Project builds on ‘One Health’ testing and disease surveillance collaborations in ArizonaContinue reading
Category Archives: AZBio News
First Patient Treated in Ivy Brain Tumor Center’s Phase 0 Clinical Trial of Pamiparib in Newly Diagnosed and Recurrent Glioblastoma
Study designed to rapidly assess drug’s ability to penetrate the blood-brain barrier in humansContinue reading
Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for targeted treatment with LORBRENA (lorlatinib)
- About 235,000 people in the US will be diagnosed with lung cancer in 2021, with non-small cell lung cancer (NSCLC) accounting for 84 percent of all lung cancers1
- ALK — anaplastic lymphoma kinase — is an important biomarker found in NSCLC, and targeted therapies have been shown to dramatically improve progression-free survival compared to the previous standard of care2,3,4
- The VENTANA ALK (D5F3) CDx Assay5 is now FDA approved as a companion diagnostic in four targeted treatments, providing more options to lung cancer patients
Castle Biosciences Launches DecisionDx-Melanoma Integrated Test Result Utilizing Artificial Intelligence to Predict Individualized Risk
Newly validated i31-GEP algorithm integrates DecisionDx-Melanoma continuous score with clinicopathologic factors designed to provide a more precise, personalized likelihood of sentinel lymph node positivity
C-Path Receives FDA Qualification for the Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C)
TUCSON, Ariz., March 9, 2021 — Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium announces the qualification of the Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C) by the U.S. Food and Drug Administration (FDA). The DIBSS-C was developed by the PRO Consortium’s Irritable Bowel Syndrome (IBS) Working Group to support symptom-based efficacy endpoints in clinical trials for products intended to treat constipation-predominant IBS (IBS-C) in adults. Qualification of the DIBSS-C represents a major milestone for the IBS Working Group and is the PRO Consortium’s fourth clinical outcome assessment (COA) to be qualified through the COA Qualification Program within FDA’s Center for Drug Evaluation and Research.Continue reading
NIH starting enrollment for third trial of blood clotting treatments for COVID-19
The National Institutes of Health has launched the last of three Phase 3 clinical trials to evaluate the safety and effectiveness of blood thinners to prevent life-threatening blood clots in adults diagnosed with COVID-19. The first patient in the trial was enrolled on February 15.
Arizona passes 2 million mark for COVID-19 vaccine doses administered
High-intensity state outreach brings COVID-19 campaign to underserved populations
PHOENIX — Arizona has administered its 2 millionth dose of COVID-19 vaccine as the state and local partners work to get the currently limited supply into arms as quickly as possible, including highly targeted efforts in underserved areas. Continue reading
Researchers at the Barrow Neurological Institute at Phoenix Children’s Hospital and the University of Utah Seek to Discover New Cerebral Palsy Genes
Datavant and the Cerebral Palsy Research Network Announce Partnership to Enable Investigation of Genetic Basis of Cerebral PalsyContinue reading
Jeffrey Kordower to lead ASU’s fight against neurodegenerative diseases
Arizona State University has announced the appointment of Jeffrey Kordower as the founding director of the ASU-Banner Neurodegenerative Disease Research Center and endowed chair as The Charlene and J. Orin Edson Distinguished Director at the Biodesign Institute.Continue reading
FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine
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Action Advances Fight Against COVID-19, Follows Comprehensive Evaluation of Available Safety, Effectiveness and Manufacturing Quality Information by FDA Career Scientists, Input from External Experts