2. >>R&D

Viela Adds Momentum To Burgeoning NMOSD Market With Pivotal Inebilizumab Results

 
• By Jo Shorthouse

2019 could be the year when three drugs are approved for rare disease neuromyelitis optica, a previously untreatable condition. Viela Bio is the latest to announce positive data from pivotal trials of its monoclonal antibody inebilizumab.

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Viela's N-MOmentum trial results look to add treatment options for neuromyelitis optica patients • Source: Shutterstock

MedImmune LLC spin-off Viela Bio could be the third company within a year to produce encouraging pivotal study results for neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disease affecting the CNS, with no treatment options to date.

Inebilizumab, a monoclonal antibody (MAb) that binds with high affinity to CD19, a protein expressed on a broad range of B cells, met its primary and secondary endpoints in the pivotal N-MOmentum trial

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Insilico Fast-Tracks First AI-Designed TNIK Inhibitor Into Phase III For IPF

 
• By Dexter Jie Yan

InSilico will leapfrog Phase IIb to progress its AI-generated candidate for idiopathic pulmonary fibrosis directly into a Phase III trial in China, as it prepares for an IPO in Hong Kong.

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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.

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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.