Rx Industry Faces Wave of Personal Injury Suits; Avandia To Test Honed Skills

Some of the biggest names in product liability litigation will be flocking to a conference in Chicago July 13 to focus on one drug: Avandia. Mark Lanier, who won the largest jury verdict against Vioxx, is co-chairing the event. Other headliners include Christopher Seeger, a lead plaintiffs attorney in the federal Vioxx litigation, and Karen Barth Menzies, who has spearheaded dozens of cases against antidepressant products

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 

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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Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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US FDA Adcomm To Consider If Genentech’s Columvi Study Generalizable To US

 
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Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

EU Shaping Biotech Act To Unleash SME Potential

 

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.