The U.S. National Institutes of Health (NIH) has waded into the controversial question of the respective roles of rapid antigen and polymerase chain reaction (PCR) tests for detection of the SARS-CoV-2 virus, a question that roiled relations between the FDA and public health experts. According to NIH, three rapid antigen tests administered at three-day intervals offer the same level of sensitivity as PCR, a finding that will likely make itself felt in future communicable disease outbreaks.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogx, Foundation Medicine, Sonoscape Medical.
Zydus Cadila Ltd. has applied for emergency use authorization in India for its DNA plasmid COVID-19 vaccine, potentially the first shot of its kind to be approved in humans. The filing for the vaccine called ZyCoV-D will be based on a phase III study showing efficacy of 66.6% for symptomatic disease and 100% efficacy for moderate disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adlon, Alzamend Neuro, Hutchmed, Ildong, Immunic, Jazz, Lupin, Mesoblast, Puma, Prometic, Scpharmaceuticals.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Access Bio, Almac Sciences, Areum Bio, Bellaseno, Bio-Rad, Ensysce Biosciences, ERS Genomics, Exothera, Hart Medical Equipment, Icon, Leisure Acquisition Corp., Nippon Gene, Nonacus, Northwest Ohio Medical Equipment, Novigenix, Ossis, Pall, Pamgene, PRA Health Sciences, Qiagen, Seegene, Spinelife.com, Sysmex, Vivera, Zimmer Biomet.
As confirmed cases and deaths from COVID-19 continue their downward slide, biopharma research efforts remain front and center, providing a new therapeutic for emergency use in the U.S. and high-efficacy phase III data for what could become the country’s fourth vaccine and its first protein subunit option.
As life begins to return to a semblance of normal in many parts of the world, COVAX cautioned countries July 1 against adopting policies that favor specific COVID-19 vaccines.
The COVID-19 vaccine from Curevac AG looks far less protective than mRNA-based rivals, according to phase IIb/III data, but the company suggested it could still be approved in younger age groups or supplied to poorer countries at lower cost.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allogene, Direct, Emergex, Lexeo, Solasia.
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