Respiratory

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.  

As More DLL3 Bispecifics Advance, Doctors Are Adjusting To CRS, ICANS

 
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Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.

Novo Nordisk’s Semaglutide Shows Promise In Hidradenitis Suppurativa

 

An academic study of GLP-1 agonist showed promise in patients with the painful skin condition but with no signs that the Danish drugmaker will pursue the indication, smaller players in the space may be interested.

Syros’s AML Failure Sparks MDS Program Jitters, But Fears May Be Overblown

 

Discontinuation of the AML study created concern about potential readthrough to a pivotal MDS trial, but the company and analysts pointed out differences in the diseases.


Pierre Fabre Pushes To Be Partner Of Choice For Budding Biotechs

 
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Francesco Hofmann, head of R&D at the mid-sized French group, tells Scrip that its strategy of not playing in the spaces that are dominated by big pharma is paying off.

Galderma Gets First Biologic To Market With Nemluvio Approval

 

Nemluvio is a first-in-class IL-31 inhibitor that the US FDA approved for prurigo nodularis.

ARS Gets Early FDA Approval For Needle-Free Epinephrine

 
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ARS will compete directly with EpiPen and other injectable products with inhaled neffy as the first needle-free epinephrine therapy for severe allergy attacks. EU approval is thought imminent.

GSK Raises Its Guidance For Everything Except Vaccines

 

Second quarter revenues are up but RSV jab woes drag on the company’s stock.    


Flagship Inks Another Big Pharma Development Deal, This Time With GSK

 

The deal includes up to 10 medicines, with an initial focus on immunology and respiratory diseases, and is similar to one the VC firm made with Pfizer last year.

Boehringer Looks To Revitalise Its Pipeline

 

With sales of its big sellers Jardiance and Ofev to start shrinking in the next few years, the German group is teeing up a suite of new drugs.    

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

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

Victory For Verona As FDA Approves Potential COPD Blockbuster

 
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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.


Savara’s Persistence May Pay Off In Rare Lung Disease

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

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.    

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.

AstraZeneca Advancing Respiratory Aspirations In China

 
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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.


Quick Listen: Scrip's Five Must-Know Things

 
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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. 

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.    

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

 
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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.

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.