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NEWS

Akeso Receives NMPA Approval to Initiate P-II Trials of AK139 Across Seven Indications

Shots: The Chinese NMPA has approved the initiation of P-II trials of AK139 across seven indications, incl. COPD, severe bronchial asthma, chronic spontaneous urticaria, allergic rhinitis, CRSwNP, mod. to sev. atopic dermatitis, & prurigo nodularis AK139 is an IL-4Rα/ST2 bispecific antibody that blocks both the IL-4/IL-13 pathway via binding to IL-4Rα subunit & the IL-33/ST2…
February 11, 2026

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NEWS

GSK Reports the EC Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The EC has approved Nucala as an add-on maintenance treatment of adults with uncontrolled COPD characterised by raised blood eosinophils phenotype on a combination of an inhaled corticosteroid, a long-acting beta2-agonist (LABA), & a long-acting muscarinic antagonist Approval was based on the P-III (MATINEE) trial assessing Nucala (100mg, SC, Q4W; n=403) vs PBO (n=401)…
February 6, 2026

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NEWS

GSK Reports the NMPA Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The Chinese NMPA has approved Nucala as an add-on maintenance treatment of adults with inadequately controlled COPD characterised by eosinophilic phenotype based on the P-III (MATINEE & METREX) trial; EMA filing is under review MATINEE assessed Nucala (100mg, SC, Q4W) vs PBO in COPD pts (n=804) with type 2 inflammation while METREX evaluated it…
January 5, 2026

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GSK New
NEWS

GSK Reports the US FDA’s Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The US FDA has approved Nucala as an add-on treatment for inadequately controlled COPD & eosinophilic phenotype based on the P-III (MATINEE & METREX) trial; EMA & NMPA’s submissions are under review MATINEE assessed Nucala (n=403; 100mg, SC, Q4W) vs PBO (n=401) in COPD pts (n=804) with type 2 inflammation while METREX evaluated it…
May 23, 2025

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Sanofi & Regeneron
NEWS

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Shots: Japan’s MHLW has approved Dupixent to treat COPD in adults whose disease is inadequately controlled with existing therapy Approval was based on P-III (BOREAS) trial assessing Dupixent + SoC vs PBO in uncontrolled COPD adults with elevated blood eosinophils, which showed reduced exacerbations & improved lung function; data from BORUS & its replicate P-III (NOTUS)…
March 28, 2025

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GSK
NEWS

GSK Reports the China’s NMPA Acceptance of Nucala (Mepolizumab) as an Add-on Treatment for COPD

Shots: China’s NMPA has accepted the NDA for Nucala as an add-on treatment for COPD with eosinophilic phenotype based on P-III (MATINEE) study; global regulatory filings is ongoing The MATINEE study assessing Nucala (100mg, Q4W, SC) vs PBO in addition to inhaled triple therapy in COPD pts (n=804) with type 2 inflammation achieved its 1EP, showing…
February 20, 2025

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Viewpoints_Dr. Robert Fogel_Janet Franklin_Dr. Dave Singh
VIEWPOINTS

ATS 2024: Robert Fogel, Janet Franklin, and Dave Singh from AstraZeneca & Amgen in Conversation with PharmaShots

Shots:  Recently AstraZeneca and Amgen presented the results in late-breaking session from the COURSE trial, a proof-of-concept study evaluating tezepelumab in COPD  The PoC study was carried out in people with moderately to very severe COPD with a broad range of eosinophil levels  Today, at PharmaShots we have Robert Fogel from AstraZeneca, Janet Franklin from…
October 8, 2024

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Viewpoints_Robert Fogel_Dave Singh
VIEWPOINTS

AstraZeneca at ATS’24: Robert Fogel & Dave Singh in a Stimulating Conversation with PharmaShots

Shots:  Cardiopulmonary events associated with COPD are responsible for an increasing mortality rate in COPD patients. ETHOS trial, a posthoc analysis navigates BGF’s impact on a wide range of cardiopulmonary outcomes beyond COPD exacerbations  The post-hoc analysis reveals that AstraZeneca’s Breztri led to a 20% reduction in the risk of severe cardiopulmonary events. AstraZeneca is currently…
September 30, 2024

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Viewpoints_Andrew Menzies-Gow
VIEWPOINTS

AstraZeneca at ATS’24: Andrew Menzies-Gow from AstraZeneca in a Stimulating Conversation with PharmaShots

Shots:  AstraZeneca presented 59 abstracts, including 12 late-breaking posters at the American Thoracic Society, focussing on the unmet needs in COPD, EGPA, and other chronic respiratory diseases  Today, at PharmaShots, we have Andrew Menzies-Gow, sharing insights from the MANDARA study that evaluated Fasenra (benralizumab) for EGPA, a rare debilitating condition  Andrew stresses reducing the use…
July 3, 2024

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