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Biogen Vumerity Receives Full US Approval, But GI Comparison With Tecfidera Must Wait

 
• By Bridget Silverman

Label offers little differentiation from Tecfidera, but head-to-head trial with custom-designed patient-reported outcome could make case for gastrointestinal tolerability advantage.

US labeling for Biogen Inc. and Alkermes PLC’s Vumerity (diroximel fumarate) does not address the gastrointestinal tolerability advantage over Biogen’s Tecfidera (dimethyl fumarate) that the companies have long said is the rationale for developing the new multiple sclerosis therapy.

The Food and Drug Administration granted full approval to the Vumerity NDA on 29 October 2019, shortly after issuing a tentative approval letter on 11 October.

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

 
• By Neena Brizmohun

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.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

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

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.