Nuvo’s Pennsaid Resubmission Delayed Again
This article was originally published in The Pink Sheet Daily
Executive Summary
Firm now projects a potential mid-2009 approval for the topical NSAID for osteoarthritis.
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R&D IN BRIEF
Pfizer halts Phase III axitinib trial: Pfizer announces the halt of Phase III axitinib trial in advanced pancreatic cancer patients late on Friday, Jan. 30. The press release was overshadowed by the news just days earlier of Pfizer's offer to merge with Wyeth (1"The Pink Sheet," Feb. 2, 2009, p. 8). The pancreatic trial evaluating axitinib - Pfizer's most advanced oncology candidate - was stopped after a data safety monitoring board found no evidence in interim results of improvement in the primary endpoint of survival in patients treated with axitinib and gemcitabine compared to gemcitabine alone (the current standard of care). Pfizer had predicted last summer that it would first file axitinib for pancreatic cancer (2"The Pink Sheet," June 23, 2008, p. 30); the firm is still committed to evaluating the VEGF receptor inhibitor in a Phase III second-line renal cell carcinoma trial and Phase II advanced non-small cell lung cancer and colorectal cancer studies
R&D IN BRIEF
Pfizer halts Phase III axitinib trial: Pfizer announces the halt of Phase III axitinib trial in advanced pancreatic cancer patients late on Friday, Jan. 30. The press release was overshadowed by the news just days earlier of Pfizer's offer to merge with Wyeth (1"The Pink Sheet," Feb. 2, 2009, p. 8). The pancreatic trial evaluating axitinib - Pfizer's most advanced oncology candidate - was stopped after a data safety monitoring board found no evidence in interim results of improvement in the primary endpoint of survival in patients treated with axitinib and gemcitabine compared to gemcitabine alone (the current standard of care). Pfizer had predicted last summer that it would first file axitinib for pancreatic cancer (2"The Pink Sheet," June 23, 2008, p. 30); the firm is still committed to evaluating the VEGF receptor inhibitor in a Phase III second-line renal cell carcinoma trial and Phase II advanced non-small cell lung cancer and colorectal cancer studies
Nuvo's Pennsaid “Approvable” For Osteoarthritis
Company plans to meet with FDA in early 2007 to discuss the topical non-steroidal anti-inflammatory treatment.