Innovative Medicines And Medical Devices

The United States has added nine more manufacturers to its most-favored-nation drug pricing program, taking the total to 26 companies that now cover 89% of the branded drug market. #MarketAccess #DrugPricing #Pharma

Cipla has licensed Sino Biopharm's HER2 biparatopic ADC TQB2102 for India, South Africa and five other emerging markets. The deal caps at USD 123 million plus double-digit royalties, with access to HER2-low breast cancer as the core case. #SyenzaNews #Oncology #MarketAccess #DrugDevelopment

Insurers are spending billions on breakthrough medicines, but the tests that decide who gets them are still an afterthought. Kathryn Phillips lays out four reforms to link drug and diagnostic policy pathways. #SyenzaNews #diagnostics #healtheconomics #MarketAccess

The FDA has cleared Abbott's Libre Duo 10 Day, the first continuous glucose ketone monitor that tracks ketones and glucose every minute to flag diabetic ketoacidosis risk before it becomes an emergency. #SyenzaNews #Diabetes #MedicalDevices #MarketAccess

The FDA has opened a public consultation on regulating generative AI medical devices, proposing a two-axis risk framework and a competency-based approach to premarket review. Comments close 19 October 2026.

📉 Why are EMA orphan authorisations set to drop in 2026? Latest statistics reveal a significant decline in orphan medicinal product authorisations by the European Medicines Agency, raising questions about the future pipeline for rare disease therapies. This trend could reshape drug development priorities across Europe. Read the full analysis to understand the implications for patients and industry. #SyenzaNews #pharmaceuticals #regulatoryaffairs #innovation #MarketAccess

The NICE Decision Support Unit and EEPRU have released updated Stata, Excel and R commands for mapping EQ-5D-3L data to the new EQ-5D-5L value set, giving UK HTA analysts a validated route to convert legacy three-level utility data ahead of NICE's adoption of the five-level value set.

💰 Is pembrolizumab delivering high value for HNSCC in Switzerland? A new analysis confirms the immunotherapy offers strong cost-effectiveness, supporting smarter resource allocation and improved patient outcomes in oncology. Explore the full economic evaluation and its implications for market access. #SyenzaNews #oncology #HealthEconomics #costeffectiveness #MarketAccess

Is tirzepatide delivering better value than semaglutide for patients and payers? A fresh analysis shows how tirzepatide can drive greater cost savings alongside improved health outcomes in obesity and type 2 diabetes management. Discover the key findings shaping treatment and reimbursement decisions. #SyenzaNews #pharmaceuticals #HealthEconomics #costeffectiveness

❓ How is Portugal’s approval of ublituximab reshaping access to multiple sclerosis therapies? The decision introduces new restrictions that could limit patient options and complicate market entry for innovative MS treatments. Explore the full implications for healthcare access and regulatory strategy. #SyenzaNews #pharmaceuticals #HealthcareInnovation #MarketAccess #healthcarepolicy

Is the PRIME scheme growing more exclusive for innovative medicines? Eligibility criteria for the European Medicines Agency’s PRIME scheme remain highly selective in 2026, underscoring the rigorous standards required to secure early regulatory support for therapies addressing unmet medical needs. Discover what this means for drug developers and patients. #SyenzaNews #regulatoryaffairs #drugdevelopment #innovation #MarketAccess

Portugal's INFARMED has blocked public funding for Datroway in breast cancer, citing insufficient added value.