Biocraft precluded by preliminary federal court ruling from manufacturing and marketing cefadroxil, the generic of Bristol-Myers' Duracef and Ultracef, until a final ruling is made. The court is requesting that "controlled inter-party scientific experiments be conducted to fully assess the test data previously obtained by Biocraft," the generic firm noted. Biocraft received ANDA approval for cefadroxil on Feb. 10. The firm filed suit in January seeking a declaratory judgment that Bristol-Myers' cefadroxil patent is invalid.
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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.
