Recommendations provided for sponsors and eCOA providers to facilitate the continued collection of PRO data in clinical trials.Continue reading
Category Archives: AZBio News
NIH launches the Rapid Acceleration of Diagnostics (RADx) Initiative.
- 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.
C-Path Receives Letter of Support from EMA on Type 1 Diabetes Biomarker Initiative
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
Moderna Announces IND Submitted to U.S. FDA for Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
- 600 participant Phase 2 study to begin upon IND acceptance and safety data from ongoing NIH-led Phase 1 study
- Planning underway for Phase 3 study; study expected to begin in the fall of 2020
Sonora Quest Laboratories Now Offering COVID-19 Antibody Testing in Arizona
TEMPE, Ariz. (April 24, 2020) – Sonora Quest Laboratories, the market share leader in diagnostic laboratory testing in Arizona, announced today that it will ramp up its fight against COVID-19 and offer antibody testing for coronavirus (COVID-19) using blood specimens. With this new offering, Sonora Quest now provides healthcare providers in Arizona access to a COVID-19 antibody test as well as the molecular diagnostic testing that has been offered since mid-March.Continue reading
Banner Health urges former COVID-19 patients to donate plasma for current patients
Banner Research provides Donation Coordinators to assist potential donors
PHOENIX (April 24, 2020) – With the need for “convalescent plasma” to treat critically ill COVID-19 patients ramping up as cases rise, Banner Research is providing donation coordinators in metro Phoenix, Tucson and Northern Colorado to help recovered COVID-19 patients get through the plasma donation process. The donation coordinators are equipped to assess qualifying criteria for potential donors, answer questions and explain how the donation process works.Continue reading
Johnson & Johnson Announces Collaboration to Expand Manufacturing Capabilities For its COVID-19 Vaccine Candidate in Support of the Company’s Goal to Supply More Than One Billion Vaccine Doses Globally
Company Signs Agreement with Emergent BioSolutions in the U.S. As Part of its Investment
First in Series of Anticipated Strategic Collaborations Designed to Further the Company’s Goal of Ensuring Global Supply of a Safe and Effective Vaccine for COVID-19Continue reading
Pathogen and Microbiome Institute at NAU to test the antiviral activity of 2X-121, a Danish Company’s PARP inhibitor, against Coronavirus
Hørsholm, Denmark (April 22nd, 2020) – Oncology Venture A/S (“OV” or the Company) today announced that it has entered into an agreement with the Pathogen and Microbiome Institute at Northern Arizona University (NAU) to test the antiviral activity of 2X-121, its PARP inhibitor, against Coronavirus.Continue reading
Caris Life Sciences Launches Whole Exome Sequencing with MI Exome
The most comprehensive suite of molecular testing in the industry includes a new whole exome sequencing (DNA) assay complementing the Company’s breakthrough whole transcriptome sequencing (RNA) performed on every patient Continue reading