Peter Marks’ March 28 letter giving one week’s notice of his resignation as director of the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) is sending more ripples of uncertainty throughout the industry. Marks, who has helmed CBER for nearly a decade, blamed his departure on recently confirmed Health and Human Services (HHS) Secretary Robert Kennedy, who has made a career out of his anti-vaccine stance.
Everest Medicines Ltd. has obtained IND clearance from the FDA for EVM-14, an off-the-shelf mRNA cancer vaccine targeting multiple tumor-associated antigens and designed to treat various cancers, including non-small-cell lung cancer and head and neck cancer.
Aim Vaccine Co. Ltd. may become the first company to gain regulatory clearance of a prophylactic iterative serum-free human rabies vaccine. Beijing-based Aim said it is preparing a regulatory submission of its independently developed rabies vaccine based on positive phase III results that showed good safety, immunogenicity and immune persistence.
Breaking with a 30-year tradition, the U.S. FDA selected the strains for the next flu vaccine March 13 without convening its independent vaccine advisory committee. Instead, the agency brought together 15 scientific and public health experts from within the FDA, the CDC and the Department of Defense to make the recommendations for the next flu season. That group met the same day that the agency’s Vaccines and Related Biological Products Advisory Committee had been scheduled to make the selection.
Shortly before the Senate Health, Education, Labor and Pensions Committee was to hold the first ever confirmation hearing for a U.S. CDC director March 13, it issued a statement saying the hearing was canceled due to the White House withdrawing its nomination of Dave Weldon, a physician and former congressman from Florida.
Aim Vaccine Co. Ltd. may become the first company to gain regulatory clearance of a prophylactic iterative serum-free human rabies vaccine. Beijing-based Aim said it is preparing a regulatory submission of its independently developed rabies vaccine based on positive phase III results that showed good safety, immunogenicity and immune persistence.
Researchers from Diosynvax Ltd. presented data from a study that aimed to evaluate the efficacy of a pan-H5 vaccine designed using computational biology and being developed for protection against avian influenza.
Peptide-based vaccines deliver tumor-specific antigens to dendritic cells (DCs), triggering tumor-targeted T-cell responses. A peptide-peptide conjugate technology previously developed by researchers from Uppsala University and collaborators enhances this process by using multiple tetanus toxin-derived B-cell epitopes (MTTEs) to facilitate in vivo antigen delivery and DC activation.
Jay Bhattacharya will have his work cut out for him if he wins confirmation as the next director of the U.S. NIH. Besides getting NIH committees back on track to evaluate grant applications and calming the fears of researchers and other staff who have seen about 1,200 colleagues cut from their ranks in recent weeks, Bhattacharya will face the task of rebuilding public trust in the NIH itself.
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