Partnering hopes may have dimmed for Poniard Pharmaceuticals Inc. with the unveiling of Phase II results with picoplatin in metastatic colorectal cancer, news that follows the failure of the chemotherapy agent late last year in a Phase III trial against small-cell lung cancer. (BioWorld Today)

Last week's Tarceva news - unlike the thumbs-down vote by an FDA advisory panel in December - came as little surprise: The action date for a decision on the already-marketed EGFR drug in a new indication, first-line maintenance therapy for non-small-cell lung cancer, has been set back 90 days to April 18.

SAN FRANCISCO - The day after an offshore earthquake measuring 6.5 on the Richter scale rocked northern California - not the Big One, but enough to heighten anxiety - attendees packed the J.P. Morgan Healthcare Conference at the Westin St. Francis hotel, where speakers from the lectern and speculators in the hallways mulled the still-shaky state of biotech.

With the FDA's Jan. 16 action date approaching for MannKind Corp.'s inhaled insulin Afresa, Wall Street grows less and less excited about the prospects for anything actually happening, given the agency's "glacial pace" - in the words of analysts at Hapoalim Securities - and the lack of an advisory panel for the Exubera-spooked candidate.

The decision to steer its main antioxidant strategy away from a successful Phase I cancer program toward chronic kidney disease proved lucrative for Reata Pharmaceuticals Inc., which gained $35 million up front - and potentially much more as development moves ahead - through a deal centered on Nrf2-targeting bardoxolone with Kyowa Hakko Kirin Co. Ltd. (BioWorld Today)