News

Advances in our understanding of the genetic, immunological, and environmental factors that contribute to the pathogenesis of psoriasis have led to the development of very effective precision therapies that alleviate patient morbidity and improve quality of life, especially for patients with moderate to severe disease.

The results of a 2018 survey of sponsor, CRO, and technology companies.

Cell and gene therapies are the latest wave of advanced technologies that will shape the face of the modern-day biopharma arena, enabling a path to pinpoint a faulty gene or cellular mechanism at the root of a specific disease.

uMotif worked with IDEO to shape a patient-centric approach by focusing on human-centered design.

As FDA continues to advance the role of patients in designing clinical trials with meaningful and accurate endpoints, it is seeking more input from stakeholders on how best to identify clinical outcomes most important to patients and caregivers.

Imagine you are in charge of European legislation on pharmaceuticals. Imagine you've been told to draft rules on how to conduct clinical assessments at European level to help measure the value of a medicine. What would you go for?

In this article, Crissy MacDonald reviews the key changes in ICH E6 (R2), discuss the challenges organizations are facing, and present actionable recommendations for organizations to implement now.

A new report on EU's digital health strategy also calls for closer coordination of national HTA arrangements-but both policy initiatives couldn't be more different.

FDA is joining with other federal health agencies and the biomedical community to advance science, regulatory policies, and reimbursement strategies to combat the need for new medicines for infectious diseases.