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After Makary's FDA exit, biopharma exhales: Signal Survey

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After Makary's FDA exit, biopharma exhales: Signal Survey

When Endpoints Signal released the Q3 Biopharma Sentiment Index last week, it showed a level of industry optimism not seen in years. Behind the topline figure, one area of improvement really stood out: the regulatory environment. The Q3 Biopharma Sentiment Index (we call it the BPSI) is based on our survey of 569 industry insiders and was the first fielded since Marty Makary resigned as FDA commissioner on May 12. It's the closest thing we have to a before-and-after reading of his exit, and the verdict was pretty clear: Relief. In a quarter where overall sentiment moved firmly into positive territory for the first time since the post-pandemic crash, regulation was the only area where pessimists still outnumbered optimists. But the gap is closing fast. The relative score for current regulatory conditions increased to 75, from 50 in Q2 and a miserable reading of just 23 a year ago. A score of 100 would indicate neutral sentiment. “I’m hopeful that stability will return to the FDA now that some of the most egregious leadership is gone,” wrote a biotech C-suite executive with more than 20 years of experience in the field. height = h + 'px'; break; } } } }); } The recent improvement mirrors the jump in regulatory sentiment following the departure of FDA biologics chief Vinay Prasad in April. Prior to those two officials stepping down, discontent was nearly universal. In February, following the Q1 survey, I wrote about the hailstorm of hundreds of open-field complaints about the upheval in Washington.


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