Clinical Trials

Novartis' oral BTK inhibitor remibrutinib met its primary endpoint in the Phase III REMODEL-1 and REMODEL-2 trials, cutting annualized relapse rates versus teriflunomide in relapsing multiple sclerosis. #SyenzaNews #MultipleSclerosis #MarketAccess #Neurology

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

South Africa is preparing to register and introduce a new tuberculosis vaccine if late-stage Phase 3 trials succeed. Cabinet confirmed the plans this week and welcomed a Serum Institute of India agreement to manufacture TB vaccines for global distribution. #SyenzaNews #globalhealth #clinicaltrials #MarketAccess

EMA has authorised Ablymico, a synthetic liraglutide for weight management. The approval, granted on 15 July 2026, covers adults, adolescents and children from age six. Ablymico is bioequivalent to Saxenda but is produced by chemical synthesis rather than living cells. #SyenzaNews #MarketAccess #Obesity #GLP1

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

Hanmi Pharm has signed a licensing deal with Genentech for its novel obesity candidate HM17321, worth up to $2.3 billion. The UCN2 analog is designed to cut weight while preserving lean muscle mass, a gap GLP-1 therapies have not filled. #SyenzaNews #biotechnology #drugdevelopment #MarketAccess

Weill Cornell researchers have proposed ASTRA, a multi-agent system that would delegate routine clinical trial work to AI agents while human experts keep the final say on clinical and regulatory decisions.

The European Commission has approved Trodelvy plus Keytruda for first-line metastatic triple-negative breast cancer, making Trodelvy the first ADC-based backbone across PD-L1 status.

Merck and Moderna's individualized neoantigen therapy intismeran has cleared its first Phase 3, beating KEYTRUDA alone in resected high-risk melanoma. The open question now is how payers value a medicine made for one patient at a time.

📉 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

🧬 Could your gut microbiota reveal clues about psychopathic traits? New research highlights how distinct microbial profiles may serve as biomarkers, opening fresh paths for mental health diagnostics and targeted interventions in psychiatry. Explore the study’s implications for precision approaches to behavioral health. #SyenzaNews #biotechnology #precisionmedicine #innovation