Allergan's Freedom From Expression Suit Challenges Gov't REMS, Off-Label Powers

The firm wants to go beyond the REMS requirements and offer treatment guidance, not just risk information, about the use of Botox for spasticity, an unapproved condition.

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More from Pink Sheet

EU Fines Alchem Over Buscopan API Cartel

 
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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 In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 

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.

Korea Pre-Review Consultations Help Accelerate R&D

 
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A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.