Regulatory

A working group of EU regulators has developed a comprehensive repository of fee requirements relating to the Clinical Trials Regulation to help sponsors navigate the diverse demands of member states in the European Economic Area.

The Pierre Fabre-partnered allogeneic T-cell immunotherapy is already available in Europe but hopes of a US approval have been hit by a complete response letter citing problems at a third-party manufacturing facility.

The European Medicines Agency has published new policies on handling conflicts of interests for its scientific committee members, experts and management board members.

The FDA has approved the IL-23 inhibitor for Crohn's disease to add to its ulcerative colitis approval and put the drug in a position to compete with the likes of AbbVie's Skyrizi and Johnson & Johnson's Stelara.

The European Medicines Agency has published new policies on handling conflicts of interests for its scientific committee members, experts and management board members.

On the back of a stellar showing in Phase III, apitegromab is going to be filed in the US and Europe in the coming weeks for spinal muscular atrophy and CEO Jay Backstrom believes it will be a $2bn blockbuster.

XGene's pain candidate has shown positive results in a US bunionectomy trial and the Chinese company is also eyeing chronic and cancer pain indications for its contender, which may provide a competitor to Vertex's suzetrigine.

Testing by third-party lab accumulated 35,862 data points from 70 brands and 160 products as a benchmark for the study’s findings. Council for Responsible Nutrition criticized the study as lacking “critical context” and potentially “misleading consumers rather than empowering them.”

Egypt is the first African country to win a WHO maturity level 3 benchmarking rating for medicines and vaccines that are locally produced and imported.