Europe Likes Schering’s Bridion, But Not Takeda’s Rozerem
This article was originally published in The Pink Sheet Daily
Executive Summary
New opinion includes CHMP skepticism of insomnia drug.
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After failing to submit safety data on time during the drug’s first FDA review, Merck has its data together and is armed with a new hypersensitivity study in advance of the second panel review for its anesthesia product.
Schering Plough’s Bridion Faces FDA Setback
Safety concerns render anesthesia injection “not approvable” in U.S.
Schering Plough’s Bridion Faces FDA Setback
Safety concerns render anesthesia injection “not approvable” in U.S.
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