FDA appoints Richard Pazdur as Director of CDER

The U.S. Department of Health and Human Services and the U.S. Food and Drug Administration announced that Richard Pazdur, M.D., has been appointed director of the Center for Drug Evaluation and Research. “Pazdur is a 26-year veteran of the FDA and the founding director of its Oncology Center of Excellence. A renowned regulatory innovator, Dr. Pazdur developed an integrated approach for cross-center coordination of oncology product review to expedite the development of novel cancer therapies. He also led the agency’s launch of a series of initiatives that streamlined oncology drug approvals, access, and labeling: Project Orbis to provide a framework for concurrent submission and review of oncology products among international partners, Project Facilitate to support oncology professionals in completing expanded access requests for cancer patients, and Project Renewal to update the prescribing information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date,” the FDA stated. Publicly traded large-cap drugmakers include AstraZeneca (AZN), Bristol Myers (BMY), Eli Lilly (LLY), GSK (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Companies working on gene therapies include Sarepta (SRPT), Capricor Therapeutics (CAPR), Taysha Gene Therapies (TSHA), MeiraGTx (MGTX), Crispr Therapeutics (CRSP), Editas Medicine (EDIT), Beam Therapeutics (BEAM), Caribou Biosciences (CRBU) and Intellia Therapeutics (NTLA).