Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the FDA.

Industry experts have provided insight into how oncology clinical trials can be designed for success from the outset and rendered as patient-centric as possible.

Bristol Myers Squibb (BMS) has revealed that its Phase III trial assessing Reblozyl with JAKi therapy did not meet its primary goal.

Ocugen has dosed the first subject in its Phase II/III GARDian3 trial of modifier gene therapy candidate, OCU410ST.

Hengrui Pharma and Kailera Therapeutics have reported positive topline data from the former’s Phase III trial (HRS9531-301) of HRS9531.

AstraZeneca’s anselamimab has failed to show any benefit in patients with light chain (AL) amyloidosis in two Phase III trials.

The UK MHRA has granted approval for Cybin to initiate the EMBRACE study to assess CYB003 for the adjunctive treatment of MDD.

UroMems is set to enter the pivotal trial phase with its device for treating stress urinary incontinence (SUI).

The growing prevalence of prediabetes among children and adolescents suggests that unhealthy, inactive lifestyles are increasing in the US.

UK & Ireland, experts provided insights on market trends within the clinical trial industry and advice on engagement strategies.

With the aim of being the largest life sector by 2035 behind only the US and China, the UK government is ramping up commercialisation.