Regulatory

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include Hympavzi, Pfizer's treatment for adults and adolescents with severe hemophilia A or B without inhibitors.

This week, Zimmer Biomet announced a new role of chief movement officer for Arnold Schwarzenegger, J&J MedTech receives IDE approval for Ottava, Dassault Systèmes with US FDA develop first guide for virtual twins, Mainz Biomed and Thermo Fisher team up to fight colorectal cancer.

The European Medicines Agency has recommended against EU marketing approval for two drugs targeting children.

Patients in the ICU continue to die from SARS-CoV-2-induced acute respiratory distress syndrome, says InflaRx, which is one of companies whose product the European Medicines Agency today announced should be approved for marketing in the EU.

After an initial rejection, the European Medicines Agency now says that Eisai/Biogen’s Alzheimer’s disease drug should be approved, albeit with a recommendation for initial generic screening and ongoing safety scans.

The Therapeutic Goods Administration says it wants to balance regulatory burden on sponsors with the need to improve its monitoring of medicine shortages.

As China faces the potential loss of a big customer base, the US off-patent industry starts to look for new relationships elsewhere. While building domestic manufacturing capabilities would be the ultimate American dream, the government has yet to offer the carrot, not just the stick.

A session at the recent KoNECT conference in Seoul looked at Korea’s strengths in clinical trials but also at what's needed to further improve its global competitiveness as a location for studies.

Tariffs are expected again under a second Trump Administration and the future of the Americas Partnership for Economic Prosperity is uncertain, says the Personal Care Products Council, which will continue to push for regulatory alignment and lower trade barriers.

A panel of experts from J&J, UCB and Takeda deliberated on the use of AI and internal processes to strike the right balance between speed and accuracy in MLR reviews that could protect a company from serious repercussions. They also spoke of the need for regulatory systems to catch up.