GlaxoSmithKline's OTC Garage Sale Includes alli, FiberChoice

GlaxoSmithKline includes the alli weight-loss brand in its planned divestment of international OTCs worth about $813 million in 2010 sales, or 10% of the firm's total Consumer Healthcare business.

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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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Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

UK Promises To ‘Turbocharge’ Clinical Trials As US Tariff Threat Remains

 

Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.

Industry Urged To Respond To EU Expectations On Using Animal Testing Alternatives

 

The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.