BioCentury This Week

A pair of lawmakers have dealt the Biosecure Act a setback that could derail the legislation, even as Congress continues its push to reduce reliance on China in the life sciences. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin explains why Sen. Rand Paul (R-Ky.) and Rep. Jamie Raskin (D-Md.) refused to sign off on inclusion of the anti-China biotech bill in the must-pass National Defense Authorization Act, what provisions the defense bill has that seek to enhance U.S. biotech supply chain resilience and whether Biosecure can be resurrected. And in the latest in neurology, Executive Editor Selina Koch discusses Novartis and PTC's $1 billion deal for the biotech’s Huntington disease therapy, and how several biotechs are poised to take therapies against the long undruggable KCC2 to the clinic for neurological disorders. Heads up: BioCentury’s JPM Guide 2025 is out now.

View full story: https://www.biocentury.com/article/654420

00:00 - Introduction
01:42 - Biosecure Setback
10:01 - Novartis' $1B PTC Deal 
16:28 - KCC2 Activation

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

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On the latest BioCentury This Week podcast, Washington Editor Steve Usdin and colleagues discuss how President-elect Donald Trump’s pick to lead NIH, Jay Bhattacharya, would lead NIH and how that could affect the biopharma industry.
The BioCentury team then discusses its analysis of abstracts released ahead of the American Society of Hematology (ASH) and Society for Immunotherapy of Cancer (SITC) annual conferences, highlighting methods for applying dual or bispecific CAR T cell designs to solid tumors. And they also analyze FDA approvals of products by biotech companies, noting that current trends show biotechs shedding their reliance on pharma to get drugs across the finish line for approval.

View full story: https://www.biocentury.com/article/654363

00:00 - Introduction
01:08 - Trump's NIH Pick
12:13 - Multi-targeted CAR Ts
19:26 - Biotech FDA Approvals

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

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Positive vibes about biotech emanating from the Jefferies Healthcare Conference were overshadowed by the uncertainty that is ahead because of the result of the U.S. elections. On the latest BioCentury This Week, BioCentury’s editors discuss how the unconventional cabinet nominations of the incoming Trump administration have cast a pall over what had been growing enthusiasm for the prospects of the biotech sector. Washington Editor Steve Usdin also discusses what the nomination of Marty Makary as the next FDA Commissioner could mean for the sector, and recaps the latest update on the Biosecure Act. The BioCentury editors also discuss which pharmas are in or out in making a challenge to Eli Lilly and Novo Nordisk in the obesity market.

View full story: https://www.biocentury.com/article/654319

00:00 - Introduction
00:32 - Jefferies Conference Takeaways
06:25 - Trump Nominations
17:41 - Biosecure Act Update
21:01 - Pharma in Obesity

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

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Giving 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, and the recent bolus of West-East deals, including two around anti-PD-(L)1 x VEGF bispecifics: BioNTech's acquisition of Biotheus, and Merck's licensing of global rights to a LaNova asset.

View full story: https://www.biocentury.com/article/654233

00:00 - Introduction
01:12 - RFK Jr. & HHS
13:15 - Blenrep's Comback
19:25 - China Deals

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

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Trump 2.0 presents opportunities and challenges for leaders of the biopharma industry, which needs effective public policy to thrive. On the latest BioCentury This Week, BioCentury Washington Editor Steve Usdin explains what those opportunities are and lays out the potential impact on the public policy environment, which could have repercussions on FDA and beyond.
BioCentury’s editors then analyze how companies, academics and advocates are pushing back on claims that they should have disclosed the results of APOE4 genotype testing to Alzheimer’s trial participants and investigations by Chinese authorities into AstraZeneca China President Leon Wang and fellow AZ employees past and current, assessing what’s known about the allegations and whether the situation could affect other MNCs operating in the country.

View full story: https://www.biocentury.com/article/654157

00:00 - Introduction
01:01 - Prepping for Trump
09:41 - Alzheimer's Ethics
17:44 - AstraZeneca's Challenges in China
21:51 - Myths and Misperceptions

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

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It’s too soon to conclude anti-amyloid therapies are safe for use by Alzheimer’s patients in the real world, even as early reports are encouraging, argues BioCentury Executive Editor Selina Koch on the latest BioCentury This Week podcast. Koch and colleagues discuss takeaways from this year’s Clinical Trials on Alzheimer’s Disease annual meeting, including conclusions from adverse event data for Leqembi lecanemab and what the true test of appropriate use and safety for the drug might look like.
BioCentury’s editors also assess Phase II data presented at CTAD by UCB that provide some of the first clues about what species of tau to target and in which patients. And they discuss what results of Tuesday’s presidential contest in the U.S. will mean for FDA, as well as the state of play for China biotech as the industry continues to grind out its first bear market.

View full story: https://www.biocentury.com/article/654075

00:00 - Introduction
01:23 - CTAD: Anti-amyloids
14:22 - CTAD: UCB's tau data
19:47 - FDA & the Election
28:16 - China Summit Debrief

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

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Twenty years of innovation in therapies targeting EGFR provides a case study in how generation of differentiated products against the target can drive market growth. On the latest BioCentury This Week podcast, BioCentury’s editors discuss EGFR as a prime example of the value in best-in-class development strategies, with meaningful improvements across multiple modalities delivering substantial therapeutic benefits to patients. Analogous best-in-class opportunities aren’t limited to cancer, but are also playing out in other settings such as immunology.
The editors then discuss a recent event that hosted FDA commissioner Rob Califf and four former commissioners, all of whom agreed a major role of the FDA commissioner is to protect the agency from political interference.
Washington Editor Steve Usdin also previews his conversation with FDA’s Richard Pazdur, and Editor in Chief Simone Fishburn details takeaways from her Q&A with James Sabry, who recently became CBO at BioMarin Pharmaceutical.

View full story: https://www.biocentury.com/article/653926

00:00 - Introduction
00:38 - EGFR Case Study
08:45 - FDA Commissioners & Politics
19:19 - James Sabry's Timeline

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

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Cross-border geopolitical tensions and a prolonged capital crunch are compelling biopharma companies from Beijing to Boston to rethink their strategies on everything from deal-making and raising capital to manufacturing and use of CROs. On a special edition of the BioCentury This Week podcast, McKinsey’s Franck Le Deu and Wendy Pan of BayHelix and Goodwin join BioCentury on the eve of next week’s eleventh annual BioCentury-BayHelix China Healthcare Summit in Shanghai to discuss the dynamics affecting biotechs in China looking beyond the country’s borders and Western biopharma companies seeking innovation and partners in China, as well as the latest trends, such as U.S. VCs and/or management teams building newcos around China assets. They also detail highlights among the three-day event’s speakers, panels and fireside chats.

The BioCentury-BayHelix China Healthcare Summit will take place Oct. 30 through Nov. 1 at the St. Regis Shanghai Jian in Shanghai. For information on registering to attend and/or becoming a presenting company, click here.

View full story: https://www.biocentury.com/article/653959

00:00 - Introduction
03:32 - The View from BayHelix
06:59 - The View from McKinsey
18:57 - Summit Highlights

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

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At least 25 venture firms have raised a total of more than $17 billion in funds this year, with Forbion unveiling the largest-ever European biopharma fund at €1.2 billion last week. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how Forbion deployed its prior fund and quickly raised fresh funds and what that — and other funds — say about the state of financing private biotechs in Europe and elsewhere.
The editors then assess takeaways from BioCentury’s conversation with NIH’s Daniel Reich on data that could shape drug development’s future for progressive multiple sclerosis, and neurodegeneration broadly, as well as how the first clinical data from an RNA-editing oligonucleotide therapy from Wave Life Sciences demonstrate that it’s possible to change a single base in an RNA to correct a disease-causing mutation in patients.

View full story: https://www.biocentury.com/article/653924

00:00 - Introduction
02:48 - VC Funds
11:50 - New Chapter for MS
23:48 - Wave's Data

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

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There is a growing mandate among researchers and VCs to provide proof of causal human biology for new targets. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the different strategies being deployed to identify causal links to disease using observational patient data or human cell models, including the challenges that come with each approach and the various computational methodologies companies are using.
They also discuss the outcome of FDA’s advisory committee meeting on Barth syndrome candidate elamipretide from Stealth Biotherapeutics, and the implications of the discussion for review of ultrarare disease therapies more broadly.
Diving into the deal of the day, the editors review the proposal by H. Lundbeck to acquire Longboard Pharmaceuticals for $2.6 billion, and discuss how the biotech’s therapy for developmental epilepsies may stack up against competitors.

View full story: https://www.biocentury.com/article/653843

00:00 - Introduction
00:34 - Causal Biology and Big Data
17:52 - FDA's Ultra-Rare Decision
27:29 - Lundbeck Acquires Longboard

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

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

00:00 - Introduction
02:13 - 4Q Public Markets Preview
16:16 - What's on at the China Summit
28:25 - Fixing FDA's Advisory Panels
34:09 - Recap: The BioCentury Show with Lee Fleisher

View full story: https://www.biocentury.com/article/653793

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

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Approval of BMS’s first-in-class schizophrenia drug is good news for patients and the company’s thinning pipeline alike, but maximizing Cobenfy’s commercial potential depends on readouts in additional indications. On the latest BioCentury This Week podcast, BioCentury’s editors assess the significance of the new therapy and what the pharma needs to do to make its launch a success.
They also discuss the impact of the withdrawal of Pfizer's sickle cell therapy; the work left unfinished on biotech-related legislation in Congress; BioAge's NASDAQ IPO; and the importance of FDA’s Oncologic Drugs Advisory Committee meeting on the use of PD-1 inhibitors in patients with certain tumors expressing low levels of PD-L1. This episode of BioCentury This Week was sponsored by Parexel Biotech.

View full story: https://www.biocentury.com/article/653732

00:01 - Sponsor Message: Parexel BioTech
01:41 - BMS Schizophrenia Drug
12:28 - Pfizer Withdrawal's Oxbryta
18:26 - ODAC and PDL1
23:56 - D.C. Update
26:51 - BioAge IPO

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

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The ESMO Congress yielded another win for cancer immunotherapy target TIGIT, but the readout resurfaced worries about the mechanism’s past failures to turn positive earlier stage data into Phase III success. On a special edition of the BioCentury This Week podcast, BioCentury’s editors deliver their takeaways from this year’s meeting, including analysis of data for TIGIT blocker belrestotug from iTeos Therapeutics, a colorectal cancer readout featuring J&J's Rybrevant and an antibody-drug conjugate from Genmab. The BioCentury team is joined by Gwyn Bebb, who is global franchise head for oncology at podcast sponsor Parexel. Bebb discusses what’s changed in the oncology landscape in the 10 years since the approval of the first immunotherapies, observations that COVID-19 vaccines might have a role in treating cancer and developments in the radiopharma field. This episode of BioCentury This Week was sponsored by Parexel Biotech.

View full story: https://www.biocentury.com/article/653681

00:01 - Sponsor Message: Parexel BioTech
01:55 - iTeos' TIGIT Data
04:56 - Rybrevant Colorectal
07:22 - Gwyn Bebb's Take
21:38 - More ESMO Highlights

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

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Rep. Frank Pallone’s misunderstanding of how the pediatric priority review voucher program works has been one factor undermining support for an incentive that brings new drugs to kids, argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin explains how the voucher process works and why it’s valuable to the country’s youngest patients, as well as to small biotechs and larger biopharma alike.
Usdin also discusses the latest twists and turns for the Biosecure Act, and BioCentury’s Stephen Hansen assesses the obesity data from Novo Nordisk that destroyed more than $30 billion in value for the Danish pharma. This episode of BioCentury This Week was sponsored by Parexel Biotech.

View full story: https://www.biocentury.com/article/653633

00:01 - Sponsor Message: Parexel Biotech
01:47 - Pediatric PRVs
06:42 - Biosecure Act
12:44 - Novo's Obesity Miss

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

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On a special edition of the BioCentury This Week podcast, BioCentury’s editors deliver their takeaways from the debut Grand Rounds conference, which focused on whether biotech can write a more successful playbook for translating from target to product. Weaving together takeaways from the panels, fireside chat and keynote at the conference, the editors assess the tensions between generalizability and fit-for-purpose models, between having control and capturing complexity, and, in human data, between scale and robustness/reliability, particularly for longitudinal readouts. The editors also discuss BioCentury's Q&A with USC Keck School’s Patrick Lyden, who explained how high-quality, reproducible preclinical science can be feasible.

View full story: https://www.biocentury.com/article/653631

00:00 - Introduction
02:56 - Generalizability vs. Fit for Purpose
10:03 - Control vs. Complexity
17:57 - Scale vs. Robustness in Human Data
26:25 - Hypothesis-Driven vs. Unbiased Research
28:50 - Grand Rounds 2025


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

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On 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.

View full story: https://www.biocentury.com/article/653538

00:01 - Sponsor Message: Parexel Biotech
01:30 - IPOs
10:56 - GLP-1 & Obesity
22:18 - AI & Biotech

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

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Will 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 Woodcock to bolster quality in biopharmas’ manufacturing. This episode of BioCentury This Week was sponsored by Parexel Biotech.

View full story: https://www.biocentury.com/article/653507

00:01 - Sponsor Message: Parexel Biotech
01:39 - Akeso's Bispecific Challenge
08:22 - Vaxcyte Pneumococcal Vaccine
12:32 - Woodcock's Quality Initiative
14:48 - Recap: The BioCentury Show on Biosimilars

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In this year’s series of Back to School essays, BioCentury’s editors ask whether the era of human first, causal biology and personalized medicine can reshape drug discovery to solve the weakest link in biotech — translation to the clinic. On a special edition of the BioCentury This Week podcast, the three authors of BioCentury’s 32nd Back to School edition, Editor in Chief Simone Fishburn, Executive Editor Selina Koch, and Executive Director of Biopharma Intelligence Lauren Martz, discuss how industry can solve its biggest bottleneck.

The editors zero in on inflammation and immunology, specifically how immunoproteomics upstage genomics in I&I target discovery, and neurology, notably how neuroscience companies are reducing to practice the concept of human-first discovery. Finally, they discuss the thread that runs through it all — precision medicine — and how biomarkers can help validate targets while bringing precision medicine to I&I and neurology.

View full story: https://www.biocentury.com/article/653485


00:00 - Introduction
01:32 - Introducing Back to School
10:42 - Validation Tools
14:50 - I&I
21:00 - Neurology
27:19 - Precision Medicine

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A 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 the latest trends among pharma’s deals with biotechs over the past 12 months. Plus, a preview BioCentury’s annual Back to School package, next week’s new Grand Rounds R&D conference and highlights from this month’s Distillery roundup of translational papers.

View full story: https://www.biocentury.com/article/653385


00:00 - Introduction
01:36 - Biosecure on Deck
04:33 - Priority Review Vouchers
08:11 - BioCentury IRA Survey
17:07 - Back to School: Target Discovery
19:49 - Translational Highlights

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Shaking up an underwhelming year for fresh biotech paper, a trio of biotechs filed to go public on NASDAQ last week. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the IPO filings by MBX and Massachusetts companies Zenas and Bicara. Washington Editor Steve Usdin returns to the podcast to provide updates on the Inflation Reduction and Biosecure acts, as well as the life sciences policies of presidential candidates Donald Trump and Kamala Harris. And Director of Biopharma Intelligence Karen Tkach Tuzman zeroes in on the latest trends among pharma’s deals with biotechs over the past 12 months and the latest start-up out of Versant Ventures, Borealis.

View full story: https://www.biocentury.com/article/653354

00:00 - Introduction
01:48 - Biotech IPOs
12:48 - Washington Update
20:39 - Versant, Novartis Newco
24:34 - Pharma-Biotech Deal Trends

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Grand 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 Life Science Tennessee. There is still time to register for BioCentury Grand Rounds, which will take place Sept. 9-11 in Nashville. Network, partner and debate key bottlenecks in translation. See the conference website for more information.

View full story: https://www.biocentury.com/article/653324

00:00 - Introduction
00:13 - Spotlight Grand Rounds
02:03 - Conference Themes
08:40 - Nashville's Biotech Ecosystem
16:58 - Paul Peter Tak on I&I
25:22 - McKinsey Report Preview

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The 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 sought approval of its MDMA program to treat post-traumatic stress disorder (PTSD), and preview this year’s BioCentury Back to School report, which focuses on whether biotech can write a more successful playbook for translating from target to product.

Take part in BioCentury’s Snap Survey on the IRA and Part D pricing. We’ll be publishing the results next week, which means we need your input now! All results will be anonymous.

View full story: https://www.biocentury.com/article/653298

00:00 - Intro
01:32 - Medicare Drug Pricing
11:38 - Psychedelic Setback
18:53 - Back to School Preview

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Pharmaceutical 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 preview some of the highlights of the upcoming Grand Rounds conference. The event, BioCentury’s first R&D conference, takes place Sept. 9-11 in Nashville, Tenn. and tackles the roadblocks in the translation of science into new medicines.

View full story: https://www.biocentury.com/article/653239

00:00 - Intro
01:31 - Wilson’s Vision for Gene Therapy
14:23 - Inside Korea's Biotech
21:45 - BioCentury's Grand Rounds

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A substantial part of the biopharma ecosystem involves deals between biotechs and academics, with smaller companies accessing assets to add to their pipelines and technologies to help solve problems. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the interplay of biotech and academia, including how deals between the groups often come outside the hubs of Boston and the Bay Area and what types of indications and technologies are common focus points. They also discuss new data in Alzheimer’s for Leqembi from Eisai and Biogen that provide insight into how to get the most out of anti-amyloid mAbs for the disease, and what’s next for James Wilson now that the gene therapy pioneer is moving on from the University of Pennsylvania.

View full story: https://www.biocentury.com/article/653174

00:00 - Intro
04:25 - Biotech-Academia Deals
12:04 - Leqembi's Latest Data
19:20 - What's Next for James Wilson

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Europe’s CHMP has again ruled in contrast to FDA for a neurology product, this time on Biogen and Eisai’s Leqembi for Alzheimer’s disease. On the latest BioCentury This Week podcast, BioCentury editors discuss the similarities and differences between Leqembi lecenamab and Aduhelm aducanumab, the first anti-amyloid mAb from Biogen and Eisai and what it means for the next in line from that class, Kisunia donanemab from Eli Lilly. The editors also break down last week’s ODAC meeting, which discussed trials in perioperative cancer for checkpoint inhibitors, and talk about the looming delay in reauthorization of the rare pediatric priority review voucher program. They also assess the implications of the investigation by the House Select Committee on the Chinese Communist Party into clinical trials run in Chinese military hospitals and the Xinjiang Uyghur Autonomous region, a story broken last week by Washington Editor Steve Usdin.

View full story: https://www.biocentury.com/article/653010

02:06 - CHMP Leqembi Decision
09:53 - Perioperative Cancer
17:45 - Pediatric Review Vouchers 
23:55 - Beyond Biosecure

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Alpha emitters are the latest trend in the hot radioligand space, but there’s debate about which isotope offers the best attributes for optimizing safety and efficacy. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the benefits and challenges that come with developing radiopharmaceuticals using lead-212 versus its more well-known counterpart actinium-225. They also discuss Editor-in-Chief Simone Fishburn’s conversation with Susan Galbraith, EVP of Oncology R&D at AstraZeneca, the latest innovations in delivering lipid nanoparticles to specific tissues beyond the liver, and the most recent oral GLP-1 obesity data from Roche.

View full story: https://www.biocentury.com/article/653008

00:00 - Intro
05:36 - Radiopharma Alpha Emitters
12:18 - AZ’s Susan Galbraith
21:40 - Lipid Nanoparticles
25:22 - Oral GLP-1 Race

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Buysiders are upbeat headed into the back half of the year, but uncertainty over the Federal Reserve’s timing on interest rate cuts is keeping that sentiment in check. On the latest BioCentury This Week podcast, BioCentury’s editors preview the public markets’ second half of 2024, discussing the appetite for biotech IPOs and M&A and what investors are looking for as they read the Fed tea leaves.
They also discuss Congress’ FDA budget squeeze, the growing momentum of the Biosecure Act — which seeks to rein in Chinese CDMOs and genomics companies in the U.S. — and the legacy of IR/PR pioneer Lisa Burns, who passed away this month after spending years advising biotech CEOs and investors.

View full story: https://www.biocentury.com/article/652968

00:00 - Intro
02:54 - 3Q Markets Preview
12:33 - Policy Update
18:40 - Remembering Lisa Burns

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The 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 Danielle Golovin’s analysis of LNP innovation and Paul Bonanos’ take on Monday’s $3.2 billion M&A move by Eli Lilly. This episode of BioCentury This Week was sponsored by Nxera Pharma.

View full story: https://www.biocentury.com/article/652898

00:01 - Sponsor Message: Nxera Pharma
01:24 - U.K. Biopharma
08:14 - IRA
10:28 - Biosecure Act
14:49 - Breakthrough Designation Pathway

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The 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 Chang about how his lab, and the five companies he has co-founded, have turned serendipitous discoveries about poorly understood nucleic acid types into translational strategies. This episode of BioCentury This Week was sponsored by Nxera Pharma.

View full story: https://www.biocentury.com/article/652845

00:01 - Sponsor Message: Nxera Pharma
04:49 - Chevron Ruling's Impact
10:32 - Tumor Cell Surface Targets
15:48 - Lurie Winner: Howard Chang

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A 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 genetics is promising to remove some of the risk from neurology drug development; and preview BioCentury’s new conference, Grand Rounds, which takes place in September in Nashville, at the interface of academia and industry. This week’s podcast is sponsored by Nxera Pharma.

View full story: https://www.biocentury.com/article/652789

00:01 - Sponsor Message: Nxera Pharma
02:05 - Introducing BioCentury's Grand Rounds
06:46 - An MPS Breakthrough
14:12 - Sarepta Approval

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After whisking through Washington for the first half of the year, raising alarms, mutating and causing confusion, the Biosecure Act is now on pause. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the delay for the legislation, which seeks to drive Chinese contract development and manufacturing organizations out of the U.S., means, what will happen next, and how it will impact life sciences companies.

View full story: https://www.biocentury.com/article/652771

03:09 - What's In, What's Out
05:41 - Broader Impact
11:07 - Wake-up Call

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The avian flu outbreak is a fire drill that is showing how poorly the U.S. is prepared for the next pandemic. On the latest BioCentury This Week podcast, BioCentury's editors recap last week’s BioCentury Show conversation with Rick Bright, including the former BARDA director’s insights on the opportunities for biotechs to help fill voids in surveillance, point-of-care diagnostics, vaccines and therapeutics and the need for the government to provide leadership and funding to empower industry. They also discuss new SEC rules that will make reverse mergers less attractive; the Supreme Court’s mifepristone ruling and a trio of neuro-focused stories -- one on FDA’s guidance on presymptomatic Alzheimer’s, another on an advisory committee’s discussion about Eli Lilly's anti-amyloid therapy donanemab and a third focused on what neuroscience biotech companies need to consider when pitching VCs and pharmas. This week’s podcast is sponsored by Nxera Pharma.

0:01 - Sponsor Message: Nxera Pharma
01:40 - Pandemic Prep Problems
11:11 - Reverse Mergers
15:43 - Alzheimer's
25:31 - SCOTUS

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BIO’s annual meeting took place amid heightened industry concerns regarding the Biosecure Act, which took yet another unexpected turn this week. On a special edition of the BioCentury This Week recapping the meeting, BioCentury's editors discuss the latest on the anti-China biopharma legislation, including misperceptions of what the bill seeks to accomplish.
Special guest Chris Cargill, the CEO of Nxera Pharma, joins the podcast to discuss the expanded APAC presence at this year’s BIO; Japan’s push to build the biotech ecosystem in the country; and how Nxera (formerly Sosei) is evolving. And finally, BioCentury’s editors deliver the takeaways from Karen Tkach Tuzman’s BIO panel focused on radiopharmaceuticals, including debate on the merits of long- versus short-lived radioisotopes. This week’s podcast is sponsored by Nxera Pharma.

View full story: https://www.biocentury.com/article/652686

00:01 - Sponsor Message: Nxera Pharma
02:34 - BIO Wrap: Biosecure 
09:12 - Japan & Nxera
18:52 - Radiopharma 

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A snub by an FDA advisory committee for an MDMA-psychotherapy combination is unlikely to read through to other psychedelic therapies in the pipeline. On the BioCentury This Week podcast, BioCentury’s editors discuss the shortcomings of the Lykos Therapeutics product’s clinical development program and why other psychedelics likely won’t face the same hurdles. The editors also assess FDA’s new platform technology designation and the first-in-human clinical trials described at this year’s American Society of Clinical Oncology (ASCO) meeting. This week’s podcast is sponsored by Nxera Pharma.

View full story: https://www.biocentury.com/article/652639

00:01 - Sponsor Message: Nxera Pharma
01:41 - Psychedelic Setback
12:38 - FDA's Platform Play
21:39 - ASCO Innovations

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Four takeouts with upfront payments north of $1 billion to close out May mark the latest run of VC exits from biotech M&A and help expand the pipelines of large biopharmas in renal, ophthalmic and immunologic indications. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how two of the takeouts -- Asahi Kasei’s buy of Calliditas and Biogen’s acquisition of HI-Bio -- showcase how the renal field is on the rise. Turning to Washington, the editors explain why the House Select Committee on the Chinese Communist Party is expanding its remit to Chinese therapeutic developers and commercial competitiveness — with an initial focus on Legend and GenScript. And, finally, they assess data from ASCO that demonstrate how immunotherapies are making progress in “cold” colorectal cancers. This week’s podcast is sponsored by Nxera Pharma.

View full story: https://www.biocentury.com/article/652597

00:01 - Sponsor Message: Nxera Pharma
1:35 - Biotech M&A
11:40 - Biosecure Act
23:00 - ASCO

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A theme among late-breaker presentations at this year’s American Society of Clinical Oncology meeting is the push by companies to move targeted therapies into earlier lines of treatment. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what they’re watching for in ASCO’s headline presentations and deliver highlights from abstracts released late last week as the oncology meeting readies to kick off on Friday. The editors also discuss the interest by FDA’s Janet Woodcock in a new approval pathway for ultrarare therapies, the Foundation for the National Institutes of Health’s initiative to support development of therapies and diagnostics for ALS, and Biogen's $1B+ acquisition of HI-Bio. This week’s podcast is sponsored by Nxera Pharma.

View full story: https://www.biocentury.com/article/652531

0:01 - Sponsor Message: Nxera Pharma
1:43 - ASCO
6:46 - Ultrarare Diseases
14:52 - FNIH's ALS Push
20:27 - Biogen M&A

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New BIO CEO John Crowley is reorganizing BIO in a bid to reshape how the organization communicates and enhance its focus on patients. BioCentury’s editors also recap the 24th annual Bio€quity Europe conference that was held in San Sebastián, Spain last week, as well as highlights from last week’s American Society of Gene and Cell Therapy conference. The editors also discuss impressive early data from Endeavor BioMedicines in idiopathic pulmonary fibrosis and Phase Ib obesity data from Roche. This week’s podcast is sponsored by Nxera Pharma.

View full story: https://www.biocentury.com/article/652453

0:01 - Sponsor Message: Nxera Pharma
1:08 - BioEquity Europe recap
7:08 - Shake up at BIO
13:37 - ASGCT highlights
20:39 - Endeavor IPF data
22:20 - Roche obesity data

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“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 why he hopes and believes the Supreme Court will rule for FDA in litigation over the abortion drug mifepristone; and explained his view that approval of Aduhelm to treat Alzheimer’s disease was one of FDA’s worst decisions.

The BioCentury Show is now available as an audio podcast. The 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/652427

00:00 -  The BioCentury Show Podcast 
01:51 - Lowe’s Blog
05:30 - Biosecure Act
09:53 - AI & Drug Discovery
17:33 - FDA, The Abortion Drug, & Aduhelm
22:05 - Lessons from COVID

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Lawmakers’ changes to the Biosecure Act create breathing room for U.S. biopharma companies to move on from Chinese CDMOs, Washington Editor Steve Usdin said. On the latest BioCentury This Week podcast, Usdin and his BioCentury colleagues discuss what the revisions mean for biotechs and what’s next for the legislation, plus how WuXi AppTec is defending itself against the bill’s allegations. Director of Biopharma Intelligence Paul Bonanos discusses last week’s surge in venture activity, including the largest biotech round, a $200 million series C by Lonnie Moulder’s Zenas BioPharma, as well as recent deals of note, including one for Maze Therapeutics. The biotech found a new partner for its Pompe disease program in Shionogi, months after Sanofi pulled out of a deal for the therapy amid FTC scrutiny. This week’s podcast is sponsored by Nxera Pharma.

View full story: https://www.biocentury.com/article/652402

00:01 - Sponsor Message: Nxera Pharma
03:24 - Biosecure Revisions
09:34 - WuXi AppTec Responds
14:42 - Venture Raises
19:32 - Deals of Note

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It 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 companies. “We have absolute certainty that ESG is important."

The BioCentury Show is now available as an audio podcast. The 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/652294

00:00 - The BioCentury Show Podcast
02:12 - Spain’s Biotech Ecosystem
10:06 - Investment Criteria
15:03 - ESG, Diversity
28:29 - AI in Drug Development

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Next week's Bio€quity Europe conference in San Sebastián will focus on how European biotechs can rise above the noise to attract investors, partners and talent. McKinsey & Co.’s Alexandra Zemp and Paula Olazábal of Ysios Capital joined BioCentury to outline the opportunities and challenges faced by Spain’s biopharma ecosystem and preview some of the conference’s networking events, fireside chats and panel discussions. EBD Group's Claire Macht also joined to detail what to expect in terms of attendees and one-on-one partnering meetings at the event. Bio€quity Europe 2024 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/652371

00:00 - Intro
03:27 - Spanish Biotech Ecosystem
08:13 - McKinsey's Insights
12:08 - Event Preview
17:26 - BioЄquity Europe C-Level Attendees

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One 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 to quantify the benefits accelerated approval has had for cancer patients, and what’s next for the Biosecure Act and similar legislation seeking to rein in Chinese CDMOs and genomics companies. This week’s podcast is sponsored by Nxera Pharma.

Don’t miss BioCentury’s new podcast, The BioCentury Show, featuring BioCentury one-on-one with an industry KOL. It’s available 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/652335

00:01 - Sponsor Message: Nxera Pharma
01:43 - ASGCT Preview
10:37 - BioCentury Show Podcast
14:21 - Accelerated Approval 
19:48 - Biosecure: What’s Next

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Led 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 discuss the $1 billion launch of AI-guided therapeutics developer Xaira. Finally, BioCentury’s Joshua Berlin joins the podcast to preview BioCentury’s upcoming conference Bio€quity Europe, which kicks off May 12 in San Sebastián. This week’s podcast is sponsored by Jeito Capital.

View full story: https://www.biocentury.com/article/652273

0:01 - Sponsor Message: Jeito Capital
1:55 - Energizing Gene Therapy
6:28 - Pfizer Hemophilia Approval
11:36 - Bio€quity Europe Preview
18:03 - Arch & Foresite's AI Biotech Build
19:32 - Ono's Deciphera Takeout

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A “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 in the Editor’s Commentary.
BioCentury’s editors also discuss how an FDA advisory committee’s support for a myeloma metric makes the broader case for endpoint innovation; why a group of biotechs is delisting from U.K. stock exchange AIM; and the launch of well-funded obesity play Metsera Inc. For more of BioCentury’s coverage of obesity therapeutics, see our Hot Topics page. This week’s podcast is sponsored by Jeito Capital.

View full story: https://www.biocentury.com/article/652185

0:01 - Sponsor Message: Jeito Capital
1:54 - Defending Accelerated Approval
8:44 - Endpoint Innovation
12:55 - Challenges for U.K.'s AIM
18:16 - Obesity Launch: Metsera

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Vertex 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 also preview BioCentury’s first R&D conference — Grand Rounds — which will focus on the biotech industry’s interface with academia, bringing together decision-makers and the next innovators in Nashville, Sept. 9-11. This week’s podcast is sponsored by Jeito Capital.

View full story: https://www.biocentury.com/article/652107

0:01 - Sponsor Message: Jeito Capital
1:30 - Introducing BioCentury's Grand Rounds
3:59 - Vertex’s Alpine Takeout
9:38 - Goldman’s Venture Strategy
14:33 - Reading the IRA Tea Leaves

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M&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-drug conjugates paradigm. Editor in Chief Simone Fishburn also previews Grand Rounds, BioCentury’s first R&D conference, which will focus on the biotech industry’s interface with academia, bringing together decision-makers and the next innovators in Nashville Sept. 9-11. To learn more about BioCentury Grand Rounds and opportunities to present, see the conference website. This week’s podcast is sponsored by Jeito Capital.

View full story: https://www.biocentury.com/article/651996

0:01 - Sponsor Message: Jeito Capital
1:15 - Introducing BioCentury's Grand Rounds
3:53 - 2Q Markets Preview
12:48 - AACR Takeaways
15:46 - ADCs & DACs

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Upcoming catalysts could drive value creation at NASDAQ’s newest biotech, Boundless Bio, after it stumbled in its trading debut last week. On the latest BioCentury This Week podcast, BioCentury’s editors discuss Boundless’ IPO in the context of the current market for fresh paper and profile the “sweat equity” model of Avalon, the VC firm led by Jay Lichter. Turning to Washington, BioCentury’s editors assess possible outcomes for the Supreme Court case on abortion drug mifepristone, and why the court’s pending decision could safeguard FDA from judicial second-guessing. The team also analyzes the agency’s first ever complete response letter for lack of confirmatory trial enrollment.  This week’s podcast is sponsored by Jeito Capital.

View full story: https://www.biocentury.com/article/651937

0:01 - Sponsor Message: Jeito Capital
4:15 - Biotech IPOs
7:50 - Avalon BioVentures
11:14 - FDA at SCOTUS
16:29 - Confirmatory Trials

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Bills 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 lessons from Orchard Therapeutics on what it takes to get FDA’s approval for an ultrarare disease drug.
For BioCentury’s complete coverage of the Biosecure Act and similar legislation in Senate, visit the Hot Topics page for the topic

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Putting patients at center stage is at the core of John Crowley’s vision for BIO as he begins his tenure leading the biotech trade group. On the latest BioCentury This Week podcast. Washington Editor Steve Usdin details Crowley’s plans to revitalize BIO at a time when effective representation in Washington is more important than ever.
BioCentury’s editors also discuss FDA’s landmark approval of Madrigal's liver disease drug and a decision by FDA’s Oncologic Drugs Advisory Committee to support a pair of BCMA-directed CAR T cell therapies in earlier lines to treat multiple myeloma, and what’s needed to help avoid deaths during the period while patient wait for the CAR T cells to be produced.

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A congressional committee meeting last week on biotech and national security provided a glimmer of hope that lawmakers could be persuaded to consider taking steps to bolster the U.S. bioeconomy, BioCentury Washington Editor Steve Usdin explains why the at times cartoonish spectacle of lawmakers pushing anti-China biotech bills highlights the need for scientists and entrepreneurs to build relationships in Washington.
Plus: Editor in Chief Simone Fishburn argues that the future of diversity should not be bound up in the fate of DEI. And BioCentury's editors discuss the pivotal trial setback for Amylyx in ALS and what may be on FDA’s agenda as is schedules an advisory meeting for Lilly's Alzheimer's therapy donanemab.

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