Stephen Hahn is the next commissioner of the FDA. What that means for the FDA and its attitude to R&D and approval standards is unclear.
Hahn came through his Senate confirmation hearing without giving away much about his views on R&D and approval standards. That is partly a reflection of questioners focusing on other topics, most notably vaping, but is also a consequence of the low-risk approach Hahn took to the hearing, where he repeatedly avoided taking hard, definitive positions by vowing to follow the science and data.
The upshot is biopharma enters a new period of the FDA without a clear read on the direction Hahn will take the agency. There were signs after Scott Gottlieb left that the agency would take a tougher line than in the past, most notably when it rejected Sarepta Therapeutics’ Vyondys 53. However, with the FDA reversing that decision months later and Hahn’s position unclear, it is questionable whether the initial Vyondys 53 rejection will be seen as a blip or a harbinger of a new approach.
Events in the new year, notably Biogen’s aducanumab filing, should start to provide some answers. However, the impact of whatever changes Hahn tries to enact may be short-lived given the potential for the Democrats to win the 2020 election and install a new leader at the FDA.
By Nick Paul Taylor
Source: Fierce Biotech
The companies will explore opportunities to apply Flagship’s innovative bioplatforms – an ecosystem that currently comprises 41 companies – to scientific challenges in disease areas within cardiometabolic and rare diseases and initiate research programmes based on these.
BD is expanding its long-running partnership with the blood collection company Babson Diagnostics. The two companies have been working together since 2019 on a device that can gather small volumes of blood from the capillaries in the fingertip without requiring any specialized training, and beginning with a focus on supporting primary care in retail settings.
Wednesday, Australian biotech CSL said (PDF) the regulatory review of its $11.7 billion acquisition of Switzerland’s Vifor Pharma will take “a few more months,” suggesting it won’t be able to close the transaction by June 2022 as previously expected.