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Home » Topics » COVID-19

COVID-19
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Russia Pursues Single-Dose, Light Version of Sputnik V Vaccine

March 24, 2021
Russian researchers are reportedly seeking approval for a single-dose version of the Sputnik V COVID-19 vaccine and are conducting clinical trials in Russia, the United Arab Emirates and Ghana. Read More

COVAX Will Hold Back 5 Percent of Vaccine Doses for Emergencies

March 24, 2021
The COVAX vaccine-sharing program will stockpile 5 percent of its vaccine doses for high-risk populations in humanitarian settings or for emergency outbreaks, said Gavi, the Vaccine Alliance, which operates the global program alongside the World Health Organization and the Coalition for Epidemic Preparedness Innovations. Read More

Regeneron/Roche COVID-19 Antibody Cocktail Cuts Hospitalizations and Deaths

March 24, 2021
Regeneron Pharmaceuticals’ and Roche’s antibody cocktail, REGEN-COV (casirivimab/imdevimab), reduced the risk of hospitalization or death by 70 percent in high-risk nonhospitalized COVID-19 patients in a late-stage trial, the companies have said. Read More

Pfizer Launches Phase 1 Trial for Oral COVID-19 Antiviral

March 24, 2021
Pfizer is conducting a U.S. phase 1 trial of an oral COVID-19 antiviral, PF-07321332, a protease inhibitor that can stop the virus from replicating. An oral drug would be much easier to administer than an intravenous formulation — a significant advantage during the pandemic. Read More

CDER’s Office of Compliance Reports on its Activities in 2020

March 24, 2021
The Center for Drug Evaluation and Research (CDER) highlights efforts to deal with drug shortages, sham COVID-19 products and poorly compounded drugs, as well as its enforcement successes amidst the pandemic, in its latest annual report from its Office of Compliance, released yesterday. Read More

AstraZeneca Rushes to Provide Updated Vaccine Data as NIH Raises Questions

March 24, 2021
In yet another setback for AstraZeneca, U.S. health officials raised concerns that the company included outdated information in its interim analysis of data from its U.S. phase 3 vaccine trial, prompting AZ to say it will release the results of its primary analysis by Thursday. Read More
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FDA Cautions Against Using Thermal-Imaging Devices for COVID-19 Detection

March 24, 2021
These systems have not been shown to be accurate when used to take the temperature of multiple people at the same time and should not be used for mass temperature screening, the FDA said. Read More
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LumiraDx Issues Software Update to Address False-Positive Issues with COVID-19 Test

March 24, 2021
The company said that approximately 1 percent of the test strips in 24 lots distributed in Europe have been affected by the manufacturing issue. Read More

Oramed, Premas Pursue Oral COVID-19 Vaccine Candidate

March 23, 2021
Oramed Pharmaceuticals has partnered with Premas Biotech to launch a joint venture, Oravax Medical, meant to develop the world’s first COVID-19 oral vaccine. Read More

EMA Joins FDA in Cautioning Against Use of Ivermectin for COVID-19

March 23, 2021
The European Medicines Agency (EMA) has advised against the use of Merck’s anti-parasitic drug Stromectol (ivermectin) for the prevention and treatment of COVID-19. Read More

EU Could Start Withholding AstraZeneca Vaccine Shots From UK

March 23, 2021
As the EU’s COVID-19 vaccine supply woes intensify, the 27-member bloc is signaling it could make good on its threat to halt exports of vaccine doses to the UK as soon as this week. Read More

AZ Plans Emergency Use Filing Within Weeks Based on Positive U.S. Trial Data

March 23, 2021
AstraZeneca’s (AZ) COVID-19 vaccine clocked in at 79 percent efficacy in preventing symptomatic infection and fully shielded against severe disease and hospitalization in the company’s phase 3 U.S. trial, opening the door for an Emergency Use Authorization (EUA) filing with the FDA in a matter of weeks. Read More
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