Schering-Plough has responded to FDA regarding the NDA for Saphris (asenapine) sublingual tablets one month after receiving a "complete response" letter for the atypical antipsychotic, the firm announced Feb. 20. FDA had requested supplemental data from the existing database but did not ask for additional clinical trials for the drug, which is under review for acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar 1 disorder in adults as monotherapy (1"The Pink Sheet" DAILY, Jan. 14, 2009). The original action date for the NDA was in June
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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FDA Commissioner Martin Makary suggested 60 new molecular entities could be approved in 2025, which appears possible, but can the strained staff deliver?
PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.
Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.