Clinical Trials

Novotech's CEO talks about rising interest for trials in regions with “regulatory agility” and “strategic insulation” from geopolitical complexity, especially among emerging and mid-sized biotech sponsors. Operational "reassessment” among some sponsors on exposure to China-based CROs/CRDMOs is another area he discussed.

Urologists at the Cleveland Clinic in Ohio and Abu Dhabi collaborated successfully to perform the first transcontinental robotic-assisted focal therapy for prostate cancer using EDAP’s Focal One HIFU robotic system. The procedure served as proof of concept for future teleprocedures. EDAP’s CEO Ryan Rhodes told Medtech Insight other hospitals are also showing interest in this type of collaboration.

As GLP-1 agonists surge to blockbuster status transforming diabetes and obesity treatment, Richard DiMarchi, the pioneering scientist behind their development, recounts the inside story of the drug class in a fireside chat.

Roivant president Eric Venker was named CEO of Immunovant to guarantee execution of the development plan for IMVT-1402 in six indications, now including Sjögren’s disease and cutaneous lupus erythematosus.

Appointed CEO 12 months ago, Anthony Costello wasted no time in orchestrating strategic change at Medidata. He talked to In Vivo about the art of the pivot and how to constantly push boundaries.

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.

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.

The integration of digital health tools into clinical research and patient care is gaining momentum, and Merck KGaA, Darmstadt, Germany is not letting the grass grow under its feet. With an approach to digital biomarkers, the company is seeking to redefine how neurological diseases are monitored and managed.

A new European initiative will help trial sponsors better understand whether digitization and decentralized clinical trials of drugs generate less carbon than traditional methods.

Henlius has reported progress in its development of a bevacizumab product for treating ophthalmic diseases, with its Essex-partnered HLX04-O candidate meeting its primary endpoint in a Phase III trial. Meanwhile, Outlook Therapeutics has taken another shot at getting its own ophthalmic bevacizumab approved in the US after resubmitting its filing.