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Patient-Focused Meeting On Vitiligo Could Galvanize R&D As The First Drug Candidates In A Long Time Advance

 
• By Bridget Silverman

US FDA meeting directs attention to the vitiligo patient experience as a small group of potential treatments, led by topical Janus kinase inhibitors, are at the Phase II hinge point.

Vitiligo on the hands. Shutterstock 1621981522
The US FDA continues to solicit patient input as it assembles a Voice of the Patient report for vitiligo, through methods old and new. • Source: Shutterstock

The US Food and Drug Administration’s first patient-focused drug development meeting of 2021 highlighted an undertreated condition, the skin pigmentation disorder vitiligo, that could be on the verge of seeing active new drug development.

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EMA Initiative To Address Information Overload In CTIS Training Materials

 
• By Vibha Sharma

The European Medicines Agency has launched a phased initiative to consolidate the wide array of training materials for the Clinical Trials Information System, aiming to eliminate duplication, ensure consistency, improve accessibility and enhance user-friendliness.

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 
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India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.

French Bill Could Improve Clinical Research, But Further Action Is Required

 
• By Francesca Bruce

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

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FDA Special Assistant Høeg’s Vaccine Concerns On Display At ACIP

 
• By Sue Sutter

Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 
• By Bridget Silverman

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HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.