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Home » Topics » COVID-19

COVID-19
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Pfizer, BioNTech Seek Authorization for COVID-19 Vaccinations in Teens

April 12, 2021
Pfizer and BioNTech have requested a revised Emergency Use Authorization for their COVID-19 vaccine, allowing its use in adolescents 12 to 15 years old. Read More

EMA Expands AstraZeneca Safety Probe After Reports of Rare Disorder

April 12, 2021
In more bad news for AstraZeneca, the European Medicines Agency (EMA) announced that its safety committee is investigating reports of capillary leak syndrome, a rare, potentially life-threatening disorder, in individuals inoculated with the company’s COVID-19 vaccine. Read More

White House Official: Emergent’s Bayview Facility Could Be Authorized This Month

April 12, 2021
Emergent BioSolutions’ beleaguered Baltimore, Md., facility, which Johnson & Johnson has taken over to exclusively produce its vaccine, may be cleared to start shipping out J&J doses before the month is over, according to the White House’s COVID-19 response leader. Read More

Eli Lilly’s and Incyte’s Olumiant Fails in Late-Stage COVID-19 Trial

April 9, 2021
Eli Lilly’s and Incyte’s Janus kinase (JAK) inhibitor Olumiant (baricitinib) proved unable to significantly reduce progression to noninvasive ventilation for COVID-19 patients in a phase 3 trial, though the drug still managed to significantly reduce the risk of death. Read More

NIH Launches Phase 2 Study of Allergic Reactions to Moderna and Pfizer/BioNTech Vaccines

April 8, 2021
The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has begun a phase 2 study to evaluate the risk of allergic reactions to the Moderna and Pfizer/BioNTech COVID-19 vaccines in patients who are severely allergic or have a mast-cell disorder. Read More

EMA Links AstraZeneca Vaccine to Rare Blood Clots

April 8, 2021
The European Medicines Agency (EMA) announced yesterday that AstraZeneca should include the risk of very rare blood clots on the list of possible side effects of its COVID-19 vaccine — and a UK vaccines advisory committee said it would be “preferable” not to give the vaccine to individuals under age 30. Read More
Takeda

Takeda Halts Development on COVID-19 Plasma Therapy

April 8, 2021
The phase 3 study enrolled nearly 600 adult participants across 63 sites in the U.S. and 10 additional countries. Read More

Army Begins Testing of COVID-19 Vaccine Targeting Variants

April 7, 2021
The U.S. Army this week began phase 1 testing of a COVID-19 vaccine it developed, which is aimed at protecting against many coronavirus variants. Read More

Catalent to Boost U.S. Production of Moderna’s Covid-19 Vaccine

April 7, 2021
Moderna has expanded its existing agreement with Catalent to boost COVID-19 vaccine production at Catalent’s fill-and-finish facility in Bloomington, Ind., to supply the U.S. market. Read More

Oxford Pauses Trial Assessing AstraZeneca COVID-19 Vaccine in Children

April 7, 2021
The University of Oxford said it has paused a trial evaluating its COVID-19 vaccine co-developed with AstraZeneca in children and teenagers while it awaits additional information on the risk of blood clots from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Read More
emergency use authorization approved

FDA Grants Emergency Clearance for Symbiotica’s COVID-19 Antibody Test

April 7, 2021
The test is meant to help identify patients who have generated an immune response to SARS-CoV-2, which indicates they have previously been infected. Read More

FDA Issues Guidance on Generic Development and Submissions During Pandemic

April 6, 2021
The FDA released Q&A guidance yesterday on bioequivalence (BE) studies for generic drugs and abbreviated new drug application (ANDA) submissions during the COVID-19 pandemic. Read More
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