Biotech company warned over diabetes drug info

Wed, 27 Jun 2012
The Food and Drug Administration (FDA) in the United States has launched an attack on the biotech company Amylin about its testing on the side effects of two of its diabetes drugs.

The regulator has accused Amylin of withholding key data from patient testing regarding the cardiac side effects of the diabetes drugs Byetta and Bydureon. The FDA claimed that the company had offered just the title of a study and not its contents, and when asked for the data on Bydureon, it gave them an updated version of previous Byetta documentation.

Mary Parks, a division director of the FDA who oversees diabetes treatments, said the case "has been long and complicated�in part due to Amylin's withholding of information on Byetta that FDA deemed important to its evaluation of the safety and effectiveness of Bydureon."

Amylin is being considered for take-over by a range of international competitors, such as AstraZeneca, Roche, Bristol-Myers Squibb, Pfizer, Sanofi and Merck, who are looking to increase their market share in diabetes drugs, especially with many patents currently due to expire.

Amylin commented that "it was "committed to being transparent with regulatory agencies, the patients and physicians who put their trust in our products and our investor community. Our interactions with regulatory agencies have been, and will continue to be, forthright and timely".
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