Japan’s Ministry of Health, Labour and Welfare approved the Regen-Cov (casirivimab/imdevimab, also known as Ronapreve) antibody cocktail for the treatment of patients with mild to moderate COVID-19 via intravenous infusion.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Ardelyx, Ionctura, Keiferx, Myovant, Octapharma, Sanofi, Swedish Orphan.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Annovis, Anthos, Biomarin, Bonus, Ionctura, Lineage Cell, Mediwound, Merck, Ose, Rain, Sesen, SK Life, Wave.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3a-diagnostics, Agilent Technologies, Clx Health, Guided Therapeutics, Health Decisions, Micronoma, Novocardia, Ortho Regenerative Technologies, Pacific Biosciences, Premier Research, Quest Diagnostics, San Omniome, Shandong Yaohua Medical Instrument, Terumo Europe, Theator, Thomas Scientific, Xphyto Therapeutics.
New preclinical data from Immunome Inc. gets the company closer to the clinic for studying its three-antibody cocktail’s effect on SARS-CoV-2. “We will file an IND this quarter and get into the clinic,” Immunome’s CEO, Purnanand Sarma, told BioWorld. “Since the number of cases is rising, unfortunately, we think a clinical study could be conducted reasonably quickly.”
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Almirall, Aquestive, Astrazeneca, Bluerock, Elucida, G1, Kadmon, Kyowa Kirin, Lyndra, Merck & Co., Oblato, Receptor Life Sciences, Sinovac, Xenikos, Yisheng.
Aditxt Technologies Inc. enhanced its immune response test for COVID-19 by adding a high-sensitivity neutralizing antibody quantification. With the expansion, the multidimensional test, Aditxtscore, provides a comprehensive measure of the strength of an individual's immune response to the novel coronavirus.