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Merck Hopes To Make A Success Story of CETP Inhibitors And Obesity Drugs

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Merck is hoping to find success where other firms have failed: its late stage pipeline includes two programs in drug classes where the lead candidates from other companies have not managed to gain approval.

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R&D In Brief

Heplisav clinical hold may be released in near future: Positive Phase III results for Dynavax's hepatitis B vaccine Heplisav bring the firm closer to submitting a response to FDA's clinical hold on the TLR9-based drug, the company says Aug. 6. FDA placed Dynavax/Merck's Heplisav on clinical hold in March after one subject came down with a rare inflammatory disease. Dynavax said the response should be complete in the "near future." In the Phase III Heplisav Short-regimen Trial (PHAST) of 2,427 patients in Germany and Canada ages 11-55, 95 percent of subjects dosed twice with Heplisav developed antibodies against HBV after 12 weeks. Of patients dosed three times with the standard HBV vaccine, GlaxoSmithKline's Engerix-B, 81 percent developed antibodies after 28 weeks. Full results will be released later. Susquehanna analyst Derek Jellinek predicted the total development plan will be delayed by at least two quarters and expects an update in two to four months. Merck had initially estimated an NDA filing in 2010 (1Pharmaceutical Approvals Monthly January 2008, p. 13)

Roche Exorcizes Torcetrapib’s Ghost: CETP Candidate Starts Phase III

If those who do not learn from the past are condemned to repeat it, then Roche’s extensive study of Pfizer’s torcetrapib is the Swiss firm’s attempt to avoid a repeat of the first cholesterol ester transfer protein inhibitor’s performance.

IFRA Hosts Capitol Hill Scent Experience In Timeout From Policy Concerns

The International Fragrance Association North America took a break from its higher-stakes advocacy work Nov. 1 to give lawmakers and congressional staffers a "scent experience." Perfumers from six of the group's biggest members were on hand with "Scents of Home," joined by Monell Center researchers to educate attendees on the mechanics of scent and the important role it plays in people's lives.

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