RabAvert shelf life: "While Connaught may have internal data which demonstrates a four-year shelf life stability for [its rabies vaccine] Imovax IM, their FDA approved dating period is much shorter" at 30 months, Chiron said in a Nov. 19 letter to "The Pink Sheet" ("The Pink Sheet" Nov. 10, T&G-2). FDA approved dating period for Chiron Behring's RabAvert rabies vaccine is 36 months, "although we have internal data demonstrating shelf life stability greater than four years under 2-8 conditions," Chiron said. In addition, RabAvert labeling notes that a test for the persistence of antibody showed that neutralizing antibody titers >.5 IU/mL were present two years after immunization and that the incidence of headache in trials of RabAvert vs. human diploid cell vaccine as 52% for RabAvert and 45% for HDCV...
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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.’
Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.
After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.
Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.
