Research & Evidence

Bristol Myers Squibb Reinforces Efficacy of MS Drug, Zeposia

by Samantha McGrail

Bristol Myers Squibb recently announced interim results from a Phase 3 open-label extension trial, which showed the long-term efficacy and safety profile of Zeposia in patients with relapsing forms of...

FDA Approves Eli Lilly and Company’s Breast Cancer Treatment

by Samantha McGrail

FDA recently approved Eli Lilly and Company’s Verzenio to treat adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), early breast...

Cerner Leverages Real-World Evidence to Advance Therapies

by Samantha McGrail

Cerner recently launched a new operating unit, Cerner Enviza, that offers data-driven solutions and research services to clarify multi-dimensional data through real-world evidence and...

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...

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...

WHO Recommends Broad Roll-Out of GSK’s Malaria Vaccine For Children

by Samantha McGrail

GSK recently welcomed the World Health Organization’s (WHO) recommendation for the broader development of GSK’s RTS, S malaria vaccine to reduce childhood illness and deaths from malaria in...

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...

J&J’s Chief Scientific Officer Paul Stoffels Announces Retirement

by Samantha McGrail

Johnson & Johnson recently announced that Paul Stoffels, MD, current vice-chairman of the executive committee and chief scientific officer of Johnson & Johnson, will retire at the end of...

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...

AstraZeneca Invests in VaxEquity for saRNA Therapeutics Platform

by Samantha McGrail

AstraZeneca and VaxEquity recently collaborated to discover, develop, and commercialize a self-amplifying RNA (saRNA) therapeutics platform.  The long-term research collaboration aims to optimize...

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...

Thermo Fisher Launches System to Scale Gene Therapy Workflows

by Samantha McGrail

Thermo Fisher Scientific recently launched the integrated Gibco AAV-MAX Helper Free AAV Production System to enable scalable gene therapy workflows. The solution aims to simplify AAV vector production...

AbbVie Helps to Advance Gene Therapy for Chronic Retinal Diseases

by Samantha McGrail

AbbVie and Regenxbio recently partnered to develop and commercialize RGX-314, a potential one-time gene therapy to treat various chronic retinal diseases.  Researchers are currently evaluating...

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,...