Mylan Has Strong Quarter But Huge GMP Overhang
This article was originally published in The Pink Sheet Daily
Executive Summary
With new execs in place, firm raises EPS guidance for 2009, just days after coming under fire for quality control allegations.
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FDA's Woodcock Expresses Concern Not All Generics Are Equivalent, But OGD May Have Solution
It didn't seem like deliberate choice to play good cop-bad cop, but Acting Office of Generic Drugs Director Keith Webber and Center for Drug Evaluation and Research Director Janet Woodcock offered a near textbook version of it at the recent Generic Pharmaceutical Association Fall Technical Conference.
FDA's Woodcock Expresses Concern Not All Generics Are Equivalent, But OGD May Have Solution
It didn't seem like deliberate choice to play good cop-bad cop, but Acting Office of Generic Drugs Director Keith Webber and Center for Drug Evaluation and Research Director Janet Woodcock offered a near textbook version of it at the recent Generic Pharmaceutical Association Fall Technical Conference.
Legal News In Brief
Mylan files suit against Pittsburgh Post-Gazette: Mylan filed a civil suit against the Pittsburgh Post-Gazette, alleging that the newspaper improperly obtained and misconstrued confidential internal documents in a series of articles about its West Virginia generic plant. "The articles mischaracterized a minor deviation from internal Mylan procedure, creating the false appearance of significant quality and regulatory issues at Mylan's Morgantown, W.Va. plant when no such issues existed," Mylan said. The suit, filed in the Circuit Court of Monongalia County, W.Va., stemmed from an initial story published in late July (1"The Pink Sheet" DAILY, July 30, 2009). In an Aug. 20 Post-Gazette article, Publisher and Editor-in-chief John Robinson Block stated that the allegations are "meritless" and that the paper plans to challenge the suit. An FDA inspection following the first published Post-Gazette piece has been closed, and the agency noted that "the firm appears to have conducted an adequate investigation." The agency said it plans no additional action