Shows
BioCentury This WeekEp. 314 - Prasad, Lilly Obesity, Acadia & BiosecurPhase 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 targ...2025-08-1239 min
BioCentury This WeekEp. 313 - Lessons from FDA's Prasad. Plus: What's next for Novo, BayerThe 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 t...2025-08-0533 min
BioCentury This WeekEp. 312 - Biotech Progress ReportA 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 pres...2025-07-3029 min
BioCentury This WeekEp. 311 - The Asia Deals Landscape, U.K. Biotech & MoreThis 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 companie...2025-07-2942 min
BioCentury This WeekEp. 310 - Sarepta & What's Next for Gene Therapy. Plus: Leading FDA's CDERLast 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...2025-07-2231 min
BioCentury This WeekEp. 309 - 3Q Markets Preview; Quantum Computing; Makary’s First 100 DaysChinese 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. This episode of BioCentury This Week w...2025-07-1537 min
BioCentury This WeekEp. 308 - Grand Rounds - Europe PreviewThere 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; Sally Mardikian, business development director, Astrazeneca; and Kristin-Anne Rutter, executiv...2025-07-0931 min
BioCentury This WeekEp. 307 - How Cancer Regulation is — and isn’t — Changing at FDAOncology 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 dev...2025-07-0929 min
BioCentury This WeekEp. 306 - Treg Inflection Point; Biotech's Next Big Story; Tax Bill ConsequencesTreg-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 analys...2025-07-0831 min
BioCentury This WeekEp. 305 - FDA's Future; In Vivo CAR T Plays; Psychedelics; CDK2The 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 Abbv...2025-07-0138 min
BioCentury This WeekEp. 304 - Syncona Reshapes Fund; Lilly's $1B Verve Bet; FDA's 2-Track FuturePublicly 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...2025-06-2435 min
BioCentury This WeekEp. 303 - Gene Therapy Safety, Amylin in Obesity & FDA's FutureThe 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, an...2025-06-1733 min
BioCentury This WeekEp. 302 - Takeaways from BioCentury Grand Rounds ChicagoWith 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...2025-06-1231 min
BioCentury This WeekEp. 301 - ASCO’s First-in-Human Trials, Crossover Investors & FDA's Rare Disease PlansTranslational 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...2025-06-1035 min
BioCentury This WeekEp. 300 - Biotech’s $13B Deal Day, ASCO's Hot Targets, Drug Pricing ThreatDealmaking 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 leadin...2025-06-0338 min
BioCentury This WeekEp. 299 - ASCO, EpCAM, Rocket & HK IPOsDutch 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...2025-05-2830 min
BioCentury This WeekEp. 298 - Takeaways from the 25th Bio€quity EuropePolitical 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/6559982025-05-2338 min
BioCentury This WeekEp. 297 - European Biotech's Moment? Plus: Biomarin, Boston Deals & Novo Nordisk CEOThe 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 Korn...2025-05-2035 min
BioCentury This WeekEp. 296 - Trends in Obesity, Vinay Prasad at FDA, Ovarian Cancer InsightsBiopharmas 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...2025-05-1333 min
BioCentury This WeekEp. 295 - Bio€quity Europe 2025 PreviewThis 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...2025-05-0928 min
BioCentury This WeekEp. 294 - AACR Spotlight on SMARCA2 degraders. Plus: David Baker, Drug PricingAmong 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 Medica...2025-05-0630 min
BioCentury This WeekEp. 293 - Tau Time for Alzheimer's. Plus: FDA Delays, Merck's $4B Deal, HK IPOsBelief 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 t...2025-04-2931 min
BioCentury This WeekEp. 292 - Myasthenia Gravis Spotlight & AACR PreviewBiopharma 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 mee...2025-04-2625 min
BioCentury This WeekEp. 291 - Grand Rounds - U.S. PreviewThe 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 #asco2025-04-2531 min
BioCentury This WeekEp. 290 - Biotech Survey Sees Tough Days Ahead. Plus: FDA, China SpeedThe 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 k...2025-04-2238 min
BioCentury This WeekEp. 289 - Replacing Animal Models. Plus: RFK Jr. & FDAFDA’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...2025-04-1536 min
BioCentury This WeekEp. 288 - FDA and Tariffs Turmoil, and AACR PreviewLoss 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 t...2025-04-0826 min
BioCentury This WeekEp. 287 - The Bear is Back: Marks’ Ouster, Tariffs and a Tumbling XBIBiotech 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.2025-04-0125 min
BioCentury This WeekEp. 286 - Sofinnova’s Pan-European Accelerator, China Biotechs, Trump TariffsEuropean 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 polici...2025-03-2524 min
BioCentury This WeekEp. 285 - BIO's Trump 2.0 Plan. Plus: Autoimmune CAR Ts & Telix's Radiopharma PlayBIO 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...2025-03-1828 min
BioCentury This WeekEp. 284 - Takeaways from the East-West SummitWhile 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 India2025-03-1241 min
BioCentury This WeekEp. 283 - Makary’s FDA Agenda, Amylin in Obesity and Life After DEIThe 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 merito...2025-03-1131 min
BioCentury This WeekEp. 282 - CRISPR Lessons: Plus, AbbVie Enters ObesityThe 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 o...2025-03-0423 min
BioCentury This WeekEp. 281 - Roche Reboot and 5 Things on Trump 2.0Once 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 ques...2025-02-2522 min
BioCentury This WeekEp. 280 - China Competition. Plus: FDA Firings and Biotech IPOsRather 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 th...2025-02-1927 min
BioCentury This WeekEp. 279 - East-West Summit PreviewWestern 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...2025-02-1529 min
BioCentury This WeekEp. 278 - Trump 2.0’s Impact on FDA, NIH. Plus: Precision MedicineWhite 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 ho...2025-02-1126 min
BioCentury This WeekEp. 277 - Asia's NewCo Model, FDA Tipping Point, Vertex's Pain DrugThe 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...2025-02-0425 min
BioCentury This WeekEp. 276 - Precision Neuropsychiatry Spotlight With ICON's Peter SchuelerPsychiatric 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’...2025-01-3121 min
BioCentury This WeekEp. 275 - Series As & Innovation. Plus: Rocky Transition at FDA, NIHBioCentury’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 Tru...2025-01-2833 min
BioCentury This WeekEp. 274 - 2025 Biotech Preview: Markets, Catalysts and AIWith 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 editor...2025-01-2236 min
BioCentury This WeekEp. 273 - JPM 2025 Wrap: Sunny Skies & MegaroundsSunshine 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 - Neurol...2025-01-1722 min
BioCentury This WeekEp. 272 - JPM Deal Buzz & Rep. Auchincloss’ Take on BiopharmaJ&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 Tr...2025-01-1427 min
BioCentury This WeekEp. 271 - Biotech in the New Year. Plus: Beyond BiosecureCan 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...2025-01-0734 min
BioCentury This WeekEp. 270 - Temple’s FDA Legacy. Plus: Chinese Innovation & Novo Obesity DataPreview: 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 underw...2024-12-3134 min
BioCentury This WeekBonus Content - Trends in Global Biopharma Deals: Lazard’s Kingston and RaineWith 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 av...2024-12-2334 min
BioCentury This WeekEp. 269 - Trends in VC Funds, Obesity Start-ups and MoreLately, 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-t...2024-12-1733 min
BioCentury This WeekEp. 268 - Biosecure Setback & Novartis' $1B PTC DealA 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...2024-12-1021 min
BioCentury This WeekEp. 267 - Trump's NIH Pick & Multi-targeted CAR TsOn 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 ph...2024-12-0327 min
BioCentury This WeekEp. 266 - Jefferies Recap, FDA Commissioner & Biosecure UpdatePositive 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 di...2024-11-2626 min
BioCentury This WeekEp. 265 - RFK Jr. & HHS, Blenrep's Comeback, China DealsGiving RFK 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 biopharmas and for patients. He calls on biopharma leaders to speak out and affirm basic truths, even if it puts them in harm’s way.BioCentury’s editors also discuss why new data for GSK's Blenrep — an oncology therapy withdrawn two years ago — help make the case for introducing new therapies earlier in the course of treatment...2024-11-1929 min
BioCentury This WeekEp. 264 - Prepping for Trump & Alzheimer's EthicsTrump 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 empl...2024-11-1229 min
BioCentury This WeekEp. 263 - Alzheimer Insights: Anti-Amyloid Safety & Tau TeaserIt’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...2024-11-0534 min
BioCentury This WeekEp. 262 - EGFR Case Study, FDA & PoliticsTwenty 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...2024-10-2923 min
BioCentury This WeekEp. 261 - China Summit: Reinventing Your China StrategyCross-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 la...2024-10-2431 min
BioCentury This WeekEp. 260 - VC Funds, New Chapter for MS, Wave's DataAt 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...2024-10-2231 min
BioCentury This WeekEp. 259 - Causal Biology and Big Data, Ultra-Rare Drugs at FDAThere 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....2024-10-1533 min
BioCentury This WeekEp. 258 - Breaking the Bear: 4Q Public Markets PreviewBiopharma 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 t...2024-10-0839 min
BioCentury This WeekEp. 257 - Schizophrenia, Sickle Cell Drugs, D.C. UpdateApproval 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...2024-10-0132 min
BioCentury This WeekEp. 256 - ESMO Recap: Keeping TIGIT Alive, Rybrevant & Immunotherapy AnniversaryThe 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...2024-09-2626 min
BioCentury This WeekEp. 255 - Pediatric PRVs, Biosecure & Novo's Obesity MissRep. 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...2024-09-2421 min
BioCentury This WeekEp. 254 - Takeaways from Grand Rounds 2024On 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, repr...2024-09-2134 min
BioCentury This WeekEp. 253 - IPOs, GLP-1 & Obesity, AI & BiotechOn the latest BioCentury This Week podcast, BioCentury’s editors assess the shifting market for biotech IPOs, including the profiles of the three companies that went public on NASDAQ last week, the aftermarket performance of the year's IPO class, and the prospects for more companies to make their own debut in the coming months. BioCentury’s editors also discuss whether the rush to GLP-1s for obesity will mirror the development of PD-1s for cancer and the impact on biopharma of the recent mainstream expansion of AI. This episode of BioCentury This Week was sponsored by Parexel Biotech. ...2024-09-1732 min
BioCentury This WeekEp. 252 - Akeso's Bispecific, Vaxcyte & Woodcock's Quality MindsetWill bispecifics be the drugs to dethrone cancer’s biggest blockbusters? Akeso is the latest company with a bispecific to impress in a head-to-head study, this one for non-small cell lung cancer. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the latest data from Akeso’s ivonescimab, a VEGFxPD-1 bispecific antibody that went up against Keytruda pembrolizumab in one of its largest indications, first-line non-small cell lung cancer.The editors also discuss data from Vaxcyte that the infectious disease company parlayed into the year’s largest follow-on financing and a new initiative by FDA veteran Janet Woo...2024-09-1018 min
BioCentury This WeekEp. 250 - Biosecure, Priority Review Vouchers & Target DiscoveryA vote on the Biosecure Act in the U.S. House of Representatives early next week shines the spotlight back on legislation seeking to rein in Chinese CDMOs and genomics companies, as Congress returns to work. On the latest BioCentury This Week podcast, BioCentury’s editors handicap the legislation’s chances of passage in the House and Senate and assess what’s at stake for the law authorizing rare pediatric disease priority review vouchers.They also discuss the results of BioCentury’s snap poll gauging the biopharma industry’s reaction to the IRA Medicare drug price negotiation program, recalling...2024-09-0430 min
BioCentury This WeekEp. 248 - Grand Rounds Preview: Eyes on the TargetGrand Rounds is an R&D meeting that represents BioCentury’s latest initiative to create new networks linking academic discoveries with translational skills and the investors who will finance them, BioCentury co-founder, President and CEO David Flores said on a special edition of the BioCentury This Week podcast previewing the new conference. The meeting, on Sept. 9-11 in Nashville, focuses on whether biotech can write a more successful playbook for translating from target to product.The podcast features three special guests who will be at the conference: McKinsey's Guang Yang, Candel Therapeutics' Paul Peter Tak, and Abby Trotter of...2024-08-2333 min
BioCentury This WeekEp. 247 - Drug Pricing, Psychedelic Setback & Back to SchoolThe Biden administration has disclosed what Medicare will pay for the first graduates of its drug price negotiation program but biopharma companies, biotech investors and patient advocates are still waiting for the government to reveal how those prices were determined — details that are critical to informing the decisions that will shape the future of medicine. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what last week’s disclosure tells us — and what information is yet to come.They also discuss why psychedelics companies believe they can avoid the hurdles that tripped up Lykos Therapeutics as it sough...2024-08-2025 min
BioCentury This WeekEp. 246 - Wilson’s Vision for Gene Therapy. Plus: Korea Biotech & Grand RoundsPharmaceutical companies and some investors may have once again become wary of gene therapy, but the modality’s future is bright, according to Jim Wilson. On the latest BioCentury This Week podcast, BioCentury’s editors discuss takeaways from BioCentury’s exclusive interview with the AAV trailblazer, including Wilson’s prediction that the benefits of the therapies will extend beyond rare genetic diseases, and the rationale for his new therapeutics company, Gemma Biotherapeutics.BioCentury’s head of corporate alliances & business development, Josh Berlin, then joins the podcast team to detail the challenges and opportunities for biotech in South Korea, and to pre...2024-08-1332 min
BioCentury This WeekEp. 241 - U.K. Biopharma on the Move. Plus: IRA, BiosecureThe U.K.’s life sciences ecosystem boasts “palpable energy at the very innovation end of the spectrum in biotech, with a lot of really quality science,” BioCentury Editor in Chief Simone Fishburn says on the latest BioCentury This Week podcast. Fishburn assesses the maturation of the country’s biotech industry, including the need for an influx of capital to catalyze the sector’s growth. Washington Editor Steve Usdin discusses the latest developments for the Inflation Reduction and the Biosecure acts as well as the benefits of the breakthrough therapy pathway. Also on BioCentury.com, listeners may want to check out...2024-07-0918 min
BioCentury This WeekEp. 240 - Chevron Ruling's Impact. Plus: Tumor Targets, Lurie WinnerThe impact on FDA and the biopharma industry of the Supreme Court’s move to overturn the legal doctrine that courts defer to federal agencies’ interpretations of ambiguous laws will take years to come into focus; for now, the clearest effects of the Chevron ruling will be on disputes over exclusivity and other non-science issues. On the latest BioCentury This Week podcast, BioCentury’s editors analyze the court’s decision, including how FDA could adjust how it operates. The editors also discuss tumor cell surface targets off the beaten path, and BioCentury’s Q&A with Lurie Prize winner Howard Cha...2024-07-0221 min
BioCentury This WeekEp. 239 - Rare Disease Spotlight: MPS & DMDA biomarker breakthrough could shave years off the development of therapies for a group of devastating, progressive ultrarare diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss FDA’s agreement to allow biopharma companies to use a biomarker as the basis for accelerated approval of neuronal mucopolysaccharidoses therapies, which marks an important inflection point, both for MPS and rare diseases in general. The editors also assess FDA’s decision to grant full approval to and expand the label of Sarepta DMD gene therapy Elevidys delandistrogene moxeparvovec, igniting another controversy over the agency's decision-making; discuss how human geneti...2024-06-2524 min
BioCentury This WeekBonus Content - Derek Lowe Unplugged: AI; Biosecure; FDA, Abortion & SCOTUS; and more“I’m a short-term pessimist and a long-term optimist” about the potential for AI to transform drug development, Derek Lowe, author of the In the Pipeline blog, told BioCentury Washington Editor Steve Usdin on the latest BioCentury Show. Lowe's skepticism about claims that AI will rapidly transform the field is driven by a belief that the “problems that we have in the drug industry that we want to solve are almost inversely proportional to the ability of AI to solve them." Lowe also discussed the Biosecure Act and U.S. reliance on Chinese contract manufacturing and development organizations; talked about wh...2024-05-1632 min
BioCentury This WeekBonus Content - Ysios' Karen Wagner: How Europe's Biotechs Can Rise Above the NoiseIt sounds obvious, but still needs saying, says Ysios Capital's Karen Wagner. “How do you rise above the noise? By having the most spectacular data.” In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Wagner discussed the theme of the upcoming Bio€quity Europe conference — rising above the noise: in a sea of competition where companies vie for attention among investors and pharmas, what are the characteristics that allow them to differentiate? Wagner explains what she and her team looks for in a biotech before investing, and also discusses the role of ESG policies, including diversity, in compa...2024-05-0931 min
BioCentury This WeekEp. 229 - ASGCT Preview, Accelerated Approval Plus: The Latest in BiosecureOne of the big themes of this week’s ASGCT meeting will be CAR T cells in cancer and beyond. On the latest BioCentury This Week podcast, BioCentury’s editors preview the American Society of Gene and Cell Therapy’s annual meeting. Much of the CAR T field has reoriented from cancer to autoimmune diseases over the past year. Now, researchers are looking even farther afield. According to abstracts released ahead of ASGCT, the engineered T cell modality may have new benefits to offer patients with asthma, Duchenne muscular dystrophy or HIV. The editors also discuss a study aiming...2024-05-0728 min
BioCentury This WeekEp. 228 - Energizing Gene Therapy. Plus: AI Newco, Ono-DecipheraLed by CBER Director Peter Marks, FDA is moving forward with policies that aim to improve access to gene therapies for patients with rare diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how FDA plans to use regulatory policies to overcome barriers that are slowing gene therapy, as well as how Pfizer hopes to ensure access to its newly approved hemophilia gene therapy. The editors also assess the $2.4 billion acquisition of Massachusetts oncology company Deciphera by Japan’s Ono as it seeks to diversify its pipeline beyond Opdivo and expand its global footprint. They also disc...2024-04-3023 min
BioCentury This WeekEp. 227 - Defending Accelerated Approval. Plus: Endpoint Innovation & AIM AmissA “drive-by analysis of accelerated approval is intellectual malpractice,” argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues explain why a paper on the expedited regulatory pathway written by researchers at the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital misleads the public about the value of drugs granted accelerated approval. The paper also fails to grasp the pathway’s purpose, which is “to allow risk-taking when there’s evidence that a therapy is reasonably likely to benefit patients who are suffering from a serious condition,” Usdin writes i...2024-04-2322 min
BioCentury This WeekEp. 226 - Vertex’s Alpine Buy, Goldman’s Venture & IRA Tea LeavesVertex Pharmaceuticals' acquisition of Alpine Immune Sciences will bolster a growing kidney disease franchise that could help diversify Vertex’s business beyond its blockbuster cystic fibrosis franchise. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what attracted Vertex to Alpine and why it believes its newly acquired therapy can outshine others for IgA nephropathy. The editors discuss how Goldman Sachs aims to scale private biotechs via its venture strategy and the likely key factors for CMS as it determines prices for the first cohort of drugs in Medicare drug price negotiations under the Inflation Reduction Act. They...2024-04-1622 min
BioCentury This WeekEp. 225 - 2Q Markets Preview & AACR TakeawaysM&A has been driving a recovery for biotech, with $62 billion in takeouts in the past six months restocking specialist investors’ coffers for their next wave of investments. On the latest BioCentury This Week podcast, BioCentury’s editors assess the state of the public markets heading into the second quarter, including the outsize role PIPEs have had in financing industry’s comeback. They also discuss their takeaways from analyzing nearly 7,000 abstracts from the American Association for Cancer Research and the editors’ insights on why degrader-antibody conjugates are emerging as the next contenders to build on the success of the antibody...2024-04-0921 min
BioCentury This WeekEp. 223 - Biosecure, Bruce Booth & Ultrarare DrugsBills seeking to rein in Chinese CDMOs and genomics companies will deal a massive blow to biotech companies, if passed in their current form, according to results from an industry survey conducted by BioCentury. On The latest BioCentury This Week podcast, BioCentury’s editors discuss results from the survey, including responses that underscore executives’ concerns that the legislation would cause delays in drug development and a majority’s displeasure with BIO’s about-face to support the measures.They also discuss takeaways from Editor in Chief Simone Fishburn’s conversation on The BioCentury Show with Atlas Venture’s Bruce Booth, and l...2024-03-2628 min
BioCentury This WeekEp. 191 - Circular RNA, Psychedelics, & Upcoming BioCentury SummitsCircular RNA’s durability could convey efficacy and manufacturing advantages over therapies based on linear mRNA. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the rising therapeutic modality, with a look at the technology, companies and investors in the space. They also assess the pipeline of psychedelic therapies as the product candidates move toward proof of concept, homing in on psilocybin-based product candidates, which are the most abundant and some of the most advanced. BioCentury Head of Business Development Josh Berlin joins the podcast to preview BioCentury’s upcoming conferences, the Oct. 2-4 BioCentury-BayHelix East West Summit...2023-08-2222 min
BioCentury This WeekEp. 190 - Obesity Mechanisms, Noubar Takeaways, Scleroderma Platform TrialThere’s a tectonic shift happening in obesity research and drug development, BioCentury Editor in Chief Simone Fishburn said on the latest BioCentury This Week podcast. Fishburn and colleagues discuss how the success of obesity therapies from Novo Nordisk and Eli Lilly targeting the incretin axis has galvanized a wave of drug development with different molecular targets as well as last week’s threshold-setting cardiovascular outcomes trial data from Novo and recent obesity deals by the two companies.BioCentury’s editors also discuss takeaways from Fishburn’s conversation with Flagship Pioneering’s Noubar Afeyan on The BioCentury Show, plus the S...2023-08-1518 min
BioCentury This WeekEp. 187 - Alnylam-Roche; Plus: Insights on the IRA, FTCA hypertension deal with Roche will help Alnylam execute on its growth strategy of moving into more prevalent diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the deal does for both companies and why plans for a cardiovascular outcomes trial (CVOT) before the launch of zilebesiran are critical for maximizing the program’s commercial opportunity.BioCentury’s editors also preview this week’s episode of The BioCentury Show, in which Washington Editor Steve Usdin speaks with Alkermes about the politics and policy environment around drug pricing and the Inflation Reduction Act and assess the latest d...2023-07-2424 min
BioCentury This WeekEp. 185 - Leqembi's Launch, Biotech IPOs, Sarepta ApprovalFull approval of Leqembi lecanemab-irmb will unlock reimbursement and energize Alzheimer’s R&D, but the launch will be slow, said BioCentury Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleagues break down the takeaways from BioCentury’s interview with Chris Viehbacher, CEO of Biogen, and discuss the challenges of launching a product for a disease that has until now been untreatable.BioCentury’s editors also discussed the prospects for the IPO window in the second half now that the market for follow-on financings is showing signs of life, and the controversy surrounding Elevid...2023-07-1125 min
BioCentury This WeekEp. 179 - DMD Gene Therapies, CBER & NIHIf FDA approves Sarepta's gene therapy for Duchenne muscular dystrophy, patients will soon face the difficult choice between taking this treatment or waiting for a better option among the “unprecedented” amount of innovation ahead in DMD, as taking both may not be an option, BioCentury Executive Director Lauren Martz said on the latest BioCentury This Week podcast. Martz and colleagues assess the landscape for DMD gene therapies ahead of the May 29 PDUFA date for delandistrogene moxeparvovec.Also on the show, BioCentury Washington Editor Steve Usdin discusses takeaways from his conversation with FDA's Peter Marks; three tasks for Monica Bert...2023-05-2327 min
BioCentury This WeekEp. 167 - The IRA, T Cell Therapies & The Distillery On the latest BioCentury This Week podcast, BioCentury’s editors assess how companies are upending pipeline and business strategies due to the Inflation Reduction Act, along with other takeaways from a survey on the IRA’s implications, conducted by BioCentury with the support of BIO. They also discuss CMS’s memo outlining how it intends to implement the IRA’s price-setting provisions, the T cell therapy landscape and insights from BioCentury’s Distillery. This week’s podcast is sponsored by Jeito Capital. Reach us by sending a text2023-03-2122 min
BioCentury This WeekEp. 165 - SVB Fallout, Plus: Pfizer-SeagenOn the latest BioCentury This Week podcast, BioCentury’s editors assess the fallout from the collapse of SVB and the sale of SVB UK to HSBC. BioCentury’s editors also discuss the proposed $43 billion acquisition of Seagen by Pfizer, takeaways from CDER Director Patrizia Cavazzoni’s conversation with Washington Editor Steve Usdin on The BioCentury Show and Editor in Chief Simone Fishburn’s call for pharma to put more women in the C-suite. This week’s podcast is sponsored by Jeito Capital.Reach us by sending a text2023-03-1424 min
BioCentury This WeekEp. 161 - New Cancer Paradigms, Distilling Innovations, & IPOsLast week’s Oncologic Drugs Advisory Committee meeting to discuss PD-1 inhibitor Jemperli offered insights into new endpoints, single-arm studies and the future of FDA advisory committee panels. On the latest BioCentury This Week podcast, BioCentury’s editors assess how GSK's standout dataset in a rare form of rectal cancer could qualify the program for exceptions to FDA’s standard practices and what it could mean for patients. BioCentury’s editors also discuss signs of greater regulatory flexibility on the important but controversial overall survival endpoint, highlights from BioCentury’s Distillery and what NASDAQ debuts by Mineralys and Structure say about...2023-02-1417 min
BioCentury This WeekEp. 151 - Alzheimer's Takeaways, U.K. Biotech, Charles ForumCTAD data for lecanemab showed more definitively than any past readout that targeting β-amyloid can lead to clinical benefit for Alzheimer’s patients, but the field is still wrestling with its use as a surrogate endpoint, BioCentury Executive Editor Selina Koch said on the latest BioCentury This Week podcast. Koch and the BioCentury podcast team break down the implications of data from Eisai and Roche at last week’s Clinical Trials on Alzheimer’s Disease meeting and look ahead to what’s next for the field. BioCentury’s editors also discussed how proposed changes to the U.K.’s R&D tax credi...2022-12-0626 min
BioCentury This WeekEp. 145 - What's Next for BIO, Plus: Pfizer, GSK BIO needs to pick a leadership team rather than a leader to give the trade group all the skills it needs moving forward, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin and Editor in Chief Simone Fishburn discuss how BIO needs to address the challenges it now faces, as well as the results of BioCentury’s industry-wide survey on the state of the trade group.BioCentury’s podcast team also assess the latest developments in RSV product development, the infectious disease pipelines of Pfizer and GlaxoSmithKline, and top takeaways from Fishburn’s conversation on The...2022-11-0820 min
BioCentury This WeekEp. 143 - East-West Summit PreviewMcKinsey’s Franck Le Deu and BayHelix’s Guo-Liang Yu join the BioCentury This Week podcast to discuss globalization and cross-border innovation in the biopharma and preview the upcoming BioCentury-BayHelix East-West Summit. BioCentury’s co-founders — CEO Dave Flores, Chairman Karen Bernstein — and Editor in Chief Simone Fishburn and BioCentury head of BD Josh Berlin also join the podcast to discuss the importance of globalization for biopharma and patients, the current environment for cross-border dealmaking and expected highlights of the East-West Summit, which will take place in Redwood City, Calif., Nov. 14-16.Reach us by sending a text2022-10-2824 min
BioCentury This WeekEp. 142 - Lundbeck, Biogen, Biden & Biomanufacturing, Nora VolkowA pair of neurology companies are in the spotlight on the latest edition of the BioCentury This Week podcast. BioCentury’s editors assess how Lundbeck has evolved in the past five years, with a fresh emphasis on first in class in its revamped pipeline, and how Biogen could acquire its way into being a near-term growth company. BioCentury’s editors also discuss the Biden administration’s initiative that seeks to compensate for decades of underinvestment in the nation’s biomanufacturing capacity and takeaways from Nora Volkow, director of NIH’s National Institute on Drug Abuse, during her appearance last week on Th...2022-10-2526 min
BioCentury This WeekEp. 138 - FDA User Fee Endgame, East-West Summit & BiogenEverything’s at stake for FDA as user fee legislation approaches a critical deadline this week, Washington Editor Steve Usdin says on the latest episode of BioCentury This Week. Usdin details the next steps in the process, which FDA reforms are being dropped from the “clean” user fee bill and the future of healthcare legislation. BioCentury’s editorial team also recaps the top takeaways from Global Blood Therapeutics CEO Ted Love’s appearance on The BioCentury Show, previews the upcoming BioCentury-BayHelix East-West Biopharma Summit and assesses two upcoming milestones for Biogen: an FDA decision on tofersen for amyotrophic lateral sclerosis...2022-09-2727 min
BioCentury This WeekEp 135 Pt. 5 - A Portrait of Biopharma's New LeadersDigital fluency, the imperative to have an impact on society and an eagerness to make change now, not in future decades, mark the future leaders of the industry, says BioCentury Editor in Chief Simone Fishburn. On the fifth and concluding BioCentury This Week podcast accompanying Back to School 2022, Fishburn and BioCentury’s editorial team discuss the defining traits of industry’s incoming generation of leaders and the evolving skills required for the future of biotech. Access all of BioCentury's Back to School content here.https://www.biocentury.com/topics/back-to-school-auth Reach us by sending a text2022-09-0219 min
BioCentury This WeekEp 135 Pt. 4 - Filling Biopharma's Talent PipelineThe need to recruit and train regulators is acute in developed as well as low- and middle-income countries, BioCentury Washington Editor Steve Usdin says. On the fourth of five BioCentury This Week podcasts accompanying Back to School 2022, Usdin and BioCentury’s editorial team discuss how drawing top talent means agencies must persuade candidates that careers are infused with purpose and support a vital mission. BioCentury Senior Editor Karen Tkach Tuzman says biopharma companies, facing their own talent crunch, will benefit from making themselves more visible, accessible and instructive to new entrants. Access all of BioCentury's Back to School content he...2022-09-0216 min