TUCSON, Ariz., April 30, 2020 — Tucson-based Critical Path Institute (C-Path) today announced the appointment of two new members to its Board of Directors: James W. Newman, CPA, former Executive Chairman of Victory Pharma, Inc. and Tomas Salmonson, Ph.D., M.Sc., former Chair of the Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA).
VLA15 is the only active Lyme disease vaccine program in clinical development today, and covers six serotypes that are prevalent in North America and Europe. The investigational multivalent protein subunit vaccine, VLA15, targets the outer surface protein A (OspA) of Borrelia, an established mechanism of action for a Lyme disease vaccine. OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick.Continue reading
On April 29, 2020, Daniel O’Day, Chairman & CEO, Gilead Sciences shared an Open Letter following the official press release containing data on Remdesivir and COVID-19.
“The results from the global, placebo-controlled trial run by the National Institute of Allergy and Infectious Diseases (NIAID) are positive. They show that patients with COVID-19 who received remdesivir recovered faster than similar patients who received placebo” O’Day writes. “There is still more work to do and remdesivir has not been approved, but all of us at Gilead are humbled by what these promising results might mean for patients. After years of research and hard work on remdesivir, there is relief and gratitude among our teams today that their efforts have been so worthwhile.”
Study Demonstrates Similar Efficacy with 5- and 10-Day Dosing Durations of RemdesivirContinue reading
Dr. Theresa Cullen is the new Pima County Public Health Director, effective June 1. Dr. Cullen has had a distinguished career as a public health physician, including retiring as a Public Health Service Officer from the federal government with the rank of Rear Admiral and Assistant U.S. Surgeon General.
PHOENIX — Governor Doug Ducey today announced an extension of physical distancing measures while laying out a step-by-step approach to continue reenergizing Arizona’s economy. The Governor today issued an Executive Order extending Arizona’s Stay Home, Stay Healthy, Stay Connected Order until May 15, 2020.
The order also continues Arizona’s gradual economic reopening, allowing retail businesses to begin partial operations starting next week. Under the order, retail businesses currently not operating can begin curbside pick-up on Monday, May 4, followed by expanded in-person operations on Friday, May 8 as long as they implement social distancing and sanitation measures established by the United States Department of Labor or the Arizona Department of Health Services.Continue reading
Recommendations provided for sponsors and eCOA providers to facilitate the continued collection of PRO data in clinical trials.Continue reading
- NIH mobilizes national innovation initiative for COVID-19 diagnostics
- Initiative aims to speed delivery of accurate, easy-to-use, scalable tests to all Americans.
- With a $1.5 billion investment from federal stimulus funding, the newly launched Rapid Acceleration of Diagnostics (RADx) initiative will infuse funding into early innovative technologies to speed development of rapid and widely accessible COVID-19 testing
- NIH is urging all scientists and inventors with a rapid testing technology to compete in a national COVID-19 testing challenge for a share of up to $500 million over all phases of development.
TUCSON, Ariz., April 28, 2020 — The Critical Path Institute (C-Path) today announced that its Type 1 Diabetes (T1D) Consortium has received a letter of support from the European Medicines Agency (EMA) to facilitate the development and validation of the proposed regulatory qualification of pancreatic islet autoantibodies commonly used in clinical practice to diagnose T1D: insulin autoantibodies, glutamic acid decarboxylase 65, and insulinoma antigen-2 autoantibodies as enrichment biomarkers for T1D clinical trials.Continue reading