The U.S. 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.
While 2020 is certainly a hard year to beat, 2021 has so far recorded a respectable amount of biopharma deals and is on track to exceed every other year.
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.
Celltrion Inc. is riding high after receiving full approval for Regkirona (regdanvimab), as a treatment for COVID-19 in South Korea, seven months after the Ministry of Food and Drug Safety (MFDS) granted it conditional marketing approval in February 2021.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Abbvie, Abcellera, Alvotech, Aveo, Beigene, Biogen, Biomea, Biontech, BMS, Deciphera, Galapagos, Henlius, Innocare, Janssen, Keymed, Merck, Moderna, Pfizer, Protagonist, Roche.
Pfizer Inc. and Biontech SE have announced new data that could pave the way for childhood COVID-19 vaccine programs, with findings of a trial showing their shot is safe and effective in children of 5 to 12 years of age.
LONDON – Researchers in the U.K. have applied the heft of national population-level databases to devise a new algorithm that predicts those people who are most at risk of hospitalization and death from COVID-19, despite having received two doses of vaccine.
The FDA’s Vaccines and Related Biological Products Advisory Committee rejected an sBLA for a third, booster dose of the COVID-19 vaccine Comirnaty from Pfizer Inc.-Biontech SE for ages 16 and over, then unanimously approved a recommendation for those ages 65 and older along with individuals at high risk of severe COVID-19 to get the booster.
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