
SAHPRA’s Friday deadline: why companies should, and should not, join the device-registration test
SAHPRA has opened Phase 2 of its medical device registration feasibility study, with expressions of interest due by 16:30 on Friday 18 September 2026. The test is voluntary and unpaid, but it is a rare chance to shape how South Africa registers devices before the process becomes mandatory. #SAHPRA #MedicalDevices #RegulatoryAffairs #MarketAccess
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AI in health technology assessment: what stays human
Alec Morton of NUS explains how AI is changing health technology assessment, what stays human, and why cheaper analysis could mean more health economics.

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Rewarding Quality, Not Just Price: What the EU Public Procurement Act Means for Medicines
The European Commission’s EU Public Procurement Act would make quality, not price, the default for public tenders. EFPIA supports the shift, with one warning: resilience should not become local-content rules. #SyenzaNews #EUProcurement #Medicines #MarketAccess #HealthPolicy

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UK Commission Sets Out a Framework for AI Healthcare Regulation
An independent UK commission has published its recommendations for regulating AI in healthcare. The report calls for staged approvals and continuous real-world monitoring, alongside stronger enforcement powers for the MHRA. #SyenzaNews #AI #Healthcare #MarketAccess

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AI in Portuguese Healthcare: What Should Portugal Want It to Do?
Nova SBE’s Saúde em Perspetiva podcast asks what Portugal’s National Health Service should want from AI, and where the red lines sit. #SyenzaNews #DigitalHealth #AIinHealthcare

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Sandoz Bio100 Biosimilars Plan Targets 100 Products by 2040 and Doubles 2025 Sales by 2035
Sandoz has put a date on its golden decade for biosimilars. The Bio100 plan targets more than 100 biosimilars by 2040, about 80% coverage of biosimilar-addressable LoE value from 2035, and a doubling of 2025 net sales. #SyenzaNews #MarketAccess #Biosimilars #ValueCreation

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Semaglutide Linked to Fewer Asthma Attacks and COPD Exacerbations in UK Records
Real-world UK data presented at ERS 2026 link semaglutide to fewer asthma attacks and COPD exacerbations. The indication stays metabolic, but the signal raises a real question for value and access teams. #SyenzaNews #MarketAccess #GLP1 #Respiratory

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FDA Grants Accelerated Approval to Camizestrant for ESR1-Mutated Breast Cancer
Camizestrant (Etcamah) gains accelerated FDA approval for ESR1-mutated advanced breast cancer, with median progression-free survival of 16 months versus 9.2 months in SERENA-6. #SyenzaNews #BreastCancer #FDA #Oncology

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South Africa Initiates 55,123 People on Twice-Yearly Lenacapavir PrEP
South Africa has initiated 55,123 people on twice-yearly lenacapavir PrEP in the programme’s first 94 days. Demand is strongest in Gauteng and KwaZulu-Natal; branded supply, second-dose retention and the 2027 generic tender are the real constraints. #SyenzaNews #HIVPrevention #Lenacapavir #MarketAccess

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Novartis and The Max Foundation Mark 25 Years of Cancer Access in LMICs
Novartis and The Max Foundation mark 25 years of partnership that has delivered cancer treatment to more than 100,000 patients across 71 LMICs. The next test is whether the model can carry a broader oncology portfolio and transition to country funding.
#SyenzaNews #MarketAccess #GlobalHealth

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Proteomic aging clocks detect biological age reversal in IPF drug trial
An Insilico Medicine phase 2a trial found six proteomic aging clocks all detected lower biological age in patients treated with rentosertib, an AI-designed drug for idiopathic pulmonary fibrosis. #SyenzaNews #Proteomics #AgingClocks #DrugDiscovery #IPF
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