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Respiratory

Set Alert for Respiratory

Sanofi Secures World First Approval For Dupixent In COPD With EU Nod

The French drugmaker can now boast seven approvals for its huge-earning IL-4/IL-13 inhibitor.

Respiratory Approvals

Victory For Verona As FDA Approves Potential COPD Blockbuster

The respiratory specialist is set to hit the ground running with Ohtuvayre, the first COPD inhaled product with a novel mechanism of action to be approved in over two decades.

Respiratory Approvals

Savara’s Persistence May Pay Off In Rare Lung Disease

Five years after a Phase III failure, Savara reports pivotal data supporting approval of molgramostim as the first drug for autoimmune pulmonary alveolar proteinosis.

Clinical Trials Drug Approval Standards

Cagrisema Leads The Charge For 2025

2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.

Launches Companies

Dupixent Gets A Yes For COPD From The CHMP

Sanofi and Regeneron could have the first biologic on the market for COPD – and a potentially better one is in the works.

Approvals Respiratory

Insmed Planning 2025 Launch For Brensocatib In Bronchiectasis

The drug maker anticipates a smooth regulatory path and has already begun to rapidly expand its sales force across most of the US.

Clinical Trials Business Strategies

AstraZeneca Advancing Respiratory Aspirations In China

The company is adopting a two-pronged strategy to capitalize on its presence in the country to expand the market for its inhaled therapies and biologics for asthma and COPD.

China Respiratory

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: Biogen’s immunology acquisition; AstraZeneca looks to cement respiratory lead; why US FTC is tough on pharma; the US election’s impact on pharma; and how new AI tools are impacting medical affairs. 

M & A Commercial

GSK Tailors SWIFT Readout Towards Asthma Approval

The twice-yearly depemokimab will soon head to the regulators, but it will need to succeed repeatedly if it is to make the £3bn peak sales GSK is hoping for.

Clinical Trials Respiratory

Amgen/AstraZeneca’s Tezspire Shows Efficacy In Broader COPD Population

Anti-TSLP antibody Tezspire (tezepelumab) showed efficacy in a Phase IIa study versus placebo in COPD patients with lower eosinophil levels than those tested in Dupixent’s pivotal studies.

Clinical Trials Respiratory

Endeavor Rockets Ahead With IPF Drug After Phase IIa Results

The biotech plans to run a Phase II study of ENV-101 in IPF and PPF, followed by a Phase III study that would start in 2026.

Clinical Trials Business Strategies

AstraZeneca Confident Of Cementing Lead In Respiratory

The UK major’s head of respiratory and immunology, Pablo Panella, tells Scrip that AstraZeneca’s well established presence in the field “gives us an edge.”

Respiratory Clinical Trials

J&J Gets Into The Anti-TSLP Game With Proteologix Buyout

The privately held biotech will bring J&J a pair of bispecific antibodies expected to target multiple pathologic pathways in atopic dermatitis and asthma.

M & A Business Strategies

With Blackstone’s $300m, Uniquity Will Take On Tezspire In Respiratory Disease

Built around a TSLP-targeted antibody licensed from Merck, Uniquity begins with $300m from Blackstone to fund Phase II in asthma and COPD. But other anti-TSLP competition looms.

Financing Business Strategies

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: AstraZeneca’s Vaxzevria farewell; the next wave of cardiometabolics; Pfizer recruits prominent analyst: foundation pleas for China rare disease therapies; and Gossamer partners up for respiratory therapy.

Coronavirus COVID-19 Vaccines

Gossamer Partners With Chiesi To Accelerate Seralutinib Development

Already in Phase III for PAH, Gossamer said it can take seralutinib into Phase III for PH-ILD at least four years earlier than planned under its alliance with respiratory disease expert Chiesi.

Deals Strategy
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