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news.Edison product given orphan status in US
The designation provides an accelerated review and a seven-year period of exclusivity upon FDA approval. The FDA granted orphan drug designation to Edison’s EPI-A0001 based on review of
The designation provides an accelerated review and a seven-year period of exclusivity upon FDA approval. The FDA granted orphan drug designation to Edison’s EPI-A0001 based on review of
The company now plans to file the drug for marketing approval in the US and Europe in the second half of 2006. The trial evaluated women with refractory
Preclinical studies with D93 have demonstrated its ability to reduce angiogenesis and inhibit tumor growth in in vivo models of several types of cancer. CancerVax plans to initiate
The product is the first treatment ever approved for Pompe disease and one of the first for an inherited muscle disorder. “This is an extraordinary moment for Pompe
Under the terms of the agreement, Arius will receive an upfront technology access fee of $2 million, consisting of $1 million each in cash and equity investment respectively,
The study evaluated over 500 thousand participants between the ages of 50 and 69 over a five-year period. The researchers found no evidence of an increased risk of
Predix shareholders may receive an additional milestone payment of $35 million upon the achievement of certain unspecified clinical or strategic objectives. Epix is a developer of pharmaceuticals for
“By unlocking the three-dimensional structure of this enzyme – known as papain-like-protease (PLpro) – we now have a molecular road map to design new drugs that could potentially
Amgen said that it expects the $22.50 per share deal to dilute its earnings per share in 2006 and 2007 in the range of $0.05 to $0.10. However,
Pharmacopeia acquired exclusive rights to certain lead and backup DARA (dual angiotensin and endothelin receptor antagonist) development candidates, and plans to initiate preclinical development studies immediately. “This is