Cell Therapeutics To Launch First Commercial Product Trisenox With 16 Reps

Cell Therapeutics will launch its first commercial product Trisenox for treatment of acute promyelocytic leukemia with an internal oncology sales force of 16 reps, CTI CEO James Bianco, MD, told a Sept. 27 conference call.

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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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Brazil Pilots Digital Drug Pack Inserts

 

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

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EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 

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US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.