Richard Pazdur took the top job at FDA’s Center for Drug Evaluation and Research after receiving vows that he would be leading CDER free from political interference. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the issues that could prove to be flashpoints between Pazdur and the heads of FDA and HHS, including personnel, RSV mAbs, puberty blockers and SSRIs.
BioCentury's analysts assess bispecific innovation at the annual meeting of the Society for Immunotherapy of Cancer (SITC) and the growing field of companies pursuing RNAi, many of which have multiple unpartnered assets. Also featured in this week's episode: new funds from European VCs Medicxi and Sofinnova Partners, FDA’s new plausible mechanism pathway and the Trump administration’s “most favored nation” drug-pricing plan, which is turning out to be much more less onerous to drug companies than its original description suggested. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.

View full story: https://www.biocentury.com/article/657631

#RNAiTherapeutics #BispecificAntibodies #CD3TCellEngagers #MechanismOfAction #ImmunoOncology #PlausibleMechanismPathway #RegulatoryScience #ClinicalTranslation

00:01 - Sponsor Message: Voyager Therapeutics
03:08 - FDA's Richard Pazdur
13:08 - Plausible Mechanism Pathway
19:30 - Most Favored Nation
23:12 - Takeaways from SITC
28:05 - RNAi in China
33:21 - European VCs

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Ep. 334 - Pazdur’s New FDA Role, SITC & China RNAi

BioCentury This Week

Ep. 334 - Pazdur’s New FDA Role, SITC & China RNAi