In a double-blow to psychedelic therapy, the FDA has rejected an application for MDMA-assisted treatment of PTSD, while a prominent medical journal has retracted three key papers on the subject. The agency, which had granted Breakthrough Therapy Designation to MDMA in 2017, signaled it may be open to changing its mind if presented with data…
Pharma R&D returns rebound in 2023, but regulatory challenges and AI advances demand further strategic adaptation
Deloitte’s 14th annual report on pharma innovation reveals a modest uptick in R&D returns for 2023, with the projected internal rate of return (IRR) for the pharma sector rising to 4.1% after hitting a low of 1.2% in 2022. Yet the report emphasizes the need for biopharma companies to adapt to ongoing challenges and leverage…
Development challenges and regulatory changes for cell and gene therapies
Cell and gene therapies are the fastest growing area for drug development. The groundwork for this category was laid with the mapping of the human genome in 2003, and the field has developed rapidly in the intervening decades. These powerful therapies have significant potential for the treatment of cancer and other previously “undruggable” diseases. But…