Merck's therapeutic human papilloma virus vaccine Gardasil showed significant protection against infection and pre-cancerous lesions in a Phase II trial, the company says April 6. Two and a half years post-vaccination, the combined incidence of persistent infection from HPV six, 11, 16 or 18 and related genital disease was reduced by 90% compared to placebo (p<0.001). The 552-patient study included women between 16 and 23 years of age, with a primary endpoint of efficacy at day one, month two and month six. Results were published in the April 2005 Lancet Oncology. Merck plans to file a Gardasil BLA in the second half of 2005. GlaxoSmithKline has a royalty stake in Gardasil under a cross-licensing deal announced in February (1Pharmaceutical Approvals Monthly February 2005, p. 18). GSK has not announced a filing timeframe for its own HPV vaccine, Cervarix...

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials.