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Recent Posts

SAHPRA SAPC Regulatory Enforcement: Addressing Unregistered GLP-1 and GIP Products
SAHPRA SAPC regulatory enforcement has intensified following the seizure of all GLP-1 and GIP injectable products at iDexis (Pty) Ltd trading as Sentra Pharmacy. An inspection on 11 May 2026 revealed the facility was manufacturing and distributing unregistered medicines containing semaglutide, ti...

Impact of MDR Software Regulations on Medical Device Innovation
MDR software regulations under the EU’s Medical Device Regulation (EU 2017/745) are creating heavy operational and financial pressures, according to a survey of 35 SaMD manufacturers listed in the EUDAMED database. Financial burdens hit 88.6 % of respondents at significant or severe levels, while...

Key Milestone in GBA-PD Therapy Development Achieved with ACTIVATE Study Completion
Bial announced the completion of the treatment period in its Phase 2b ACTIVATE study evaluating BIA 28-6156 (pariceract) in patients with Parkinson’s disease (PD) who carry a pathogenic mutation in the glucocerebrosidase 1 (GBA1) gene, referred to as GBA-PD. The 78-week double-blind treatment pha...