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Articles: Regulatory Issues |
Prior Articles
Where is Industry Getting it Wrong? A Review of Quality Concerns Raised at Day 120 by the Committee for Medicinal Products for Human Use during European Centralised Marketing Authorisation Submissions for Chemical Entity Medicinal Products
Journal of Pharmacy and Pharmaceutical Sciences, 08/10/09
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Watson Pharmaceuticals and Arrow Group Receive FTC Second Request
Watson Pharmaceuticals, 08/07/09
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Teva Announces Appeals Court Ruling Affirming Invalidation Of Yasmin Patent
Teva Pharmaceutical Industries, 08/06/09
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Regulatory update: mepolizumab for the treatment of hypereosinophilic syndrome
GlaxoSmithKline, 08/05/09
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Amgen and Wyeth Statement on FDA Announcement About Tumor Necrosis Factor Blockers
Amgen, 08/05/09
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Biopure Files Voluntary Petition for Relief Under Chapter 11 of the United States Bankruptcy Code
BioPure, 08/04/09
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Biopure Corporation Receives Notice of Delisting from Nasdaq
BioPure, 08/04/09
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Biopure Receives Notices About Nasdaq Listing Compliance
BioPure, 08/04/09
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Biopure Receives Notice of Nasdaq Delisting
BioPure, 08/04/09
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Biopure Receives Extension of Time to Regain NASDAQ Listing Compliance
BioPure, 08/04/09
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Update on FDA Registration of Actemra, a Humanized Anti-Human IL-6 Receptor Monoclonal Antibody for Rheumatoid Arthritis
Chugai Pharmaceutical Co., 08/03/09
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Genzyme Provides Update on Allston Landing Plant
Genzyme, 08/03/09
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CareFusion issues update regarding previously disclosed June 2009 recall of the Alaris system
Cardinal Health, 07/30/09
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Cell Therapeutics, Inc. Announces Closing of Public Offering of Common Stock and Warrants
Cell Therapeutics, 07/30/09
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Prescription misuse among adolescents
American Pharmacists Association, 07/29/09
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Taro Sues Synerx Pharma, Karalex Pharma and DPT Laboratories for Patent Infringement
Taro Pharmaceuticals USA, 07/29/09
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FDA Issues Complete Response Letter for INTUNIV (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents
Shire, 07/29/09 Mylan Reports That the FDA Determined That All Accusations Were Unfounded
Mylan, 07/29/09 Chugai Files NDA for a Renal Anemia Agent R744
Chugai Pharmaceutical Co., 07/29/09
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Grant of warrants to board members, management and employees in genmab a/s
Genmab, 07/28/09
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