Medical Device Innovation South Africa: Breaking Down Systemic Barriers
Medical device innovation South Africa is hindered by deep structural obstacles that prevent locally developed technologies from reaching patients, despite the country’s considerable technical expertise. South Africa’s medical technology sector remains trapped in a cycle of heavy import dependenc...
Expanding Access to Hormonal IUDs in South Africa through Generic Innovation
The launch of AVIBELA marks a significant milestone for hormonal IUD South Africa, introducing the country’s first generic levonorgestrel 52 mg intrauterine device. Developed by Medicines360 and commercialized in partnership with Pharma Dynamics, AVIBELA is more than 99% effective at preventing p...
Regulatory Divergence in PSMA Targeted Therapy: Implications for European Market Access
Novartis withdrew its European Medicines Agency (EMA) application to expand the indication for Pluvicto® (lutetium (177Lu) vipivotide tetraxetan). The company sought to include adult patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have not yet received chem...
PIONEER TEENS Trial Reveals Oral Semaglutide Diabetes Breakthrough for Pediatric Patients
Important results from the PIONEER TEENS phase 3a trial! Oral semaglutide diabetes therapy delivered statistically superior glycemic control compared with placebo in children and adolescents aged 10–17 years with type 2 diabetes. The trial met its primary endpoint with a 0.83% greater reduction i...
Terminal Complement Inhibition: Promising Results in IgAN from the I CAN Trial
Terminal complement inhibition with Ultomiris (ravulizumab) delivered a statistically significant and clinically meaningful reduction in proteinuria at week 34 in adults with immunoglobulin A nephropathy (IgAN) at high risk of progression. According to the prespecified interim analysis of the Pha...
Advancing Multicenter AKI Prediction: Benefits of Collaborative Models Over Localized Approaches
New evidence demonstrates that multicenter AKI prediction models significantly outperform locally trained single-center models for forecasting postoperative acute kidney injury (AKI) after cardiac surgery. The study, published in npj Digital Medicine, analyzed 43,926 cardiac surgery c...







