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.’
Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
