Patient Outcomes

Two Doses of Moderna’s COVID-19 Vaccine Effective in Children

by Samantha McGrail

Moderna recently announced that two doses of its COVID-19 vaccine showed a robust neutralizing antibody response in children six to under 12 years of age.  The Phase 2/3 KidCOVE randomized...

Pfizer, BioNTech COVID-19 Vaccine Booster Dose 95.6% Effective

by Samantha McGrail

Pfizer and BioNTech recently announced that their COVID-19 vaccine booster was 95.6 percent effective in individuals compared to placebo.    The randomized, controlled Phase 3 trial...

CDC Unanimously Recommends J&J, Moderna COVID-19 Vaccine Booster

by Samantha McGrail

CDC recently recommended Johnson & Johnson and Moderna’s COVID-19 vaccine booster shots for all eligible individuals who receive any FDA authorized vaccine.  The organization...

FDA Authorizes Moderna, J&J Booster COVID-19 Vaccine Dose

by Samantha McGrail

FDA recently granted emergency use authorization to both the Moderna and Johnson & Johnson respective COVID-19 vaccine booster doses.  The agency specifically approved Moderna’s booster...

FDA Approves First Treatment for Rare Disease Congenital Athymia

by Samantha McGrail

FDA recently approved Rethymic to treat pediatric patients with rare disease congenital athymia.  Congenital athymia is a rare immune disorder in which a child is born without a thymus. The...

FDA Recommends Booster Dose of Moderna’s COVID-19 Vaccine

by Samantha McGrail

FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recently recommended a booster dose of Moderna’s COVID-19 vaccine, mRNA-1273, at the 50 microgram...

FDA Recommends Authorization For J&J’s COVID-19 Vaccine Booster

by Samantha McGrail

FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recently recommended emergency use authorization for a booster dose of Johnson & Johnson’s COVID-19 vaccine. VRBPAC...

AstraZeneca’s COVID-19 Antibody Prevents and Treats COVID-19

by Samantha McGrail

AstraZeneca recently announced that its COVID-19 antibody, AZD7442, reduced severe COVID-19 or death compared to placebo in non-hospitalized patients with mild-to-moderate symptomatic...

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...

FDA Approves Kite’s CAR T-Cell Therapy For Leukemia

by Samantha McGrail

FDA recently approved Kite’s chimeric antigen receptor (CAR) T-cell therapy, Tecartus, to treat adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia...

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...

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...

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...

Improving Adult Vaccination Rates, Health Outcomes Globally

by Samantha McGrail

Nearly 44 percent of adults ranked staying up to date on vaccines as important before the COVID-19 pandemic, rising to 65 percent after the pandemic, according to a new survey by Kantar on behalf of...

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...

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...

Merck’s Pneumococcal Vaccine Meets Key Endpoints in Phase 3 Trial

by Samantha McGrail

Merck recently announced that its pneumococcal 15-valent conjugate vaccine, Vaxneuvance, met key immunogenicity and safety endpoints in a Phase 3 clinical trial.  The PNEU-PED study enrolled...

Novartis’ Diabetic Macular Edema Drug Successful in 2 Trials

by Samantha McGrail

Novartis recently announced that two Phase 2 clinical trials assessing its diabetic macular edema drug, Beovu, demonstrated overall well-tolerated safety profiles. The global, randomized Kite and...

CMS Rule Allows Payers to Negotiate Prescription Drug Pricing

by Jessica Kent

CMS has issued a final rule allowing payers to negotiate prescription drug pricing based on how well these drugs work for patients, a policy that could reduce overall healthcare spending and...