BioCentury This Week

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

The boom in the creation of companies that were launched in the West based on assets sourced in Asia signals China's galloping speed of innovation. On the latest BioCentury This Week podcast, BioCentury's editors discuss the “NewCo Model,” who the players are, from CEOs and companies to investors; the areas of innovation the start-ups are tackling; and the evolution of the trend. (Read about the company that kicked off the trend, Arrivent, here.)The editors also assess how personnel losses at FDA from the Trump administration's plans to slash government payrolls are likely to cause short- and long-term harm for the agency and the drug approval process. And a new pain therapy from Vertex is in the spotlight as the CF specialist enters new turf.View full story: https://www.biocentury.com/article/65494600:00 - Introduction01:20 - Asia's NewCo Model15:24 - FDA Tipping Point19:29 - Vertex's Pain DrugTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Psychiatric drug development has had major wins over the past year-and-a-half — think Karuna Pharmaceuticals' $14 billion takeout by Bristol Myers Squibb and the subsequent launch of a new schizophrenia therapy — but targeted neuropsychiatric drug development is still in its infancy. On a special edition of the BioCentury This Week podcast, BioCentury's editors detail the promise of precision medicine in the space and break down what recent setbacks for key players mean for next steps in the clinic. The team is joined by special guest Peter Schueler, SVP of drug development solutions, neurosciences, at ICON, who delivers takeaways from this month's the ECNP Roadmap Meeting on Precision Psychiatry in Frankfurt and a recent white paper by ICON. This episode of BioCentury This Week was sponsored by ICON Biotech.View full story: https://www.biocentury.com/article/654903 00:01 - Sponsor Message: ICON Biotech02:20 - Precision Neuropsychiatry06:39 - Insights from ICON's Peter Schueler15:59 - Challenges in NeuropsychTo 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 analysis of the technologies behind last year's biotech series A raisers sees progress in nanoparticles, CAR cell therapies, degraders and antibody-drug conjugates. On the latest BioCentury This Week podcast, BioCentury's editors discuss the trends spotted in 2024's crop of more than 150 series A rounds — from top therapeutic areas and modalities to the leading investors funding the innovation.The editors turn to Washington for takeaways from BioCentury's “exit interview” with Patrizia Cavazzoni, the recently departed director of FDA's Center for Drug Evaluation and Research, and checks in on FDA and NIH's turbulent transition under Trump 2.0.Finally, the podcast team previews BioCentury's upcoming fourth East-West Summit, which will focus on globalizing Asia innovation and the red-hot “Newco Model” in Singapore March 3-5, and the twenty-fifth Bio€quity Europe, which will be held in Belgium in May. This episode of BioCentury This Week was sponsored by ICON Biotech.View full story: https://www.biocentury.com/article/65483700:01 - Sponsor Message: ICON Biotech01:57 - Series As: Trends in Innovation12:18 - BioCentury Conferences Preview18:45 - Insights from FDA's Cavazzoni21:58 - Turbulence at FDA, NIHTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

With political uncertainty overshadowing market sentiment going into 2025, BioCentury's editorial team assesses the bull and bear arguments for biotech in the New Year on the BioCentury This Week podcast's Public Markets Preview. Will continued uncertainty drive biotech sentiment in the coming months, or will the bear arguments fail to manifest, stymied by M&A and other positive factors?In the second part of the 2025 Preview, BioCentury's editors highlight some of the key catalysts in bispecifics, immunology and inflammatory (I&I), new modalities, and neurology and obesity they are watching in the year ahead. Finally, the editors discuss how VC firms focused on AI-driven drug development are thinking about the resources and strategies needed to turn promise into reality. This episode of BioCentury This Week was sponsored by ICON Biotech.View full story: https://www.biocentury.com/article/65477200:01 - Sponsor Message: ICON Biotech02:33 - Market Uncertainty12:50 - Biotech Catalysts 21:12 - Obesity22:57 - Neurology28:54 - AI: VC PerspectivesTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Sunshine and a stream of deals brightened the mood at this year's J.P. Morgan Healthcare Conference, offering a pleasant counterpoint to continued pessimism over the state of the capital markets. On the latest BioCentury This Week podcast, BioCentury's editors deliver their takeaways from biotech's annual kick-off event from megarounds and Asian newcos to the new state of M&A and pending change at FDA.View full story: https://www.biocentury.com/article/65472300:00 - Introduction01:52 - Market Sentiments and Deal Expectations04:42 - Cross-Border Deals and Asia's Growing Influence07:12 - Neurology and Innovation in Biotech14:44 - VC Trends and Megarounds20:00 - Upcoming East West SingaporeTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

J&J's $14.6 billion takeout of neurology play Intra-cellular Therapies headlined a buzzy start to the J.P. Morgan Healthcare Conference, where a flurry of deal announcements recalled the conference's pre-pandemic days. On the latest BioCentury This Week podcast, BioCentury's editors discuss the takeout of Intra-cellular, the third 11-digit neuro M&A in the past 13 months, as well as M&A involving Idrx and GSK, and Scorpion Therapeutics and Eli Lilly. Turning to Washington, the team explores what's behind BIO CEO John Crowley's visit to Mar-a-Lago to meet with President-elect Donald Trump, impending changes at FDA under Trump 2.0 and key takeaways from Rep. Jake Auchincloss appearance on BCTW's sister podcast, The BioCentury Show. The team also breaks down the key trends in the past year in FDA approvals. This episode of BioCentury This Week was sponsored by ICON Biotech.View full story: https://www.biocentury.com/article/65469400:01 - Sponsor Message: ICON Biotech02:38 - JPM Deal Buzz11:20 - Washington Update16:08 - Rep. Auchincloss' Take on Biopharma 21:01 - FDA Regulatory DecisionsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Can biotech break free of the macro factors that have buffeted the industry of late? On the first BioCentury This Week podcast of 2025, BioCentury's editors offer their predictions for the New Year and — exploring the themes from Simone Fishburn's latest Letter from the Editor — ask whether biotech can overcome the financing environment, policy concerns and geopolitical tension that have been hammering the industry to deliver on the meaningful strides companies have been taking to deliver innovations to patients.Plus, Washington Editor Steve Usdin discusses what U.S. policymakers need to do now in the wake of a year's worth of wrangling over the Biosecure Act, and Executive Editor Selina Koch breaks down readouts from Neumora on its KOR antagonist navacaprant to treat major depressive disorder and Axsome Therapeutics for its AXS-05 to treat agitation in Alzheimer's patients. This episode of BioCentury This Week was sponsored by ICON Biotech.View full story: https://www.biocentury.com/article/654620 00:01 - Sponsor Message: ICON Biotech01:51 - Biotech's Repeating Challenges10:52 - Biotech in the New Year23:07 - Beyond Biosecure28:10 - Neurology ReadoutsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Preview: In his five decades at FDA, Robert “Bob” Temple helped revolutionize the ways medical products are developed and regulated. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin reflects on the legacy of Temple. Temple, who is retiring, crafted the modern clinical trial paradigm, created the accelerated approval pathway, and set precedents for incorporating patient perspectives in regulatory decisions. Usdin also discusses the opportunities and threats for the agency under Trump 2.0.BioCentury's editors also discuss China's academic innovation, arguing that a wave of new target biology is now coming from Chinese university labs and the underwhelming results from CagriSema's latest readout. Phase III data for the most important weight loss candidate from  Novo Nordisk A/S (CSE:NOVO-B; NYSE:NVO) failed to differentiate the product from Eli Lilly's Zepbound.View full story:https://www.biocentury.com/article/654574/temple-s-fda-legacy-plus-chinese-innovation-novo-obesity-data-a-biocentury-podcast00:00 - Introduction02:03 - Bob Temple's Legacy16:13 - China's Academic Innovation26:20 - CagriSema Obesity DataTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

With most of the highly attractive late-stage assets already scooped up, pharmas are turning their sights to Phase II companies, and lining up their case to make an attractive offer and move fast. About 40% of the M&A deals in 2023-24 were completed in less than six weeks, from approach to announcement, according to Lazard's data. Michael Kingston and Dale Raine, global co-heads of biopharma at Lazard, joined The BioCentury Show this week to discuss the M&A outlook amid the still-precarious biotech financing landscape.The BioCentury Show, featuring BioCentury one-on-one with an industry KOL, is available on Apple, Spotify and wherever you listen to your favorite podcasts and in video podcast format on BioCentury's YouTube channel.View full story: https://www.biocentury.com/article/65385800:00 - Introduction03:01 - Capital Markets Outlook06:01 - M&A15:19 - Breaking Down Deals24:29 - AsiaTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Lately, it appears some biotech VCs have hit a ceiling, capping their new funds at or below the amount of their previous vehicles, says Paul Bonanos on the latest BioCentury This Week. Bonanos and his BioCentury editorial colleagues discuss what's behind the trend as they assess VC fundraising in this post-‘supercycle' era. The editors also evaluate the state of play for venture-backed obesity plays and which VCs are active in the space, as well as takeaways from the latest BioCentury Show podcast featuring Aoife Brennan, CEO of Climb Bio. Finally, the team features the new book from long-time biotech executive and current SV Health Investors partner Tim Harris, In Pursuit of Unicorns: A Journey through 50 Years of Biotechnology.View full story: https://www.biocentury.com/article/65448800:00 - Introduction02:08 - Trends in VC Funds12:16 - Obesity Start-ups19:46 - The BioCentury Show with Aoife Brennan26:50 - Tim Harris' New Book: In Pursuit of UnicornsTo 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 lawmakers have dealt the Biosecure Act a setback that could derail the legislation, even as Congress continues its push to reduce reliance on China in the life sciences. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin explains why Sen. Rand Paul (R-Ky.) and Rep. Jamie Raskin (D-Md.) refused to sign off on inclusion of the anti-China biotech bill in the must-pass National Defense Authorization Act, what provisions the defense bill has that seek to enhance U.S. biotech supply chain resilience and whether Biosecure can be resurrected. And in the latest in neurology, Executive Editor Selina Koch discusses Novartis and PTC's $1 billion deal for the biotech's Huntington disease therapy, and how several biotechs are poised to take therapies against the long undruggable KCC2 to the clinic for neurological disorders. Heads up: BioCentury's JPM Guide 2025 is out now.View full story: https://www.biocentury.com/article/65442000:00 - Introduction01:42 - Biosecure Setback10:01 - Novartis' $1B PTC Deal 16:28 - KCC2 ActivationTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

On the latest BioCentury This Week podcast, Washington Editor Steve Usdin and colleagues discuss how President-elect Donald Trump's pick to lead NIH, Jay Bhattacharya, would lead NIH and how that could affect the biopharma industry.The BioCentury team then discusses its analysis of abstracts released ahead of the American Society of Hematology (ASH) and Society for Immunotherapy of Cancer (SITC) annual conferences, highlighting methods for applying dual or bispecific CAR T cell designs to solid tumors. And they also analyze FDA approvals of products by biotech companies, noting that current trends show biotechs shedding their reliance on pharma to get drugs across the finish line for approval.View full story: https://www.biocentury.com/article/65436300:00 - Introduction01:08 - Trump's NIH Pick12:13 - Multi-targeted CAR Ts19:26 - Biotech FDA ApprovalsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Positive vibes about biotech emanating from the Jefferies Healthcare Conference were overshadowed by the uncertainty that is ahead because of the result of the U.S. elections. On the latest BioCentury This Week, BioCentury's editors discuss how the unconventional cabinet nominations of the incoming Trump administration have cast a pall over what had been growing enthusiasm for the prospects of the biotech sector. Washington Editor Steve Usdin also discusses what the nomination of Marty Makary as the next FDA Commissioner could mean for the sector, and recaps the latest update on the Biosecure Act. The BioCentury editors also discuss which pharmas are in or out in making a challenge to Eli Lilly and Novo Nordisk in the obesity market.View full story: https://www.biocentury.com/article/65431900:00 - Introduction00:32 - Jefferies Conference Takeaways06:25 - Trump Nominations17:41 - Biosecure Act Update21:01 - Pharma in ObesityTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Giving Robert F. Kennedy Jr. control of HHS would be disastrous, argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Expanding on his Editor's Commentary, Usdin explains why Kennedy would be an unmitigated disaster for FDA, NIH and CMS, for companies that research, develop and manufacture medicines and for people around the world who rely on those companies and agencies. He calls on biopharma leaders to speak out and affirm basic truths, even if it puts them in harm's way.BioCentury's Lauren Martz gives her take on why new data for Blenrep belantamab mafodotin — an oncology therapy withdrawn two years ago — help make the case for introducing new experimental therapies such as the antibody-drug conjugate from GSK earlier in the course of treatment.And Paul Bonanos and his editorial colleagues discuss the recent bolus of West-East deals, including two around anti-PD-(L)1 x VEGF bispecifics: the acquisition of Biotheus by BioNTech for $800 million up front, and the licensing of global rights by Merck & Co. to a program from LaNova Medicines for $588 million. Monday's Deals Report in BioCentury captures three more deals for China bispecifics.View full story: https://www.biocentury.com/article/65423300:00 - Introduction01:12 - RFK Jr. & HHS13:15 - Blenrep's Comback19:25 - China DealsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Trump 2.0 presents opportunities and challenges for leaders of the biopharma industry, which needs effective public policy to thrive. On the latest BioCentury This Week, BioCentury Washington Editor Steve Usdin explains what those opportunities are and lays out the potential impact on the public policy environment, which could have repercussions on FDA and beyond.BioCentury's editors then analyze how companies, academics and advocates are pushing back on claims that they should have disclosed the results of APOE4 genotype testing to Alzheimer's trial participants and investigations by Chinese authorities into AstraZeneca China President Leon Wang and fellow AZ employees past and current, assessing what's known about the allegations and whether the situation could affect other MNCs operating in the country.View full story: https://www.biocentury.com/article/65415700:00 - Introduction01:01 - Prepping for Trump09:41 - Alzheimer's Ethics17:44 - AstraZeneca's Challenges in China21:51 - Myths and MisperceptionsTo 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 too soon to conclude anti-amyloid therapies are safe for use by Alzheimer's patients in the real world, even as early reports are encouraging, argues BioCentury Executive Editor Selina Koch on the latest BioCentury This Week podcast. Koch and colleagues discuss takeaways from this year's Clinical Trials on Alzheimer's Disease annual meeting, including conclusions from adverse event data for Leqembi lecanemab and what the true test of appropriate use and safety for the drug might look like.BioCentury's editors also assess Phase II data presented at CTAD by UCB that provide some of the first clues about what species of tau to target and in which patients. And they discuss what results of Tuesday's presidential contest in the U.S. will mean for FDA, as well as the state of play for China biotech as the industry continues to grind out its first bear market.View full story: https://www.biocentury.com/article/65407500:00 - Introduction01:23 - CTAD: Anti-amyloids14:22 - CTAD: UCB's tau data19:47 - FDA & the Election28:16 - China Summit DebriefTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Twenty years of innovation in therapies targeting EGFR provides a case study in how generation of differentiated products against the target can drive market growth. On the latest BioCentury This Week podcast, BioCentury's editors discuss EGFR as a prime example of the value in best-in-class development strategies, with meaningful improvements across multiple modalities delivering substantial therapeutic benefits to patients. Analogous best-in-class opportunities aren't limited to cancer, but are also playing out in other settings such as immunology.The editors then discuss a recent event that hosted FDA commissioner Rob Califf and four former commissioners, all of whom agreed a major role of the FDA commissioner is to protect the agency from political interference. Washington Editor Steve Usdin also previews his conversation with FDA's Richard Pazdur, and Editor in Chief Simone Fishburn details takeaways from her Q&A with James Sabry, who recently became CBO at BioMarin Pharmaceutical.View full story: https://www.biocentury.com/article/65392600:00 - Introduction00:38 - EGFR Case Study08:45 - FDA Commissioners & Politics19:19 - James Sabry's TimelineTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Cross-border geopolitical tensions and a prolonged capital crunch are compelling biopharma companies from Beijing to Boston to rethink their strategies on everything from deal-making and raising capital to manufacturing and use of CROs. On a special edition of the BioCentury This Week podcast, McKinsey's Franck Le Deu and Wendy Pan of BayHelix and Goodwin join BioCentury on the eve of next week's eleventh annual BioCentury-BayHelix China Healthcare Summit in Shanghai to discuss the dynamics affecting biotechs in China looking beyond the country's borders and Western biopharma companies seeking innovation and partners in China, as well as the latest trends, such as U.S. VCs and/or management teams building newcos around China assets. They also detail highlights among the three-day event's speakers, panels and fireside chats.The BioCentury-BayHelix China Healthcare Summit will take place Oct. 30 through Nov. 1 at the St. Regis Shanghai Jian in Shanghai. For information on registering to attend and/or becoming a presenting company, click here.View full story: https://www.biocentury.com/article/65395900:00 - Introduction03:32 - The View from BayHelix06:59 - The View from McKinsey18:57 - Summit HighlightsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

At least 25 venture firms have raised a total of more than $17 billion in funds this year, with Forbion unveiling the largest-ever European biopharma fund at €1.2 billion last week. On the latest BioCentury This Week podcast, BioCentury's editors discuss how Forbion deployed its prior fund and quickly raised fresh funds and what that — and other funds — say about the state of financing private biotechs in Europe and elsewhere.The editors then assess takeaways from BioCentury's conversation with NIH's Daniel Reich on data that could shape drug development's future for progressive multiple sclerosis, and neurodegeneration broadly, as well as how the first clinical data from an RNA-editing oligonucleotide therapy from Wave Life Sciences demonstrate that it's possible to change a single base in an RNA to correct a disease-causing mutation in patients.View full story: https://www.biocentury.com/article/65392400:00 - Introduction02:48 - VC Funds11:50 - New Chapter for MS23:48 - Wave's DataTo 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 a growing mandate among researchers and VCs to provide proof of causal human biology for new targets. On the latest BioCentury This Week podcast, BioCentury's editors discuss the different strategies being deployed to identify causal links to disease using observational patient data or human cell models, including the challenges that come with each approach and the various computational methodologies companies are using.They also discuss the outcome of FDA's advisory committee meeting on Barth syndrome candidate elamipretide from Stealth Biotherapeutics, and the implications of the discussion for review of ultrarare disease therapies more broadly.Diving into the deal of the day, the editors review the proposal by H. Lundbeck to acquire Longboard Pharmaceuticals for $2.6 billion, and discuss how the biotech's therapy for developmental epilepsies may stack up against competitors.View full story: https://www.biocentury.com/article/65384300:00 - Introduction00:34 - Causal Biology and Big Data17:52 - FDA's Ultra-Rare Decision27:29 - Lundbeck Acquires LongboardTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Biopharma buysiders and bankers at long last believe the conditions are ripe for biotech growth and outperformance, BioCentury's Stephen Hansen says on the latest BioCentury This Week podcast. Hansen and colleagues take stock of the sector's growth potential after three long years of the bear market as they discuss BioCentury's 4Q24 Public Markets Preview.Also on this week's show, Washington Editor Steve Usdin discusses his Editor's Commentary, in which he argues that FDA leaders planned reforms for its advisory committee process fall far short of what they need to do. Usdin then delivers takeaways from the most recent edition of BioCentury This Week's sister podcast, The BioCentury Show, which features a behind-the-scenes look at CMS's anti-amyloid mAb decision-making process with Lee Fleisher, the former CMO of the agency.Finally, BioCentury's Josh Berlin joins the podcast to preview the eleventh annual BioCentury-BayHelix China Healthcare Summit, which runs Oct. 30 to Nov. 1 in Shanghai. The theme of this year's conference, which features panels of pharma BD&L leaders and blue chip investors as well as a lineup of presenting companies, is reinventing your China strategy.View full story: https://www.biocentury.com/article/653793To submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Approval of BMS's first-in-class schizophrenia drug is good news for patients and the company's thinning pipeline alike, but maximizing Cobenfy's commercial potential depends on readouts in additional indications. On the latest BioCentury This Week podcast, BioCentury's editors assess the significance of the new therapy and what the pharma needs to do to make its launch a success.They also discuss the impact of the withdrawal of Pfizer's sickle cell therapy; the work left unfinished on biotech-related legislation in Congress; BioAge's NASDAQ IPO; and the importance of FDA's Oncologic Drugs Advisory Committee meeting on the use of PD-1 inhibitors in patients with certain tumors expressing low levels of PD-L1. This episode of BioCentury This Week was sponsored by Parexel Biotech.View full story: https://www.biocentury.com/article/65373200:01 - Sponsor Message: Parexel BioTech01:41 - BMS Schizophrenia Drug12:28 - Pfizer Withdrawal's Oxbryta18:26 - ODAC and PDL123:56 - D.C. Update26:51 - BioAge IPOTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The ESMO Congress yielded another win for cancer immunotherapy target TIGIT, but the readout resurfaced worries about the mechanism's past failures to turn positive earlier stage data into Phase III success. On a special edition of the BioCentury This Week podcast, BioCentury's editors deliver their takeaways from this year's meeting, including analysis of data for TIGIT blocker belrestotug from iTeos Therapeutics, a colorectal cancer readout featuring J&J's Rybrevant and an antibody-drug conjugate from Genmab. The BioCentury team is joined by Gwyn Bebb, who is global franchise head for oncology at podcast sponsor Parexel. Bebb discusses what's changed in the oncology landscape in the 10 years since the approval of the first immunotherapies, observations that COVID-19 vaccines might have a role in treating cancer and developments in the radiopharma field. This episode of BioCentury This Week was sponsored by Parexel Biotech.View full story: https://www.biocentury.com/article/65368100:01 - Sponsor Message: Parexel BioTech01:55 - iTeos' TIGIT Data04:56 - Rybrevant Colorectal07:22 - Gwyn Bebb's Take21:38 - More ESMO HighlightsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Rep. Frank Pallone's misunderstanding of how the pediatric priority review voucher program works has been one factor undermining support for an incentive that brings new drugs to kids, argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin explains how the voucher process works and why it's valuable to the country's youngest patients, as well as to small biotechs and larger biopharma alike.Usdin also discusses the latest twists and turns for the Biosecure Act, and BioCentury's Stephen Hansen assesses the obesity data from Novo Nordisk that destroyed more than $30 billion in value for the Danish pharma. This episode of BioCentury This Week was sponsored by Parexel Biotech.View full story: https://www.biocentury.com/article/65363300:01 - Sponsor Message: Parexel Biotech01:47 - Pediatric PRVs06:42 - Biosecure Act12:44 - Novo's Obesity MissTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

On a special edition of the BioCentury This Week podcast, BioCentury's editors deliver their takeaways from the debut Grand Rounds conference, which focused on whether biotech can write a more successful playbook for translating from target to product. Weaving together takeaways from the panels, fireside chat and keynote at the conference, the editors assess the tensions between generalizability and fit-for-purpose models, between having control and capturing complexity, and, in human data, between scale and robustness/reliability, particularly for longitudinal readouts. The editors also discuss BioCentury's Q&A with USC Keck School's Patrick Lyden, who explained how high-quality, reproducible preclinical science can be feasible.View full story: https://www.biocentury.com/article/65363100:00 - Introduction02:56 - Generalizability vs. Fit for Purpose10:03 - Control vs. Complexity17:57 - Scale vs. Robustness in Human Data26:25 - Hypothesis-Driven vs. Unbiased Research28:50 - Grand Rounds 2025To submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text