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UPDATE 2-FDA staff cautious about J&J's latest Xarelto application

2014-01-15 02:12:29| Biotech - Topix.net

The U.S. Food and Drug Administration appears skeptical that data submitted by Johnson & Johnson proves its anticoagulant Xarelto is effective in reducing the risk of further heart problems in patients who have recently suffered a heart attack.

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Appendix A - Application

2014-01-14 22:59:38| PortlandOnline

Word Document, 120kbCategory: 2014 Section 108 NOFA

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UPDATE 1-FDA staff cautious about J&J's latest Xarelto application

2014-01-14 18:38:04| Food - Topix.net

The U.S. Food and Drug Administration appears skeptical that data submitted by Johnson & Johnson proves its anticoagulant Xarelto is effective in reducing the risk of further heart problems in patients who have recently suffered a heart attack.

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Merck Initiates Rolling Submission of U.S. Biologics License Application for MK-3475, an Investigational Anti-PD-1 Immunotherapy, in Patients with Advanced Melanoma

2014-01-13 14:30:00| Merck.com - Research & Development News

Dateline City: WHITEHOUSE STATION, N.J. Expects to Complete Application in First Half of 2014 WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, said today it has started a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application for MK-3475, the companys investigational anti-PD-1 immunotherapy, for patients with advanced melanoma who have been previously treated with ipilimumab. A rolling submission allows completed portions of the application to be submitted and reviewed by the FDA on an ongoing basis. Language: English Contact: MerckMedia:Ian McConnell, 908-423-3046Claire Mulhearn, 908-423-7425orInvestors:Carol Ferguson, 908-500-1101Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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PIAC Application Form

2014-01-10 22:55:02| PortlandOnline

Apply to Serve on PIAC Word Document, 87kbCategory: Apply to serve on PIAC

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