Amgen's shameful silence covers up reasons for FDA drug rejection

The Street

25 August 2016 - An Amgen drug to treat secondary hyperparathyroidism was rejected by U.S. FDA  but the company has offered no public explanation for why the drug's marketing application was denied.

An Amgen medicine to treat secondary hyperparathyroidism was rejected by the FDA on Wednesday, but in an egregious abdication of corporate transparency, the company offered no public explanation at all for why the company's marketing application was denied.

Amgen delighted in touting the bright prospects of the drug known as Parsabiv to investors as it cleared several late-stage clinical trials. Now that the U.S. FDA has rejected Parsabiv, Amgen owes investors a lot more disclosure than the opaque statement issued Wednesday night:

"Amgen is said tobe reviewing the complete response letter, and we anticipate a post-action meeting with the FDA later this year to discuss the complete response."

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , US