Vinay Prasad, the chief medical and chief scientific officer at the US Food and Drug Administration and director of its biologics’ drug division, is to leave the FDA at the end of April. Dr Prasad’s departure was announced on 6 March by Marty Makary, the FDA Commissioner, and follows a period of disquiet within industry and patient advocacy groups about the way decisions have been made on new drug applications.
The gene therapy developer, uniQure NV, has asked for a second meeting with the US Food and Drug Administration to discuss the agency’s recommendation for further clinical development of its candidate therapy for Huntington’s disease AMT-130. The gene therapy is intended as a one-time treatment for Huntington’s, a rare neurodegenerative disorder. uniQure produced data from a Phase 1/2 trial in September 2025 which was intended as a pivotal study leading to a regulatory submission.
argenx SE delivered an operating profit of $1.1 billion for 2025 – its first ever annual operating profit. This was due to a near doubling of the company’s net sales even as large outlays were made for research and development. A continuous, high level of spending on R&D has enabled the company to expand the scope of a novel target for llama-derived antibodies for autoimmune diseases. The company’s main focus is neurology and the lead product is Vyvgart (efgartigimod), which has three approved indications.
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