FDA and biopharma industry representatives have agreed on most elements of the next Prescription Drug User Fee Act deal, including an increase in the application fee to about $4 million by 2027 from the current $2.9 million level, sources briefed on the negotiations told BioCentury.
Manufacturing constraints have prevented even the most pioneering cell therapy companies from meeting patient demand for their life-saving treatments. They are still in the works, but could fully automated, closed manufacturing platforms be potential game changers?
With the massive amounts of capital raised by global public and private biopharmaceutical companies last year generating approximately $134 billion – a total that was almost double the previous record of about $69 billion raised in 2015 – it is not surprising that financing for the regenerative medicine and advanced therapy sector also set an annual record.
Challenges presented by the COVID-19 pandemic did not stop progress in research or clinical development of gene and cell therapies, according to a state-of-the-industry briefing by Alliance of Regenerative Medicine.
The Alliance for Regenerative Medicine applauded the plan’s links to the European Health Data Space. That proposal could facilitate the assessment for cutting-edge cancer therapies, for example, by gathering real world evidence and data, according to the group, which represents cell and gene therapy companies.
“As we begin 2021 bolstered by this exceptional growth, healthcare systems need to fully prepare for the coming wave of ATMP approvals,” writes ARM’s Paige Bischoff.
Cell and gene therapies achieved record growth in 2020, surpassing prior high points in terms of financings and approvals. Janet Lambert, CEO of the Alliance for Regenerative Medicine (ARM), painted a rosy picture despite a few challenges at the 2021 Cell & Gene State of the Industry Briefing during this year’s Biotech Showcase, held virtually January 11-15.
