Amgen IMDELLTRA Monitoring Time Cut to 6-8 Hours as FDA Approves Label Update for ES-SCLC
The FDA has approved a label update cutting Amgen IMDELLTRA monitoring time for the first two doses from 22-24 hours to 6-8 hours, a change aimed at easing treatment burden for ES-SCLC patients in community oncology settings.
Novo Nordisk Rebrand: Company Unveils ‘Novo’ Name and ‘Lasting Health Starts Now’ Platform
The Novo Nordisk rebrand introduces the single ‘Novo’ brand name, a ‘Lasting Health Starts Now’ platform, and a new culture framework called The Novo Way, unveiled by CEO Mike Doustdar ahead of the company’s 21 September Capital Markets Day in London.
Johnson & Johnson RYBREVANT Amivantamab NSCLC Regimen Delivers Longest Reported Survival in EGFR Exon 20 Lung Cancer
Final PAPILLON trial results show Johnson & Johnson’s RYBREVANT (amivantamab-vmjw) plus chemotherapy achieved a 34.3-month median overall survival in EGFR exon 20 insertion-positive NSCLC — the longest reported to date in this historically hard-to-treat population.
AstraZeneca Enhertu DESTINY-Lung04 Trial Demonstrates 14.3-Month Median PFS in First-Line HER2-Mutant NSCLC
Results from the AstraZeneca Enhertu DESTINY-Lung04 Trial show a 37% reduction in risk of disease progression or death, establishing first-line efficacy for T-DXd in HER2-mutant non-small cell lung cancer.
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.