Category Archives: AZBio News

C-Path’s PSTC, D-RSC Receive Positive FDA Response for Drug-Induced Skeletal Muscle Injury Biomarkers

Posted on by

Safety biomarkers aim to provide an additional tool for detecting acute drug-induced skeletal muscle injury in phase 1 clinical trials.

TUCSON, Ariz., July 22, 2020 — Critical Path Institute (C-Path) announced today that the Biomarker Qualification Program (BQP) at the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration (FDA) issued a positive response to the Letter of Intent (LOI) developed by C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC), for a panel of four safety biomarkers of acute drug-induced skeletal muscle injury.

Continue reading→

C-Path’s PSTC, D-RSC Receive Positive FDA Response to Plan for Liver Safety Biomarker

Posted on by

Biomarker aims to provide an additional tool for detecting the onset of hepatic injury in clinical trials involving patients with inherited muscle disorders.

TUCSON, Ariz., July 21, 2020 — Critical Path Institute (C-Path) announced today that the Biomarker Qualification Program (BQP) at the Center for Drug Evaluation and Research (CDER) from the U.S. Food and Drug Administration (FDA) issued a positive response to the Qualification Plan (QP) for glutamate dehydrogenase (GLDH) as a safety biomarker for drug-induced liver injury (DILI), developed by C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC).

Continue reading→

Patients, Employers, Labs and Health Insurance Providers Call on Congress to Dedicate Funding for COVID-19 Testing to Get America Back to Work and School

Posted on by

WASHINGTON, D.C. – The National Consumers League, the American Clinical Laboratory Association (ACLA) and America’s Health Insurance Plans (AHIP) joined nearly 50 leading stakeholders representing patients, employers, clinical laboratories, health insurance providers and other leaders from across health care community yesterday in sending a letter to congressional leadership requesting dedicated federal funding for the critical testing needed to reopen the country.Continue reading→

Pfizer and BioNTech Announce Agreement with U.S. Government for up to 600 Million doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

Posted on by

U.S. government placed an initial order of 100 million doses for $1.95 billion and can acquire up to 500 million additional doses
Americans to receive the vaccine for free consistent with U.S. government’s commitment for free access for COVID-19 vaccines
Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021Continue reading→

AZBio Releases RFP To Engage a Fundraising Consultant for AZAdvances

Posted on by

The Arizona Bioindustry Association, Inc. (AZBio) is issuing this Request for Proposals (RFP) to qualified firms to provide fundraising services to support the capitalization of the Arizona endowment within AZAdvances (www.azadvances.org).  AZAdvances is a division of the Opportunity Through Entrepreneurship Foundation, a 501c3 public charity with offices at 107 S Southgate Drive, Chandler, AZ 85226.Continue reading→

Novartis launches first-of-its-kind not-for-profit portfolio of medicines for symptomatic treatment of COVID-19

Posted on by
  • Portfolio of 15 generic and over-the-counter (OTC) medicines from Sandoz division addresses urgent unmet needs of low- and lower-middle-income countries to treat patients with COVID-19 symptoms
  • Portfolio will be sold at zero-profit to governments in up to 791 eligible countries during the pandemic and until a vaccine or curative treatment is available
  • Early access to treatment for managing  COVID-19 symptoms is critical to preventing healthcare system overload

Continue reading→