New FDA Vaccine Rules Could Nix Pre-Election COVID-19 Shot
October 8, 2020
By Neozene

The following article originally appeared in FiercePharma and was written by Eric Sagonowsky A weeks-long feud between the White House and FDA over COVID-19 vaccine guidelines took another turn Tuesday as the agency released vaccine recommendations despite efforts by the White House to keep them under wraps. The FDA advises two months of monitoring after patients’ final doses, which could thwart President Donald Trump’s desire for a shot before the election. As COVID-19 vaccines move closer to potential reviews at the FDA, experts with the agency last month prepared to publish a

Study Confirms That Steroids Save Very Ill COVID Patients
September 3, 2020
By Neozene

The following article originally appeared in FiercePharma and was written by Angus Liu When researchers in the U.K. said in June that the low-cost corticosteroid dexamethasone could reduce death rates in critically ill COVID-19 patients, clinicians still had doubts about whether to change their treatment practice without full data. But findings from a series of clinical trials from around the world, along with a new meta-analysis—all of which were published on Wednesday in JAMA—will likely change that. The findings “provide definitive data that corticosteroids should be first-line treatment for critically ill patients

Congress Urges FDA to Better Scrutinize COVID-19 Antibody Tests
April 27, 2020
By Neozene

This article originally appeared in FierceBiotech and was written by Conor Hale Members of Congress have called on the FDA to re-evaluate its stance toward COVID-19 antibody tests. Since mid-March, the agency has allowed diagnostic developers to bring their products to market without any outside evaluation that the results they produce are accurate. Instead, these manufacturers can proceed after validating the tests themselves, but they are not required to share those results. Companies must also print labels saying their antibody tests are not FDA approved or authorized and should not be used