FDA’s midstream decision to expand a biomarker qualification draft guidance to include patient-reported outcome tools has perplexed pharma stakeholders, which seem to think the agency would have been better off leaving well enough, and PROs, alone.
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
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.
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.
