BioCentury This Week

Marty Makary wasn't the only official on the outs at FDA last week in another tumultuous turn of events for the regulatory agency. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses who's in, who's out and what's next at FDA — and why the changes may mean more conservative decision-making at the agency in the near term.BioCentury's analysts also discuss the new obesity targets that came to light at last week's annual meeting of the European Congress on Obesity, the market for biotech IPOs, and the emergence of degrader-antibody conjugates. DACs pair the tissue-targeting logic of antibody-drug conjugates (ADCs) with the catalytic activity of protein degraders. 3C Therapeutics is the latest entrant to the field, pitching its TriCore platform as a modular backbone for DAC generation. This episode of the BioCentury podcast is brought to you by Jeito Capital.View full story: https://www.biocentury.com/article/659510#FDA #ObesityDrugDevelopment #BiotechIPO #DACs #Biopharma00:01 - Sponsor Message: Jeito Capital 02:53 - FDA Leadership Shakeup10:35 - Obesity Target Hunt16:07 - Biotech IPOs20:02 - Degrader-antibody Conjugates28:42 - Serif: Non-viral DNATo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

China's speed in generating first-in-human data has catalyzed a race across the globe to reshape regulatory requirements to compete. BioCentury's analysts, along with special guests Detlev Mennerich, head of Boehringer Ingelheim Venture Fund, and Mehdi Ainouche, partner at Jeito Capital, discussed where Europe fits in that landscape and other takeaways from the 26th annual Bio€quity Europe conference in Prague. This special episode of BioCentury This Week has been brought to you by Jeito Capital.View full story: https://www.biocentury.com/article/659450#EuropeanBiotech #ClinicalDevelopment #BiopharmaInnovation #DrugDevelopment #LifeSciencesStrategy00:01 - Sponsor Message: Jeito Capital 03:14 - China's Speed Challenge04:08 - Europe's Clinical Trial Opportunity11:48 - Speed vs. Capital Efficiency15:52 - Takeaways from Richard Pazdur19:58 - FDA Uncertainty and Global Alternatives26:50 - Biopharma M&A Outlook33:34 - The Next Wave of ScienceTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Marty Makary's hold on the top job at FDA is slipping, with White House leaks about President Donald Trump's displeasure with the FDA commissioner shifting the question from whether he will be fired to when. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin discusses the pressures on Makary, how long he will hold onto his post, and the leading candidates to succeed him.BioCentury's analysts then discuss solutions to AAV's redosing problem, which could reignite industry interest in a modality that has fallen out of favor, and other topics in the spotlight at this week's American Society of Gene and Cell Therapy annual meeting. The analysts also discuss opportunities to attend and present academic posters at the third BioCentury Grand Rounds U.S. conference June 3-5 in Seattle. This episode of the BioCentury This Week podcast has been brought to you by Jeito Capital.View full story: https://www.biocentury.com/article/659426#FDA #GeneTherapy #AAV #CellTherapy #Biopharma00:01 - Sponsor Message: Jeito Capital01:43 - Bio€quity Europe Prague Highlights04:54 - Makary on Thin Ice14:37 - Grand Rounds Poster Pitch16:40 - AAVs at ASGCTTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

UCB is the latest biopharma player to consummate a multibillion-dollar deal amid a surge in biotech M&A activity, acquiring Ken Song's Candid Therapeutics, one of the leading T cell engager companies. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the $2 billion takeout and the opportunity in the TCE space.They also assess the drug development landscape for leukodystrophies and the market for biotech IPOs on NASDAQ, where a trio of biotechs exceeded expectations last week, lifting hopes that the window for new listings is broadening. Looking ahead to June, the analysts also preview the third BioCentury Grand Rounds U.S. conference. This episode of the BioCentury This Week podcast was brought to you by Jeito Capital.View full story: https://www.biocentury.com/article/659365#BiotechMA #TCellEngagers #Leukodystrophy #BiotechIPO #TranslationalScience00:01 - Sponsor Message: Jeito Capital02:19 - Grand Rounds Seattle12:47 - UCB's Candid Buy20:27 - Leukodystrophies Pipeline27:22 - Biotech IPOsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

More than 175 new oncology targets surfaced at this year's American Association for Cancer Research annual meeting in San Diego, with the focus on new ways to enhance the immune response against solid tumors and to make existing immunotherapies more effective. On the latest BioCentury This Week podcast, BioCentury's analysts assess the new targets identified among the thousands of abstracts at AACR, as well as emerging pan-RAS inhibiting antibody-drug conjugates.The analysts also discuss Eli Lilly's latest deal — for a JAK-2 inhibitor from Ajax — and what the current pace of M&A and partnerships says about the state of biopharma dealmaking. This episode also features Kurma Partners' new venture fund and the latest in BioCentury's Emerging Company Profile series, spotlighting U.K.-based rheumatoid arthritis company Elevara Medicines. This episode of the BioCentury This Week podcast was brought to you by IQVIA Biotech.View full story: https://www.biocentury.com/article/659298#AACR #OncologyTargets #Immunotherapy #BiotechMA #ADC00:01 - Sponsor Message: IQVIA Biotech02:50 - AACR: New Targets11:08 - AACR: Pan-RAS Inhibitor ADCs15:35 - Biopharma Deals23:53 - Kurma's New Venture Fund27:28 - Emerging Company Profile: ElevaraTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Bispecific antibodies and dual-payload antibody-drug conjugates were in the spotlight at this year's American Association for Cancer Research meeting in San Diego as biotechs unveiled their latest preclinical and first-in-human oncology data. On a special edition of the BioCentury This Week podcast, IQVIA Biotech CMO James Kyle Bryan joins BioCentury's analysts to discuss what AACR revealed about modalities gaining traction, plus shares his perspective on de-risking clinical development and eliminating the “white space” that delays biotechs' timelines in the clinic. This episode of the BioCentury This Week podcast was brought to you by IQVIA Biotech.View full story: https://www.biocentury.com/article/659235 #AACR #BispecificAntibodies #ADC #OncologyData #ClinicalDevelopment 00:01 - Sponsor Message: IQVIA Biotech01:43 – AACR Early Signals05:17 – Antibody Innovation09:22 – Dual Payload ADCs13:48 – De-Risking Drug Development19:16 – Looking Ahead to ASCOTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The past week has delivered the largest M&A deal ever for a private, venture-backed biopharma, the second-largest follow-on ever for a NASDAQ-traded biotech and what could soon become the largest biotech IPO ever on NASDAQ. On the latest BioCentury This Week, BioCentury's analysts discuss Eli Lilly's $3.25 billion takeout of in vivo CAR T company Kelonia, the market debut by obesity play Kailera and an upsized follow-on by Revolution on the back of its pancreatic cancer data.The analysts also discuss how autoimmune T cell engagers are diverging from their oncology roots and the potential implications of President Donald Trump's executive order on psychedelic therapies. BioCentury's analysts also take time to remember Sofinnova Partners' Denis Lucquin, father of French biotech. This episode of the BioCentury This Week podcast was brought to you by IQVIA Biotech.View full story: https://www.biocentury.com/article/659183#BiotechMA #BiotechIPO #CART #TCellEngagers #PsychedelicMedicine00:01 - Sponsor Message: IQVIA Biotech04:20 - Lilly's Kelonia Buy10:31 - T Cell Engagers23:07 - Psychedelics Executive Order35:14 - CBER Director Search37:37 - Public Markets Roundup42:14 - Remembering Denis LucquinTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

A pathway proposed by FDA to cut the time it takes biopharma companies to get to first-in-human trials is more ambitious than similar policies in Australia, China and the U.K. On the latest BioCentury This Week podcast, BioCentury's analysts assess the proposal, as well as a concession for the biopharma industry on first-in-human studies in PDUFA reauthorization negotiations with FDA.The analysts also discuss the latest pair of billion-dollar biotech deals: Gilead's $3.2 billion takeout of antibody-drug conjugate company Tubulis and the acquisition of Soleno by Neurocrine for $2.9 billion for its Prader-Willi asset. Finally, BioCentury's analysts discuss the new $6.3 billion Blackstone Life Sciences fund and the €1 billion vehicle unveiled last week by European VC Jeito Capital. This episode of the BioCentury This Week podcast was brought to you by IQVIA Biotech.View full story: https://www.biocentury.com/article/659127#FDA #FirstInHuman #BiotechMergers #BiotechInvesting #LifeSciencesVC00:01 - Sponsor Message: IQVIA Biotech03:24 - FDA First-in-Human11:44 - America First PDUFA Policy17:43 - Gilead Buying Tubulis23:41 - Blackstone's New Fund28:37 - Jeito Capital30:44 - Parker InstituteTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Biotech has been resilient as the financial markets teeter under global volatility. For now, M&A and financings, if not IPOs, are continuing, but will the Mideast conflict halt biotech's recovery? On the latest BioCentury This Week podcast, BioCentury's Stephen Hansen breaks down the near-term and long-term outlook for a biotech industry hoping to continue the growth of 2H25.BioCentury's analysts also discuss the impact of the Trump administration's tariffs on the biopharma industry and last week's biggest deals: the pending $6.3 billion takeout of Centessa  by Eli Lilly and the proposed $5.6 billion acquisition of Apellis by Biogen. This episode of the BioCentury This Week podcast was brought to you by IQVIA Biotech.Register now as a delegate or apply to join the 2026 Presenting Company Class before the 26th Bio€quity Europe May 4-6 in Prague sells out.View full story: https://www.biocentury.com/article/659040#BiotechMarkets #BiotechMA #GlobalVolatility #DrugPricingPolicy #BiopharmaStrategy00:01 - Sponsor Message: IQVIA Biotech05:09 - 2Q26 Preview17:09 - Pharma Tariffs24:04 - C-Path Initiative26:32 - Lilly Deal32:19 - Biogen DealTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Biotech innovators around the world are finding speed to be the driver for investment and partnering — speed to early human data and speed to de-risk assets. The new momentum from Asia, in particular China, has added a fresh challenge for European biotech on top of falling equity and R&D investment in Europe and a complex drug pricing landscape. On a special edition of the BioCentury This Week podcast on the eve of the 26th Bio€quity Europe conference, EQT Life Sciences' Christoph Broja and Prague Bio CEO Petra Kinzlová join BioCentury's analysts to discuss the challenges faced by European biotech today and what the best strategy is to compete in this new era.Kinzlová also describes a growing biotech ecosystem in the Czech Republic, which will host Bio€quity Europe May 4-6.View full story: https://www.biocentury.com/article/659002#EuropeanBiotech #ClinicalDevelopmentSpeed #ChinaBiotech #DrugPricing #BiotechInvestment01:10 - Bio€quity Europe Preview04:32 - Czech Innovation Hubs09:52 - Pricing, Trials, Funding13:07 - Fixing Trial Bottlenecks17:49 - Pension Capital and RiskTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

A flurry of deals, several with sizable upfront payments, has energized the biotech sector in March. On the latest BioCentury This Week podcast, BioCentury's Paul Bonanos assesses last week's deals by Merck, which is laying out $6.7 billion to acquire Terns, and Gilead, which is buying Ouro for about $1.7 billion up front.Gilead's deal comes as the Foster City, Calif.-based biotech is looking to defend its position in HIV while resetting in inflammation and immunology and growing its oncology footprint through business development. BioCentury's Lauren Martz analyzes the company's pipeline following her recent conversation with CMO Dietmar Berger.Turning to the U.K., Editor in Chief Simone Fishburn details her conversation with CEO of MHRA, Lawrence Tallon, regarding what new reforms in the U.K. mean for drug developers and how he views initiatives helping to build the sector and place the U.K. in the race to become a destination for clinical trials.Rates for the 26th Bio€quity Europe May 4-6 in Prague increase after this week. Register now as a delegate or apply to join the 2026 Presenting Company Class before the conference sells out.View full story: https://www.biocentury.com/article/658974#BiotechMA #BiopharmaStrategy #DrugDevelopment #UKBiotech #ClinicalTrials00:00 - Introduction01:09 - Merck Buying Terns04:31 - Gilead, Galapagos Deal09:35 - Growing Gilead19:20 - Tallon's Vision for U.K. BiotechTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

After 20 years of platform building and resets, Arrowhead Pharmaceuticals is making a bid to become a large-cap biotech. On the latest BioCentury This Week podcast, BioCentury's analysts discuss how the company has built a pipeline and set of enabling technologies that could enable a steep period of value creation based on RNAi.The team then analyzes the $2 billion deal between Synnovation and Novartis for a pan-mutant-selective PI3Kα inhibitor. The analysts also assess where AI is integrating into the biotech venture funnel and provide insights into ultra-rare disease advocacy, FDA's search for a successor to CBER Director Vinay Prasad, and the Trump administration's most-favored nation (MFN) drug pricing policy.View full story: https://www.biocentury.com/article/658892#RNAiTherapeutics #BiotechMA #PI3KAlpha #AIDrugDiscovery #DrugPricingPolicy00:00 - Introduction01:14 - Bio€quity Europe05:33 - Arrowhead16:49 - Synnovation Novartis20:00 - AI in Biotech Venture27:07 - Rare Disease Advocacy31:22 - MFN Pricing PolicyTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Biotechs have been pricing follow-ons at a steady pace, with some companies parlaying data into upsized deals, and others even beginning to debut on NASDAQ — but will geopolitical tensions and war in the Middle East scuttle the forward momentum? On the latest BioCentury This Week podcast, BioCentury's analysts take the temperature of the markets for biotech."They also discuss last week's late-stage epilepsy data from Xenon Pharmaceuticals, which revived the biotech's stock and the Kv7 target.And, in a Rare Disease Spotlight, BioCentury's analysts discuss how Friedreich ataxia is moving into a mechanistic second act, with biotechs pivoting from stabilizing the mitochondrial damage caused by frataxin loss to developing therapies designed to fix the gene itself.View full story: https://www.biocentury.com/article/658810#BiotechMarkets #EpilepsyResearch #Kv7 #RareDisease #GeneTherapy00:00 - Introduction03:23 - Market Sentiment09:58 - Xenon Phase III Win18:03 - Friedreich Ataxia PipelineTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Biotechs in South Korea and other regions of Asia outside of China need to lean into innovation to distinguish themselves from their Chinese counterparts. On a special edition of the BioCentury This Week podcast, BioCentury's analysts are joined by industry guests Ya-Ting Lei and Luther (Ruizhe) Zhao to discuss why the best path for biotechs in Korea and Japan is to lean into target, biology and modality risk, as well as other takeaways from the fifth BioCentury-BayHelix Biopharma Summit, which ran March 9-12 in Seoul and Daejeon, South Korea.Lei is director of BD Asia at Merck KGaA, and Zhao is VP, China clinical analytics at Caidya.View full story: https://www.biocentury.com/article/658776#AsiaBiotech #SouthKoreaBiotech #BiopharmaSummit #BiotechInnovation #DrugDevelopmentStrategy00:00 - Introduction02:32 - Key Takeaways05:46 - Faster Trials, Better Data08:19 - Global Diligence, Local Success15:13 - Cross Border Synergies17:34 - Korean BiotechTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The second ousting of Vinay Prasad from FDA in the past eight months won't lead to major changes at the agency, other than selecting a successor tasked with keeping FDA out of the news ahead of the coming midterm elections. On the latest BioCentury This Week podcast, Washington editor Steve Usdin lays out why the former CBER director was pushed out at FDA and what's next for the agency following his departure.BioCentury's editors also discuss the next wave of therapies for idiopathic pulmonary fibrosis, including whether new candidates might go beyond slowing disease to halt or even reverse progression, the biological complexity that makes fibrosis so challenging, and what the 20-plus Phase II programs could teach the field about fibrosis biology.Also up for discussion were recent clinical wins — as well as more complicated readouts — from psychedelic therapies; plus the latest data updates from obesity treatments, with a focus on amylin agonists.View full story: https://www.biocentury.com/article/658698#FDA #IdiopathicPulmonaryFibrosis #PsychedelicTherapies #ObesityDrugs #AmylinAgonists00:00 - Introduction01:56 - Prasad's Departure15:27 - Fibrosis Therapies23:35 - Psychedelics Clinical Catalysts28:24 - Obesity UpdatesTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Can a strong U.S. biopharma industry be reconciled with the successful emergence of China? And can China be a catalyst of positive change across the global industry, even if this implies some level of rebalancing away from the U.S.? On the latest BioCentury This Week podcast, BioCentury's analysts discuss a Guest Commentary by McKinsey Senior Partner Emeritus Franck Le Deu, who argues that a multipolar biopharma world in which the U.S. continues to thrive even as China becomes meaningfully stronger can emerge.The analysts also discuss BioCentury's latest Rare Disease Spotlight, which focuses on a wave of therapies aiming to activate retinal function in Stargardt disease patients.Turning to FDA, BioCentury Washington Editor Steve Usdin discusses recent public statements by FDA Commissioner Marty Makary, questions about Vinay Prasad's future, and the plausible mechanism pathway.View full story: https://www.biocentury.com/article/658606 #GlobalBiopharma #ChinaBiotech #RareDisease #StargardtDisease #FDAPolicy 00:00 - Introduction02:47 - Multipolar Biopharma World13:39 - Rare Disease Spotlight25:15 - Makary Remarks31:14 - Plausible Mechanism FrameworkTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Gilead is acquiring Arcellx for $7.8 billion up front three years after forging a partnership with the biotech around a cell therapy for multiple myeloma. On the latest BioCentury This Week podcast, BioCentury's analysts assess what the deal does for the Foster City, Calif.-based biotech's pipeline.The analysts also discuss the case for using ctDNA as a surrogate endpoint for early cancer trials. Turning to Washington, Steve Usdin offers his takeaways from last week's PhRMA Forum, which focused on China and the Trump administration's most favored nation (MFN) drug pricing policy, and on the lessons that can be drawn from FDA's about-face on the recent vaccine application from Moderna.View full story: https://www.biocentury.com/article/658516#BiotechMA #MultipleMyeloma #ctDNA #DrugPricingPolicy #FDA00:00 - Introduction02:34 - Gilead's Arcellx Buy11:14 - ctDNA Surrogate Endpoints21:59 - PhRMA Forum Takeaways29:19 - FDA Moderna U-turnTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

As targeted protein degradation gains momentum, oral selective estrogen receptor degraders are emerging as one of its most advanced proving grounds. On the latest BioCentury This Week podcast, BioCentury's Lauren Martz assesses how the oral SERD landscape is evolving.Washington Editor Steve Usdin then discusses setbacks at FDA for an orphan therapy from Disc Medicine and a vaccine from Moderna, and why he is calling on life sciences industry leaders to publicly demand the dismissal of Vinay Prasad, FDA's CSO, CMO, and director of CBER.View full story: https://www.biocentury.com/article/658455#TargetedProteinDegradation #OralSERDs #OncologyDrugDevelopment #FDASetbacks #CBER00:00 - Introduction03:12 - Oral SERD Spotlight11:40 - Setbacks at FDA15:12 - Disc Medicine CRLTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

2025 marked the end of a four-year slide in series A financings for biotechs, with 144 biotechs raising an aggregate of $8 billion, up $1 billion from the prior two years. On the latest BioCentury This Week podcast, BioCentury's Danielle Golovin assesses which companies VCs backed last year and what their investments say about where technology is headed.Washington Editor Steve Usdin offers a perspective on why compounded Wegovy is an assault on the biopharma industry and also explains how the spending bill signed into law last week is a rebuke to proposed White House biomedical cuts.And Executive Editor Selina Koch unpacks her interview on The BioCentury Show podcast with neuroscientist and Seaport Chair Steven Paul, noting that while serendipity drives drug discovery in psychiatry, it's engineering that gets it across the finish line.View full story: https://www.biocentury.com/article/658367#BiotechFinancing #SeriesAFunding #VentureCapital #DrugDiscovery #BiopharmaPolicy00:00 - Introduction02:15 - Start-up Spotlight11:03 - Compounded Wegovy18:10 - Congress Rebuffs Trump Cuts23:50 - Steve Paul on NeuropsychiatryTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

RNAi and exon-skipping therapies headline the list of regulatory and pivotal data catalysts in 2026, while new lipid-lowering mechanisms, modalities, and precision medicines define cardiovascular disease catalysts this year. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the most important milestones of the year in new modalities, CV and renal diseases.The analysts also discuss a new regulation in China introducing orphan drug exclusivity that could incentivize development of rare disease therapies.Dig into the BioCentury's catalyst picks and the new China policy below• 2026 Catalysts: The rise of RNAi• 2026 Cardiovascular Catalysts: Lp(a) on the Horizon• 2026 Obesity Catalysts: Launches, readouts and challengers• 2026 Catalysts: Breakthrough progress in renal disease• AZ signals all-in on obesity via CSPC deal for $1.2B up front• China's orphan drug exclusivity could bolster market, incentivize developmentView full story: https://www.biocentury.com/article/65828600:00 - Introduction02:28 - RNAi and Antisense Therapies06:37 - Neuromuscular and Musculoskeletal10:33 - Renal Disease Catalysts22:26 - China's New Orphan RulesTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

New rules in China will accelerate the country's cell and gene therapy sector by reshaping how investigator-initiated trials are conducted and commercialized. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the new framework and why it will create a powerful incentive for deploying new gene and cell therapies.Executive Editor Selina Koch discusses which milestones she is watching in neurology in the year ahead, from psychedelics to Alzheimer's disease. Finally, Senior Biopharma Analyst Danielle Golovin discusses a pair of stories from BioCentury's Emerging Company Profile series: one focused on Yale spinout Bexorg Inc., which is rethinking CNS drug discovery with a whole-human-brain model, and another on Elkedonia S.A.S., a French start-up aiming at ELK1 to reboot neuroplasticity in depression.View full story: https://www.biocentury.com/article/65818900:00 - Introduction03:14 - Speeding China's Innovation10:36 - Neuro Catalysts22:01 - NewcosTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The biotech bull is back, and buysiders believe this market has staying power for the first time in nearly five years. On a special episode of the BioCentury This Week podcast, Director of Biopharma Intelligence Stephen Hansen and colleagues discuss Hansen's 2026 Public Markets Preview, which found interest rates, policy in Washington and fundamentals finally aligning and a wave of launches and M&A that could keep capital flowing into the sector.View full story: https://www.biocentury.com/article/658154#BiotechBullMarket #PublicMarkets #BiotechMA #IPOOutlook #FDApolicy00:00 - Introduction00:41 - Market Sentiment07:55 - Biotech's Next Wave14:47 - Lingering Concerns23:29 - IPOs26:47 - M&ATo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Next-generation induced proximity technologies are coming of age after a decade of industry focus on PROTACs. On the latest BioCentury This Week podcast, BioCentury's analysts discuss Senior Biopharma Analyst Danielle Golovin's four-part analysis of how next-generation targeting chimeras (TACs) are evolving. The analysts assess the $2.2 billion takeout of Rapt Therapeutics by GSK, which gave the pharma an allergy asset that the biotech sourced in China in 2024, and movement in Washington on priority review vouchers, NIH's budget and the White House's “most favored nation” drug pricing policy. The analysts also discuss takeaways from their meetings on the sidelines of the J.P. Morgan Healthcare Conference.View full story: https://www.biocentury.com/article/658112#InducedProximity #TargetingChimeras #BiotechMA #DrugPricingPolicy #JPMHealthcare00:00 - Introduction 03:17 - JPM Highlights09:17 - GSK's Acquisition of RAPT14:46 - Next-Generation Targeting Chimeras21:41 - MFN and Pediatric PRVsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The J.P. Morgan Healthcare Conference kicked off this week with sunny skies over San Francisco and more financial momentum than the biotech industry has seen in years. On a special “on the road” edition of the BioCentury This Week podcast, recorded on the sidelines of the annual JPM conference, special guests joined BioCentury's analysts to discuss the biotech ecosystems in Asia.The wide-ranging conversation spans dealmaking, including the pricing dynamics of assets in China and RNAi's prospects of becoming the region's next hot modality; plus the state of the capital markets, the global implications of “China speed” in the clinic, and what's changing for start-ups in Japan.Joining BioCentury were Panacea Venture's James Huang, MayTech Global Investments' Ingrid Yin, DLA Piper's Ting Xiao and CBRE's Matt Gardner.The podcast was recorded at the 12th East-West Healthcare Reception, hosted by BioCentury, MayTech Global and Panacea.View full story: https://www.biocentury.com/article/658081#JPMHealthcare #AsiaBiotech #ChinaBiotech #RNAiTherapeutics #BiotechCapitalMarkets00:00 - Introduction02:02 - Split Screen 2026 05:57 - China's Rapid Progress08:01 - AI and Biotech16:58 - Deal Prices22:56 - Public Markets28:47 - Innovation Across AsiaTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Riding the tailwind of a strong 2H25, the days leading up to biotech's annual kickoff meeting in San Francisco delivered billions in capital raised and more than two dozen deals announced. On the latest BioCentury This Week podcast, BioCentury's analysts discuss two of the largest deals announced at the start of the J.P. Morgan Healthcare Conference, a partnership for a bispecific between AbbVie and RemeGen and the launch of “NewCo” AirNexus Therapeutics by Haisco Pharmaceutical and a syndicate led by Frazier Life Sciences.The analysts also discuss Washington Editor Steve Usdin's policy outlook for the year ahead, and Executive Director of Biopharma Intelligence Lauren Martz's analysis of trends in FDA's 2025 approvals.View full story: https://www.biocentury.com/article/658052#JPMHealthcare #BiotechFinancing #BiopharmaPartnerships #FDAApprovals #BiotechPolicy00:00 - Introduction01:55 - JPM Deals11:49 - Policy Outlook19:30 - Trends in Drug ApprovalsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The New Year begins with biotech running along parallel storylines. There's cause for optimism as the industry's financing gears have begun to churn again and innovation remains as strong as it has ever been, while there's cause for concern as the world's most stable, progressive, science-based regulatory system has become unpredictable amid new leadership at HHS, FDA, and NIH. On the first episode of the BioCentury This Week podcast's seventh year, BioCentury's analysts assess the state of play for biotech in the U.S., Europe, and Asia.The discussion ranges from recent changes at NIH to what's next for rare pediatric disease priority review vouchers, and from Europe's opportunity as FDA enters uncertain terrain to Japan's evolving biotech landscape.Early bird rates for BioCentury and BayHelix's fifth East-West Biopharma Summit end Friday. Act now to join investors, dealmakers and innovators in Seoul this March to source innovation from Asia, or accelerate your own pipeline by finding the right Asia partner.View full story: https://www.biocentury.com/article/657978#BiotechOutlook #FDAUncertainty #GlobalBiotech #RarePediatricDiseasePRV #NIHLeadership00:00 - Introduction01:46 - 2026 Outlook03:56 - Policy Landscape11:48 - Priority Review Vouchers15:03 - Global Perspectives16:57 - Spotlight on Japan21:55 - European Biotech OpportunitiesTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

This past year was an inflection point for biotech: The markets woke up, M&A and China had strong showings, drug development offered key trends, and new leadership at FDA shuffled the regulatory deck. On the latest BioCentury This Week podcast, BioCentury's analysts make their picks for the biggest biopharma readouts, deals and regulatory and policy moves of 2025 and what they are forecasting for the year ahead.The analysts also recap biotech highlights of the past two weeks, including the $4.8 billion takeout of Amicus Therapeutics by BioMarin Pharmaceutical.View full story: https://www.biocentury.com/article/657933#BiotechOutlook2026 #BiopharmaTrends #BiotechMA #FDALeadership #ChinaBiotech00:00 - Introduction 02:31 - BioMarin's $4.8B Amicus Deal06:07 - Year-end Biotech Highlights16:37 - Analyst Picks and Predictions30:01 - Policy and Regulatory LandscapeTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

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 #SBIRFunding00:00 - Introduction01:45 - Obesity Data12:17 - Kymera's Breakthrough21:45 - FDA Survey Results29:41 - SBIR Funding StalemateTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

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 leadersView full story: https://www.biocentury.com/article/657781#BiotechMA #CARTTherapy #EpilepsyResearch #AlzheimersDisease #FDA02:37 - Biotech M&A06:39 - In vivo CAR T10:08 - Semaglutide for Alzheimer's16:17 - Praxis22:11 - FDATo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

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 #AlzheimersResearch00:00 - Introduction01:53 - Novo's Alzheimer's Miss13:19 - FDA's New Vaccine Policy19:53 - Funding C> BiotechsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

A baffling decision by FDA to issue a complete response letter for a pediatric medicine the medical community stood behind is just the latest example raising concerns that the agency is shifting the regulatory goalposts amid a lack of transparency. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin explains how the absence of advisory committee meetings at FDA is in part to blame for a lack of consistency in decision-making and divergence from decisions taken by other global regulatory agencies. VP and Editor-in-Chief Simone Fishburn then discusses the takeaways from Franck Le Deu's guest commentary on how China's biotech ecosystem is evolving, and whether government support for the sector is helping or hindering its overall health. BioCentury's analysts also discuss whether conventional CRISPR therapies will ever be commercially successful, and what's next for NLRP3 inhibitors to treat obesity following the first set of Phase II data for the class.We'd also like to invite our listeners to participate in our important survey about their experiences interacting with FDA. To take the survey, please go to BioCentury's FDA Sentiment Survey. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.View full story: https://www.biocentury.com/article/657698#FDARegulation #CRISPRTherapies #NLRP3Inhibitors #ChinaBiotech #DrugApproval00:01 - Sponsor Message: Voyager Therapeutics01:31 - FDA Sydnexis CRL07:36 - CDC Vaccine Claims09:55 - China's Innovation Arc16:49 - CRISPR Commercial Viability 26:39 - NLRP3 for ObesityTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

There is cautious optimism around continued M&A momentum and the public equities markets as biotech heads into the New Year. On a special edition of the BioCentury This Week podcast recorded in London during London Life Sciences Week, BioCentury's Simone Fishburn and Stephen Hansen were joined by a trio of guests to discuss their key takeaways from the week and expectations for next year, including trends in M&A and creative deal structures for business development.The group also discussed the potential for biotech venture investing to make a comeback as a key asset class for LPs, especially in the U.K., as the government continues to encourage pension funds to invest more broadly.The three guests joining BioCentury included Luciana Griebel from law firm Morgan Lewis, James Critchley from PJT Partners, and Carmine Circelli from the British Business Bank.The podcast was recorded Nov. 19 on stage at the Victoria House in London as part of the 3rd Biotech CEO & Investor Reception.BioCentury's next recording “on the road” will take place on the sidelines of the annual J.P. Morgan Healthcare Conference in San Francisco in January at the 11th East West Healthcare Reception hosted by BioCentury, Panacea Venture and Maytech Global Investments.View full story: https://www.biocentury.com/article/657686#BiotechMandA #DrugDevelopment #VentureCapital #LifeSciences #LondonLifeSciencesWeek00:00 - Introduction02:24 - Market Recovery08:02 - Growth and Influence16:24 - Creative Dealmaking21:40 - Role of CVRs25:52 - Pension Funds and Venture Capital30:09 - AI Bubble34:17 - Accelerating Clinical TrialsMorgan Lewis has prepared its materials for this podcast for general informational purposes only. They do not and are not intended to constitute legal advice. This podcast was recorded on Nov. 19. Morgan Lewis does not guarantee the accuracy or timeliness of the information contained in these materials and disclaims any obligation to advise you of any changes in the law. You should always refer to original source documents for complete information and consult directly with an attorney for advice, including on the latest developments in this rapidly changing area of the law.To submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Voyager CEO and former head of R&D at Biogen Al Sandrock is more optimistic than ever about the prospect of bringing clinically meaningful solutions to patients with Alzheimer's disease and other neurodegenerative disorders. The threads of progress are finally coming together, he said in a special episode of the BioCentury This Week podcast. From the first disease-modifying therapies for Alzheimer's disease, to a growing biomarker toolkit, to an expanding set of genetically validated targets in other neurodegenerative conditions — and, crucially, to delivery vehicles capable of broadly and deeply penetrating the brain — neurology drug development may be poised to accelerate. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.View full story: https://www.biocentury.com/article/657678#AlzheimersDisease #AAVGeneTherapy #BloodBrainBarrier #TauTargeting #Neurodegeneration00:01 - Sponsor Message: Voyager Therapeutics 03:41 - Voyager's Approach to Gene Therapy15:07 - Alzheimer's Disease25:25 - Big Biotech to Small Biotech29:21 - Neurodegenerative Diseases31:19 - FDA FlexibilityTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

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 #ClinicalTranslation00:01 - Sponsor Message: Voyager Therapeutics 03:08 - FDA's Richard Pazdur13:08 - Plausible Mechanism Pathway19:30 - Most Favored Nation23:12 - Takeaways from SITC28:05 - RNAi in China33:21 - European VCsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Today's South Korean biotechs have a risk-on mentality, a willingness to partner, and strategies focused on globalization. On a special edition of the BioCentury This Week podcast recorded at Venture Café Cambridge, BioCentury is joined by a quartet of investors and executives with deep knowledge of Korea's life sciences ecosystem to discuss Korea biotech's push to globalize and the opportunities in the country for Western companies. The four guests joining BioCentury were Aram Hong, CEO of Korean start-up Apollon; investors Spencer Nam and Debra Peattie; and Boehringer Ingelheim GmbH's Andy Whittle.The podcast was recorded Nov. 6 on stage at the Venture Café Cambridge during the K-Blockbuster Night hosted by KHIDI, the Korea Health Industry Development Institute. BioCentury analyses discussed during the podcast include one on Asian deals and another on the speed of clinical trials in China. BioCentury returns to Asia early next year for the 5th East-West Summit, March 9-11 in Seoul. This episode of the BioCentury This Week podcast is brought to you by KHIDI.View Full story: https://www.biocentury.com/article/657558#KoreaBiotech #Globalization #LifeSciences #BiotechEcosystem #PharmaDeals #ClinicalDevelopment #Innovation #BiotechLeadership00:01 - Sponsor Message: KHIDI05:08 - Asia Deals and Korea's Role09:12 - Boehringer's Perspective13:51 - Apollon's Journey17:24 - Building Relationships23:20 - Investors' View To submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

With ObesityWeek yielding eye-catching amylin data and a bidding war that ran to $10 billion for Metsera, weight loss companies were center stage in biotech last week. On the latest edition of the BioCentury This Week podcast, BioCentury's analysts explained why Pfizer's victory for the start-up over European rival Novo Nordisk doesn't necessarily mean a broader U.S. policy shift against foreign acquisitions of domestic biotechs.Turning to ObesityWeek readouts, they discuss Eli Lilly's data for amylin monotherapy eloralintide, arguing that just as Lilly did with GLP-1 agonists, the company is again setting the benchmark by which all other molecules in the class will be measured.BioCentury's analysts also discuss takeaways from Washington Editor Steve Usdin's Commentary, which finds FDA in a crisis of politicized decisions, plummeting morale, and a hollowed workforce, and highlights from BioCentury's interview with gene therapy pioneer Jim Wilson as he rethinks the funding model for ultrarare disease therapies to keep his mission on track. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.View full story: https://www.biocentury.com/article/657545#ObesityWeek #Amylin #GLP1 #Eloralintide #DrugMechanism #FDA #RareDisease #GeneTherapy00:01 - Sponsor Message: Voyager Therapeutics 01:53 - Pfizer Wins Metsera08:48 - Lilly's Amylin Data13:06 - Funding Ultrarare Therapies20:51 - What's Next for FDATo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Novo Nordisk's unsolicited $8.5 billion bid for Metsera has thrown a wrench into Pfizer's plans to return to the obesity race via its acquisition of the New York-based start-up. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the details of the competing bids and what's at stake for the pair of suitors.The analysts also assess the reasons behind the abrupt departure of Center for Drug Evaluation and Research Director George Tidmarsh from FDA and a surge in activity on the Hong Kong stock exchange. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.View full story: https://www.biocentury.com/article/657475#Biotech #PharmaDeals #ObesityDrugs #MergersAndAcquisitions #FDA #LifeSciences #GlobalBiotech #HongKongMarket00:01 - Sponsor Message: Voyager Therapeutics01:53 - Metsera M&A15:23 - Tidmarsh Ouster25:12 - Hong Kong IPOsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

China is setting a new bar for the speed of clinical development and redefining the time it takes an asset to get to the clinic. On a special edition of the BioCentury This Week podcast recorded on stage at the 12th BioCentury BayHelix China Healthcare Summit in Shanghai, BioCentury's Simone Fishburn argued that China's emerging new standard for swift entry to the clinic could upend the bottleneck of translational development and usher in a new paradigm that could have a “massive impact globally.”Fishburn and her BioCentury colleagues Joshua Berlin and Jeff Cranmer were joined by a trio of cross-border KOLs — John Zhu, CEO of antibody-drug conjugate company DualityBio; Matt Hewitt, CTO of  Charles River Laboratories' manufacturing business division; and Bing Wang, CFO of Akeso — to discuss the speed of generating first-in-human data, Innovent's $1.2 billion deal with Takeda, an evolving biotech talent pool, and the state of the financial markets.“For me, it really feels like 2025 is the year that biotech globally woke up to China,” Fishburn said.BioCentury returns to Asia early next year for the 5th East-West Summit, March 9-11 in Seoul. Register today as a delegate or apply to join the Presenting Company Class to take advantage of early bird rates.#ChinaInnovation #DrugDevelopment #PharmaDeals #GlobalBiotech #PharmaInnovation #siRNA #BrainToVein00:00 - Introduction02:49 - China Speed12:27 - Clinical Trails 17:34 - Global Strategy26:59 - Financial Markets IPOs36:52 - TalentTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Novartis' biggest deal in more than a decade gives the Swiss pharma three programs for muscular dystrophies that are close to the finish line. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the $12 billion deal for Avidity in the context of Novartis' recent acquisitions and the antibody-oligonucleotide conjugate platform it is gaining.The team dives into RNA versus DNA modalities, noting antisense and siRNA approaches appear to be gaining traction with major pharmas as traditional gene therapy and gene editing approaches hit rocky times. Still, they note hopeful progress among base editing therapies given the promising early track records of over a dozen base editors in the clinic. They also discuss BioCentury's conversation with base editing inventor David Liu; Alkermes' $2.1 billion acquisition of Avadel; and β-catenin data from Parabilis. This episode of BioCentury This Week is sponsored by Evotec.View full story: https://www.biocentury.com/article/657412#AntibodyOligonucleotideConjugates #RNAtherapeutics #BaseEditing #MuscularDystrophy #WntPathway #BetaCatenin #Orexin2Receptor #PrecisionMedicine00:01 - Sponsor Message: Evotec 02:04 - 12th China Healthcare Summit08:11 - Novartis' $12B Deal16:58 - Alkermes M&A20:01 - David Liu Base Editing25:02 - Parabilis' DataTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Next-generation platforms and technologies are getting closer to cracking one of biopharma's biggest problems: delivering medicines, and mAbs in particular, to the brain. On the latest BioCentury This Week podcast, BioCentury's Selina Koch details the latest innovations in blood-brain-barrier shuttles and how the technologies could transform the treatment of neurological diseases.BioCentury's Lauren Martz discusses her conversation with Tony Wood, CSO of GSK, which included the pharma's strategy for indication expansion, why it prefers RNA modalities over AAV-based gene therapies, and how its quest for causal biology has evolved over the years.Washington Editor Steve Usdin discusses the first set of FDA's new commissioner's national priority review vouchers, and why the voucher program is unlikely to function as an incentive capable of steering future behavior. Usdin also discusses the potential impact of FDA staffing reductions on the sector. This episode of BioCentury This Week is sponsored by Evotec.View full story: https://www.biocentury.com/article/657326#BloodBrainBarrier #Neurology #DrugDelivery #MonoclonalAntibodies #RNAtherapeutics #CausalBiology #FDA00:01 - Sponsor Message: Evotec01:57 - Brain Shuttles13:57 - GSK Q&A20:08 - FDA VouchersTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

It's been a tough year for cell and gene therapy — patient deaths, high-profile companies pulling out of the space, and sour investment sentiment. But the field has had some promising readouts in the clinic recently, and it continues to mature, showing steady progress despite challenging market conditions. On the latest BioCentury This Week podcast, Evotec's Bernd Mühlenweg joins BioCentury's analysts to give his view of the field and offer takeaways from this month's Cell & Gene Meeting on the Mesa in Phoenix. This episode of BioCentury This Week is sponsored by Evotec. View full story: https://www.biocentury.com/article/657278To submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Biotech's fourth quarter began with a familiar feeling, with indicators pointing toward an improving public market even as political and regulatory uncertainty has buysiders reluctant to say industry has returned to sustainable growth. On the latest BioCentury This Week podcast, BioCentury's analysts assess the state of biotech's public markets. The analysts discuss the Senate's move to limit access to Chinese CDMOs, the latest developments in the White House's “most favored nation” drug pricing negotiations, and the U.K.'s attempt to win over pharma companies via adjusting thresholds at NICE. Finally, they analyze a pair of billion-dollar-plus M&A deals: the $4.7 billion deal by Novo Nordisk to acquire liver disease company Akero and the $1.5 billion takeout of in vivo cell therapy company Orbital by Bristol Myers. This episode of BioCentury This Week is sponsored by Evotec.View full story: https://www.biocentury.com/article/657260#biotech #biopharma #pharma #lifescience #drugpricing #MFN00:01  Sponsor Message: Evotec02:12  4Q Markets Preview13:25  China CDMOs24:35  Drug Pricing Deals NHS31:22  Drug Pricing Deals M&ATo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The short-term consequences for Pfizer from its “most favored nation” drug pricing deal with the White House are negligible, but the long-term effects on the industry could be profound and permanent. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses why the deal by Pfizer Inc. (NYSE:PFE) changes everything — and nothing — and what's next in wrangling over drug pricing between industry and the Trump administration. The analysts also discuss PDUFA negotiations between FDA and leaders of BIO and PhRMA, how multi-site IITs could help bridge the academia-industry gap, and how TCG X plans to deploy its new $1.3 billion fund. This episode of BioCentury This Week is sponsored by Evotec.View full story: https://www.biocentury.com/article/657192#biotech #biopharma #pharma #lifescience #financialmarkets #drugpricing #MFN00:01  Sponsor Message: Evotec03:31  Pfizer MFN Deal16:05  PDUFA Reauthorization20:31  Investigator-Initiated TrialsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Genmab's $8 billion acquisition of multispecifics company Merus is the Danish biotech's largest step toward marketing its own pipeline. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the evolution of Genmab, which, for many years, relied on a partnership model that delivered blockbuster revenues but now is making a change as a patent cliff looms.The analysts also assess the tenure of Emma Walmsley the longtime CEO of GSK, and what's next for the U.K. pharma under incoming CEO Luke Miels. Turning to the U.S., Washington Editor Steve Usdin discusses President Donald Trump's looming tariff threat on imports of branded drugs, which Usdin says would hurt small biotechs the most. Usdin also analyzes the response of multinational pharmaceutical companies to the president's demand that they make “most favored nation” price concessions, now that Monday's deadline has passed. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/657131#biotech #pharma #deals #FGF21 #MASH #Interleukin5 #asthma #PhRMA #PBM #tarriff #MFN00:01 - Sponsor Message: IQVIA Biotech02:26 - Genmab's Merus Buy09:43 - CEO Switch at GSK17:22 - Trump Tariff Threat21:17 - MFN Drug PricingTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

AI is bringing sweeping changes to drug development, from how targets are discovered to optimizing clinical trials to maximize an asset's chance for success. On a special edition of the BioCentury This Week podcast, IQVIA's Greg Lever joins BioCentury's analysts to discuss agentic AI's short- and long-term prospects to help biotechs discover new targets, predict success in preclinical development, and enhance clinical operations. This episode of BioCentury This Week is sponsored by IQVIA Biotech. View full story: https://www.biocentury.com/article/657086#Biotech #Biopharma #DrugDevelopment #ClinicalTrials #TargetDiscovery #AgenticAI #GraphRAG #DeRisking00:01 - Sponsor Message: IQVIA Biotech01:22 - AI in Biotech05:01 - Machine Learning06:21 - Generative AI and Language Models08:37 - Agentic AI12:43 - AI in Target Discovery23:44 - AI in Clinical Trial DesignTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Is this the U.K.'s moment to capitalize on its biotech ecosystem? That was one of the primary themes discussed at the debut Grand Rounds — Europe conference last week in Cambridge, U.K. BioMarin's James Sabry and Astex's Michelle Jones joined BioCentury's analysts on a special edition of the BioCentury This Week podcast recorded live at the event to discuss their key takeaways from the two-day conference.Beyond the state of the U.K. biopharma ecosystem, the analysts discussed the meeting's major science themes, including what's next for DNA damage repair pathway targets, both inside and outside of cancer; whether obesity should be recast as a brain disease; and the cutting edge of small molecule design.View full story: https://www.biocentury.com/article/657082#UKBiotech #TranslationalMedicine #DrugPricing #GlobalCollaboration #Aging #Biologics #SmallMolecules #Biobanking00:00 - Introduction00:35 - Key Takeaways02:14 - The State of the U.K. Biotech Ecosystem09:01 - Scientific Highlights & Panel Takeaways22:44 - Closing Remarks and Future EventsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

A takeout that could be worth as much as $7.3 billion has Pfizer back in the obesity drug development race. On the latest BioCentury This Week podcast, BioCentury's analysts discuss Pfizer's acquisition of Metsera and its obesity assets. Plus: Editor in Chief Simone Fishburn gives a recap of BioCentury's Grand Rounds — Europe meeting, which included a fireside chat with Patrick Vallance on the state of the life sciences ecosystem in the country. The BioCentury analysts also assess the state of hot-button policy issues in Washington, such as drug pricing and China. Finally, they analyze the state of play among therapies for narcolepsy on the heels of the World Sleep Congress in Singapore. Check out BIO Chairman Fritz Bittenbender's conversation with BioCentury Washington Editor Steve Usdin on BioCentury This Week's sister podcast, The BioCentury Show. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/657065 #ObesityDrugs #PharmaDeals #BiotechDeals #MergersAndAcquisitions #DrugDevelopment #Narcolepsy00:01 - Sponsor Message: IQVIA Biotech03:46 - Pfizer's Obesity M&A14:54 - U.K. in Focus28:20 - U.S. Drug Pricing, China Policy40:07 - Narcolepsy PipelineTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Merck's announcement that it is moving its R&D out of the U.K. highlights concerns about the country's life sciences policies. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the life sciences ecosystem in the U.K., including MHRA CEO Lawrence Tallon's plans to create a world-class regulatory environment. They also discuss a bill passed by the U.S. House of Representatives that would end most U.S.-China academic research collaborations, and the recent success of 40-year-old biotech Insmed. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/656997#biotech #biopharma #pharma #lifescience #MHRA #China #RandD #DrugDevelopment00:01 - Sponsor Message: IQVIA Biotech01:25 - U.K. Biopharma04:40 - Grand Rounds Cambridge09:45 - SAFE Research Act18:01 - Spotlight on Insmed26:32 - Sen. Cassidy's Vaccine CalloutTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Molecular biologist and Nobel Prize winner David Baltimore made foundational contributions to the biopharma industry and was the essential figure behind such research institutions as the Whitehead Institute for Biomedical Research and the Broad Institute. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the legacy of Baltimore, who passed away this past weekend at 87.The analysts also discuss Atlas Venture's new $400 million opportunity fund, the clinical development pipelines for metabolic-associated steatohepatitis (MASH) and chronic urticaria, and late-stage atopic dermatitis data from Sanofi. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/656942#biotech #biopharma #DavidBaltimore #ReverseTranscriptase #MASH #Rezdiffra #GLP1 #ChronicUrticaria #Dupixent00:01 - Sponsor Message: IQVIA Biotech03:19 - Remembering David Baltimore06:20 - Atlas' New Opportunity Fund09:16 - The Growing MASH Pipeline15:57 - Sanofi's Atopic Dermatitis Data18:51 - Exploring Chronic Urticaria TreatmentsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Two veteran biotech leaders are launching a new company with ambitions in the cardiovascular disease space. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the debut of Corsera Health, a biotech led by John Maraganore and Clive Meanwell that is developing an AI-guided early risk assessment tool alongside dual-acting therapy that could stave off heart disease.The team then discusses how FDA has been quietly positioning itself to disrupt the childhood vaccine schedule, as well as the effects of changes to the Medicare drug negotiation program that were included in the tax and budget bill Congress passed in July.View full story: https://www.biocentury.com/article/656897#Corsera #DiseaseInterception #CardiovascularHealth #HeartDisease #FDA #VaccinePolicy #Medicare #DrugPricing00:00 - Introduction01:26 - Maraganore, Meanwell Newco09:17 - BioCentury's Back to School14:51 - Vaccine Disruption at FDA26:01 - Medicare Drug NegotiationsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

There's been a rare IPO filing on NASDAQ as LB Pharma looks to test the market during a year that has seen little activity among U.S. biotechs even as green shoots continue to appear on the Hong Kong stock exchange. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the market for biotech IPOs on NASDAQ and in Hong Kong.The analysts then assess FDA's about-face on Stealth BioTherapeutics' Barth syndrome therapy, putting the decision in the context of a changing regulatory agency; and a BioCentury Guest Commentary that argues that the university-industry engine that drives U.S. innovation is under attack. Also mentioned on this week's podcast: BioCentury's 33rd Back to School package, which reimagines FDA; the upcoming 12th China Healthcare Summit in Shanghai; the evolution of dealmaking in China; and Annalisa Jenkins' take on MHRA and the U.K. biotech ecosystem on The BioCentury Show.View full story: https://www.biocentury.com/article/656849#Biotech #IPO #Pharma #FDA #RareDisease #Biopharma #DrugDevelopment #HealthcareInnovation #HongKongIPO00:00 - Introduction 02:48 – LB Pharma Tests IPO Market07:01 – Hong Kong IPO Momentum09:53 – China Summit Preview13:40 – FDA Reversal on Stealth Bio18:15 – Bayh-Dole Clash & Innovation ThreatsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text