BioCentury This Week

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

BioCentury's third annual analysis of pharma company deals finds that bispecifics and degraders are in, cell and gene therapies are out, and China is bringing much more than me-too assets to cross-border deals. On the latest BioCentury This Week podcast, BioCentury's analysts assess a year's worth of deals between pharmas and biotechs to tease out emerging trends.The analysts also discuss last week's FDA approval of a vector-based immunotherapy from Precigen to treat a rare respiratory disease and whether the decision will set a precedent of more flexibility for rare disease therapies. They then take stock of recent translational coverage in BioCentury, including a report by Denali of a way to avoid a key safety issue of anti-amyloid-targeting mAbs.BioCentury's Grand Rounds — Europe will take place in Cambridge, U.K., Sept. 17-19. The conference seeks to bridge academia, industry and investors for breakthrough innovation.View full Story: https://www.biocentury.com/article/656802#PharmaDeals #CrossBorderDeals #Bispecifics #TargetedProteinDegradation #RareDisease #Neurodegeneration00:00 - Introduction01:38 - Pharma Deals10:41 - Precigen14:40 - Denali's BBB Tech25:20 - Grand Rounds EuropeTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Dealmaking between Western and Chinese biopharmas has been one of the year's bright spots, as a maturing biotech landscape in China converges with Western demand for innovative assets, driving record deal flow. At the same time, the Hong Kong stock exchange has emerged as the hottest market for biotech IPOs, at a time when the NASDAQ window remains shut.These themes will be in the spotlight at the 12th BioCentury-BayHelix China Healthcare Summit Oct. 22-24 in Shanghai. On this special edition of the BioCentury This Week podcast, a trio of biopharma leaders join BioCentury's analysts to discuss the landscape: McKinsey's Franck Le Deu, former BD executive Ji Li, and HBM Holdings' Mike Patten.BioCentury, BayHelix and Insights Partner McKinsey & Company invite you to visit Shanghai for the 12th China Healthcare Summit at the St. Regis Shanghai Jingan. For more information, click here; to apply to join the 2025 Class of Presenting Companies click here. View full story: https://www.biocentury.com/article/656773#ChinaBiotech #CrossBorderDeals #HongKongIPO #BiotechInvesting #LifeSciencesFinance00:00 - Introduction02:09 – Key Trends06:03 – View from McKinsey13:36 – Evolution of Deal Landscape20:24 – Learning from China24:00 – China-China M&A & NewCosTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Phase III data from Lilly's orforglipron in obesity fell short of investor expectations, but they appear to be enough to obtain approval and wide use. On the latest BioCentury This Week podcast, BioCentury's analysts discuss why the first-in-class oral small molecule GLP-1R agonist's clean safety profile and clear manufacturing advantage over oral peptides give the product a leg-up in the market.They then discuss Vinay Prasad's return to FDA after a brief hiatus, the revamped strategy of 32-year-old San Diego biotech Acadia Pharmaceuticals, and an attempt in the Senate to revive the Biosecure Act targeting China biotechs.Finally, the analysts preview this year's Back to School package, which reimagines FDA. At a time of unprecedented change in government agencies, BioCentury's 33rd Back to School asks what FDA could look like if it were reorganized from the ground up to create the regulator patients deserve and industry needs. View full story: https://www.biocentury.com/article/656727#orforglipron #CBER #VinayPrasad #AcadiaPharmaceuticals00:00 - Introduction00:49 - Prasad07:09 - Back to School12:29 - Lilly Obesity21:58 - Acadia's Comeback28:50 - Biosecure ActTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The ouster of Vinay Prasad after three months running FDA's Center for Biologics Evaluation and Research could signal a reset is ahead for CBER. On the latest BioCentury This Week podcast, BioCentury's analysts discuss what the latest shakeup at the regulatory agency says about what's next for FDA.The analysts also assess two leading European pharmas: obesity and diabetes company Novo Nordisk, which named a new CEO last week while cutting its 2025 forecast, and Bayer, which is gearing up for launches and is revamping its pipeline to restart growth. Finally, they discuss the promising clinical data that's reviving interest in masking technologies that conditionally activate biologics.View full story: https://www.biocentury.com/article/656649#FDA #CBER #NovoNordisk #ObesityDrugs #Bayer01:05 - Prasad's Ouster14:59 - Novo's New CEO21:14 - Bayer's Growth Strategy26:05 - Masked BiologicsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

A handful of encouraging signals is cause for cautious optimism for biotech headed into the second half of the year — companies have been able to parlay strong data into follow-on capital and M&A activity is picking up. That said, the IPO market continues to be closed and concerns about U.S. drug pricing and FDA stability continue to weigh on expectations for a robust near-term sector recovery.Special guest Megan Hooton from IQVIA Biotech joins BioCentury's analysts on a special edition of the podcast to discuss key indicators of progress for the biopharma sector. Hooton is president of IQVIA Biotech, which sponsored this episode of the pod.View full story: https://www.biocentury.com/article/656614#biotech #biopharma #pharma #lifescience #BiotechTrends #ClinicalTrials #GeneTherapy #CellTherapy00:01 – Sponsor Message: IQVIA Biotech02:37 – Biotech Markets06:41 – Clinical Highlights10:26 – Insights from Meg Hooton23:10 – Advanced TherapiesTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

This week's deal between GSK and Jiangsu Hengrui is a prime example of how Western biopharmas have begun to recognize the innovation and opportunities being fostered in China — and how it's no longer all about fast followers.On the latest BioCentury This Week podcast, BioCentury's analysts put the collaboration between GSK and Jiangsu Hengrui Pharmaceuticals, two of the most active cross-border dealmakers, into the context of East-West dealmaking over the past 30 months, assessing the innovation that is driving the rush to partner with biotechs in China, Japan, South Korea and beyond, and the types of companies looking to Asia for assets.BioCentury's analysts also discuss Steve Bates' outsized role in building the U.K. biotech hub, as he readies to take on a new role in the U.K. government. They examine new VC funds from Omega Funds and Brandon Capital, FDA's new national priority voucher pilot program, and fallout from how FDA and  Sarepta Therapeutics handled the deaths of four patients who had received the biotech's gene therapies. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/656592#biotech #biopharma #pharma #lifescience #EastWestDealmaking #ChinaBiotech #UKBiotech #FDAPolicy00:01 - Sponsor Message: IQVIA Biotech02:48 - Asia Deals Landscape17:32 - Steve Bates & U.K. Biotech25:46 - FDA's New Voucher Pilot31:01 - New VC Funds35:28 - SareptaTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Last week's public disclosure that a gene therapy from Sarepta had caused a third death led FDA to ask the company to stop distributing its DMD gene therapy Elevidys, a move the biotech has resisted. The deaths, and disputes between FDA and Sarepta, raise questions about the future of AAV gene therapies, as well as the future of FDA's platform technology designation. On the latest BioCentury This Week podcast, BioCentury's analysts unpack the events surrounding Sarepta's gene therapies and discuss how FDA, industry and patient groups should come together to learn the lessons from the tragic, avoidable deaths.BioCentury's analysts also assess Monday's appointment of Stanford professor and biotech executive George Tidmarsh to lead FDA's Center for Drug Evaluation and Research, and check in on the latest trends in venture financings. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/656537#biotech #biopharma #pharma #lifescience #GeneTherapy #AAVTherapy #Sarepta #Elevidys00:01 - Sponsor Message: IQVIA Biotech02:03 - Gene Therapy17:59 - Leading CDER27:00 - Venture ReportTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Chinese biotech is the lone bright spot for the biopharma financial markets in 1H25, as macro concerns about the most favored nation (MFN) pricing policy and FDA weigh on the prospects for biotech elsewhere. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the positives — and negatives — impacting investor sentiment headed into the second half of the year. The team also discuss where the quantum computing revolution could have its biggest impact on drug development, and review the proposals and accomplishments of FDA Commissioner Marty Makary over his first 100 days in office.View full story: https://www.biocentury.com/article/#biotech #biopharma #pharma #lifescience #financialmarkets #FDA #quantumcomputingReach us by sending a text

Grand Rounds heads to Europe: first meeting Sept. 17 in Cambridge, U.K.There are many reasons why it may be the European biomedical ecosystem's moment to shine, and advances at the academia-industry interface are a core part of that story, particularly in Cambridge, U.K. — the site of the inaugural BioCentury Grand Rounds – Europe conference.On a special edition of the BioCentury This Week podcast, BioCentury's analysts are joined by four leaders in the Cambridge, U.K., life sciences community to preview the Sept. 17-19 meeting: Kathryn Chapman, executive director of Innovate Cambridge; Anne Horgan, partner, Cambridge Innovation Capital (CIC); Sally Mardikian, business development director, Astrazeneca plc (LSE:AZN; NASDAQ:AZN); and Kristin-Anne Rutter, executive director of Cambridge University Health Partners (CUHP).The BioCentury team and its Cambridge counterparts discuss the conference's themes and how they relate to the region's strengths, and offer both some tough love and a warm invitation to early-stage innovators looking for science-forward investors and partners.View full story: https://www.biocentury.com/article/656373#biotech #biopharma #pharma #lifescience #Discovery #Translation #BioCenturyGrandRoundsEuropeReach us by sending a text

Oncology regulation has been less affected by recent changes in FDA leadership than other parts of the agency. On a special sponsored edition of the BioCentury This Week podcast, BioCentury's analysts assess what has and hasn't changed at FDA when it come to regulating cancer therapeutics. Special Guest Liz O'Brien joins BioCentury's analysts to discuss how biotechs can navigate FDA's Project Optimus and EMA's Joint Clinical Assessment as well as the differences between the two agencies. O'Brien is a former EMA regulator who is now therapeutic expert, oncology and women's health, drug development solutions at BioCentury This Week sponsor ICON Biotech. View full story: https://www.biocentury.com/article/656371#biotech #biopharma #pharma #lifescience #FDA #cancer #CAR_T00:01 - Sponsor Message: ICON Biotech02:30 - FDA Cancer Regulations07:48 - Project Optimus25:12 - CAR T REMS RemovalTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Treg-based cell therapies are nearing a clinical proof-of-concept inflection point, but in an environment that has dramatically shifted with the advent of CAR T therapies for autoimmune diseases. On the latest BioCentury This Week podcast, BioCentury's analysts discuss what these cell therapies need to show to be relevant in the fast-changing I&I world, and which types of indications may best suit the cells' unique profile.The team also explores the biotech sector's ongoing struggle to capture the interest of generalist investors, and what the next major theme might be to draw them back.The analysts then break down the key provisions in the recently passed U.S. reconciliation tax bill, highlighting the positive and negative developments, as well as the missed opportunities for the industry. This episode of BioCentury This Week was sponsored by IQVIA Biotech. View full story: https://www.biocentury.com/article/656376#biotech #biopharma #pharma #lifescience #CellTherapy #TregTherapy #CAR_T00:01 - Sponsor Message: IQVIA Biotech01:19 - Treg Inflection Point10:57 - Biotech's Next Big Story22:36 - Tax Bill ConsequencesTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The Trump administration's overhaul of FDA is still underway, but the agency has already veered away from its decades-long trajectory in ways that will profoundly reshape medical product development and the lives of U.S. patients. On the latest BioCentury This Week podcast, BioCentury's analysts assess who the winners and losers are likely to be as FDA changes shape.The analysts discuss a pair of in vivo CAR T companies: Esobiotec, whose story offers a case study in product-focused strategy, and Capstan Therapeutics, whose in vivo CAR T platform for immunological disorders attracted a buyer in Abbvie. The team also analyzes why data from Compass Pathways for psilocybin therapy COMP360 disappointed investors despite hitting the endpoint, and how molecular glues could be the future of selective CDK2 targeting. This episode of BioCentury This Week was sponsored by ICON Biotech.View full story: https://www.biocentury.com/article/656341#biotech #biopharma #pharma #lifescience #RandD #drugapproval00:01 - Sponsor Message: ICON Biotech02:26 - BioCentury Grand Rounds Europe05:02 - FDA's Future15:03 - Psychedelics22:53 - Esobiotech's Fast Exit31:37 - Molecular Glues and CDK234:43 - Abbvie's Capstan BuyTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Publicly traded U.K. investment firm and company builder Syncona is restructuring its fund amid ongoing market challenges in the biopharma industry. On the latest BioCentury This Week podcast, BioCentury's analysts discuss how the firm will steer its portfolio toward returns for shareholders, while aiming to build a new fund away from public markets. The analysts then assess Eli Lilly's takeout of cardiovascular base editing company Verve, and what Washington Editor Steve Usdin calls FDA's new “two-track” future for evaluating new therapies for approval — those with clear-cut benefits and those with ambiguous efficacy safety and efficacy profiles — in light of the many departures of senior FDA staff. They also discuss NASDAQ's largest biopharma IPO — by Caris —  in two years, the latest obesity readouts, FDA Commissioner Marty Makary's priority pathway and Usdin's Q&A with new BIO Chair Fritz Bittenbender. This episode of BioCentury This Week was sponsored by ICON Biotech.View full story: https://www.biocentury.com/article/656266#biotech #biopharma #pharma #lifescience #finance #CV #FDA00:01 - Sponsor Message: ICON Biotech02:14 - Syncona Restructures Fund10:08 - Lilly's $1B Verve Takeout21:45 - FDA's 2-Track FutureTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The tragic death of a second non-ambulatory DMD patient treated with Sarepta's Elevidys gene therapy marks a turning point for the field and should drive all stakeholders to come together to figure out how to safely treat patients with this new modality. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the opportunity FDA, companies and patient advocates have to share data and identify a safe path forward for the gene therapy field, both in DMD and beyond.The analysts also review promising early data for amylin agonists to treat obesity from Metsera and Eli Lilly, and discuss the vision for FDA's future laid out by Commissioner Marty Makary and CBER director Vinay Prasad. This episode of BioCentury This Week was sponsored by ICON Biotech.View full story: https://www.biocentury.com/article/656214#biotech #biopharma #pharma #lifescience #obesity #FDA #DMD00:01 - Sponsor Message: ICON Biotech01:19 - Gene Therapy Safety11:55 - Amylin in Obesity18:17 - FDA's FutureTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

With federal funding at risk and VCs increasingly focused on de-risked assets, academia is facing unprecedented headwinds despite rapid advancements in innovation. One potential bright spot: Pharma, which is turning to academia to access first-in-class innovation. But many in pharma complain it is difficult to work with academia.On a special Grand Rounds edition of the BioCentury This Week podcast, BioCentury analysts and special guests discuss a new way of thinking and a new era of collaboration between academia and industry.View full story: https://www.biocentury.com/article/656177#biotech #biopharma #pharma #lifescience #Discovery #Translation #BioCenturyGrandRounds00:00 - Introduction02:38 - Key Findings07:42 - Collaboration and Opportunities 25:52 - BioCentury Grand Rounds EuropeTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Translational trends at this year's ASCO meeting featured new and selective ways to target cell surface receptors on solid tumors. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the findings from Executive Director of Biopharma Intelligence Lauren Martz's deep dive into first-in-human studies at the American Society of Clinical Oncology meeting, including how immunocytokines, solid tumor CAR Ts and Chinese innovation are thriving in early trials.The analysts also examine the signs of strain and resilience in biotech's crossover investors, as well as FDA's plans for revamping rare disease regulation. This episode of BioCentury This Week was sponsored by ICON Biotech.View full story: https://www.biocentury.com/article/656139#biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment00:01 - Sponsor Message: ICON Biotech02:11 - ASCO's First-in-Human Trials12:46 - Crossover Investor Health Check22:54 - FDA's Rare Disease PlansTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Dealmaking by a pair of pharmas has given the biotech industry its best day of transactions in months, tallying nearly $13 billion in guaranteed payments across two deals. On the latest BioCentury This Week podcast, BioCentury's analysts discuss how the takeout of Blueprint Medicines for $9.1 billion up front gives Sanofi a drug for a rare immunological disorder and bolsters the French pharma's already strong presence in immunology. The analysts also assess the $3.5 billion partnership between BioNTech and Bristol Myers Squibb for an asset targeting cancer's hottest target, PD-(L)1 x VEGF, and underwhelming data from the leading asset against the target, PD-1 x VEGF bispecific ivonescimab, from Summit and Akeso Inc. Those data coincided with the kick-off of the American Society of Clinical Oncology (ASCO) meeting in Chicago, where almost a dozen companies were presenting readouts for another hot target, CLDN18.2. Evopoint is among the companies; its program recently attracted Astellas as a partner. Meanwhile, the biopharma industry is racing to counter the White House's most favored nation drug pricing strategy. BioCentury's Washington analyst, Steve Usdin, explains the urgency and details some of industry's options.View full story: https://www.biocentury.com/article/656097#biotech #biopharma #pharma #lifescience #deals00:00 - Introduction04:39 - Sanofi Buys Blueprint09:22 - BMS-BioNTech20:01 - Hot Targets23:40 - 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

Dutch biotech Merus' EGFR x LGR5 bispecific antibody has caught investors' attention in the run-up to ASCO as a new approach to block EGFR signaling. On the latest BioCentury This Week podcast, BioCentury's analysts discuss Phase II data from Merus for petosemtamab as they preview the American Society of Clinical Oncology's upcoming annual meeting. The analysts also assess a setback in a gene therapy trial for Rocket Pharmaceuticals, renewed interest in cancer target EpCAM, and a flurry of biopharma activity on the Hong Kong stock exchange. Finally, the team previews BioCentury's second annual Grand Rounds R&D meeting, which takes place next week in Chicago. This episode was sponsored by Jeito Capital.View full story: https://www.biocentury.com/article/656038#biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment00:01 - Sponsor Message: Jeito Capital24:52 - HK IPOs07:12 - ASCO16:37 - EpCAM20:16 - RocketTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Political and market turmoil has raised questions whether the U.S. can retain its biopharma leadership position, and in turn presents Europe with an opportunity to attract talent back to the continent with an offer of a more stable biomedical funding and regulatory environment. Jeito Capital's Ksenija Pavletic and Cambridge Innovation Capital's Anne Horgan join BioCentury's analyst to wrap up the 25th annual Bio€quity Europe conference in Bruges, Belgium, by discussing their key takeaways from the two-day event. This episode was sponsored by Jeito Capital.View full story: https://www.biocentury.com/article/655998#biotech #biopharma #pharma #lifescience #networking00:01 - Sponsor Message: Jeito Capital02:10 - Key Takeaways09:13 - Challenges and Opportunities for Europe19:23 - Capital Efficiency and Success Stories28:27 - Leadership, Teams & TalentTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The turbulence that has come with the Trump administration's policies related to the U.S. biopharmaceutical industry is creating an opening for Europe to bolster its life sciences industry. On the latest BioCentury This Week podcast, BioCentury's editors look at how Europe can capitalize on staffing cuts at FDA and NIH and an uncertain policy environment to lure back talent to bolster regulatory agencies and biotech R&D engines and attract assets and partners from China.The editors also discuss two biotech deals driven by former leaders of BD at Roche, Biomarin's James Sabry and Sophie Kornowski at Boston Pharmaceuticals. Under the leadership of Sabry and CEO Alexander Hardy, Biomarin delivered its first takeout in a decade by acquiring Inozyme as it positions itself to take advantage of a regulatory and policy environment that they believe is favorable to their rare disease strategy. CEO Kornowski, meanwhile, executed on a plan to focus her company on a single liver disease asset that GSK acquired for $1.2 billion up front. Finally, BioCentury's editors discuss the management shake-up at obesity company Novo Nordisk, where Lars Fruergaard Jørgensen, the leader who spearheaded Novo Nordisk's transformation into a dominant player in obesity, is stepping down.Chan Zuckerberg Chicago Biohub is hosting an exclusive, invite-only reception on June 3 — the eve of BioCentury's Grand Rounds conference — gathering top voices in biotech innovation and investment to exchange bold ideas, spark new collaborations and channel the energy of Chicago's thriving innovation ecosystem. If you're interested in attending, please register here. This episode was sponsored by Jeito Capital.View full story: https://www.biocentury.com/article/655964#biotech #biopharma #pharma #lifescience #politics #policy #law00:01 - Sponsor Message: Jeito Capital05:05 - European Biotech's Moment?19:00 - Boston Pharma, Biomarin Deals29:41 - Novo Nordisk CEOTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Biopharmas developing therapies for obesity are looking to a future where the quality of weight loss matters as much as the quantity — what targets and programs could help realize that vision? On the latest BioCentury This Week podcast, BioCentury's editors discuss the signaling pathways that may exclusively target fat mass while preserving, or even increasing, lean mass — and which companies are playing in the space.The editors also assess what Vinay Prasad's past comments say about how he might lead FDA's Center for Biologics Evaluation and Research (CBER) — and examine how investors are evaluating the possibility that he might move the bar for regulatory approvals. The team then introduces the first in a new BioCentury series, with a look at a Literature Dive into ovarian cancer “atlases” — large-scale molecular profiling studies that point to predictive signatures and patient stratification strategies. This episode was sponsored by Jeito Capital.View full story: https://www.biocentury.com/article/655898#biotech #biopharma #pharma #obesity #FDA #CBER #LifeScience #OvarianCancer00:01 - Sponsor Message: Jeito Capital03:22 - Obesity: Quality over Quantity15:47 - Prasad at FDA27:58 - Ovarian Cancer AtlasesTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

This year's Bio€quity Europe conference — the 25th edition of the event — will focus on what's next for Europe amid biotech's current complex moment, Editor in Chief Simone Fishburn said on a special edition of the BioCentury This Week podcast previewing the meeting, which kicks off May 12 in Bruges, Belgium. McKinsey & Co.'s Alexandra Zemp and Henk Joos, an investment specialist at Medvia, which fosters health innovation in Flanders, joined BioCentury to discuss the state of Belgium's biopharma ecosystem and preview some of the conference's networking events, fireside chats and panel discussions. Claire Macht, portfolio director, Europe, of BioCentury's conference partner EBD Group, also joined the podcast to detail what to expect in terms of one-on-one partnering meetings at the event.Bio€quity Europe 2025 is sold out, but space on the waitlist remains, and digital passes are available. See the conference website for more information.View full story: https://www.biocentury.com/article/655883#biotech #biopharma #pharma #networking #LifeScience00:00 - Introduction01:25 - What's Next for Europe?06:58 - Belgium's Biotech Ecosystem10:29 - McKinsey on European Biotech15:27 - Partnering, Panels of NoteTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Among the formerly undruggable targets gaining translational momentum, SMARCA2 has intrigued researchers for its potential to treat challenging solid tumors. On the latest BioCentury This Week podcast, BioCentury's editors zero in on preclinical research supporting different degraders of SMARCA2 at this year's American Association for Cancer Research (AACR) annual meeting.They also discuss takeaways from Editor in Chief Simone Fishburn's conversation with David Baker, the Nobel-prizewinning pioneer in protein design, and Steve Usdin reports that pharmaceutical industry executives are in a state of alarm over President Trump's push to include a “most favored nation” policy for Medicaid drug purchases in budget reconciliation legislation. Usdin also discusses why industry executives are confident of a fix for the Inflation Reduction Act's “pill penalty” and FDA Commissioner Marty Makary's decision to reject proposals to reorganize the agency. This episode was sponsored by Jeito Capital.View full story: https://www.biocentury.com/article/655851#biotech #biopharma #pharma #LifeScience #RandD #DrugDevelopment #AACR #SMARCA200:01 - Sponsor Message: Jeito Capital03:01 - AACR Spotlight11:21 - David Baker Protein Design19:12 - Trump's Drug Pricing PlanTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Belief in tau — both as a target and surrogate endpoint — for Alzheimer's is building among leaders in the field. On the latest BioCentury This Week podcast, Executive Editor Selina Koch discusses how tau could be reaching a tipping point. Also on this week's episode, Washington Editor Steve Usdin details how political moves have begun to intrude into the Trump administration's regulation of vaccines, a topic that's also taken up by Phil Krause and Luciana Borio in a BioCentury Guest Commentary published Monday. BioCentury's editors then discuss delays for drug regulation at FDA, Merck KGaA's $3.9 billion deal to acquire Springworks, and why biotech IPOs could soon have a moment in Hong Kong. This episode of BioCentury This Week podcast is sponsored by RemeGen.View full story: https://www.biocentury.com/article/655780#biotech #biopharma #pharma #lifescience #alzheimers #RandD #DrugDevelopment #IPO00:01 - Sponsor Message: RemeGen Co.02:06 - Tau Time for Alzheimer's13:10 - Vaccine Drama at FDA23:32 - Merck KGaA's SpringWorks Buy24:52 - Hong Kong 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

Biopharma companies are vying to dethrone Vyvgart as a leading therapy for myasthenia gravis, with the latest data for therapies treating the rare autoimmune neuromuscular disease coming at this month's American Academy of Neurology. On a special episode of the BioCentury This Week podcast, BioCentury's editors discuss the landscape for MG therapies, including anti-BLyS and APRIL therapy telitacicept from Remegen. Joining BioCentury's editors are Qing Zuraw, chief development officer of podcast sponsor RemeGen, and Amit Sachdev, PI on global trials of the biotech's therapy. BioCentury's editors also preview the American Association for Cancer Research annual meeting, where degraders and bispecifics are defining translational trends at this year's event. This episode of BioCentury This Week podcast was sponsored by RemeGen.View full story: https://www.biocentury.com/article/655751#biotech #biopharma #pharma #lifescience #AAN #AACR00:01 - Sponsor Message: RemeGen Co.01:02 - Myasthenia Gravis at AAN08:31 - RemeGen's Telitacicept18:03 - AACR: Targets and TrendsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The academia-industry interface is more important than ever for sustaining biomedical innovation's forward momentum, even as the Trump administration injects turbulence into academic funding for universities. On a special edition of the BioCentury This Week podcast, BioCentury's Simone Fishburn and Karen Tkach Tuzman preview Grand Rounds, BioCentury's second annual R&D conference, along with special guests.Spots are filling up for the Grand Rounds U.S. Presenting Company Class of 2025. Find out how to apply here.View full story: https://www.biocentury.com/article/655696#biotech #biopharma #pharma #lifescience #academia #chicago #asco00:00 - Introduction01:42 - Key Themes and Featured Sessions07:37 - Chicago's Role in Biotech Innovation15:06 - McKinsey's Insights25:18 - Upcoming Events and Networking OpportunitiesTo 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 community is reeling, fearful and furious about the fallout of tariff, FDA and NIH policies, according to BioCentury's newly released Risk Sentiment survey. On the latest BioCentury This Week podcast, BioCentury's editors discuss takeaways from the survey, which polled 328 biopharma stakeholders during April 10-14. The editors dissect the latest from Washington, including comments from FDA Commissioner Marty Makary on a new pathway for ultrarare drugs and his plans to reform advisory committee meetings, as well as last week's executive order on drug pricing. They also discuss how China's biotechs may have cracked one of the key bottlenecks for both speeding up and de-risking early drug development — and what this means for U.S. biotech. This episode of BioCentury This Week podcast was sponsored by RemeGen.View full story: https://www.biocentury.com/article/655690#biotech #biopharma #pharma #lifescience #FDA #politics #policy #law00:01 - Sponsor Message: RemeGen Co.02:00 - Sentiment Survey20:18 - Makary's FDA Plans29:51 - China SpeedTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

FDA's plan to move away from animal toxicity testing could expedite INDs and cut costs for biopharma companies, while helping the U.S. maintain its position as a clinical research hub. On the latest BioCentury This Week podcast, BioCentury's editors discuss the agency's new three-year road map to reduce animal safety studies for mAbs. The editors then discuss the deepening morale crisis at FDA after HHS Secretary Robert F. Kennedy Jr. accused the agency of corruption, encouraged staff to report supervisors over approval decisions they oppose, and endorsed conspiracy theories about the “deep state.” They assess the impact of whipsawing tariff policies and turmoil at FDA on biotech indexes — and why the sky isn't falling just yet for biotech's specialist investors. The editors also highlight recent stories on base editors' efficiency boom and how exosomes are finding new life. This episode of BioCentury This Week podcast was sponsored by RemeGen.View full story: https://www.biocentury.com/article/65562200:01 - Sponsor Message: RemeGen Co.02:38 - Replacing Animal Models09:40 - RFK Jr. & FDA19:36 - NIH30:02 - BioPharma Market Pulse33:23 - Innovation HighlightsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Loss of leadership, cuts to staffing and a proposed reorganization at FDA have heightened biotech risk amid an already turbulent macroeconomic climate, according to BioCentury's Washington editor Steve Usdin. On the latest BioCentury This Week podcast, BioCentury's editors discuss how the turmoil at FDA could affect a sector already grappling with the uncertainty brought by the Trump administration's trade war.The editors also explore the growing pipeline of VEGF-targeted bispecifics in a preview of upcoming presentations at annual meeting for the American Association for Cancer Research (AACR). And they discuss how companies may once again need to lean on their bear market survival toolkit, as part of BioCentury's 2Q25 Financial Markets Preview. This episode of BioCentury This Week was sponsored by RemeGen Co.View full story: https://www.biocentury.com/article/65556600:01 - Sponsor Message: RemeGen Co. 01:19 - FDA and Tariffs Turmoil16:54 - AACR Preview20:44 - Bear Market ToolkitTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Biotech indexes are tumbling after one of FDA's last veteran leaders was pushed out by HHS Secretary RFK Jr. and the threat of tariffs weigh on a key biotech index. On the latest BioCentury This Week podcast, BioCentury's editors discuss the factors driving down the XBI, which has now crossed into bear market territory and the latest turmoil at FDA, now that CBER Director Peter Marks has been ousted. Plus, inflammation and immunology companies are finding ways beyond precision medicine to boost responses. BioCentury's editors assess one approach — bispecific antibodies that block two inflammatory pathways instead of one.View full story: https://www.biocentury.com/article/65548800:00 - Introduction00:51 - XBI's Return to the Bear Market11:26 - Marks Ouster & Turmoil at FDA18:07 - Bispecifics for I&ITo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

European venture firm Sofinnova Partners is expanding the reach of its Biovelocita accelerator beyond Italy to stretch across the greater continent. On the latest BioCentury This Week podcast, BioCentury's editors discuss how Biovelocita became the largest life sciences accelerator in Europe. The editors also discuss Novo Nordisk's latest addition to its obesity pipeline via a deal in China, and how the partnership reflects the state of cross-border dealmaking more broadly. And Washington Editor Steve Usdin assesses President Trump's threat to impose 25% tariffs on pharmaceutical imports and provides an update on how FDA's staff is navigating the policies of the new administration. Finally, Editor in Chief Simone Fishburn discusses BioCentury's upcoming Grand Rounds meetings.View full story: https://www.biocentury.com/article/65543800:00 - Introduction02:25 - Sofinnova's Pan-European Accelerator08:27 - China Biotechs14:59 - Trump TariffsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

BIO is engaging with President Donald Trump to protect and improve FDA. It's also hoping biopharmas can dodge tariffs and find paths to modify the Inflation Reduction Act and reinstate pediatric priority review vouchers. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin delivers takeaways from his conversation with John Crowley, CEO of the industry trade group.BioCentury's editors also discuss how autoimmune CAR T companies are competing for resources and the end-to-end radiopharma ambitions of Telix Pharmaceuticals. A 2023 landscape on the radiopharma space can be found here.View full story: https://www.biocentury.com/article/65537000:00 - Introduction02:09 - BIO's Trump 2.0 Plan14:00 - Autoimmune CAR Ts21:05 - Telix's Radiopharma PlayTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

While the culling of companies in the biotech bear market may have yet to subside, creative cross-border deal-making on innovative assets is spreading across Asia's Arc of Innovation. Sciwind Biosciences Co. Ltd.'s Jing Shu and A*Star's Lisa Ooi join BioCentury to wrap up the 4th annual BioCentury-BayHelix East-West Biopharma Summit in Singapore by discussing deal-making trends, the rise of new technologies and the deepening of biotech ecosystems from India to Japan.View full story: https://www.biocentury.com/article/65531800:00 - Introduction01:58 - Key Takeaways08:42 - Innovation in Japan and India12:54 - Building Biotech Ecosystems31:14 - NewCo ModelTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The almost certain confirmation of Marty Makary as FDA commissioner this month will cap a transition marked by internal upheaval and political infighting. On the latest BioCentury This Week podcast, BioCentury's editors discuss Thursday's confirmation hearing for President Donald Trump's pick to lead the agency and Makary's hints at what we can expect from his agenda.The editors also discuss whether the advantages of amylin agonists could help the therapies outshine GLP-1 in obesity, why the latest weight loss data from CagriSema weighed on shares of Novo Nordisk, and a call to deliver on the meritocracy ideal, now that DEI is dead.View full story: https://www.biocentury.com/article/65530200:00 - Introduction01:10 - Makary's FDA Agenda10:50 - Amylin in Obesity24:21 - Life After DEITo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The track record of biotechs launched to create curative therapies using CRISPR-Cas9 provides new insights into the old debate over whether platform companies should validate their technology on established targets or pursue new ones. On the latest BioCentury This Week podcast, BioCentury's editors discuss the lessons learned by this small group of companies since their launch a decade ago. They also discuss the entrance of AbbVie into the obesity race via a $350 million deal with Gubra for a clinical stage amylin agonist — does it signal AbbVie's belief in amylin monotherapy, or will the company be hunting for more obesity assets? The editors also talk about recommendations to streamline the early-stage development of rare disease therapies in the U.S.View full story: https://www.biocentury.com/article/65521400:00 - Introduction00:36 - CRISPR Companies09:22 - AbbVie Enters Obesity Race17:19 - Rare Disease Drug ChallengesTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Once pharma's oncology powerhouse, Roche is charting a new course that extends beyond its traditional stronghold in cancer therapeutics. On the latest BioCentury This Week podcast, BioCentury's editors discuss how the Swiss pharma has reshaped its strategy for long-term growth. They also discuss another tumultuous weekend for staff at FDA and NIH, as well as the challenges of precision medicine for psychiatric conditions.View full story: https://www.biocentury.com/article/65515700:00 - Introduction00:45 - Roche Reboot08:47 - Precision Medicine in Psychiatry13:07 - 5 Things on Trump 2.0To submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Rather than fretting over increasing competition from Chinese life sciences companies, biotechs in the U.S. should rise to the challenge and learn from their competitors. On the latest BioCentury This Week podcast, BioCentury's editors discuss the increasing pace of innovation from China and how U.S. biotechs need to meet the moment, delivering key takeaways from Editor in Chief Simone Fishburn's fireside chat with industry leader John Maraganore at the BIO CEO & Investor Forum in New York last week. The team also discusses the fallout from staffing cuts at FDA — severely damaged morale among remaining staff and the potential for a higher approval bar, among others — leadership at the agency and the state of biotech IPOs on NASDAQ and in Korea.View full story: https://www.biocentury.com/article/65511200:00 - Introduction00:58 - Competing with China14:13 - FDA, NIH Staff Cuts20:16 - Biotech IPOs To submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Western VCs are paying more attention than ever to innovation emerging from Asia — from antibody-drug conjugates to bispecifics, AI and beyond — as the NewCo Model becomes the latest trend to bridge talent, assets and venture money across the Pacific and on to North America and Europe. On a special edition of BioCentury This Week podcast, a trio of leaders from Asia's life sciences ecosystem — Khoo Shih of Singaporean investor ClavystBio, McKinsey & Company's Anirudh Roy Popli and Wendy Pan of Goodwin and BayHelix — join the BioCentury team to set the stage for the fourth BioCentury-BayHelix East-West Biopharma Summit. They discuss the innovations driving the deal flow from East to West, including the creation of start-ups in the West formed around assets from Asia. The summit takes place March 3-5 in Singapore.View full story: https://www.biocentury.com/article/65510800:00 - Introduction04:49 - The Newco Model and Industry Trends09:13 - BayHelix and Cross-Border Transactions11:31 - McKinsey's Perspective on Asian Innovation26:58 - Final Thoughts and Registration InformationTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

White House plans to slash FDA and NIH risk decimating two agencies at the core of U.S. biomedical innovation. On the latest BioCentury This Week podcast, BioCentury's editors assess draft plans by the Trump administration that seek to halve FDA staff, cut NIH, and reduce overhead payments to academic institutions. The policy addressed in a recent Guest Commentary for BioCentury, “Defending the NIH, the NSF and the foundation of American science,” by the Scleroderma Research Foundation's Luke Evnin, Peter Rubin of No Patient Left Behind, and Ra Capital's Peter Kolchinsky.BioCentury's team also discusses how biotechs are becoming increasingly successful at navigating the obstacles to get precision therapies across the FDA finish line.View full story: https://www.biocentury.com/article/65503400:00 - Introduction00:59 - FDA, NIH & Trump 2.016:26 - Biotechs & Precision MedicineTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text