Note: This episode was briefly published with an incorrect audio file, which has since been corrected. FDA is prepared to approve <a href='https://www.biocentury.com/article/660761'>psychedelic therapies</a> for chronic psychiatric disorders before sponsors have fully determined how long the effects last or when patients should receive second or subsequent doses. On the latest BioCentury This Week podcast, BioCentury's analysts assess the latest guidance on psychedelics from FDA. The team also discusses takeaways from <a href='https://www.biocentury.com/article/660751'>Michael Davis'</a> first interview as CDER director, plus preclinical advances positioning <a href='https://www.biocentury.com/article/660754'>suppressor tRNA</a> for Duchenne, cystic fibrosis, and other nonsense-mutation diseases. They also highlight Emerging Company Profiles on <a href='https://www.biocentury.com/article/660704'>BrainChild</a> and <a href='https://www.biocentury.com/article/660662'>Cloverleaf</a>. View full story: <a href='https://www.biocentury.com/article/660792'>https://www.biocentury.com/article/660792</a> #Psychedelics #FDA #GeneTherapy #ClinicalTrials #DrugDevelopment 0:00 - Introduction 1:13 - Psychedelics at FDA 10:20 - Mike Davis Leads CDER 22:29 - Suppressor tRNAs Advance To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.<a target="_blank" href="https://www.buzzsprout.com/1035190/fan_mail/new">Reach us by sending a text</a>

Note: This episode was briefly published with an incorrect audio file, which has since been corrected. FDA is prepared to approve psychedelic therapies for chronic psychiatric disorders before sponsors have fully determined how long the effects last or when patients should receive second or subsequent doses. On the latest BioCentury This Week podcast, BioCentury's analysts assess the latest guidance on psychedelics from FDA. The team also discusses takeaways from Michael Davis' first interview as CDER director, plus preclinical advances positioning suppressor tRNA for Duchenne, cystic fibrosis, and other nonsense-mutation diseases. They also highlight Emerging Company Profiles on BrainChild and Cloverleaf. View full story: https://www.biocentury.com/article/660792 #Psychedelics #FDA #GeneTherapy #ClinicalTrials #DrugDevelopment 0:00 - Introduction 1:13 - Psychedelics at FDA 10:20 - Mike Davis Leads CDER 22:29 - Suppressor tRNAs Advance To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

Note: This episode was briefly published with an incorrect audio file, which has since been corrected. FDA is prepared to approve <a href="https://www.biocentury.com/article/660761" rel="noopener noreferrer">psychedelic therapies</a> for chronic psychiatric disorders before sponsors have fully determined how long the effects last or when patients should receive second or subsequent doses. On the latest BioCentury This Week podcast, BioCentury's analysts assess the latest guidance on psychedelics from FDA. The team also discusses takeaways from <a href="https://www.biocentury.com/article/660751" rel="noopener noreferrer">Michael Davis'</a> first interview as CDER director, plus preclinical advances positioning <a href="https://www.biocentury.com/article/660754" rel="noopener noreferrer">suppressor tRNA</a> for Duchenne, cystic fibrosis, and other nonsense-mutation diseases. They also highlight Emerging Company Profiles on <a href="https://www.biocentury.com/article/660704" rel="noopener noreferrer">BrainChild</a> and <a href="https://www.biocentury.com/article/660662" rel="noopener noreferrer">Cloverleaf</a>. View full story: <a href="https://www.biocentury.com/article/660792" rel="noopener noreferrer">https://www.biocentury.com/article/660792</a> #Psychedelics #FDA #GeneTherapy #ClinicalTrials #DrugDevelopment 0:00 - Introduction 1:13 - Psychedelics at FDA 10:20 - Mike Davis Leads CDER 22:29 - Suppressor tRNAs Advance To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.<a href="https://www.buzzsprout.com/1035190/fan_mail/new" rel="noopener noreferrer">Reach us by sending a text</a>

Ep. 387 - Psychedelics at FDA, Mike Davis’ CDER & tRNAs

Mechanisms broad enough to matter across many diseases, from mitochondrial health to the biology of aging, emerged as a defining theme at Grand Rounds Europe in Amsterdam. On a special live edition of the BioCentury This Week podcast, BioGeneration Ventures' Oskar Slotboom, NautaDutilh's Ruud Smits and Leyden Labs' Dinko Valerio join BioCentury's analysts to discuss women's health and sleep as lenses on disease, and the shift toward prevention. The panel also weighs the limits of "Frankenstein" multiparatopic molecules and AI-driven discovery, knowledge gaps in autonomous labs, new China first-in-human rules, and what Novartis' Lp(a) miss means for genetically validated targets. View full story: <a href='https://www.biocentury.com/article/660970'>https://www.biocentury.com/article/660970</a> #EuropeBiotech #DrugDiscovery #TranslationalMedicine #GeneticTargets #HealthSpan 0:00 Introduction 2:10 Bridging Academia & Industry 14:51 Key Themes 26:02 Toolbox and Biology 31:05 Lp(a) Fallout & Genetic Targets To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.<a target="_blank" href="https://www.buzzsprout.com/1035190/fan_mail/new">Reach us by sending a text</a>

Mechanisms broad enough to matter across many diseases, from mitochondrial health to the biology of aging, emerged as a defining theme at Grand Rounds Europe in Amsterdam. On a special live edition of the BioCentury This Week podcast, BioGeneration Ventures' Oskar Slotboom, NautaDutilh's Ruud Smits and Leyden Labs' Dinko Valerio join BioCentury's analysts to discuss women's health and sleep as lenses on disease, and the shift toward prevention. The panel also weighs the limits of "Frankenstein" multiparatopic molecules and AI-driven discovery, knowledge gaps in autonomous labs, new China first-in-human rules, and what Novartis' Lp(a) miss means for genetically validated targets. View full story: https://www.biocentury.com/article/660970 #EuropeBiotech #DrugDiscovery #TranslationalMedicine #GeneticTargets #HealthSpan 0:00 Introduction 2:10 Bridging Academia & Industry 14:51 Key Themes 26:02 Toolbox and Biology 31:05 Lp(a) Fallout & Genetic Targets To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

Mechanisms broad enough to matter across many diseases, from mitochondrial health to the biology of aging, emerged as a defining theme at Grand Rounds Europe in Amsterdam. On a special live edition of the BioCentury This Week podcast, BioGeneration Ventures' Oskar Slotboom, NautaDutilh's Ruud Smits and Leyden Labs' Dinko Valerio join BioCentury's analysts to discuss women's health and sleep as lenses on disease, and the shift toward prevention. The panel also weighs the limits of "Frankenstein" multiparatopic molecules and AI-driven discovery, knowledge gaps in autonomous labs, new China first-in-human rules, and what Novartis' Lp(a) miss means for genetically validated targets. View full story: <a href="https://www.biocentury.com/article/660970" rel="noopener noreferrer">https://www.biocentury.com/article/660970</a> #EuropeBiotech #DrugDiscovery #TranslationalMedicine #GeneticTargets #HealthSpan 0:00 Introduction 2:10 Bridging Academia &amp; Industry 14:51 Key Themes 26:02 Toolbox and Biology 31:05 Lp(a) Fallout &amp; Genetic Targets To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.<a href="https://www.buzzsprout.com/1035190/fan_mail/new" rel="noopener noreferrer">Reach us by sending a text</a>

Ep. 390 - Live from Amsterdam: Grand Rounds Europe takeaways

Seven global approvals in five years, validated biomarkers and FDA flexibility have turned <a href='https://www.biocentury.com/article/660896'>IgA nephropathy</a> from a neglected rare disease into a crowded field, with Biogen, Novartis, Takeda, Climb Bio and Jade chasing targets such as APRIL, BAFF and CD38. On the latest BioCentury This Week podcast, BioCentury's analysts assess how next-generation therapies are competing on safety and longer dosing intervals. The analysts also discuss Heidi Overton's FDA commissioner <a href='https://www.biocentury.com/article/660917'>confirmation hearing</a> and lingering questions about her independence, new pharma tariff guidance that leaves exemptions unclear, and how <a href='https://www.biocentury.com/article/660906'>reverse mergers</a> paired with nine-figure PIPEs became a viable IPO alternative. Plus, Merck's $400 million upfront bet on a preclinical KRAS G12C molecular glue. View full story: <a href='https://www.biocentury.com/article/660935'>https://www.biocentury.com/article/660935</a> #IgANephropathy #FDA #BiotechIPO #DrugDevelopment #ClinicalTrials 0:00 Introduction 1:30 Grand Rounds: Europe Recap 6:03 IgA Nephropathy Pipeline 14:57 Overton Hearing 22:19 Commerce's Tariff Guidance 24:28 Reverse Mergers' New Look To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.<a target="_blank" href="https://www.buzzsprout.com/1035190/fan_mail/new">Reach us by sending a text</a>

Seven global approvals in five years, validated biomarkers and FDA flexibility have turned IgA nephropathy from a neglected rare disease into a crowded field, with Biogen, Novartis, Takeda, Climb Bio and Jade chasing targets such as APRIL, BAFF and CD38. On the latest BioCentury This Week podcast, BioCentury's analysts assess how next-generation therapies are competing on safety and longer dosing intervals. The analysts also discuss Heidi Overton's FDA commissioner confirmation hearing and lingering questions about her independence, new pharma tariff guidance that leaves exemptions unclear, and how reverse mergers paired with nine-figure PIPEs became a viable IPO alternative. Plus, Merck's $400 million upfront bet on a preclinical KRAS G12C molecular glue. View full story: https://www.biocentury.com/article/660935 #IgANephropathy #FDA #BiotechIPO #DrugDevelopment #ClinicalTrials 0:00 Introduction 1:30 Grand Rounds: Europe Recap 6:03 IgA Nephropathy Pipeline 14:57 Overton Hearing 22:19 Commerce's Tariff Guidance 24:28 Reverse Mergers' New Look To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

Seven global approvals in five years, validated biomarkers and FDA flexibility have turned <a href="https://www.biocentury.com/article/660896" rel="noopener noreferrer">IgA nephropathy</a> from a neglected rare disease into a crowded field, with Biogen, Novartis, Takeda, Climb Bio and Jade chasing targets such as APRIL, BAFF and CD38. On the latest BioCentury This Week podcast, BioCentury's analysts assess how next-generation therapies are competing on safety and longer dosing intervals. The analysts also discuss Heidi Overton's FDA commissioner <a href="https://www.biocentury.com/article/660917" rel="noopener noreferrer">confirmation hearing</a> and lingering questions about her independence, new pharma tariff guidance that leaves exemptions unclear, and how <a href="https://www.biocentury.com/article/660906" rel="noopener noreferrer">reverse mergers</a> paired with nine-figure PIPEs became a viable IPO alternative. Plus, Merck's $400 million upfront bet on a preclinical KRAS G12C molecular glue. View full story: <a href="https://www.biocentury.com/article/660935" rel="noopener noreferrer">https://www.biocentury.com/article/660935</a> #IgANephropathy #FDA #BiotechIPO #DrugDevelopment #ClinicalTrials 0:00 Introduction 1:30 Grand Rounds: Europe Recap 6:03 IgA Nephropathy Pipeline 14:57 Overton Hearing 22:19 Commerce's Tariff Guidance 24:28 Reverse Mergers' New Look To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.<a href="https://www.buzzsprout.com/1035190/fan_mail/new" rel="noopener noreferrer">Reach us by sending a text</a>

Ep. 389 - IgA nephropathy, Overton hearing, reverse mergers' new look

A pair of high profile clinical setbacks has wiped out more than $40 billion in market cap for Novartis, most of which stemmed from the <a href='https://www.biocentury.com/article/660738'>Phase III miss</a> of antisense oligonucleotide therapy pelacarsen. On the latest BioCentury This Week podcast, BioCentury's analysts unpack the fallout for Lp(a) as a cardio target and whether issues with the target, modality or treatment setting contributed to the therapy's lack of efficacy. The analysts also review BioCentury's annual big <a href='https://www.biocentury.com/article/660691'>pharma deals analysis</a>, which found industry's largest players leaning into disruptive platforms such as bispecifics, in vivo CAR Ts, siRNAs, and degraders. In Washington, Steve Usdin reports on most-favored nation <a href='https://www.biocentury.com/article/660710'>drug pricing carve-outs</a> and policy pressure on mid-tier biotechs – plus the conspicuous lack of U.S. biotechs coming to the table -- pays tribute to the late <a href='https://www.biocentury.com/article/660712'>Peter Barton Hutt</a>, the former FDA Chief Counsel who shaped foundational elements of modern FDA law. View full story: <a href='https://www.biocentury.com/article/660746'>https://www.biocentury.com/article/660746</a> #CardiovascularDisease #DrugPricing #BiotechMA #ClinicalTrials #FDA  0:00 - Introduction  1:23 - Novartis Phase III Fallout 18:24 - Annual Pharma Deals Analysis 27:42 - MFN Carve-Outs 32:39 - Remembering Peter Barton Hutt To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.<a target="_blank" href="https://www.buzzsprout.com/1035190/fan_mail/new">Reach us by sending a text</a>

A pair of high profile clinical setbacks has wiped out more than $40 billion in market cap for Novartis, most of which stemmed from the Phase III miss of antisense oligonucleotide therapy pelacarsen. On the latest BioCentury This Week podcast, BioCentury's analysts unpack the fallout for Lp(a) as a cardio target and whether issues with the target, modality or treatment setting contributed to the therapy's lack of efficacy. The analysts also review BioCentury's annual big pharma deals analysis, which found industry's largest players leaning into disruptive platforms such as bispecifics, in vivo CAR Ts, siRNAs, and degraders. In Washington, Steve Usdin reports on most-favored nation drug pricing carve-outs and policy pressure on mid-tier biotechs – plus the conspicuous lack of U.S. biotechs coming to the table -- pays tribute to the late Peter Barton Hutt, the former FDA Chief Counsel who shaped foundational elements of modern FDA law. View full story: https://www.biocentury.com/article/660746 #CardiovascularDisease #DrugPricing #BiotechMA #ClinicalTrials #FDA 0:00 - Introduction 1:23 - Novartis Phase III Fallout 18:24 - Annual Pharma Deals Analysis 27:42 - MFN Carve-Outs 32:39 - Remembering Peter Barton Hutt To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

A pair of high profile clinical setbacks has wiped out more than $40 billion in market cap for Novartis, most of which stemmed from the <a href="https://www.biocentury.com/article/660738" rel="noopener noreferrer">Phase III miss</a> of antisense oligonucleotide therapy pelacarsen. On the latest BioCentury This Week podcast, BioCentury's analysts unpack the fallout for Lp(a) as a cardio target and whether issues with the target, modality or treatment setting contributed to the therapy's lack of efficacy. The analysts also review BioCentury's annual big <a href="https://www.biocentury.com/article/660691" rel="noopener noreferrer">pharma deals analysis</a>, which found industry's largest players leaning into disruptive platforms such as bispecifics, in vivo CAR Ts, siRNAs, and degraders. In Washington, Steve Usdin reports on most-favored nation <a href="https://www.biocentury.com/article/660710" rel="noopener noreferrer">drug pricing carve-outs</a> and policy pressure on mid-tier biotechs – plus the conspicuous lack of U.S. biotechs coming to the table -- pays tribute to the late <a href="https://www.biocentury.com/article/660712" rel="noopener noreferrer">Peter Barton Hutt</a>, the former FDA Chief Counsel who shaped foundational elements of modern FDA law. View full story: <a href="https://www.biocentury.com/article/660746" rel="noopener noreferrer">https://www.biocentury.com/article/660746</a> #CardiovascularDisease #DrugPricing #BiotechMA #ClinicalTrials #FDA&nbsp; 0:00 - Introduction&nbsp; 1:23 - Novartis Phase III Fallout 18:24 - Annual Pharma Deals Analysis 27:42 - MFN Carve-Outs 32:39 - Remembering Peter Barton Hutt To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.<a href="https://www.buzzsprout.com/1035190/fan_mail/new" rel="noopener noreferrer">Reach us by sending a text</a>

Ep. 386 - Novartis misses, pharma deals analysis, MFN carve-outs

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Ep. 86 - Woodcock's Legacy, Plus Frazier, Bain & the Distillery

Ep. 51 - Abernethy & the Obvious at FDA; Plus CEPI & EpimAb

Ep. 50 - FTC & the Zombie Pharma Dinosaurs; Plus: RIP José Baselga, NCATS & SPACs

Ep. 49 - Vaccine Vexed; Plus Assessing Lilly's Alzheimer's Data & PDUFA Preview

Ep. 48 - New Modality Deep Dive; plus Sharpless Speaks & Five Prime Scores

Ep. 47 - Whither Woodcock; plus Refresh for German Biotech & Modalities to Market

Ep. 46 - Pipeline plays for BMS, Rigel; plus J&J's vaccine panel & access for Africa

Ep. 45 - Start-Up Trends, COVID Variants and J&J's Adcomm

Ep. 44 - Biotech's IPO blizzard, plus GameStop, Porter Report & Vaccine Guidance

Ep.  43 - Europe's Next Act & the Porter Report

Ep. 42 - Warp Speed Reflections, Master Protocols & Biden’s COVID Plan

BioCentury's streaming commentary on biotech industry trends, plus interviews with KOLs. For three decades, BioCentury has helped biopharma executives and investors make business-critical decisions and build larger networks with peers across the innovation ecosystem.

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BioCentury's streaming commentary on biotech industry trends, plus interviews with KOLs. For three decades, BioCentury has helped biopharma executives and investors make business-critical decisions and build larger networks with peers across the innovation ecosystem.

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