Epkinly is now the “first and only” T-cell-engaging bispecific antibody for the subcutaneous treatment of relapsed or refractory follicular lymphoma, according to the companies.
Verona Pharma’s therapy for treating a chronic lung disease will be sold in the U.S. at a wholesale price of $2,950 per month, the U.K.-based company said on a conference call on Thursday.
The FDA rejected Merck and Daiichi Sankyo’s antibody-drug conjugate patritumab deruxtecan in a Complete Response Letter, citing problems with a third-party manufacturer.
“Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf, M.D. in an agency release. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.”
AI, and especially generative AI (GenAI), is growing at warp speed. It’s a part of everything we do, including the annual brand planning process. Yet is it being embraced as quickly as it should be? Probably not.
The task force represents diverse stakeholders from across the clinical research ecosystem, including representatives from academic medical centers and universities, biotechnology and pharmaceutical companies, AI technology researchers, and IRB ethicists, members, and chairs.