Policy
In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you’ll be hearing from Regina Hodits, managing director at Angelini Ventures and Sofia Ioannidou, VC partner at Andera Life Sciences. They explore Germany’s biotech and life sciences ecosystem, including the science, infrastructure and policy changes needed to help European companies scale globally while staying rooted in Europe.
Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.
After less than three weeks on the job, Katherine Szarama is being replaced by Karim Mikhail as acting head of the Center for Biologics Evaluation and Research. Mikhail had previously spent more than 20 years at Merck and joined the FDA last year.
Just a few days after FDA Commissioner Makary resigned, ally Tracy Beth Høeg is also leaving the agency. Her departure comes amid reports of tension over a commissioner’s voucher for Sanofi’s diabetes drug.
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.
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