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AstraZeneca & Ionis
NEWS

AstraZeneca and Ionis’ Wainzua (Eplontersen) Receives the EC’s Approval to Treat Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy

Shots: The EC has approved Wainzua to treat ATTRv-PN (stage 1/2 polyneuropathy) in adults pts based on P-III (NEURO-TTRansform) trial assessing eplontersen vs external PBO over 66wks., with follow-up to Wk. 85 & an end-of-trial evaluation. Eligible pts could then enter an ongoing OLE study Trial showed sustained benefits in co-1EPs of serum transthyretin…
March 11, 2025

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Astrazeneca
NEWS

AstraZeneca Reports P-III (MATTERHORN) Trial Data of Imfinzi as Perioperative Therapy for Stage II-IVA G/GEJ Cancers

Shots: AstraZeneca has reported P-III (MATTERHORN) trial data assessing perioperative Imfinzi + FLOT (fluorouracil, leucovorin, oxaliplatin, & docetaxel) vs PBO + FLOT in 948 pts with stage II-IVA G/GEJ cancers Pts received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles before surgery followed by Imfinzi or PBO for Q4W × 12…
March 7, 2025

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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports Interim Data of P-III (DESTINY-Gastric04) Study Evaluating Enhertu in HER2+ Metastatic Gastric Cancer Patients

Shots: The data from P-III (DESTINY-Gastric04) study showed statistically significant and clinically meaningful improvement in OS vs ramucirumab & paclitaxel in 2L HER2+ (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma pts. The safety profile observed in DESTINY-Gastric04 aligns with Enhertu's established safety record. The company expects to present data…
March 4, 2025

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Viewpoints_Caterina Brindicci
VIEWPOINTS

Enhancing Autoimmune Care: Caterina Brindicci from AstraZeneca in a Riveting Conversation with PharmaShots

Shots:   SLE-related diseases like CLE and IIM are characterized by strong type I interferon involvement. The proven efficacy of Saphnelo (anifrolumab) in SLE lays the foundation for its potential use in CLE and IIM  Recently, AstraZeneca initiated two new P-III trials, LAVENDER and JASMINE, to evaluate Saphnelo in cutaneous lupus erythematosus and idiopathic inflammatory myopathies …
March 3, 2025

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Astrazeneca
NEWS

AstraZeneca Reports Interim Data from P-III (SERENA-6) Trial of Camizestrant to Treat Advanced Breast Cancer

Shots: The P-III (SERENA-6) trial assessed camizestrant + CDK4/6 inhibitor (palbociclib/ribociclib/abemaciclib) vs AI (anastrozole/letrozole) + CDK4/6 inhibitor in 315 pts with LA/M HR+/HER2- breast cancer harboring ESR1 mutation SERENA-6 used ctDNA-guided approach to monitor ESR1 mutations at routine scans for the early detection of endocrine resistance, allowing pts to switch to camizestrant before disease…
February 26, 2025

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Viewpoints_Mina Makar
VIEWPOINTS

A Retrospective Analysis on Cardiac Amyloidosis: Mina Makar from AstraZeneca in an Illuminating Conversation with PharmaShots

Shots:  A UK observational study spanning 17 years shows a 2.9-fold increase in Cardiac Amyloidosis diagnoses, highlighting significant progress in awareness among healthcare professionals and advancements in diagnostic tools  The study underscores the importance of improving the identification and treatment of Cardiac Amyloidosis, particularly in cases with overlapping conditions such as heart failure  Mina Makar,…
February 24, 2025

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Astrazeneca
NEWS

AstraZeneca Presents Post-Hoc Data from P-III (NIAGARA) Trial of Imfinzi in Muscle-Invasive Bladder Cancer Patients regardless of Complete Pathology Response at ASCO GU 2025

Shots: The P-III (NIAGARA) trial assessed Imfinzi (4 cycles + neoadj. CT; then 8 cycles alone) vs CT with surgery in MIBC pts ± pCR; ongoing regulatory review in the US, EU, Japan & other areas Trial met its 2EPs of improved MFS (75.1% vs 65.1%) & DSS (89.2% vs 82.2%) in ITT pts (N=1063)…
February 17, 2025

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Astrazeneca
NEWS

AstraZeneca Reports CHMP Positive Opinion for Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Shots: The CHMP has recommended Imfinzi for the treatment of LS-SCLC pts whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions Opinion was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by Imfinzi…
February 6, 2025

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