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.
AstraZeneca Secures Etcamah Breast Cancer Approval in Combination With CDK4/6 Inhibitors for US Patients
AstraZeneca’s Etcamah (camizestrant) has won US FDA approval alongside CDK4/6 inhibitors for HR-positive, HER2-negative breast cancer patients who develop an ESR1 mutation before disease progression.
AbbVie’s Etentamig Multiple Myeloma Trial Meets Both Primary Endpoints in Phase 3 CERVINO Study
AbbVie’s Phase 3 CERVINO trial shows etentamig, an investigational BCMA x CD3 bispecific, significantly improved response rate and progression-free survival versus standard therapies in relapsed/refractory multiple myeloma.
AstraZeneca’s Enhertu EU Approval: Enhertu Plus Pertuzumab Cleared as First-Line Therapy for HER2-Positive Metastatic Breast Cancer
The European Commission has approved Enhertu plus pertuzumab as a first-line treatment for HER2-positive metastatic breast cancer, marking AstraZeneca and Daiichi Sankyo’s first new EU regimen in this setting in over a decade, backed by DESTINY-Breast09 data showing a 44% reduction in progression or death risk.
Lilly Merida Biosciences Acquisition: Eli Lilly to Pay $2.875 Billion for Precision Autoantibody Therapies
Eli Lilly will pay up to $2.875 billion to acquire Merida Biosciences, gaining a precision antibody-degradation platform led by Phase 1 candidate MER511 for Graves’ disease and thyroid eye disease.
Roche Vabysmo PCV Study Shows Sustained Two-Year Results in Difficult-to-Treat nAMD Subtype
New two-year data from Roche’s Phase IIIb/IV SALWEEN trial show that Vabysmo (faricimab) delivers durable vision gains and disease control in Asian patients with polypoidal choroidal vasculopathy (PCV), a severe subtype of neovascular age-related macular degeneration, while cutting treatment visits for the majority of patients.
TEZSPIRE Eosinophilic Esophagitis Trial: Amgen, AstraZeneca Report Positive Phase 3 CROSSING Results
Amgen and AstraZeneca announced that TEZSPIRE (tezepelumab-ekko) achieved statistically significant and clinically meaningful results across both co-primary endpoints and all key secondary endpoints in the Phase 3 CROSSING trial in eosinophilic esophagitis, with benefits sustained through week 52.
Abbott Libre Duo 10 Day Wins FDA Authorization as World’s First Dual Glucose-Ketone Sensor
Abbott Libre Duo 10 Day has received FDA authorization as the world’s first dual glucose-ketone biowearable, designed to alert people with diabetes to rising DKA risk while tracking glucose in real time.