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HONG KONG – Paving the way for further growth of a $2 billion sector, the CFDA has published final regulatory guidelines for biosimilars. Included are standards for research, development and evaluation. Most importantly, the CFDA also gave clear instruction on the pathway, categorization and application material needed for biosimilar registrations.
As the FDA Vaccines and Related Biological Products Advisory Committee met today to decide which flu strains to include in next year's vaccine, no one would argue that the process worked well last year.
HONG KONG – Known already as the first China-manufactured biologic used in U.S. trials, HIV candidate ibalizumab (TMB-355) won FDA breakthrough therapy designation, which could substantially accelerate the product's launch.
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