumo.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agenus, Braeburn, Cellenkos, Citius, Helsinn, Nkmax, Renovorx, Rigenerand, Sapience, Tetra Bio-Pharma, Y-mabs.
The Kaiser Family Foundation (KFF) reported that 48% of U.S. adults surveyed had postponed medical care due to the COVID-19 pandemic. In good news, more than two-thirds of those who delayed care expected to get the care they have delayed over the next three months.
The COVID-19 pandemic has demanded much of the FDA, and commissioner Stephen Hahn said on a June 1 conference call that “there have been hiccups along the way” as the enormity of the threat came into view. The agency’s use of emergency use authorizations (EUAs) has drawn criticism, but Hahn defended those EUAs and other regulatory flexibilities even has he declared that the FDA is not “walking away from” randomized, controlled clinical trials as the gold standard for premarket review.
Keeping you up to date on recent developments in cardiology, including: iPSC microtissue gives clues to heart disease; Two paths for helping patients with heart stents; COVID-19 hits stroke patients.
Eli Lilly and Co. said June 1 the first patients have been dosed in a phase I test of LY-CoV555, a potential antibody treatment for COVID-19, with results expected by June 30. Should it prove safe, the candidate could quickly move into a phase II trial to assess its efficacy, Ajay Nirula, vice president of immunology at Lilly, told BioWorld.
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