BioCentury This Week

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

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

Mid-sized biopharma companies are under growing pressure to accept most-favored nation drug pricing deals with the White House. On the latest BioCentury This Week podcast, BioCentury's analysts assess the trade-offs companies face, the litigation risks around mandatory Medicare MFN pricing demonstrations, and what happens to companies that don't sign on. The analysts also discuss Eli Lilly's acquisition of Merida , its thirteenth takeout of the year, Heidi Overton's nomination as FDA commissioner and what it signals about FDA independence, and Revolution Medicines' 35-day filing-to-approval timeline under FDA's national priority review voucher pilot. View full story: https://www.biocentury.com/article/660655 #DrugPricing #FDA #BiotechMA #Oncology #BiopharmaPolicy 0:00 - Introduction 2:14 - MFN Drug Pricing Deals 10:09 - Lilly Acquires Merida 22:22 - FDA Commissioner Pick 30:11 - RevMed's Rapid Approval To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

China has changed the global narrative on delivering early human clinical data, with a new bar for speed and efficiency. And now drug developers and policymakers around the world have gotten the message and know that this is no time for complacency. On a special edition of the BioCentury This Week podcast, BioCentury's analysts discuss why transformational reform for early clinical development will require rethinking the risk-control paradigm for first-in-human trials. It’s the subject of the 2026 Back to School issue , the 34th edition of an annual analysis that takes on one of the most pressing topics facing the biopharma industry. View full story: https://www.biocentury.com/article/660629 #ClinicalTrials #FirstInHuman #DrugDevelopment #FDA #BiopharmaPolicy 0:00 - Introduction 6:40 - U.S. 15:09 - Australia 24:00 - China 32:14 - Europe To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

A Phase III win for a melanoma vaccine from Moderna and Merck & Co. has opened the door to personalized neoantigen vaccines. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the vaccine’s prospects and the broader implications. The analysts also discuss Roche/Genentech’s deal with Hanmi, which will add to the MNC’s obesity pipeline an asset that the pharma believes could be first in class, and the White House's pick of a Trump loyalist to lead FDA – a move that has revived questions of the agency's independence. View full story: https://www.biocentury.com/article/660596 #CancerVaccines #Obesity #FDA #Oncology #DrugDevelopment 00:00 - Introduction 03:03 - Moderna 11:12 - Genentech obesity deal 15:08 - Trump's FDA pick To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

A baker’s dozen of biotechs shrugged off the summer haze to raise nearly $800 million in venture cash. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the financings, which included money for a potential challenger to Amgen’s blockbuster Tepezza and a new venture from immunology professor Georg Schett with backing from Deerfield Management, Boulevard Bio. The analysts also discuss new approaches to drug cancer’s “undruggable” β-catenin pathway, and whether Capricor’s latest regulatory move will give Duchenne muscular dystrophy therapy deramiocel new life at FDA. View full story: https://www.biocentury.com/article/660539 #BiotechFinancing #DrugDevelopment #BetaCatenin #DuchenneMuscularDystrophy #Biopharma 00:00 - Introduction 02:18 - Venture Rounds 12:02 - Drugging β-catenin 18:12 - Capricor & FDA To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

Pressure is on FDA, policymakers and academic centers in the U.S. to respond to challenges from China, Australia, and beyond to run first in human trials faster and more efficiently. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how stakeholders in the U.S. are responding to the challenge. The analysts also discuss the next frontiers of federated learning in drug discovery and the latest crop of biotech IPOs on NASDAQ, which raised over $1.2B in strong IPO run last week. View full story: https://www.biocentury.com/article/660433 #ClinicalTrials #BiopharmaPolicy #DrugDevelopment #BiotechIPO #FederatedLearning 00:00- Introduction 01:15 - Academic Centers 10:42 - Policy Picture 15:48 - Grand Rounds Europe Highlights 18:01 - Federated Learning 28:15 - NASDAQ 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

Rumors flew this weekend about a mega-merger of AstraZeneca and Bristol Myers — but would such a deal make sense? On the latest BioCentury This Week podcast, BioCentury’s analysts explain why they aren’t buying it . The team also discusses what lessons can be learned from the regulatory roller-coaster ride of Replimune’s RP1 vusolimogene oderparepvec and psychedelic therapies’ inflection point in treating depression. View full story: https://www.biocentury.com/article/660376 #BiotechMA #FDA #Psychedelics #Depression #OncolyticVirus 00:00 - Introduction 00:51 - AZ-BMS Rumors 08:07 - Replimune 20:46 - Psychedelics To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

Argenx the tier-jumping European biotech, believes its proposed $2.2 billion purchase of Forte Biosciences will add a second multi-indication product upon which it can run the strategy that has made autoimmune drug Vyvgart efgartigimod alfa a blockbuster. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the deal and put it in the context of a new cohort of large-cap companies increasingly active in biotech M&A. The analysts also assess how recent releases from Anthropic, NVIDIA, Google, OpenAI and Amazon fit into biopharma R&D workflows — and with one another. Finally, they analyze the 1H26 clinical and regulatory catalyst scorecard , which therapies hit their milestones, which missed, and what’s next through year-end. This episode of the BioCentury This Week podcast has been brought to you by CBRE . View full story: https://www.biocentury.com/article/660296 #BiotechMA #ArtificialIntelligence #DrugDevelopment #ClinicalTrials #Biopharma 00:01 - Sponsor Message: CBRE 01:57 - BioCentury AI Connector 05:47 - Argenx Acquires Forte 08:06 - Rise of Biotech Buyers 13:12 - AI Giants' Tech Stack 24:20 - Anthropic Enters Drug Development 27:41 - 2026 Catalyst To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

The departure of U.K. Science Minister Patrick Vallance is a blow for U.K. biotech. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what Vallance’s exit, the appointment of John Healey as Chancellor of the Exchequer and other changes arriving with the new Prime Minister could mean for life sciences in the country. BioCentury’s analysts also discuss an ambitious U.K. data initiative launched this month. The Health Data Research Service is intended to be a single front door to all NHS health records, offering large-scale longitudinal health data across diverse populations. Beyond the U.K., the team turns to companies to watch in Taiwan, what’s next for Biogen’s anti-tau therapy, Eli Lilly’s proposed acquisition of psychedelics company AtaiBeckley, and the latest changes at FDA. This episode of the BioCentury This Week podcast has been brought to you by CBRE . View full story: https://www.biocentury.com/article/660194 #Biotech #LifeSciences #UKBiotech #HealthData #FDA 00:01 - Sponsor Message: CBRE 02:23 - U.K. Leadership Changes 09:21 - U.K. Data Initiative 10:52 - Taiwan Biotech 16:44 - Biogen’s Tau Data 27:18 - Lilly’s Psychedelics Takeout 28:20 - FDA To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

After nearly three years of sluggish job growth, hiring is turning a corner in the U.S. life sciences industry, while the talent pool is expanding beyond the sector’s traditional hubs. On a special episode of the BioCentury This Week podcast, Ian Anderson, senior director, head of U.S. life sciences & healthcare research at CBRE, joins BioCentury’s analysts to discuss the company’s recent report on life sciences talent trends, and how those trends are driving property demand. This episode of the BioCentury This Week podcast has been brought to you by CBRE . View full story: https://www.biocentury.com/article/660118 #LifeSciences #BiotechJobs #Workforce #LifeSciencesRealEstate #Talent 00:01 - Sponsor Message: CBRE 00:45 - Industry Inflection Point 04:17 - Report Methodology 10:08 - Growth Beyond Big Hubs 15:28 - Capital Markets Signals 18:48 - AI and Space Use 20:50 - Emerging Talent 26:34 - Up-and-Coming Cities To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

M&A enthusiasm is carrying biotech amid tepid reception for launches. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss BioCentury’s 3Q26 Public Markets Preview , asking whether M&A momentum can carry biotech through year-end and what happens if the AI trade goes bust? Editor in Chief Simone Fishburn gives her perspective on what incoming Prime Minister Andy Burnham’s agenda means for U.K. life sciences. The analysts also discuss Ionis’ ATTR-CM miss and Takeda’s orexin program . This episode of the BioCentury This Week podcast has been brought to you by CBRE . View full story: https://www.biocentury.com/article/660118 #BiotechMA #BiotechInvesting #PublicMarkets #LifeSciences #DrugDevelopment 00:01 - Sponsor Message: CBRE 01:46 - 3Q Market Preview 10:54 - Burnham’s Britain 19:40 - Ionis' ATTR-CM Miss 29:12 - Takeda Orexin Program To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

Novartis is deepening its antibody-drug conjugate capabilities with its $1.1 billion acquisition of U.K. biotech Myricx Pharma. On the latest episode of the BioCentury This Week podcast, BioCentury’s analysts discuss how the deal fits with the Swiss pharma’s cancer toolkit. The analysts then discuss MHRA CEO Lawrence Tallon’s Guest Commentary in BioCentury on making regulation a catalyst for U.K. life sciences and why the primary defeat of Rep. Diana DeGette (D-Colo.) is a setback for FDA reforms. They also assess how single-cell Parkinson’s atlases reveal neuronal and glial disruptions in specific regions and stages, and the thin evidence underpinning Congress’ probe of China trial consent. This episode of the BioCentury This Week podcast has been brought to you by CBRE . View full story: https://www.biocentury.com/article/660033 #ADC #BiotechMA #ParkinsonsDisease #FDA #ChinaBiotech 00:01 - Sponsor Message: CBRE 01:15 - Novartis Buying Myricx 08:01 - U.K. Regulation 14:44 - DeGette & FDA Reform 21:51 - Parkinson's Atlas Insights 29:39 - China Trials Probe To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

New Parkinson’s disease programs aim to move beyond the historical norm of symptom management, branching into targeted therapeutics and cell therapies. On the latest BioCentury This Week podcast, BioCentury’s analysts review the most promising targets and trends shaping the Parkinson’s treatment landscape. The team then turns to AstraZeneca’s build-out of its obesity portfolio, followed by FDA’s Operation TrialBlazer and what the reforms mean for reducing the time to launch a clinical trial in the U.S. — and whether they can help close the gap with China. Finally, the analysts review recent FDA reversals of controversial regulatory decisions made under former Commissioner Marty Makary’s leadership and whether companies and investors can expect this reversion to the mean to carry forward. View full story: https://www.biocentury.com/article/659958 #ParkinsonsDisease #ObesityDrugDevelopment #FDA #ClinicalTrials #DrugDevelopment 00:00 - Introduction 01:40 - Parkinson's New Targets 11:43 - AstraZeneca's Obesity Pipeline 18:37 - FDA's Operation TrialBlazer 27:33 - FDA Leadership Outlook To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

AbbVie's $10.9 billion deal to acquire Apogee will expand its immunology pipeline by delivering assets for atopic dermatitis and asthma. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the takeout and the assets AbbVie gains. The analysts then discuss moves by FDA to reverse controversial setbacks that occurred under the agency’s former leadership and assess Acting CDER Director Michael Davis’ memo outlining how his predecessor repeatedly overruled career staff to quash a drug approval. The analysts also discuss continuing signs of political involvement at FDA. Finally, they discuss China NMPA’s first-ever approval of a CAR T for solid tumors , satricabtagene autoleucel (satri-cel) from Carsgen. View full story: https://www.biocentury.com/article/659864 #BiotechMA #Immunology #FDA #CART #ChinaBiotech 00:59 - AbbVie Buys Apogee 05:20 - uniQure U-turn 09:02 - FDA Reversals 12:32 - Tzield Memo 20:53 - Solid Tumor CAR T Approval To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

Biotech IPOs that are getting out remain hot — but will that continue into the fall? On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the market for fresh biotech paper on NASDAQ, including the $770 million debut by Parabilis, the largest IPO in the sector’s history. The analysts also discuss the Biosecure Act and U.S. policy toward China; the cachexia pipeline ; and BioCentury’s updated Innovation Distillery . View full story: https://www.biocentury.com/article/659773 #BiotechIPO #NASDAQ #BiosecureAct #Cachexia #ChinaBiotech 00:36 - Innovation Distillery 03:56 - Biotech IPOs 10:13 - Biosecure Act, WuXi AppTec 16:03 - Cachexia Pipeline 22:03 - Ouster for RFK Jr.? To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

Getting into the clinic fast to de-risk assets has become the name of the game in biotech, and at the academia-industry interface, too. From AI to NAMs to starting a Phase I trial in the U.S., BioCentury’s 3rd Grand Rounds-U.S. conference brought together academic innovators, biopharma leaders and early-stage investors to debate key bottlenecks in translation and how to make early-stage R&D investible. Sam Blackman, entrepreneur in residence at GV and co-founder of Day One Biopharmaceuticals, and Aaron Coe, managing director of innovation for the Allen Institute, joined BioCentury’s analysts on stage last week in Seattle for a podcast recording to wrap up Grand Rounds and discuss key takeaways from the event. Editor’s note: We invite you to join BioCentury and Regional Host Chairs Forbion and BGV at our next edition of BioCentury Grand Rounds , scheduled for Sept. 23-25 in Amsterdam. View full story: https://www.biocentury.com/article/659729 #TranslationalScience #DrugDevelopment #BiopharmaInnovation #AcademicInnovation #GrandRoundsUS 00:53 - World-Class Regional Hosts 02:56 - Building Grand Rounds Community 05:21 - Two Nobels, One City 07:43 - AI Goes End-to-End 09:47 - The Data Problem 14:12 - AI, Animals, Australia 19:53 - Study Startup Bottlenecks 26:11 - Early Science Investability To 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 new leadership is sailing the agency into calmer waters amid a search for a permanent commissioner and permanent center directors. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses how FDA’s new, interim leaders have changed the tone at the agency and why they are putting medicines derailed under former FDA Commissioner Marty Makary back on track. Usdin also highlights FDA’s new real-time clinical trials initiative. BioCentury’s analysts then turn to deals, including an analysis of the 20 deals Eli Lilly has done this year; Servier’s move to expand in neurology via BD; and Monday’s billion-dollar deals by Incyte, which will acquire Vega Therapeutics, and Johnson & Johnson, which is buying Firefly Bio. The team also discusses Grand Rounds U.S., held last week in Seattle, including the conference’s Rising Star prize winner Sylvain Simon of Fred Hutchinson Cancer Center. View full story: https://www.biocentury.com/article/659699 #FDA #BiopharmaDeals #ClinicalTrials #BiotechMA #GrandRoundsUS 01:23 - Grand Rounds Seattle Takeaways 04:43 - FDA's New Leaders 11:48 - FDA's Real Time Trials Pilot 20:40 - Servier Bets on Neuro 25:33 - Lilly's Deal Spree 30:21 - Dealmaking Roundup To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

Revolution Medicines continues to impress with more pancreatic cancer data, earning a standing ovation at ASCO over the weekend. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the detailed data for the company’s daraxonrasib, Akeso’s Harmoni-6 readout, as well as other results from the meeting. BioCentury’s analysts then argue that U.S. biotech executives and policymakers should embrace the challenges and opportunities that come with the rise of innovation in China — rather than sticking their heads in the sand. They also discuss why leaders of the U.S.’s biggest drug companies should use their influence to stop an OMB proposal that threatens the foundations of U.S. science. Plus: takeaways from BioCentury's conversation with Alkermes CEO Richard Pops on The BioCentury Show . View full story: https://www.biocentury.com/article/659629 #ASCO #PancreaticCancer #BiotechInnovation #ChinaBiotech #DrugDevelopment 00:00 - Introduction 01:49 - ASCO: RevMed 06:50 - ASCO: Akeso 16:33 - China U.S. Biotech Rivalry 24:15 - Science Under Threat 36:29 - Richard Pops Takeaways To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

At ASCO among presentations focused on pancreatic cancer innovation beyond KRAS; however, abstracts for the cancer conference also highlight ADCs, bispecifics and diagnostics that are broadening the field’s approach to the cancer. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Revolution’s daraxonrasib, other readouts to watch for in pancreatic cancer and what else is on BioCentury’s radar at this year’s American Society of Clinical Oncology meeting. BioCentury’s analysts also discuss a push by China hawks in Congress to get the Trump administration to invoke national security powers to narrow Chinese life sciences companies’ access to U.S. markets, technology and capital; an initiative by Rep. Jake Auchincloss (D-Mass.) that seeks to modernize how clinical trials are conducted in the U.S.; and a BioCentury analysis on new antibody-drug conjugate linker techniques. This episode of the BioCentury podcast is brought to you by Jeito Capital . View full story: https://www.biocentury.com/article/659581 #Biopharma #ASCO2026 #PancreaticCancer #ClinicalTrials #ADCInnovation 00:01 - Sponsor Message: Jeito Capital 02:26 - ASCO Preview 14:24 - U.S. China Policy 22:48 - Modernizing U.S. trials 27:17 - Optimizing ADC Linkers To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text