The EMA issued a guidance Feb. 25 outlining the requirements for manufacturers planning to modify COVID-19 vaccines to address emerging variants of the SARS-CoV-2 coronavirus.
Eight months after Beijing-based Yisheng Biopharma Co. Ltd. unveiled its recombinant protein vaccine candidate for COVID-19, YS-SC2-010, the company raised $130 million in a series B round to pave way for the vaccine to enter clinical trials in the second quarter of this year, the company’s CEO David Shao told BioWorld.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Aquestive, Bluebird, Cansino, Exelixis, Gannex, J&J, Retrotope, RDIF, Sinopharm, Viiv.
CAJICA, Colombia – Three countries have emerged as the key engines of growth for Latin America’s medical devices sector, accounting for the largest share of exports and investment in the space across the region and experiencing growth over the past decade that may have been supercharged by the COVID-19 pandemic.
The U.S FDA’s response to the pandemic has been all-consuming, but epidemiologist Michael Mina of Harvard blasted the agency’s handling of rapid testing. Mina said the agency is in possession of emergency use authorization filings for rapid antigen tests that should be acceptable, but that the FDA is “the only bottleneck” in the rapid antigen testing pipeline.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Assure Tech, Dascena, G21, Locate Bio.
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