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

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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

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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

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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

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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 [email protected].

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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 [email protected].

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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 [email protected].

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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

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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

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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 [email protected].

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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 [email protected].

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