FDA questions whether M-Vax and O-Vax "are sufficiently developed for ongoing clinical trials to be considered adequate to support a BLA," Avax reports. The autologous cancer vaccines were put on clinical hold in March, at which time Avax maintained that the hold was not related to manufacturing issues (1"The Pink Sheet" April 2, In Brief). Written communication from FDA indicates that the hold is related to Avax' handling of tumor cells, preparation of vaccines and manufacturing practices. An investigation of the firm's Philadelphia manufacturing facility is underway. Exec VP-R&D Ernest Yankee, PhD, and VP-Operations Kamy Behzadi, PhD, resigned at the request of the board of directors
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Clinical activities for its M-Vax and O-Vax autologous cancer vaccines have been placed on clinical hold pending further FDA review, company announces. "The FDA is currently examining the need to establish the sterility of tumor cells received by the company to prepare individualized cancer vaccines," Avax said. Firm maintains hold is not related to any concern with manufacturing, but is part of FDA's "evolving requirements for cell-derived products"
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials