Roche Tam-Peli SCLC Data Show 54% Reduction in Death Risk in Phase III TAISHAN-302 Trial
Roche’s collaborator MediLink reported phase III TAISHAN-302 data showing Tam-Peli (tambotatug pelitecan) reduced the risk of death by 54% versus topotecan in Chinese patients with relapsed small-cell lung cancer, meeting its primary endpoint with a favorable safety profile.
GSK Ris-Rez SCLC Data: Phase III Trial Cuts Risk of Death by 54% Versus Topotecan
GSK’s B7-H3-targeted ADC Ris-Rez cut the risk of death by 54% versus topotecan in the Phase III ARTEMIS-008 trial in relapsed small cell lung cancer in China, with a median overall survival of 18.5 months and fewer severe side effects than chemotherapy.
AstraZeneca Etcamah SERENA-4 Trial Misses Primary Endpoint in First-Line Breast Cancer Study
AstraZeneca’s Phase III SERENA-4 trial of Etcamah (camizestrant) plus palbociclib missed statistical significance for progression-free survival in first-line advanced ER-positive breast cancer, though a numerical benefit was observed. The company says the miss sharpens its focus on ESR1-mutation-driven use of Etcamah under its existing SERENA-6 approval, with safety unchanged from each medicine’s known profile.
Kyowa Kirin KHK4951 Eye Drops Report Phase 2 nAMD Data as Primary Endpoint Is Missed
Kyowa Kirin KHK4951 eye drops missed their Phase 2 primary endpoint in neovascular age-related macular degeneration, though most patients maintained vision through Week 52 with no new safety signals in Study 4951-002.
Roche Enspryng MOGAD Filing Wins FDA Priority Review as First Potential Treatment for Rare Neuroimmune Disease
The FDA has granted Priority Review to Roche’s Enspryng (satralizumab) for MOGAD, a rare autoimmune CNS disease with no approved treatments, after Phase III METEOROID data showed a 68% relapse risk reduction.
Charles River Endosafe Cartridge Manufacturing Goes Fully Automated at Massachusetts Facility
Charles River Laboratories has completed automation of its Endosafe Cartridge Technology manufacturing suite in Wilmington, Massachusetts, reporting double-digit gains in productivity, capacity and product consistency ahead of full operational scale-up in Q3 2026.
Amgen: IMDELLTRA Imfinzi Combination Delivers Landmark Survival Gain in DeLLphi-305 Trial
Amgen’s Phase 3 DeLLphi-305 trial shows the IMDELLTRA Imfinzi combination delivers a statistically significant, clinically meaningful overall survival benefit as first-line maintenance therapy in extensive-stage small cell lung cancer, alongside gains in progression-free survival and response rate.
Semaglutide Childhood Obesity Trial Meets Primary Endpoint as Novo Nordisk’s STEP Young Study Shows 40.4% of Children No Longer Classified as Having Obesity
Novo Nordisk’s phase 3 STEP Young trial found that 40.4% of children aged 6 to under 12 treated with once-weekly semaglutide were no longer classified as having obesity after 68 weeks, versus none on placebo — a first efficacy readout for semaglutide in this young age group.
Novartis Pelacarsen Lp(a)HORIZON Trial Results: Phase III Study Misses Primary Cardiovascular Endpoint
Novartis announced pelacarsen Lp(a)HORIZON trial results on September 4, 2026, revealing that the Phase III cardiovascular outcomes study did not meet its primary endpoint, even though the investigational therapy lowered Lp(a) levels in more than 8,300 patients with established cardiovascular disease.
IQVIA Predictive Clinical Development Cuts Trial Delays With AI-Powered Approach
IQVIA has launched IQVIA Predictive Clinical Development, an AI-powered platform built with Anthropic, AWS, Databricks, Microsoft, NVIDIA, Palantir and Snowflake, designed to help sponsors bring new therapies to market up to two years faster.