Chitra Sethi, Managing Editor, BioPharm International
In its effort to ensure that consistent definitions of terminology are being applied by all constituents of the ICH, the FDA has released a new guidance, E15, containing definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics.
The US FDA has approved Arcalyst (rilonacept, an interleukin-1 blocker) for the long-term treatment of two cryopyrin-associated periodic syndrome (CAPS) disorders.
On February 22, 2008, the FDA approved two biotech drugs, Avastin (bevacizumab) and HUMIRA (Adalimumab), for additional indications.
Cell Therapeutics, Inc. (CTI, Seattle, WA, www.ctiseattle.com), has formed a new spin-off company, Aequus BioPharma, Inc., to develop a novel process to extend the half-life of proteins.
