Policy and Regulation: Page 3

Health Canada approves Pfizer’s hemophilia gene therapy
By LabPulse.com staff writers
Health Canada, Canada’s regulatory agency, has approved Pfizer's Beqvez (fidanacogene elaparvovec) as a gene therapy treatment for adults with moderately severe to severe hemophilia B.
January 3, 2024
Cell Gene Therapy Dna Social
CMS final rule settles controversial proposal
By Liz Carey
A year-end final rule from the Centers for Medicare and Medicaid Services (CMS) settled a contentious proposal to include nursing degrees in the qualifications for high-complexity testing personnel under CLIA of 1988 regulations.
January 4, 2024
Regulation Wheel Social
Regulators to examine Thermo Fisher acquisition of Olink
By LabPulse.com staff writers
Shares of proteomics firm Olink dropped approximately 3% last week following the disclosure by the company that the U.K.’s regulatory body will investigate its pending acquisition by Thermo Fisher.
December 27, 2023
Regulation Wheel Social
FDA approves test for opioid use disorder risk assessment
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved a test designed to determine if a patient is at risk of developing opioid use disorder (OUD).
December 21, 2023
Pills Bottle Social
FDA grants priority review to Merck’s pneumococcal vaccine
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted priority review to Merck’s experimental pneumococcal vaccine, with a decision to be made on approval by June 17, 2024.
December 20, 2023
Vaccine Injection Social
FDA approves Abbott laboratory automation system
By LabPulse.com staff writers
Abbott’s new laboratory automation system has received U.S. Food and Drug Administration (FDA) approval, the company announced in a statement.
December 14, 2023
Fda Button Social
FDA clears BD’s new fingerstick blood collection device
By LabPulse.com staff writers
BD (Beckton, Dickinson and Company) received 510(k) clearances from the U.S. Food and Drug Administration (FDA) for its new sample collection device system that pulls blood from a fingerstick to enable common blood tests without need for a phlebotomist.
December 7, 2023
Fda Sign Dc Social
FDA issues safety warning for risk of T-cell malignancies with CAR T-cell therapies
By LabPulse.com staff writers
The FDA issued a safety warning that patients who have received treatment with BCMA- or CD19-directed autologous CAR T-cell immunotherapies may be at higher risk of developing new T-cell malignancies, including CAR-positive lymphoma.
November 30, 2023
T Cell Social
KSQ Therapeutics receives FDA clearance for trial of CRISPR-Cas9 engineered tumor therapy
By LabPulse.com staff writers
Biotech firm KSQ Therapeutics has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a phase I and II trial of KSQ-001EX, KSQ’s CRISPR-Cas9 engineered tumor-infiltrating lymphocyte program.
November 29, 2023
Crispr Cas9 Gene Editing Social
AMP, other stakeholders urge Congress to pause FDA LDT rule, update CLIA
By LabPulse.com staff writers
The Association for Molecular Pathology (AMP) requested Congress to update the Clinical Laboratory Improvement Amendments (CLIA) as an alternative to the FDA’s proposed rule to increase agency oversight of laboratory-developed tests (LDTs).
November 22, 2023
Washington Dc Capitol Social
U.K. regulators approve 'world-first' sickle-cell gene therapy
By Matt Limb
U.K. medical regulators have approved a “world-first” gene therapy that aims to cure two blood disorders: sickle cell disease and transfusion-dependent β-thalassemia. They are the first regulatory body to approve the treatment.
November 20, 2023
Sickle Cell Anemia2 Social
FDA plans to increase oversight of LDTs garner strong response
By Nick Paul Taylor
Plans to increase U.S. Food and Drug Administration (FDA) oversight of laboratory-developed tests (LDTs) have drawn a strong response from trade groups, individuals, and organizations.
November 17, 2023
Fda Sign Dc Social
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