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UPDATE 1-Vertex Pharma receives subpoena from Department of Justice

Published 2015-10-30, 09:06 p/m
© Reuters.  UPDATE 1-Vertex Pharma receives subpoena from Department of Justice
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(Adds Vertex response, details on CVS)
Oct 30 (Reuters) - Vertex Pharmaceuticals Inc VRTX.O said
it received a subpoena from the U.S. Department of Justice in
the third quarter related to its marketed medicines, seeking
documents related primarily to its "good laboratory practices"
in a bioanalytical lab.
Good laboratory practices are rules that govern non-clinical
safety studies, ensuring quality, integrity and reliability of
data. Bioanalytical labs measures drug levels in biological
samples, specifically in blood and urine.
"We are in the process of responding to the subpoena and
intend to cooperate," Vertex said in a securities filing.
The subpoena will not impact the safety, effectiveness and
commercialization of the company's existing drugs or those in
development, Vertex spokesman Zach Barber told Reuters.
Shares of the cystic fibrosis drugmaker were marginally down
after-hours.
Separately, drugmaker Mylan NV MYL.O and drugstore chain
CVS Health Corp (N:CVS) CVS.N said in their quarterly filings that
they had received subpoenas from federal agencies.
CVS said the Drug Enforcement Administration (DEA) in
September sought documents related to controlled substance
policies, procedures and practices at eight pharmacy locations
since May 2012.
Last May the company agreed to a fine of $22 million in a
settlement with the U.S. Attorney's Office for the Middle
District of Florida, resolving alleged violations of the
Controlled Substances Act.
CVS, in its filing, said it is undergoing several audits by
the DEA and is in discussions with the agency and the U.S.
Attorney's office in several locations concerning allegations
that it has violated certain requirements of the CSA.
Mylan said the U.S. Securities and Exchange Commission was
seeking documents with regard to certain "related party
matters."
CVS and Mylan's shares were little changed after the bell.
Neither company was immediately available for comment.

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