PHARMACY

Genzyme names leaders of MS, rare diseases units

BY Allison Cerra

CAMBRIDGE, Mass. — Genzyme has named leaders of two units that are part of the core focus of the drug maker’s business.

Bill Sibold, former chief commercial officer at Avanir Pharmaceuticals, was appointed to serve as head of the multiple sclerosis business, while Rogério Vivaldi, who most recently served as president of Genzyme’s renal and endocrinology business, now is the head of the rare diseases business.

Both Sibold and Vivaldi will report to Genzyme president and CEO David Meeker, who recently became part of the company’s executive team.

“These appointments are a critical step in launching the new Genzyme,” Meeker said. “Bill and Rogério are dynamic leaders with the experience, energy, vision and commitment to patients needed to move us forward.”

Genzyme is a Sanofi company.


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AstraZeneca, Targacept: TC-5214 ‘well-tolerated,’ did not meet endpoint in phase-3 trial

BY Allison Cerra

NEW YORK — AstraZeneca and Targacept released results of the first of four phase-3 clinical trials that investigated the efficacy and tolerability of a drug that could serve as an adjunct therapy to major depressive disorder patients that had an inadequate response to initial antidepressant therapies.

The drug makers said that while the drug was "well-tolerated" among study subjects, the study did not meet its primary endpoint of change after eight weeks of treatment with TC-5214, compared with placebo. The study was part of the Renaissance clinical trial program, which consists of four randomized, double-blind, placebo-controlled phase-3 studies and a fifth long-term safety study.

A new drug application for TC-5214 is expected to be filed in the United States during the second half of 2012.

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Roche seeks FDA approval for vismodegib

BY Allison Cerra

BASEL, Switzerland — The Food and Drug Administration has accepted a new drug application for a skin cancer treatment developed by Roche.

Roche said that the FDA accepted its NDA for vismodegib, designed to treat advanced basal cell carcinoma in adults for whom surgery is considered inappropriate. The application was granted priorit review status and has a confirmed action date of March 8, 2012.

“We are pleased the FDA has granted priority review for vismodegib and we look forward to working with the Agency on the review of the data," Roche chief medical officer and head of global product development Hal Barron said. “We hope to provide people with the first FDA-approved medicine for this potentially disfiguring, and in some cases fatal, disease as soon as possible.”


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