FDA reported 1,276 drug recalls last year, the third-highest level ever. Inspections of pharmacies that compounded purportedly aseptic injectables drove the numbers, but pharmaceutical manufacturers also contributed as they struggled with particulates, precipitation and other issues.

FDA reported 1,276 drug recalls last year, the third-highest level ever. Inspections of pharmacies that compounded purportedly aseptic injectables drove the numbers, but pharmaceutical manufacturers also contributed as they struggled with particulates, precipitation and other issues.

Two years ago it looked as if all was lost at Pharming: escalating costs for its Pompe's disease program and indebtedness to its JV partner Genzyme forced it into legal moratorium in August 2001. Today, Pharming's back in the game; indeed, its new management, slimmed down operations and heightened focus on cost control mirrors the many other European biotechs trying to adapt to the harsh winter. But Pharming could have avoided near death by not turning its development partner into its biggest creditor. Still, the firm's turnaround-even this far-shows a reassuring willingness among Europe's investors to assume risk and give companies another chance.

Cubist, like other companies in the anti-infectives space, was founded on the assumption that anti-infective drugs entering the clinic had a significantly lower risk of failure than other therapeutics. That risk profile may be changing because of the FDA's imposition of stricter standards for the approval of anti-microbials. So far, Cubist has met that challenge with respect to daptomycin, the Phase III antibiotic that would be the company's first marketed product. Yet, a cloud of regulatory uncertainty still lingers. But through aggressive dealmaking, Cubist has built a discovery and development pipeline that helps to balance the risk that daptomycin may run into unexpected roadblocks on the way to approval.