This week’s release of the Make America Health Again report TKTK; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona.
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The Make America Healthy Again Commission released its second report Tuesday, recommending, among other efforts, an investigation into a possible link between vaccines and the uptick in chronic disease. At a livestreamed MAHA commission meeting, Health Secretary Robert F. Kennedy painted a dire picture of the country’s health, saying the U.S. now has “the highest chronic disease burden of any country in the world.”
Looking back to last week, all eyes were on Health Secretary Robert F. Kennedy Jr.’s appearance before the Senate Finance Committee. The combative showdown amounted to little more than political theater, according to industry watchers, with Kennedy accusing former CDC Director Susan Monarez of lying in an op-ed published in the Wall Street Journal about his alleged request that she approve vaccine advisors’ recommendations in advance of their meeting later this month.
Over at the FDA, BioSpace combed through the latest cache of publicized complete response letters (CRLs), including one for Lykos’ MDMA-based therapeutic for post-traumatic stress disorder. Going forward, the agency has promised to release CRLs in real time. The greater transparency could help companies spinning on a carousel of confusion caused by all the recent regulatory change. In other FDA news, we take a deep dive into new expert panels, which some commentators view as one-sided, and into the new rare disease approval framework, which one critic called “all wrapper and no gift.” And in the weight loss space, the FDA debuted a consumer “green list” for GLP-1 ingredients.
Meanwhile, at the World Conference on Lung Cancer in Barcelona, several data readouts caught our attention. In particular, Summit Therapeutics released disappointing data for its PD-L1/VEGFa bispecific antibody ivonescimab in Western populations—a finding some analysts said could have readthroughs to Bristol Myers Squibb/BioNTech’s first ever global data readout for its L1/VEGFa bispecific.
Finally, in Biopharm Executive this week, check out features on contingent value rights, which have been getting tacked on to biopharma deals more and more, Amgen’s pipeline beyond the obesity drug MariTide and Novartis’ recent deal spree, which included the $1.4B acquisition of Tourmaline on Tuesday.
