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FDA refuses to review Alkermes' depression treatment, seeks more trials

from Reuters

Alkermes Plc has been told to conduct more clinical trials of its experimental depression treatment after the U.S. Food and Drug Administration rejected its initial application for approval, citing a lack of evidence of its effectiveness. The FDA’s decision knocked nearly $2 billion off the company’s value and spells extra cost for the Dublin-based drugmaker, which has two major drugs already in the market but for whom the ALKS 5461 depression treatment was seen as a driver of future revenue. more


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