Remove Clinical Research Remove FDA Approval Remove Hospitals Remove Trials
article thumbnail

Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine

The Pharma Data

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 37% of trial volunteers are from racial and ethnic minorities.

article thumbnail

Janssen Announces U.S. FDA Approval of INVEGA HAFYERA™ (6-month paliperidone.

The Pharma Data

The FDA approval of INVEGA HAFYERA™ is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries. DFAPA, Medical Director at ATP Clinical Research and 6-month paliperidone palmitate clinical trial investigator. “For

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Who are the AACR Scientific Achievement Award winners?

Drug Discovery World

She is also a Professor of Pathology at the Johns Hopkins University School of Medicine, Co-director of the Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and Deputy Director of the Johns Hopkins Institute for Clinical and Translational Research.

article thumbnail

Lupus Foundation of America Sees Big Win with FDA Approval of Benlysta for Lupus Nephritis

The Pharma Data

Last year, GSK announced positive results from a two-year clinical trial involving several hundred people with active lupus nephritis treated with Benlysta. This is the most extensive controlled phase 3 study in active lupus nephritis, demonstrating that Benlysta could make a clinically meaningful improvement.

article thumbnail

Insights into cellular therapies for cancer treatment

Drug Target Review

There is more to come for CAR-T cell treatments, and I would expect that perhaps in five years, oncologists and hematologists may have to rethink how they approach their fields since clinical research is moving at lightning speed. To this end, last August we opened our Cancer Center at Lehigh Valley Hospital–Hazleton campus.

article thumbnail

Dupixent® demonstrates potential to become first biologic to treat COPD by showing significant reduction in exacerbations in pivotal trial 

The Pharma Data

COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid treatment and/or lead to hospitalization or even death. Smoking is a key risk factor for COPD, but even individuals who quit smoking can still develop the disease. In the U.S.

Trials 40
article thumbnail

ACTIV Update: Making Major Strides in COVID-19 Therapeutic Development

NIH Director's Blog: Drug Development

hospitals are stretched to the limit trying to help people battling serious cases of COVID-19. This improvement stems from several factors, including the FDA’s emergency use authorization (EUA) of a number of therapies found to be safe and effective for COVID-19. Credit: NIH Right now, many U.S.