The COVID-19 pandemic is still swirling about, and rapid antigen tests are still playing a vital role in pushing back against the COVID-19 pandemic, and Australia’s TGA has responded with a guidance on when software used with rapid antigen tests qualifies as a regulated device. The TGA has classified such software as a class 3 device when used with a rapid antigen self-test, thus requiring a separate regulatory application before it can be eligible for entry in the Australian Register of Therapeutic Goods (ARTG).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogen, Biontech, Celltrion, Exelixis, Forge, Incyte, Luye, Marinus, Pfizer, Rhythm, Samsung.
The FDA has cleared Memed Diagnostics Ltd.'s blood test for distinguishing between bacterial and viral infections. The diagnostic test has been tipped as an essential step in the fight against antimicrobial resistance. While most infectious disease tests look for the pathogen, Memed BV is an advanced host immune response test that measures the levels of immune system proteins and applies proprietary algorithms to generate an immune signature.
LONDON – There were well-deserved celebrations in Paris on Sept. 20, as Jeito Capital toasted the oversubscribed close of its first fund at €534 million (US$625.5 million). This is claimed as the largest European venture fund dedicated to life sciences, exceeding the original target of €500 million, and with €340 million of the total raised under the constraints of the pandemic from January 2020 onward.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aikido, Attillaps, Bluegrass Vascular, Glaukos, Grail, Kerna, Masvida, Medifocus, N2 Biomedical, Orasure Technologies, Precision Coating, Smartlabs.