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 reviewMATINEE assessed Nucala (n=403; 100mg, SC, Q4W) vs PBO (n=401) in COPD pts (n=804) with type 2 inflammation while METREX evaluated it…

ByRidhi RastogiMay 23, 2025

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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 therapyApproval 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)…

ByRidhi RastogiMarch 28, 2025

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…

ByRidhi RastogiFebruary 20, 2025

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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…

BySaurabh ChaubeyOctober 8, 2024

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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…

BySaurabh ChaubeySeptember 30, 2024

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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…

BySaurabh ChaubeyJuly 3, 2024

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Verona Pharma’s Ohtuvayre (Ensifentrine) Receives the US FDA’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Shots: The US FDA has approved Ohtuvayre as a maintenance therapy to treat COPD patients, with its launch anticipated in Q3’24 The approval was based on the P-III (ENHANCE-1 & ENHANCE-2) studies analyzing Ohtuvayre monotx. or in addition with other maintenance therapies. Trials reached their 1EPs showing improved lung function; results were published in the…

ByDipanshu DixitJune 26, 2024

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PharmaShots Interview: Kaia Health’s Konstantin Mehl Shares Insight on the Funding to Transform the Treatment for MSK and COPD

In an interview with PharmaShots, Konstantin Mehl, President, CEO, and Founder at Kaia Health shared his views on the grant of $75M Series C funding to expand clinical capabilities & transform the treatment path for musculoskeletal (MSK) and chronic obstructive pulmonary disease (COPD) care in the US and EU.Shots:The funding will extend the offering within EU and…

BySenior EditorAugust 11, 2021

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PharmaShots Interview: Organicell’s Dr. Maria Ines Mitrani Shares Insights on the Zofin for COVID-19

In an interview with PharmaShots, Mari Mitrani, Chief Science Officer of Organicell shares her views on the positive results from the first ten COVID-19 patients treated with Zofin in India.Shots:This initial trial is being conducted in conjunction with Organicell's Indian partner, CWI India, which has entered into a product testing and distribution agreement with Organicell…

BySenior EditorJune 15, 2021

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PharmaShots Interview: Kaia Health’s Jonas Duss Shares Insights on COPD Pulmonary Rehabilitation App

In a recent interview with PharmaShots, Jonas Duss, US CEO and Co-Founder at Kaia Health shared his views on the Kaia Health's COPD Pulmonary Rehabilitation App and their collaboration with Chiesi Group to commercialize the app in EU.Shots:Kaia Health signs an exclusive agreement with Chiesi Group to commercialize the Kaia Health COPD Pulmonary Rehabilitation…

BySenior EditorJanuary 19, 2021

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

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

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

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

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

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

Verona Pharma’s Ohtuvayre (Ensifentrine) Receives the US FDA’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

PharmaShots Interview: Kaia Health’s Konstantin Mehl Shares Insight on the Funding to Transform the Treatment for MSK and COPD

PharmaShots Interview: Organicell’s Dr. Maria Ines Mitrani Shares Insights on the Zofin for COVID-19

PharmaShots Interview: Kaia Health’s Jonas Duss Shares Insights on COPD Pulmonary Rehabilitation App

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