Viropharma Inc (NASDAQ:VPHM): ViroPharma announced the FDA denied the citizen petition filed by ViroPharma on March 17, 2006 related to the FDA’s proposed in vitro method for determining bioequivalence of abbreviated new drug applications referencing Vancocin Capsules. In the FDA’s response to the citizen petition, the agency denied ViroPharma’s citizen petition and also informed the company that a final guidance for vancomycin bioequivalence consistent with the FDA’s citizen petition response is forthcoming. The FDA also informed ViroPharma in the same correspondence that the recent supplemental new drug application for Vancocin approved December 14, 2011 would not qualify for three additional years of exclusivity based on the agency’s assertion that in order for an sNDA for an old antibiotic such as Vancocin to be eligible for a grant of exclusivity, it must be a significant new use or indication. FDA also indicated that it is approving three ANDA’s for generic vancomycin capsules.
The shares closed at $22.44, down $6.17, or 21.57%, on the day. Its market capitalization is $1.59 billion.
Targacept, Inc. (NASDAQ:TRGT): Targacept announced revised top-line results from its exploratory Phase 2 clinical study of TC-6987 in asthma. Following identification of an error in the application of the agreed statistical analysis plan, a reanalysis of the data was undertaken. The reanalysis revealed a 2 ml decrease in the change in Forced Expiratory Volume from baseline to pre-dosing on day 28, which resulted in TC-6987 no longer achieving the study’s protocol-defined success criteria on that co-primary endpoint. However, TC-6987 continued in the reanalysis to meet protocol-defined success criteria on the study’s other co-primary endpoint, change in FEV1 from baseline to two hours post-dosing on day 28. Reanalysis of the post-dose measure revealed an incrementally stronger signal of a drug effect than the initial analysis.
The shares closed at $4.26, down $0.59, or 12.16%, on the day. Its market capitalization is $142.27 million.
Pfizer Inc. (NYSE:PFE): A U.S appellate court ruled that Pfizer (NYSE:PFE) can face asbestos liability suits in state court from products manufactured by its now defunct Quigley unit, reports Reuters.
The shares closed at $21.99, down $0.06, or 0.29%, on the day. Its market capitalization is $165.71 billion.
St. Jude Medical, Inc. (NYSE:STJ): St. Jude Medical (NYSE:STJ) announced it has posted information from the MAUDE database showing 377 deaths associated with the Medtronic (NYSE:MDT) Quattro Secure lead, rather than the 62 that was reported by Dr. Robert Hauser in a manuscript published online last week by the Heart Rhythm Journal. The company has called upon Dr. Hauser to state specifically whether or not he stands behind the factual accuracy of the number 62 used in comparing the St. Jude Medical Riata and Riata ST leads to the Medtronic Quattro Secure device. The company also invites Medtronic to review the MAUDE database report findings.
The shares closed at $38.53, down $0.38, or 0.98%, on the day. Its market capitalization is $12.35 billion.
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