Last week's complete response letter for Human Genome Sciences Inc. and Novartis AG's Zalbin (albinterferon alfa-2b) came as no surprise given the hepatitis C drug's history.

Despite the usual summer slowdown and some less-usual contributing factors, like a stock slump on the heels of the American Society of Clinical Oncology (ASCO) annual meeting in June, biotech fundraising continues to inch back from the brink.

After 17 years of smooth sailing – Iressa (gefitinib, AstraZeneca plc) notwithstanding – the FDA's accelerated approval process seems to have hit some choppy waters.