Chart: Antibiotics: The Triumph Of Hope Over Experience?
Johnson & Johnson's swift exit from its collaboration with Basilea for Zevtera (ceftobiprole) is only the latest setback for the antibacterial field, which has had little success in producing NME approvals in recent years.
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The first of the novel antibiotics under review at FDA for treatment of complicated skin and skin structure infections has met with an approval, with the Sept. 11 clearance of Theravance/Astellas' Vibativ (telavancin). The approval comes a year after an FDA advisory committee reviewed three novel antibiotics - telavancin, Targanta's oritavancin and Arpida's iclaprim - determining that tighter non-inferiority margins were needed for cSSSI trials. FDA had issued "complete response" letters for all three drugs; telavancin was the only one that didn't need to do another trial (1Pharmaceutical Approvals Monthly March 2009). The Medicines Company, which acquired Targanta, withdrew the European marketing application for oritavancin Aug. 20, several months after pulling the NDA from FDA. But the regulatory climate for antibiotic drug development that targets severe infections or multi-resistant organisms could be clearing up, according to a former office director speaking at the recent ICAAC conference (2"The Pink Sheet," Sept. 21, 2009). Progress is also occurring on J&J/Basilea's ceftobiprole; a recent warning letter may actually signal that FDA has processed the data integrity issues that have delayed that approval (3"The Pink Sheet" DAILY, Aug. 19, 2009)
NDA Delays: Blindsided By Site Problems
The Food & Drug Administration is listening to Capitol Hill about clinical trial data. The agency knows that both critics and defenders of the drug industry want it to ensure the credibility and integrity of clinical trial sites. Sponsors face another source of NDA delays.
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011