Studies are unfeasible, sponsors argue in advance of US advisory committee meeting that could lead to FDA ending its waiver on requiring clinical trials in pediatric patients for new testosterone replacement therapy products.

Higher logistics and energy costs are putting medtech P&Ls under pressure, and compliance with the EU MDR is draining any remaining surplus. Sustainability compliance is another cost to factor in, says BVMed chief executive Marc-Pierre Möll in part 2 of his interview with Medtech Insight at Medica 2023. 

The largest shareholder in major Japanese pharma firm Taisho, the founding Uehara family, intends to smooth the way to the restructuring and expansion of the business by acquiring and delisting all of its stock. The nearly $5bn size of the deal would makes it the biggest management buyout in Japanese corporate history.