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Home » Topics » COVID-19

COVID-19
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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In yet another setback for AstraZeneca, U.S. health officials raised concerns that the company included outdated information in its interim analysis of data from its U.S. phase 3 vaccine trial, prompting AZ to say it will release the results of its primary analysis by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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FDA Authorizes First COVID-19 Biomarker Screening Device

March 23, 2021
The monitor is not intended to substitute for a COVID-19 diagnostic and shouldn’t be used in patients who show symptoms, the FDA said. Read More

Russia, Stelis Biopharma Team Up to Make 200 Million Doses of Sputnik V

March 22, 2021
The Russian Direct Investment Fund (RDIF) and Indian contract manufacturer Stelis Biopharma have partnered to produce 200 million doses of the Sputnik V COVID-19 vaccine. Read More

HHS Delays Review of FDA Regulations to Focus on COVID-19 Relief

March 22, 2021
HHS is postponing implementation of a final rule issued late in the Trump administration that would have required the FDA to review practically every regulation it has and redirect resources away from pandemic relief efforts. Read More

FDA Warns of Misleading Registration Certificates for COVID-19 Devices

March 22, 2021
The FDA’s Office or Regulatory Programs has sent letters to 25 manufacturers, distributors and sellers telling them to stop producing and issuing these certificates. Read More
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MicrosensDx Receives CE Mark for Coronavirus Test

March 22, 2021
It can be also used to detect other pathogens, including norovirus, respiratory syncytial virus and influenza. Read More
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