OSI/Genentech's NDA for use of Tarceva as monotherapy in the treatment of non-small cell lung cancer accepted into FDA's Pilot 1 Program for rolling NDAs, OSI says June 29. The rolling NDA for erlotinib started in January (1"The Pink Sheet" June 14, 2004, p. 6). Under the program, FDA is committed to initiate review of the submitted CMC and non-clinical sections on a six-month review timeline as of the notification of Pilot I status. OSI expects to complete the NDA submission by the end of the summer, making approval possible in early 2005...
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.
The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.
