Patient Safety

Second Analysis Finds Moderna’s COVID-19 Vaccine 94.1% Effective

by Samantha McGrail

Moderna recently announced that a second primary analysis of its COVID-19 vaccine candidate, mRNA-1273, found a 94.1 percent vaccine efficiency against the coronavirus.  The Phase 3 study, COVE,...

FDA Grants Emergency Use to Regeneron’s COVID-19 Antibody Cocktail

by Samantha McGrail

FDA recently issued an emergency use authorization to Regeneron for its COVID-19 antibody cocktail, formerly known as REGN-COV2.  The cocktail is made up of casirivimab and imdevimab. The...

J&J Launches Second Global Trial of Lead COVID-19 Vaccine

by Samantha McGrail

Johnson & Johnson recently initiated a second global Phase 3 clinical trial of its lead COVID-19 vaccine candidate, Ad26.COV2.S. The trial, ENSEMBLE 2, is a pivotal, large-scale, Phase 3 trial...

Pfizer’s COVID-19 Vaccine Is Actually 95% Effective, New Data Shows

by Samantha McGrail

Pfizer and BioNTech recently announced that they concluded their Phase 3 clinical trial after their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy...

FDA Releases Guidance to Encourage Clinical Trial Diversity

by Samantha McGrail

FDA recently issued final guidance to encourage clinical trial diversity from the design to execution of the tests.  The guidance, Enhancing the Diversity of Clinical Trial...

GSK, Medicago Start Phase 2 Trial of Adjuvanted COVID-19 Vaccine

by Samantha McGrail

GSK and biopharmaceutical company Medicago recently announced the start of Phase 2/3 clinical trials of its adjuvanted COVID-19 vaccine candidate. The Coronavirus-Like Particle COVID-19 Vaccine...

Early Analysis Finds Moderna’s COVID-19 Vaccine Is 95% Effective

by Samantha McGrail

Moderna recently announced that its mRNA COVID-19 vaccine candidate proved 95 percent effective in a Phase 3 clinical trial.  The candidate, mRNA-1273, met statistical criteria pre-specified in...

Humanigen, DoD to Develop COVID-19 Antibody Treatment

by Samantha McGrail

Humanigen and the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense recently entered into a Cooperative Research and Development...

Merck Signs $2.75B Pharma Acquisition Deal with VelosBio

by Samantha McGrail

Merck recently signed a $2.75 billion pharmaceutical acquisition deal to purchase all outstanding shares of VelosBio, subject to certain customary adjustments. Clinical-stage biopharmaceutical...

Pfizer’s COVID-19 Vaccine Is Over 90% Effective, Early Data Shows

by Samantha McGrail

Pfizer and BioNTech recently announced that their mRNA-based COVID-19 vaccine candidate, BNT162b2, demonstrated evidence of efficacy against coronavirus in participants without prior evidence of...

Novartis to Develop Direct-Acting COVID-19 Antiviral Therapies

by Samantha McGrail

Novartis and Molecular Partners AG recently announced a collaboration in the form of an option and license agreement to develop, manufacture, and commercialize Molecular Partners’ anti-COVID-19...

AstraZeneca Resumes Phase 3 US Trial for its COVID-19 Vaccine

by Samantha McGrail

AstraZeneca recently announced that the Phase 3 clinical trial for its COVID-19 vaccine, AZD122, has resumed in the US after FDA deemed it safe to do so.  All clinical trials for AZD122 have now...

Johnson & Johnson Resumes Phase 3 Trial of COVID-19 Vaccine

by Samantha McGrail

Johnson & Johnson recently announced that it will resume recruitment in the Phase 3 ENSEMBLE trial of its COVID-19 vaccine, Ad26.COV2-S, after the independent Data Safety and Monitoring Board...

FDA Approves Remdesivir as the First COVID-19 Treatment

by Samantha McGrail

FDA recently approved Verklury as the first COVID-19 treatment. The approval signs off on using the drug also known as remdesivir has been signed in adults and pediatric patients 12 years of age or...

CRISPR’s CAR-T Cell Therapy Shows Promise in Clinical Trial

by Samantha McGrail

CRISPR Therapeutics, recently announced positive top-line results from its ongoing Phase 1 clinical trial evaluating the safety and efficacy of its allogeneic CAR-T cell therapy that targets...

Sanofi’s mRNA COVID-19 Vaccine Elicits High Antibody Levels

by Samantha McGrail

Sanofi and Translate Bio recently announced positive preclinical results for their mRNA-based COVID-19 vaccine candidate in mice. Specifically, the candidate called MRT5500 induced "potent"...

Roche Developing High-Volume COVID-19 Antigen Testing Product

by Samantha McGrail

Roche recently announced that it will launch a new high-volume COVID-19 antigen test, which will be made available at the end of 2020 for markets accepting the CE Mark. The Elecsys SARS-CoV-2 Antigen...

AstraZeneca’s COVID-19 Antibody Advances into Phase 3 Trials

by Samantha McGrail

AstraZeneca recently announced that its long-acting COVID-19 antibody combination will advance into two Phase 3 clinical trials at sites in and outside the US. The first trial will evaluate the safety...

Bristol Myers Squibb’s MS Drug Helps Ulcerative Colitis Patients

by Samantha McGrail

Bristol Myers Squibb recently announced results from a pivotal, placebo-controlled Phase 3 clinical trial evaluating its MS drug, Zeposia (ozanimod), in patients with ulcerative colitis...

Eli Lilly Announces Supply Deal for COVID-19 Antibody Therapies

by Samantha McGrail

Eli Lilly and Company and the Bill & Melinda Gates Foundation recently entered into an agreement to facilitate access to future COVID-19 antibody therapies in low-and middle-income...