Policy
After devastating regulatory setbacks last year, shares of uniQure and Replimune rose on the news that FDA Commissioner Marty Makary is leaving. But analysts don’t expect much relief, no matter who helms the agency.
The FDA is looking to retool drugs with sufficient evidence to support their use in other indications, particularly those with unmet need.
The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
Facing increasing pressure from both industry and the White House, FDA Commissioner Marty Makary said the strong bad press against him is “corporate spin” and that the agency has “followed the science.”
The FDA’s real-time clinical trial mechanism allows drug sponsors to transmit data immediately to the regulator through the cloud—a system that could “compress drug development timelines,” Jefferies analysts said.
Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
In this episode of Denatured, you’ll be hearing from Edoardo Negroni, co-founder & managing partner at AurorA-TT and Naveed Siddiqi, senior partner, Venture Investments at Novo Holdings. We debate whether Europe’s world-class science can be matched by a truly integrated venture ecosystem—and what it would take, in practice, to get there.
Despite exceptional regional hubs and research strength, investors say Europe still needs more integrated incubators, smarter regulation and broader pools of patient capital to keep breakthrough companies growing at home.
In this whitepaper, BioSpace reviews the major trends impacting the CDMO sector and the evolving relationship between sponsors and providers. We examine the key qualities pharma and biotech should consider in CDMO selection, and how the macroeconomic and macrodevelopment factors affecting the space play a role in this selection.
PRESS RELEASES