GSK, Dynavax To Partner On TLR Compounds In Autoimmune, Inflammatory Disease

The latest option deal for GSK brings Dynavax $10 million upfront and potential milestones up to $200 million in each of four R&D programs.

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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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Pink Sheet Podcast: Understanding The Impact Of The Latest HHS Layoffs On The US FDA

 

Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.

EMA Recommends EU Approval For Averoa’s Xoanacyl And Four Other Drugs

 

The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.

European Regulator Deals Blow For Lilly’s Alzheimer’s Drug Kisunla

 

Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.