Obesity readouts continue to be hot for biotech with new top-line data from both injectable and oral therapies pushing the boundaries on efficacy. On the latest BioCentury This Week podcast, BioCentury’s analysts break down last week’s readouts from Eli Lilly, Structure and Wave Life Sciences, and discuss a deal in the space by Pfizer.
Lilly reported the latest for its triple agonist contender retatrutide for best-in-class weight loss, while strong Phase IIb data put Structure back in the oral GLP-1 race. Meanwhile, Pfizer added an oral GLP-1R agonist via a deal). Structure and Wave parlayed their data into follow-on cash, as did Kymera after posting data for its STAT6 program KT-621 that hints at a new era for degraders in immunology.
The analysts then detailed the results of BioCentury’s industry sentiment survey on FDA, which found that politicization of the agency’s leadership, volatility and uncertainty are casting a long shadow over investor and drug developer sentiment. Finally, they discuss the impact of the congressional stalemate over the U.S. Small Business Innovation Research (SBIR) program.

View full story: https://www.biocentury.com/article/657880

#ObesityDrugDevelopment #TargetedProteinDegradation #STAT6 #FDARegulation #SBIRFunding

00:00 - Introduction
01:45 - Obesity Data
12:17 - Kymera's Breakthrough
21:45 - FDA Survey Results
29:41 - SBIR Funding Stalemate

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Fueled by cancer, obesity and cardiovascular deals, $1 billion-plus takeouts in biotech are at their highest level in a decade with three weeks to go in the year. On the latest BioCentury This Week, BioCentury’s analysts discuss the rise in large M&A deals and what the trends among the 37 acquisitions say about biopharma dealmaking.
The analysts assess first-in-human in vivo CAR T data at the American Society of Hematology meeting from Kelonia Therapeutics, which showcase the promise of the modality and justify the growing pipeline. They also break down readouts from Praxis in developmental and epileptic encephalopathy from the American Epilepsy Society Annual Meeting and from Novo Nordisk, which presented full data at the Clinical Trials on Alzheimer’s Disease meeting on semaglutide’s failure to treat Alzheimer’s disease.
Washington Editor Steve Usdin analyzes a roller-coaster week at FDA in which Richard Pazdur resigned as director of FDA’s Center for Drug Evaluation and Research and Tracy Beth Høeg became acting CDER director, a move that Usdin says will prompt staff departures, ease restraints on FDA leaders

View full story: https://www.biocentury.com/article/657781

#BiotechMA #CARTTherapy #EpilepsyResearch #AlzheimersDisease #FDA

02:37 - Biotech M&A
06:39 - In vivo CAR T
10:08 - Semaglutide for Alzheimer's
16:17 - Praxis
22:11 - FDA

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Novo Nordisk’s highly anticipated data for semaglutide in Alzheimer’s dashed hopes that the GLP-1 therapy could become a game changer in the disease. On the latest BioCentury This Week podcast, Executive Editor Selina Koch discusses the Phase III readout including what it says about the mechanism’s use in the neurodegenerative disease, Novo’s decision to skip Phase II and enroll a large patient group in a later stage trial, and what other datasets for GLP-1s in the indication have shown.
Washington Editor Steve Usdin explains why FDA’s new vaccine policies, driven by CBER Director Vinay Prasad, could have impacts more far-reaching than expected, including making it more difficult to develop or modify vaccines. And Lauren Martz, Executive Director of Biopharma Intelligence, analyzes the bleak investment outlook for cell and gene therapy companies in the U.S. and why China’s biotech ecosystem offers a glimmer of hope for sponsors of these assets.

View full story: https://www.biocentury.com/article/657721

#Semaglutide #GLP1Therapies #VaccinePolicy #CellAndGeneTherapy #AlzheimersResearch

00:00 - Introduction
01:53 - Novo's Alzheimer’s Miss
13:19 - FDA's New Vaccine Policy
19:53 - Funding C> Biotechs

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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