Eli Lilly and Company, AbCellera Biologics, Amgen, AstraZeneca, Genentech, and GlaxoSmithKline recieved approval from DOJ on July 23, 2020 to share information about manufacturing facilities and other information that could enable them to expedite the production of monoclonal antibody treatments that are determined to be safe and effective to treat COVID-19.
Phoenix-based biomedical innovator holds numerous patents and trademarks in the rapidly growing aesthetics industry
“Decathlon’s investment allows us to deliver these ground-breaking aesthetic treatments and products to providers and consumers and continue to build the most innovative solutions in the marketplace.”Continue reading
Calls for at least $75 billion in additional funding and the CDC to lead with testing protocols
Commits $100 Million in Rockefeller Foundation Funding for Global Coronavirus ResponseContinue reading
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.
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).
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Ashison Analytics GEMExTra test detects rare NRG1 gene fusions in patients whose cancer is driven by this genomic alteration for potential matching to a clinical trialContinue reading
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
Equine Amnio Solutions, LLC (EAS), a distributor of advanced, next-generation regenerative products derived from amniotic birth tissues, announced today first results from a large field study of RenoVō® for soft tissue and orthopedic horse injuries.
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