Pfizer Axes Deal For Brain Cancer Vaccine, Leaves Partner Celldex In the Lurch

A brave face: Celldex execs say they are ready and able to take brain cancer vaccine CDX-110 into Phase III without a Big Pharma partner.

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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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Sanofi Secures EU Fast-Track Status For ‘Game-Changing’ Sleeping Sickness Drug

 

If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.

Mexico Speeds Up Market Access With Regulatory Reliance Guidelines

 

Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.

UK Approves Biogen’s Qalsody After England Revises Reimbursement Approach

 

Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.