Johnson & Johnson’s (NYSE:JNJ) application to the FDA to widen the use of its Xarelto blood thinner to prevent heart attacks and strokes in people suffering from acute coronary syndrome, has been blocked. However, JNJ hasn’t given up on getting approval for the drug, in a market that could be worth $1 billion, as it says that it will cooperate with the agency in answering all questions that it may have.
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Shares of Repligen (NASDAQ:RGEN) crater, following its touching the FDA’s third rail: The agency confirms that it is requesting the biotech firm to conduct additional trials, prior to potentially gaining approval for its RG1068 synthetic human secretin used to detect pancreatic-duct abnormalities in patients suffering from pancreatitis.
Alexza Pharmaceuticals (NASDAQ:ALXA) shares move way up, as it resubmits its application for Adasuve, which is a schizophrenic and bipolar disorder treatment. Other than the resolution of a previous letter from the FDA that indicated a production deficiency, no other impediments seem to be present.
Arena Pharmaceuticals (NASDAQ:ARNA) shares more than gave back Thursday’s gains, as selling pressures on Arena continued Friday sending shares below $10 at the closing bell. An observation by SA’s Shane Blackmon pointed out that the firm’s rally has been driven by short-covering, and also saying that prior to the FDA’s expected June 27th ruling on Arena’s Locaserin weight-loss drug, “a bear raid seems inevitable,” might have had a lot to do with the dive.
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