HHS extends VaxGen's clinical-hold resolution deadline

USA-based biopharmaceutical VaxGen says that the Department of Health and Human Services (HHS) has extended to December 18 the deadline by which the firm must resolve the clinical hold on a Phase II trial of its anthrax vaccine, issued by the Food and Drug Administration (Marketletter November 9). The FDA imposed the suspension on November 3, saying that data the group had supplied was not sufficient to ensure that the product was stable enough for clinical testing.

VaxGen's contract with the HHS is worth around $877.5 million, and is part of the government's Bioshield defence program. The HHS said, in letter sent on November 15, that it "plans to issue a contract modification to re-establish the due date for VaxGen to initiate its next clinical trial." VaxGen said that it has requested a meeting with the FDA, no later than the middle of December, to address the agency's concerns.