WASHINGTON – Today, U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, requested information from stakeholders on ways to improve regulation of clinical tests in the United States. Continue reading
Category Archives: AZBio News
Chairs Rodgers and Guthrie Announce Health Subcommittee Hearing on Regulation of Diagnostic Tests
The Energy and Commerce Health Subcommittee will hold a hearing, “Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule” on Thursday, March 21 at 10:00 AM EDT.
The E&C hearing will be live streamed starting at 7 AM AZ/PDT via https://energycommerce.house.gov/Continue reading
U.S. FDA Approves Bristol Myers Squibb’s Breyanzi ® as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
PRINCETON, N.J.–Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). In R/R CLL or SLL, Breyanzi is delivered through a treatment process which culminates in a one-time infusion* with a single dose containing 90 to 110 x 106 CAR-positive viable T cells.Continue reading
The New England Journal of Medicine Publishes Cologuard Plus™ Test Results from Pivotal BLUE-C Study
Cologuard Plus is only noninvasive test to be evaluated head-to-head against an independent fecal immunochemical test, which it significantly outperformed
20,000-participant BLUE-C study included 98 colorectal cancers and reflects racial and ethnic diversity of U.S.
Company will host conference call and webcast at 8:00 a.m. ET on March 14 to discuss study resultsContinue reading
AdvaMed board chair Peter J. Arduini announces top priorities to guide the future of MedTech
WASHINGTON, D.C. – Today, AdvaMed, the Medtech Association, announced Board Chairman Peter Arduini’s priorities to guide the vision of the medtech industry over the course of his two-year term. The priorities, which are established by each new Board chair, come as AdvaMed, the leading trade association, renews its advocacy efforts in Washington and globally to address key issues impacting medtech companies and the providers and patients they serve.Continue reading
Arizonans travel to Washington with a Medtech Message
AZBio Team Members traveled to our nation’s capitol to meet with our Arizona Congressional Delegation and to share how current policies and proposed laws can help or hinder medtech innovation. Continue reading
City of Hope-developed chimeric antigen receptor (CAR) T cell therapy shows clinical activity in patients with aggressive brain tumors in a Phase 1 trial
- Half of the enrolled patients had stable disease for at least two months, two showed partial response and two experienced complete response
- Nature Medicine paper highlights delivery of CAR T cell therapy directly to the brain, a technique City of Hope developed
- This is the largest reported trial to date of CAR T therapy for solid tumors
Arizona Bioindustry Association opens office on Phoenix Bioscience Core at Connect Labs
The Phoenix Bioscience Core is excited to welcome the Arizona Bioindustry Association, Inc. (AZBio) to the PBC. Its new office in Connect Labs by Wexford Science + Technology expands on AZBio’s close relationship with the PBC and its community members. Continue reading
Reglagene Expands to Houston and Joins TMC’s Accelerator for Cancer Therapeutics
- Reglagene’s RGN6024 is on track to give new hope to provide orally administered therapy for brain cancer patients whose survival has historically been very low.
- Will speed development of RGN6024 therapy into the clinic
Exact Sciences Launches Riskguard™ hereditary cancer test in the United States
The Riskguard test detects genetic changes that can increase risk for 10 common cancers, using a simple blood or saliva sample
The test is covered by Medicare and many commercial insurance plans for eligible patientsContinue reading