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KalVista’s Novel DME Approach Moves To Clinical Trials

 
• By John Davis

Britain’s KalVista believes it is pioneering the use of kallikrein inhibitors for diabetic macular edema, including orally active derivatives, as it moves its lead compound into U.S. clinical trials.

Around 50% of all diabetic macular edema (DME) patients are believed to have inadequate therapeutic responses to VEGF inhibitors such as Genentech Inc./Novartis AG’s Lucentis (ranibizumab) and Regeneron Pharmaceuticals Inc./Bayer AGEylea (aflibercept), a finding that has spurred KalVista Pharmaceuticals Ltd. to start a U.S. clinical trial with a potential DME therapeutic featuring a novel mechanism of action.

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More from United Kingdom

Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry

 
• By Leela Barham

Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.

Non-Submissions To England’s NICE Surge Across All Disease Areas

 
• By Leela Barham

Blood cancer therapies were most proportionately impacted by the failure of pharmaceutical companies to submit evidence on their cancer therapies to England’s health technology appraisal body, shows analysis by the Pink Sheet.

UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
• By Vibha Sharma

The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

UK MHRA Tackles Staff Burnout As It Eliminates Filings Backlog

 
• By Vibha Sharma

Efforts by the medicines regulator, the MHRA, to clear all backlogs relating to its statutory functions and maintaining predictable review timeframes have put pressure on its staff.

More from Europe

Non-Submissions To England’s NICE Surge Across All Disease Areas

 
• By Leela Barham

Blood cancer therapies were most proportionately impacted by the failure of pharmaceutical companies to submit evidence on their cancer therapies to England’s health technology appraisal body, shows analysis by the Pink Sheet.

UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
• By Vibha Sharma

The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

New EU Filings

 
• By Neena Brizmohun

Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.