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Development of bifeprunox for maintenance treatment of schizophrenia discontinued
Lundbeck and Solvay have announced that they are discontinuing development of bifeprunox for the maintenance treatment of schizophrenia.
Lundbeck and Solvay have announced that they are discontinuing development of bifeprunox for the maintenance treatment of schizophrenia.
After analyzing results from an interim analysis of pooled data, the companies decided that the efficacy data did not support continued development of this agent for the stabilization of nonacute schizophrenia.
FDA issued a nonapprovable letter for bifeprunox for the acute and maintenance treatment of schizophrenia in August 2007. In its letter, FDA stated that a second study would be needed to support the approval of bifeprunox for the maintenance treatment of schizophrenia. The agency also stated that the efficacy data were not sufficient for the approval of bifeprunox for the acute treatment of schizophrenia.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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