Coronavirus

FDA Broadens Authorization for Eli Lilly’s COVID-19 Treatment

by Samantha McGrail

FDA recently broadened the emergency use authorization for Eli Lilly and Company’s COVID-19 treatment, baricitinib, to allow for treatment without remdesivir. Under the new authorization,...

FDA Expands Authorization of Regeneron’s COVID-19 Antibody Cocktail

by Samantha McGrail

FDA recently updated the emergency use authorization for Regeneron’s investigational COVID-19 antibody cocktail, REGEN-COV.  The authorization now includes post-exposure prophylaxis in...

UIC Awarded $6M to Test COVID-19 Drug Candidate For Lung Damage

by Samantha McGrail

The Department of Defense (DoD) recently awarded a $6 million technology and therapeutic development award to the University of Illinois (UIC) to test a COVID-19 drug candidate.  UIC will use the...

AstraZeneca’s COVID-19 Vaccine 82% Effective Against Variants

by Samantha McGrail

AstraZeneca recently announced that its COVID-19 vaccine, Vaxzevria, was 82 percent effective against hospitalization or death caused by the Beta/Gamma SARS-CoV-2 variants.  The results,...

J&J COVID-19 Vaccine Elicits Antibody Responses Against Variants

by Samantha McGrail

Johnson & Johnson recently announced that its COVID-19 vaccine elicited strong antibody and T-cell immune responses as long as eight months after vaccination. The results, published in the New...

FDA Authorizes Ortho Clinical’s COVID-19 Antibody Test

by Samantha McGrail

FDA recently granted emergency use authorization to Ortho Clinical Diagnostics’ COVID-19 antibody test for use as an aid in identifying individuals with adaptive immune responses to the...

Gavi Signs Agreement for Sinopharm, Sinovac COVID-19 Vaccine Doses

by Samantha McGrail

Gavi recently signed an advance purchased agreement with Sinopharm and Sinovac for their respective COVID-19 vaccines. The purchase agreements for Sinopharm’s “BBIBP-CorV” and...

FDA Updates J&J COVID-19 Vaccine Label to Include Rare Disorder

by Samantha McGrail

FDA recently updated the label on Johnson & Johnson’s COVID-19 vaccine to warn of the possible side effect of Guillain-Barre syndrome, according to multiple news outlets.  Of the 100...

Improving Health Equity Across the Pharmaceutical Industry

by Samantha McGrail

Health equity is crucial to ensuring access for all individuals to essential care. And pharmaceutical and biotechnology companies are pushing for necessary long-term changes to better meet the needs of...

J&J COVID-19 Vaccine Neutralizes Activity Against Delta Variant

by Samantha McGrail

Johnson & Johnson recently announced that a single shot of its COVID-19 vaccine generated robust and persistent activity against the SARS-CoV-2 Delta variant and other prevalent viral...

FDA Approves Key Component for Common Childhood Cancer Treatment

by Samantha McGrail

FDA recently approved Jazz Pharmaceutical’s Rylaze as a component of a chemotherapy regimen to treat the most common childhood cancer Specifically, Rylaze was approved to treat lymphoblastic...

Moderna’s COVID-19 Vaccine Elicits Activity Against All Variants

by Samantha McGrail

Moderna recently announced that its COVID-19 vaccine produced neutralizing titers against all coronavirus variants tested in a Phase 1 clinical trial.  Specifically, Moderna COVID-19 Vaccine...

US Pauses All Distribution of Eli Lilly’s COVID-19 Antibody

by Samantha McGrail

The Assistant Secretary for Preparedness and Response (ASPR) recently paused all distribution of Eli Lilly and Company’s COVID-19 antibody treatment. CDC identified that the combined frequencies...

FDA Gives EUA for Genentech’s Actemra for COVID-19 Hospitalizations

by Kyle Murphy, PhD

Genentech’s COVID-19 drug therapy Actemra (tocilizumab) is the latest to receive an emergency use authorization, FDA announced Thursday. The EUA makes the drug available to treat hospitalized...

Health Officials Say Myocarditis After COVID-19 Vaccination “Rare”

by Samantha McGrail

Federal health officials recently added new clinical guidance on the potential for myocarditis after COVID-19 vaccination for adolescents and young adults.  The statement, signed by the leaders...

Gilead’s Remdesivir Lowers Risk of Mortality in COVID-19 Patients

by Samantha McGrail

Gilead recently announced that its COVID-19 treatment, remdesivir, lowered the risk for mortality compared with matched controls in patients hospitalized with the virus. The three real-world data...

Biden Invests Over $3B to Boost COVID-19 Antiviral Development

by Samantha McGrail

The Biden Administration will invest over $3 billion to accelerate the discovery, development, and manufacturing of COVID-19 antiviral medicines. The initiative, called the Antiviral Program for...

Thermo Fisher Uses Next-Generation Sequencing to ID COVID Variants

by Samantha McGrail

Thermo Fisher Scientific recently launched the Ion AmpliSeq SARS-CoV-2 Insight Research Assay to improve surveillance and identification of new and known COVID-19 variants from samples with lower viral...

Pfizer’s Drug Helps COVID-19 Patients Hospitalized with Pneumonia

by Samantha McGrail

New data showed that Pfizer’s tofacitinib elicited a lower cumulative incidence of death or respiratory failure through day 28 compared to placebo in COVID-19 patients hospitalized with...

Regeneron’s COVID-19 Antibody Cocktail Reduces Death by 20%

by Samantha McGrail

Regeneron recently announced that its COVID-19 antibody cocktail, REGEN-COV, reduced risk of death by 20 percent in patients hospitalized with COVID-19 who had not mounted their own immune...