Biologics
FDA has promoted CBER deputy director Peter Marks to director of the office effective 1/1. Marks replaces Karen Midthun, who retired after 22 years of FDA service in December. Marks received his graduate degree in cell and molecular biology and his medical degree at New York University. He completed
Biologics
The U.S. Patent and Trademark Office (PTO) has denied two Amgen petitions that sought to review two formulation patents on AbbVie’s rheumatoid arthritis therapy Humira. The PTO rejection is seen as a potential roadblock in Amgen’s move to gain FDA approval for a biosimilar version of Humira.
Biologics
FDA has approved an expanded age indication for GlaxoSmithKline’s Hiberix [Haemophilus b conjugate vaccine (tetanus toxoid conjugate)]. The vaccine is now indicated for immunizing children aged six weeks through four years against invasive disease caused by Haemophilus influenzae type b (Hib). Approvals was based on data showing immune responses
Biologics
The U.S. Pharmacopeial Convention (USP) is developing standards for therapeutic proteins to help manufacturers in the development and analysis of their proteins. USP’s standards for these and other biologics are based on input from global scientific experts and on specifications for FDA-approved products. Published in the United
Biologics
AbbVie has petitioned FDA asking that it ensure that any biosimilar interchangeability determinations meet the “safety standards for determining interchangeability” set forth in Public Health Service Act section 351(k)(4) with respect to each condition of use for which the reference product is licensed, regardless of whether the applicant
Biologics
CBER has posted a draft guidance (XXXINSERT LINKXXX) on “Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271.” The document provides recommendations and relevant examples for complying with the
Biologics
FDA has issued a guidance, Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products, with the agency’s revised donor deferral recommendations for individuals with increased risk of transmitting HIV infections. The guidance says FDA also recommends that establishments that collect blood or