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GSK/ChemoCentryx Crohn’s Failure May Sink Hefty Phase III Program

 
• By Shirley Haley

SHIELD-1 failure puts the entire 2,500-patient plus Phase III clinical program in limbo as GSK rethinks its Crohn’s disease approach and partner ChemoCentryx’s stock loses close to half its value.

Just a week after the approval for the HIV therapy Tivicay under GlaxoSmithKline PLC’s joint venture with Pfizer Inc. – ViiV Healthcare – GSK’s plans for a surge in new drug launches hit a snag with the Phase III failure of the pharma giant’s oral Crohn’s disease therapy vercirnon, licensed from ChemoCentryx Inc.

Vercirnon, a specific CCR9 chemokine receptor inhibitor, was on a list of assets that GSK has pointed to as early...

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Speed, Reach And Impact: New Metrics To Drive EU Clinical Trials Reform

 
• By Vibha Sharma

Clinical trials in the EU will be measured against new benchmarks from 2026 to identify how the bloc’s clinical research environment compares with that of other regions, and to identify areas for improvement.

HHS Long COVID Initiative Will Focus On ‘Front Line’ Approach To Treatment

 
• By Cathy Kelly

A project to advance effective treatments for long COVID was framed as a high priority for HHS Secretary Robert F. Kennedy Jr.

Do Policy, Clinical Data, Ocaliva Exit Lend Zydus Helping Hands?

 
• By Vibha Ravi

Intercept’s Ocaliva withdrawal in the US places the spotlight on emerging PBC candidates like Zydus’s saroglitazar, a PPAR agonist that beat both Gilead’s Livdelzi and Ipsen’s Iqirvo on biochemical response in topline results. Will the withdrawal and policy developments boost Zydus’s prospects?

Blueprint For RWE: Aetion Execs Outline Real-World Data Role From Preclinical To Postmarketing

 
• By Bridget Silverman

Sponsors should systematically incorporate real-world evidence generation in all development programs, advises an epidemiology-forward “blueprint” Aetion executives developed.

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Blueprint For RWE: Aetion Execs Outline Real-World Data Role From Preclinical To Postmarketing

 
• By Bridget Silverman

Sponsors should systematically incorporate real-world evidence generation in all development programs, advises an epidemiology-forward “blueprint” Aetion executives developed.

Clawbacks And Clinical Trial Set Up Are Among UK’s Investment Deterrents

 
• By Francesca Bruce

In the wake of MSD’s decision not to invest $1.35bn in the UK, the Association of the British Pharmaceutical Industry has set out the county’s comparative strengths and weaknesses.

Merck & Co. Withdrawal Seen As Warning Of UK’s Declining Attractiveness

 
• By Andrew McConaghie

The decision to terminate discovery research was influenced by the US company’s cost-cutting measures but also discontent over the UK’s punitive clawback of revenues.