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Lilly Breathing Down Amgen/Novartis's Necks With Three Phase III Migraine Wins

 
• By Mandy Jackson

Lilly will seek FDA approval in the second half of 2017 for CGRP inhibitor galcanezumab based on three positive Phase III studies – within months of a filing for Amgen's and Novartis's CGRP inhibitor erenumab.

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Eli Lilly & Co.'s filing for US FDA approval of galcanezumab based on positive Phase III results in chronic and episodic migraines will follow close on the heels of Amgen Inc.'s BLA for the competing Novartis AG-partnered CGRP inhibitor erenumab, but it's just the first of three opportunities as Lilly builds out a headache franchise.

The company reported on May 12 that galcanezumab, which inhibits calcitonin gene-related peptide (CGRP) while erenumab targets the CGRP receptor, provided statistically significant reductions in monthly headache days for episodic migraine sufferers in the EVOLVE-1 and EVOLVE-2 trials and for chronic migraine patients in the REGAIN study

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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.’

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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.