Immunoprecise Antibodies Ltd.'s subsidiary, Talem Therapeutics LLC, has shared promising results of a new study conducted by the National Institute of Allergy and Infectious Diseases (NIAID) showing continued resilience of Polytope TATX-03 in broadly neutralizing SARS-CoV-2 variants, including two omicron sublineages that had not been previously tested.
The Biden administration recently reported that a new round of free rapid tests for the SARS-CoV-2 virus is available to the public, a development that coincides with a new surge of the latest sub-variant of the omicron variant. However, the administration is also expected to renew the public health emergency (PHE) for the pandemic, even as the White House continues to press Congress for another $22 billion in pandemic-related funding.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA hits company for deviations from drug, device GMPs; Stryker undertakes correction for AEDs; MHRA: Creams, ointments may interfere with CGM function; NICE says liver perfusion suffers for want of evidence of efficacy; NIAID testing vaccine allergy hypothesis; EC provides emergency funding for COVID-19 research; Medtronic splits Ninth Appeals’ review of lower court decision; Industry, docs push back on prior authorization.
LONDON – Astrazeneca plc promised to publish the primary analysis of the phase III U.S. trial of its COVID-19 vaccine by the morning of March 25, after chastisement from the data safety monitoring board (DSMB) for using “outdated” information in the interim results published on March 22.
Investigators at the National Institute of Allergy and Infectious Diseases have identified physiological factors that are not diseases in the narrow sense, but that nevertheless have large effects on microbiome composition.
Threads of hope and caution stitched together a wide-ranging appraisal of COVID-19 vaccines at June 9's BIO Digital plenary, "A Way Forward." The good news, delivered by one of the world's most sober participants in the pandemic response, mercifully came first.
Moderna Inc.’s chief medical officer, Tal Zaks, said that the results in hand “give us great confidence that we've got the right dose range for phase III” work slated to begin this summer with COVID-19 vaccine prospect mRNA-1273. A regulatory filing could come as early as 2021.
Following revelations that a randomized, placebo-controlled study of the Gilead Sciences Inc.’s antiviral, remdesivir, reduced time to recovery for hospitalized patients with "advanced" COVID-19, along with additional data from an open-label phase III trial from its maker, the FDA is "working with Gilead to figure out a mechanism to make this easily available to people who need it," Anthony Fauci, director of the NIH’s National Institute for Allergy and Infectious Diseases (NIAID), said April 29.
The National Institute of Allergy and Infectious Diseases has stopped a late-stage HIV vaccine study it sponsored after an interim review by the trial's independent data and safety monitoring board (DSMB) found the regimen failed to prevent HIV.
