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.
LONDON – U.K. rapid diagnostics specialist Mologic Ltd. has been acquired by a group of philanthropists led by George Soros’ Economic Development Fund and the Bill & Melinda Gates Foundation, and will be turned from a for-profit company to a social enterprise. The aim is to use the change in status to expand access to low-cost point-of-care testing for tropical diseases, including dengue, bilharzia and river blindness, as well at COVID-19. The name Mologic will be changed to Global Access Health (GAH), with the philanthropic owners saying they are to invest at least $41 million in the deal.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astellas, Eli Lilly, Fibrogen, Hutchmed, Kintor.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alexion, BMS, Corvus, GSK, Innovent, Merck, Mesoblast, Orexo.
Following the temporary lapse in FDA inspections of manufacturing sites amid the COVID-19 pandemic, this year has already seen more class I medical device recalls issued than in all of 2020. The agency is now working to remediate the interruptions resulting from the pandemic among certain manufacturers of high-risk medical devices in reporting these recalls to the FDA.
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