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Aeglea’s Rare Disease Asset Succeeds At Phase III, In Line To Become First Product

BLA Filing Expected Next Year

 
• By Ayisha Sharma

The firm’s lead candidate has shown promise in a pivotal rare disease study, setting it on track for an upcoming BLA catalyst which could lead to Aeglea’s first approved product.  

Child On Bed With IV
Pegzilarginase Was Given Intravenously To Children Aged Two And Up. • Source: Alamy

Aeglea BioTherapeutics, Inc.’s pegzilarginase has met the primary endpoint in the Phase III arginase 1 deficiency (ARG1-D) PEACE study, supporting a US filing in the first half of 2022 which could lead to the company’s first approval.

Besides a biologics license application with the US Food and Drug Administration anticipated in the first half of 2022, the Austin, TX-headquartered biotech will also work with its Swedish commercial partner, Immedica AB, to submit

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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

 
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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

 
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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.’

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

 
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Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
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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.