BioCentury This Week

There’s been a rare IPO filing on NASDAQ as LB Pharma looks to test the market during a year that has seen little activity among U.S. biotechs even as green shoots continue to appear on the Hong Kong stock exchange. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the market for biotech IPOs on NASDAQ and in Hong Kong.
The analysts then assess FDA’s about-face on Stealth BioTherapeutics' Barth syndrome therapy, putting the decision in the context of a changing regulatory agency; and a BioCentury Guest Commentary that argues that the university-industry engine that drives U.S. innovation is under attack. Also mentioned on this week’s podcast: BioCentury’s 33rd Back to School package, which reimagines FDA; the upcoming 12th China Healthcare Summit in Shanghai; the evolution of dealmaking in China; and Annalisa Jenkins’ take on MHRA and the U.K. biotech ecosystem on The BioCentury Show.

View full story: https://www.biocentury.com/article/656849

#Biotech #IPO #Pharma #FDA #RareDisease #Biopharma #DrugDevelopment #HealthcareInnovation #HongKongIPO

00:00 - Introduction 
02:48 – LB Pharma Tests IPO Market
07:01 – Hong Kong IPO Momentum
09:53 – China Summit Preview
13:40 – FDA Reversal on Stealth Bio
18:15 – Bayh-Dole Clash & Innovation Threats

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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BioCentury’s third annual analysis of pharma company deals finds that bispecifics and degraders are in, cell and gene therapies are out, and China is bringing much more than me-too assets to cross-border deals. On the latest BioCentury This Week podcast, BioCentury’s analysts assess a year’s worth of deals between pharmas and biotechs to tease out emerging trends.
The analysts also discuss last week’s FDA approval of a vector-based immunotherapy from Precigen to treat a rare respiratory disease and whether the decision will set a precedent of more flexibility for rare disease therapies. They then take stock of recent translational coverage in BioCentury, including a report by Denali of a way to avoid a key safety issue of anti-amyloid-targeting mAbs.
BioCentury’s Grand Rounds — Europe will take place in Cambridge, U.K., Sept. 17-19. The conference seeks to bridge academia, industry and investors for breakthrough innovation.

View full Story: https://www.biocentury.com/article/656802

#PharmaDeals #CrossBorderDeals #Bispecifics #TargetedProteinDegradation #RareDisease #Neurodegeneration

00:00 - Introduction
01:38 - Pharma Deals
10:41 - Precigen
14:40 - Denali's BBB Tech
25:20 - Grand Rounds Europe

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Dealmaking between Western and Chinese biopharmas has been one of the year’s bright spots, as a maturing biotech landscape in China converges with Western demand for innovative assets, driving record deal flow. At the same time, the Hong Kong stock exchange has emerged as the hottest market for biotech IPOs, at a time when the NASDAQ window remains shut.
These themes will be in the spotlight at the 12th BioCentury-BayHelix China Healthcare Summit Oct. 22-24 in Shanghai. On this special edition of the BioCentury This Week podcast, a trio of biopharma leaders join BioCentury’s analysts to discuss the landscape: McKinsey's Franck Le Deu, former BD executive Ji Li, and HBM Holdings' Mike Patten.
BioCentury, BayHelix and Insights Partner McKinsey & Company invite you to visit Shanghai for the 12th China Healthcare Summit at the St. Regis Shanghai Jingan. For more information, click here; to apply to join the 2025 Class of Presenting Companies click here.

View full story: https://www.biocentury.com/article/656773

#ChinaBiotech #CrossBorderDeals #HongKongIPO #BiotechInvesting #LifeSciencesFinance

00:00 - Introduction
02:09 – Key Trends
06:03 – View from McKinsey
13:36 – Evolution of Deal Landscape
20:24 – Learning from China
24:00 – China-China M&A & NewCos

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Phase III data from Lilly’s orforglipron in obesity fell short of investor expectations, but they appear to be enough to obtain approval and wide use. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss why the first-in-class oral small molecule GLP-1R agonist’s clean safety profile and clear manufacturing advantage over oral peptides give the product a leg-up in the market.
They then discuss Vinay Prasad’s return to FDA after a brief hiatus, the revamped strategy of 32-year-old San Diego biotech Acadia Pharmaceuticals, and an attempt in the Senate to revive the Biosecure Act targeting China biotechs.
Finally, the analysts preview this year’s Back to School package, which reimagines FDA. At a time of unprecedented change in government agencies, BioCentury’s 33rd Back to School asks what FDA could look like if it were reorganized from the ground up to create the regulator patients deserve and industry needs.

View full story: https://www.biocentury.com/article/656727

#orforglipron #CBER #VinayPrasad #AcadiaPharmaceuticals

00:00 - Introduction
00:49 - Prasad
07:09 - Back to School
12:29 - Lilly Obesity
21:58 - Acadia's Comeback
28:50 - Biosecure Act

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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The ouster of Vinay Prasad after three months running FDA’s Center for Biologics Evaluation and Research could signal a reset is ahead for CBER. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what the latest shakeup at the regulatory agency says about what’s next for FDA.
The analysts also assess two leading European pharmas: obesity and diabetes company Novo Nordisk, which named a new CEO last week while cutting its 2025 forecast, and Bayer, which is gearing up for launches and is revamping its pipeline to restart growth. Finally, they discuss the promising clinical data that’s reviving interest in masking technologies that conditionally activate biologics.

View full story: https://www.biocentury.com/article/656649

#FDA #CBER #NovoNordisk #ObesityDrugs #Bayer

01:05 - Prasad's Ouster
14:59 - Novo's New CEO
21:14 - Bayer's Growth Strategy
26:05 - Masked Biologics

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A handful of encouraging signals is cause for cautious optimism for biotech headed into the second half of the year — companies have been able to parlay strong data into follow-on capital and M&A activity is picking up. That said, the IPO market continues to be closed and concerns about U.S. drug pricing and FDA stability continue to weigh on expectations for a robust near-term sector recovery.
Special guest Megan Hooton from IQVIA Biotech joins BioCentury’s analysts on a special edition of the podcast to discuss key indicators of progress for the biopharma sector. Hooton is president of IQVIA Biotech, which sponsored this episode of the pod.

View full story: https://www.biocentury.com/article/656614

#biotech #biopharma #pharma #lifescience #BiotechTrends #ClinicalTrials #GeneTherapy #CellTherapy

00:01 – Sponsor Message: IQVIA Biotech
02:37 – Biotech Markets
06:41 – Clinical Highlights
10:26 – Insights from Meg Hooton
23:10 – Advanced Therapies

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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This week’s deal between GSK and Jiangsu Hengrui is a prime example of how Western biopharmas have begun to recognize the innovation and opportunities being fostered in China — and how it’s no longer all about fast followers.
On the latest BioCentury This Week podcast, BioCentury’s analysts put the collaboration between GSK and Jiangsu Hengrui Pharmaceuticals, two of the most active cross-border dealmakers, into the context of East-West dealmaking over the past 30 months, assessing the innovation that is driving the rush to partner with biotechs in China, Japan, South Korea and beyond, and the types of companies looking to Asia for assets.
BioCentury’s analysts also discuss Steve Bates’ outsized role in building the U.K. biotech hub, as he readies to take on a new role in the U.K. government. They examine new VC funds from Omega Funds and Brandon Capital, FDA’s new national priority voucher pilot program, and fallout from how FDA and  Sarepta Therapeutics handled the deaths of four patients who had received the biotech’s gene therapies. This episode of BioCentury This Week is sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/656592

#biotech #biopharma #pharma #lifescience #EastWestDealmaking #ChinaBiotech #UKBiotech #FDAPolicy

00:01 - Sponsor Message: IQVIA Biotech
02:48 - Asia Deals Landscape
17:32 - Steve Bates & U.K. Biotech
25:46 - FDA's New Voucher Pilot
31:01 - New VC Funds
35:28 - Sarepta

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Last week’s public disclosure that a gene therapy from Sarepta had caused a third death led FDA to ask the company to stop distributing its DMD gene therapy Elevidys, a move the biotech has resisted. The deaths, and disputes between FDA and Sarepta, raise questions about the future of AAV gene therapies, as well as the future of FDA’s platform technology designation. On the latest BioCentury This Week podcast, BioCentury’s analysts unpack the events surrounding Sarepta’s gene therapies and discuss how FDA, industry and patient groups should come together to learn the lessons from the tragic, avoidable deaths.
BioCentury’s analysts also assess Monday’s appointment of Stanford professor and biotech executive George Tidmarsh to lead FDA’s Center for Drug Evaluation and Research, and check in on the latest trends in venture financings. This episode of BioCentury This Week is sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/656537

#biotech #biopharma #pharma #lifescience #GeneTherapy #AAVTherapy #Sarepta #Elevidys

00:01 - Sponsor Message: IQVIA Biotech
02:03 - Gene Therapy
17:59 - Leading CDER
27:00 - Venture Report

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Chinese biotech is the lone bright spot for the biopharma financial markets in 1H25, as macro concerns about the most favored nation (MFN) pricing policy and FDA weigh on the prospects for biotech elsewhere. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the positives — and negatives — impacting investor sentiment headed into the second half of the year. The team also discuss where the quantum computing revolution could have its biggest impact on drug development, and review the proposals and accomplishments of FDA Commissioner Marty Makary over his first 100 days in office. This episode of BioCentury This Week was sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/656482

#biotech #biopharma #pharma #lifescience #financialmarkets #FDA #quantumcomputing

00:01 - Sponsor Message: IQVIA Biotech
04:43 - Q25 Financial Markets Preview
22:20 - Quantum Computing Impact on Biopharma
30:07 - Makary's First 100 Days

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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There are many reasons why it may be the European biomedical ecosystem’s moment to shine, and advances at the academia-industry interface are a core part of that story, particularly in Cambridge, U.K. — the site of the inaugural BioCentury Grand Rounds – Europe conference.
On a special edition of the BioCentury This Week podcast, BioCentury’s analysts are joined by four leaders in the Cambridge, U.K., life sciences community to preview the Sept. 17-19 meeting: Kathryn Chapman, executive director of Innovate Cambridge; Anne Horgan, partner, Cambridge Innovation Capital; Sally Mardikian, business development director, Astrazeneca; and Kristin-Anne Rutter, executive director of Cambridge University Health Partners.
The BioCentury team and its Cambridge counterparts discuss the conference’s themes and how they relate to the region’s strengths, and offer both some tough love and a warm invitation to early-stage innovators looking for science-forward investors and partners.

View full story: https://www.biocentury.com/article/656373

#biotech #biopharma #pharma #lifescience #Discovery #Translation #BioCenturyGrandRoundsEurope

00:00 - Introduction
01:53 - Grand Rounds Cambridge Themes
10:14 - Why Cambridge?
23:43 - Tough Love
28:02 - Join us at GlastonGeek

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Oncology regulation has been less affected by recent changes in FDA leadership than other parts of the agency. On a special sponsored edition of the BioCentury This Week podcast, BioCentury’s analysts assess what has and hasn’t changed at FDA when it come to regulating cancer therapeutics.
Special Guest Liz O’Brien joins BioCentury’s analysts to discuss how biotechs can navigate FDA’s Project Optimus and EMA’s Joint Clinical Assessment as well as the differences between the two agencies. O’Brien is a former EMA regulator who is now therapeutic expert, oncology and women’s health, drug development solutions at BioCentury This Week sponsor ICON Biotech.

View full story: https://www.biocentury.com/article/656371

#biotech #biopharma #pharma #lifescience #FDA #cancer #CAR_T

00:01 - Sponsor Message: ICON Biotech
02:30 - FDA Cancer Regulations
07:48 - Project Optimus
25:12 - CAR T REMS Removal

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Treg-based cell therapies are nearing a clinical proof-of-concept inflection point, but in an environment that has dramatically shifted with the advent of CAR T therapies for autoimmune diseases. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what these cell therapies need to show to be relevant in the fast-changing I&I world, and which types of indications may best suit the cells’ unique profile.
The team also explores the biotech sector’s ongoing struggle to capture the interest of generalist investors, and what the next major theme might be to draw them back.
The analysts then break down the key provisions in the recently passed U.S. reconciliation tax bill, highlighting the positive and negative developments, as well as the missed opportunities for the industry. This episode of BioCentury This Week was sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/656376

#biotech #biopharma #pharma #lifescience #CellTherapy #TregTherapy #CAR_T

00:01 - Sponsor Message: IQVIA Biotech
01:19 - Treg Inflection Point
10:57 - Biotech's Next Big Story
22:36 - Tax Bill Consequences

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The Trump administration’s overhaul of FDA is still underway, but the agency has already veered away from its decades-long trajectory in ways that will profoundly reshape medical product development and the lives of U.S. patients. On the latest BioCentury This Week podcast, BioCentury’s analysts assess who the winners and losers are likely to be as FDA changes shape.
The analysts discuss a pair of in vivo CAR T companies: Esobiotec, whose story offers a case study in product-focused strategy, and Capstan Therapeutics, whose in vivo CAR T platform for immunological disorders attracted a buyer in Abbvie. The team also analyzes why data from Compass Pathways for psilocybin therapy COMP360 disappointed investors despite hitting the endpoint, and how molecular glues could be the future of selective CDK2 targeting. This episode of BioCentury This Week was sponsored by ICON Biotech.

View full story: https://www.biocentury.com/article/656341

#biotech #biopharma #pharma #lifescience #RandD #drugapproval

00:01 - Sponsor Message: ICON Biotech
02:26 - BioCentury Grand Rounds Europe
05:02 - FDA's Future
15:03 - Psychedelics
22:53 - Esobiotech's Fast Exit
31:37 - Molecular Glues and CDK2
34:43 - Abbvie's Capstan Buy

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Publicly traded U.K. investment firm and company builder Syncona is restructuring its fund amid ongoing market challenges in the biopharma industry. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how the firm will steer its portfolio toward returns for shareholders, while aiming to build a new fund away from public markets. The analysts then assess Eli Lilly's takeout of cardiovascular base editing company Verve, and what Washington Editor Steve Usdin calls FDA’s new “two-track” future for evaluating new therapies for approval — those with clear-cut benefits and those with ambiguous efficacy safety and efficacy profiles — in light of the many departures of senior FDA staff. They also discuss NASDAQ’s largest biopharma IPO — by Caris —  in two years, the latest obesity readouts, FDA Commissioner Marty Makary’s priority pathway and Usdin’s Q&A with new BIO Chair Fritz Bittenbender. This episode of BioCentury This Week was sponsored by ICON Biotech.

View full story: https://www.biocentury.com/article/656266

#biotech #biopharma #pharma #lifescience #finance #CV #FDA

00:01 - Sponsor Message: ICON Biotech
02:14 - Syncona Restructures Fund
10:08 - Lilly's $1B Verve Takeout
21:45 - FDA's 2-Track Future

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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 #DMD

00:01 - Sponsor Message: ICON Biotech
01:19 - Gene Therapy Safety
11:55 - Amylin in Obesity
18:17 - FDA's Future

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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 #BioCenturyGrandRounds

00:00 - Introduction
02:38 - Key Findings
07:42 - Collaboration and Opportunities
25:52 - BioCentury Grand Rounds Europe

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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 #DrugDevelopment

00:01 - Sponsor Message: ICON Biotech
02:11 - ASCO’s First-in-Human Trials
12:46 - Crossover Investor Health Check
22:54 - FDA's Rare Disease Plans

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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 #deals

00:00 - Introduction
04:39 - Sanofi Buys Blueprint
09:22 - BMS-BioNTech
20:01 - Hot Targets
23:40 - Drug Pricing

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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 #DrugDevelopment

00:01 - Sponsor Message: Jeito Capital
24:52 - HK IPOs
07:12 - ASCO
16:37 - EpCAM
20:16 - Rocket

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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 #networking

00:01 - Sponsor Message: Jeito Capital
02:10 - Key Takeaways
09:13 - Challenges and Opportunities for Europe
19:23 - Capital Efficiency and Success Stories
28:27 - Leadership, Teams & Talent

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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 #law

00:01 - Sponsor Message: Jeito Capital
05:05 - European Biotech's Moment?
19:00 - Boston Pharma, Biomarin Deals
29:41 - Novo Nordisk CEO

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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 #OvarianCancer

00:01 - Sponsor Message: Jeito Capital
03:22 - Obesity: Quality over Quantity
15:47 - Prasad at FDA
27:58 - Ovarian Cancer Atlases

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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 #LifeScience

00:00 - Introduction
01:25 - What's Next for Europe?
06:58 - Belgium's Biotech Ecosystem
10:29 - McKinsey on European Biotech
15:27 - Partnering, Panels of Note

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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 #SMARCA2

00:01 - Sponsor Message: Jeito Capital
03:01 - AACR Spotlight
11:21 - David Baker Protein Design
19:12 - Trump's Drug Pricing Plan

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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 #IPO

00:01 - Sponsor Message: RemeGen Co.
02:06 - Tau Time for Alzheimer's
13:10 - Vaccine Drama at FDA
23:32 - Merck KGaA's SpringWorks Buy
24:52 - Hong Kong Biotech IPOs

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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 #AACR

00:01 - Sponsor Message: RemeGen Co.
01:02 - Myasthenia Gravis at AAN
08:31 - RemeGen's Telitacicept
18:03 - AACR: Targets and Trends

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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 #asco

00:00 - Introduction
01:42 - Key Themes and Featured Sessions
07:37 - Chicago's Role in Biotech Innovation
15:06 - McKinsey's Insights
25:18 - Upcoming Events and Networking Opportunities

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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 #law

00:01 - Sponsor Message: RemeGen Co.
02:00 - Sentiment Survey
20:18 - Makary's FDA Plans
29:51 - China Speed

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/655622

00:01 - Sponsor Message: RemeGen Co.
02:38 - Replacing Animal Models
09:40 - RFK Jr. & FDA
19:36 - NIH
30:02 - BioPharma Market Pulse
33:23 - Innovation Highlights

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/655566

00:01 - Sponsor Message: RemeGen Co. 
01:19 - FDA and Tariffs Turmoil
16:54 - AACR Preview
20:44 - Bear Market Toolkit

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/655488

00:00 - Introduction
00:51 - XBI's Return to the Bear Market
11:26 - Marks Ouster & Turmoil at FDA
18:07 - Bispecifics for I&I

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/655438

00:00 - Introduction
02:25 - Sofinnova’s Pan-European Accelerator
08:27 - China Biotechs
14:59 - Trump Tariffs

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/655370

00:00 - Introduction
02:09 - BIO's Trump 2.0 Plan
14:00 - Autoimmune CAR Ts
21:05 - Telix's Radiopharma Play

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/655318

00:00 - Introduction
01:58 - Key Takeaways
08:42 - Innovation in Japan and India
12:54 - Building Biotech Ecosystems
31:14 - NewCo Model

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/655302

00:00 - Introduction
01:10 - Makary’s FDA Agenda
10:50 - Amylin in Obesity
24:21 - Life After DEI

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/655214

00:00 - Introduction
00:36 - CRISPR Companies
09:22 - AbbVie Enters Obesity Race
17:19 - Rare Disease Drug Challenges

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/655157

00:00 - Introduction
00:45 - Roche Reboot
08:47 - Precision Medicine in Psychiatry
13:07 - 5 Things on Trump 2.0

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/655112

00:00 - Introduction
00:58 - Competing with China
14:13 - FDA, NIH Staff Cuts
20:16 - Biotech IPOs 

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/655108

00:00 - Introduction
04:49 - The Newco Model and Industry Trends
09:13 - BayHelix and Cross-Border Transactions
11:31 - McKinsey's Perspective on Asian Innovation
26:58 - Final Thoughts and Registration Information

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/655034

00:00 - Introduction
00:59 - FDA, NIH & Trump 2.0
16:26 - Biotechs & Precision Medicine

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/654946

00:00 - Introduction
01:20 - Asia's NewCo Model
16:22 - FDA Tipping Point
20:27 - Vertex's Pain Drug

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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 Biotech
02:20 - Precision Neuropsychiatry
06:39 - Insights from ICON's Peter Schueler
15:59 - Challenges in Neuropsych

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/654837

00:01 - Sponsor Message: ICON Biotech
01:57 - Series As: Trends in Innovation
12:18 - BioCentury Conferences Preview
18:45 - Insights from FDA's Cavazzoni
21:58 - Turbulence at FDA, NIH

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/654772

00:01 - Sponsor Message: ICON Biotech
02:33 - Market Uncertainty
12:50 - Biotech Catalysts
21:12 - Obesity
22:57 - Neurology
28:54 - AI: VC Perspectives

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/654723

00:00 - Introduction
01:52 - Market Sentiments and Deal Expectations
04:42 - Cross-Border Deals and Asia's Growing Influence
07:12 - Neurology and Innovation in Biotech
14:44 - VC Trends and Megarounds
20:00 - Upcoming East West Singapore

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/654694

00:01 - Sponsor Message: ICON Biotech
02:38 - JPM Deal Buzz
11:20 - Washington Update
16:08 - Rep. Auchincloss’ Take on Biopharma
21:01 - FDA Regulatory Decisions

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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 Biotech
01:51 - Biotech's Repeating Challenges
10:52 - Biotech in the New Year
23:07 - Beyond Biosecure
28:10 - Neurology Readouts

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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-podcast

00:00 - Introduction
02:03 - Bob Temple's Legacy
16:13 - China's Academic Innovation
26:20 - CagriSema Obesity Data

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/653858

00:00 - Introduction
03:01 - Capital Markets Outlook
06:01 - M&A
15:19 - Breaking Down Deals
24:29 - Asia

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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/654488

00:00 - Introduction
02:08 - Trends in VC Funds
12:16 - Obesity Start-ups
19:46 - The BioCentury Show with Aoife Brennan
26:50 - Tim Harris' New Book: In Pursuit of Unicorns

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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