Some recent biotech drug setbacks
COMPANY & DRUG DELAY
CORIXA: FDA has twice delayed review of this novel BEXXAR antibody for non-Hodgkin's lymphoma, most (CANCER) recently in January, because it needs more time to review the lengthy filing.
AMYLIN: FDA issued a likely-to-approve letter in SMYLIN October, contingent on additional safety (DIABETES) trials, which will take about a year.
GENENTECH FDA asked for more safety and efficacy tests /XOMA: in October, delaying approval filing by at XANELIM least six months.
GENENTECH In July, the FDA rejected the drug, asking for /NOVARTIS: additional safety data. New clinical trials are XOLAIR under way, and the companies expect to (ASTHMA) resubmit the drug at the end of 2002.
CHIRON: The application for this highly sensitive HIV PROCLEIX blood test was accepted by the FDA in March, (BLOOD TEST) 2001, but despite being granted fast-track status, approval wasn't granted until Feb. 28.
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