PhII suggests biomarker-indication for Roche advanced AMD drug
This article was originally published in Scrip
Executive Summary
Roche's lampalizumab has met its Phase II primary endpoint in the MAHALO study, slowing the progression of geographic atrophy – an advanced form of dry age-related macular degeneration (dry AMD). The bad news: significant efficacy was only seen in patients dosed monthly (so patients won’t be able to dose once every other month to reduce the number of times they have to have needles stuck in their eyes). But the good news for Roche is that the drug seemed to perform twice as well in a biomarker-defined subset of patients.
You may also be interested in...
Roche's Dry AMD Drug Lampalizumab Delivers Disappointment In Phase III
Analysts had already been doubtful about the prospects for success in the Spectri study. A second Phase III trial is ongoing, but the candidate is already being removed from revenue models.
WuXi eases CAR-T manufacturing burden with new US plant
China's WuXi PharmaTech, an R&D technology company serving the pharmaceutical, biotechnology and medical device industries, has announced construction of a new manufacturing facility in Philadelphia, US designed for cell therapy products, including chimeric antigen receptor T-cell (CAR-T) therapies. More manufacturing power is crucial to the success of this burgeoning, high-potential field.
NICE lifts Entyvio restrictions after Takeda offers discount
Takeda has managed to persuade NICE, the health technology appraisal institute for England and Wales, to recommend its ulcerative colitis drug Entyvio (vedolizumab) without the restrictions the institute had previously stipulated – as long as the company offers a discount via a patient access scheme.