Pfizer Pipeline Update Highlights 85 New Molecular Entities, 14 New Claims
This article was originally published in Pharmaceutical Approvals Monthly
Pfizer will resubmit the NDA for its next-generation selective estrogen receptor modulator lasofoxifene in December with new data, the drug maker said in a pipeline update released Aug. 6
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As Pfizer's infectious disease unit begins its recovery from the loss of exclusivity of the blockbuster Zithromax (azithromycin) in 2006 and Diflucan (fluconazole) in 2004, the company is repositioning the portfolio to focus on specialty diseases, particularly HIV and hepatitis C, Senior Director/Commercial Head-Infectious Disease Worldwide Pharmaceutical Operations Andrew Schmeltz said
Sanofi-Aventis is looking to establish its ultra low molecular weight heparin product AVE5026 - a follow-on to the firm's Lovenox - as more efficacious than enoxaparin in preventing venous thromboembolic events through a series of head-to-head trials against Lovenox
Pfizer's injectable COX-2 inhibitor parecoxib is "not approvable" a second time, the firm says Sept. 20. Pfizer plans to meet with FDA "as soon as possible" to discuss the agency's concerns. The company added that "it disagrees with the conclusions" stated in the letter. Parecoxib, the pro-drug of Pfizer's Bextra (valdecoxib), was first deemed not approvable in July 2001 (1Pharmaceutical Approvals Monthly December 2001, p. 26). Parecoxib is marketed outside the U.S. as Dynastat. Another Pfizer drug, the osteoporosis treatment Oporia (lasofoxifene), also was deemed not approvable recently; the company announced receipt of the latter letter Sept. 13...