Rolontis, a novel, long-acting granulocyte colony-stimulating factor (G-CSF) licensed out to Spectrum Pharmaceuticals, has become Hanmi Pharmaceuticals' first drug developed with its proprietary platform to approach the regulatory filings stage in global markets.
Spectrum Pharmaceuticals Inc. plans to file a BLA of its novel neutropenia drug to the US FDA in the fourth quarter of this year as the first Phase III study of Rolontis (eflapegrastim), ADVANCE, has met its primary endpoint of non-inferiority in duration of severe neutropenia in comparison to pegfilgrastim.
In January 2012, Spectrum entered into a licensing agreement with originator Hanmi Pharmaceutical Co. Ltd
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.
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.
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.’
Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.
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.
HTX-001 targeting the long non-coding RNA known as Wisper is being developed for non-obstructive hypertrophic cardiomyopathy. HAYA partnered with Lilly last year in obesity.
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.’
