Manufacturers Face Challenges and Regulatory Changes

Bempikibart (ADX-914) is a human anti-IL-7Rα antibody that blocks the IL-7 and TSLP pathways, which have been implicated in driving T cell-mediated pathological processes in autoimmune diseases.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

The policy announced by Commissioner Martin A. Makary, MD, will not preclude employees of regulated companies from presenting their views to committees, and rare exceptions will be allowed.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Vitrakvi (larotrectinib) was first granted accelerated approval by FDA in November 2018.

Development of the state-of-the-art facility was made possible by a £2 million (US$2.6 million) round of funding, and a successful inspection by MHRA was completed in March 2025.