Clinical Trials

J&J’s Early-Stage Compound Shows Promise Against Dengue Virus

by Samantha McGrail

Janssen Pharmaceutical Companies of Johnson & Johnson recently announced that an early-stage compound with a novel mechanism of action could potentially treat all dengue virus...

AstraZeneca Acquires Caelum Biosciences For Rare Disease Antibody

by Samantha McGrail

AstraZeneca’s Alexion will fully acquire the remaining equity in Caelum Biosciences for the company’s first-in-class fibril-reactive monoclonal antibody (mAb) to treat rare disease light...

J&J Submits Data to FDA to Support COVID-19 Vaccine Booster

by Samantha McGrail

Johnson & Johnson recently submitted data to the FDA to support its COVID-19 vaccine booster shot in adults 18 and older. The submission includes results from the Phase 3 ENSEMBLE study, which...

Johnson & Johnson Launches Phase 3 Trial of RSV Vaccine in Adults

by Samantha McGrail

Johnson & Johnson recently initiated a Phase 3 clinical trial to study its RSV vaccine's efficacy, safety, and immunogenicity against lower respiratory tract disease (LRTD) in adults. The...

AstraZeneca Requests FDA EUA for COVID-19 Antibody Combination

by Samantha McGrail

AstraZeneca recently submitted a request to FDA for an emergency use authorization for its long-acting COVID-19 antibody combination, AZD7442. AstraZeneca optimized AZD7442 using its YTE half-life...

J&J’s Xarelto Evokes Fewer Blood Clots in Patients Than Aspirin

by Samantha McGrail

Johnson & Johnson recently announced that Xarelto elicited fewer blood clots and clinical events strongly associated with blood clots in pediatric patients compared to treatment with aspirin. The...

Regeneron’s COVID-19 Antibody Cocktail Helps Hospitalized Patients

by Samantha McGrail

Regeneron recently announced that its COVID-19 antibody cocktail, REGEN-COV, significantly reduced viral load in patients hospitalized with the coronavirus. The trial enrolled 1,197 patients to...

Pfizer Submits Data to FDA For COVID-19 Vaccine in Children

by Samantha McGrail

Pfizer and BioNTech recently submitted data to FDA from the Phase 2/3 clinical trial of their COVID-19 vaccine in children five to 11 years of age.   Last week, the companies announced that...

FDA Approves Abbott’s Epic Plus for Aortic Valve Disease

by Samantha McGrail

FDA recently approved Abbott’s Epic Plus and Epic Plus Supra Stented Tissue Value to improve therapy options for individuals with mitral or aortic valve disease. The next-generation devices...

Pfizer Launches Trial of COVID-19 Treatment for Post-Exposure

by Samantha McGrail

Pfizer recently announced the start of a Phase 2/3 study to evaluate its COVID-19 treatment in combination with ritonavir to prevent coronavirus disease. The randomized, double-blind EPIC-PEP study...

Roche’s Tecentriq Benefits Non-Small Cell Lung Cancer Patients

by Samantha McGrail

Roche recently announced that Tecentriq elicited disease-free survival in patients with Stage II-IIA non-small cell lung cancer (NSCLC). Data from the IMpower010 trial, published in The Lancet, found...

SAS, UNC-Chapel Hill to Transform Antiviral Drug Development

by Samantha McGrail

SAS and the University of North Carolina at Chapel Hill (UNC-Chapel Hill) recently partnered to transform the antiviral drug development process and prevent infectious disease threats from turning into...

FDA Authorizes Booster Dose of Pfizer, BioNTech COVID-19 Vaccine

by Samantha McGrail

FDA recently amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow for a single booster dose six months after completing the primary series.  In December 2020,...

Second Dose of J&J’s COVID-19 Vaccine 94% Effective

by Samantha McGrail

Johnson & Johnson recently announced that a booster shot of its COVID-19 vaccine elicited 94 percent protection against coronavirus in a Phase 3 clinical trial.  The largest real-world...

J&J’s Ebola Vaccine Generates Robust Antibody Responses

by Samantha McGrail

Johnson & Johnson recently announced that its Ebola vaccine regimen, Zabdeno and Mvabea, generated robust antibody immune responses in children and adults.  The Phase 3 EBOVAC-Salone clinical...

FDA Grants Breakthrough Designation for Eli Lilly’s Diabetes Drug

by Samantha McGrail

FDA recently granted Breakthrough Designation for Eli Lilly & Company and Boehringer Ingelheim’s diabetes drug, Jardiance, as an investigational treatment for adults with heart failure with...

Pfizer, BioNTech COVID-19 Vaccine Effective in Pediatric Patients

by Samantha McGrail

Pfizer and BioNTech recently announced that two doses of their COVID-19 vaccine elicited neutralizing antibody responses in pediatric patients in a Phase 2/3 clinical trial.   In the trial,...

Resilience to Manufacture mRNA for Moderna’s COVID-19 Vaccine

by Samantha McGrail

National Resilience recently entered into a multi-year agreement with Moderna to manufacture drug substance mRNA for its COVID-19 vaccine.  Resilience is a manufacturing and technology company...

FDA Accepts Novartis BLA for Monoclonal Antibody in ESCC

by Samantha McGrail

FDA recently accepted Novartis’ Biologics License Application for its anti-PD-1 immune monoclonal antibody, tislelizumab, to treat unresectable recurrent locally advanced metastatic esophageal...

Pfizer Initiates Phase 3 Clinical Trial of RSV Vaccine in Adults

by Samantha McGrail

Pfizer recently initiated a Phase 3 clinical trial evaluating the efficacy, immunogenicity, and safety of a single dose of its respiratory syncytial virus (RSV) vaccine candidate in adults. The...