BioCentury This Week

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

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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

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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

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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

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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

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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

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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 [email protected].

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