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ALIS In Wonderland: Insmed Reaches Fairy Tale Heights On Lung Disease Results

 
• By Mandy Jackson

Insmed will commercialize ALIS, its inhaled amikaycin formerly known as Arikayce, on its own for a rare, bacteria-driven lung disease if the company can win accelerated approval based on new Phase III results.

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Insmed Inc.'s stock more than doubled after it reported positive Phase III results for its amikacin liposome inhalation suspension (ALIS) in patients with a rare lung disease, which it hopes could lead to an even wider market.

Bridgewater, NJ-based Insmed said on Sept. 5 that ALIS plus guideline-based therapy (GBT) met its primary endpoint of culture conversion by month six in adult patients with treatment-refractory nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) – a population of about 26,400 to 34,400 patients in the US, Japan and top five EU markets (EU5)

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Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 
• By Andrew McConaghie

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

More from R&D

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By Joseph Haas

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.