Clinical Trials

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

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

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

Novo Nordisk has stopped the two remaining ziltivekimab heart failure trials after a futility review, leaving ARTEMIS as the last anti-inflammatory cardiovascular outcomes bet. #SyenzaNews #MarketAccess #Cardiology #HTA

Aspen Pharmacare has walked away from local lenacapavir manufacturing over the lack of guaranteed volumes, and is instead backing Merck's once-monthly oral PrEP pill, alimatravir. #SyenzaNews #HIV #PrEP #MarketAccess

EMA's voluntary pre-submission pilot opens in September 2026. It adds earlier, more structured dialogue between applicants, rapporteurs and the Agency to curb premature filings. #SyenzaNews #MarketAccess #RegulatoryAffairs

The RECOVER-VITAL trial found nirmatrelvir-ritonavir offered no benefit for long COVID across cognitive, autonomic, or exercise symptoms. The study also shows why placebo controls matter: a large share of the placebo group improved on their own. #SyenzaNews #LongCOVID #ClinicalTrials #MarketAccess

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