Citeline Podcasts

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs consider the many concerns Richard Pazdur and others raised about the US Food and Drug Administration’s Commissioner’s National Priority Voucher Program (CNPV) (:37), including potential legal issues (10:35), as well as the possibility of releasing the full action package for an unapproved application, given the resources that likely would be required (18:16). More On These Topics From The Pink Sheet Commissioner’s National Priority Voucher Program Reflects US FDA Review Politicization, Pazdur Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/commissioners-national-priority-voucher-program-reflects-us-fda-review-politicization-pazdur-says-A43CKFRDVBHTLESE6IQE6JXLGM/ US FDA Gauging Impact, Resource Use In Commissioner’s Voucher Pilot As Concerns Grow: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-gauging-impact-resource-use-in-commissioners-voucher-pilot-as-concerns-grow-7WQB3TOQERGXJPAIV5465GOBLM/ With Unapproved Drug Complete Response Letters Now Public, Are Action Packages Next?: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/with-unapproved-drug-complete-response-letters-now-public-are-action-packages-next-S4Y5ANUYE5DOTC7YVTALA3GPIE/

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年1月9日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本期要闻—口服版Wegovy在美国上市； 2025年中盘股最大催化剂；去年小盘股转型与僵尸股清算；去年上市新药面临的商业逆风；以及中国企业全球三期临床动态。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ZV4GVVROYBEN7I6DQBOMQ3A3XE/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip의 2026년 글로벌 제약바이오 산업 전망 (1부: 자본배분과 딜메이킹)을 요약한내용입니다. https://insights.citeline.com/scrip/scrip-asks/scrip-asks-what-does-2026-hold-for-biopharma-part-1-capital-allocation-and-dealmaking-U3B4EUN3GZGNXM6QI3ZGXVMNZY/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 9, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – oral Wegovy launches in the US; the biggest mid-cap catalysts in 2025; small cap pivots and zombie killers last year; commercial headwinds for last year’s launches; and a look at Chinese firms’ global Phase III activity. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ZV4GVVROYBEN7I6DQBOMQ3A3XE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

PreVision Policy Founding Member Michael McCaughan joins Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs to discuss the career and legacy of Richard Pazdur, the long-time head of the US Food and Drug Administration’s oncology drug review division and Oncology Center of Excellence. They consider his brief stint as Center for Drug Evaluation and Research director and decision to retire (:55), his impact on oncology (4:36), as well as reflect on his famous “Pazdur Moments” (18:41), the future of legacy programs like Project Orbis (28:52), and whether the FDA can find another leader like him (33:54). More On These Topics From The Pink Sheet US FDA’s Richard Pazdur: Appreciating An Extraordinary Career: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-richard-pazdur-appreciating-an-extraordinary-career-YD2GBQ7WOZHM5BNAKWJF4OQVFM/ Modernizing Accelerated Approval: One Of Pazdur’s Biggest Legacies: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/modernizing-accelerated-approval-one-of-pazdurs-biggest-legacies-4QPXDRZ7SNBE7EUOG5VWWILGDY/

Intranasal vaccines are back in the spotlight as highly pathogenic avian influenza spreads among birds and spills over into mammals, including recent cases in dairy and poultry workers. In this episode of In Vivo, senior pharma and biotech reporter David Wild talks with Chad Costley, CEO of BlueWillow Biologics and Meagan Deming, an infectious disease researcher at the University of Maryland School of Medicine about a novel intranasal recombinant H5 flu vaccine that aims to stop infection at the gate by building mucosal immunity in the nose. They discuss recent Phase I data, pandemic‑flu preparedness, BARDA/NIH funding realities, and how BlueWillow's NanoVax platform could extend to other major respiratory threats, including TB.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年12月19日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本期要闻——再生元夹在成功与专利到期之间；第三季度十大畅销药物；礼来Retatrutide重塑减重标准；辉瑞坚守疫苗投资；赛诺菲在托布替尼困境中仍保持乐观。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XA4W4OYCVRCSNHW5ZL7TUFJF2U/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended December 19, 2025. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Regeneron caught between success and expiry; Q3’s top 10 drugs; Lilly’s Retatrutide Raises Weight-Loss Bar; Pfizer stands by vaccines investment; and Sanofi Upbeat Despite Tolebrutinib Tribulations. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XA4W4OYCVRCSNHW5ZL7TUFJF2U/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Matthew Wood, director and chief scientific officer at Oxford-Harrington Rare Disease Center, discusses the state of rare disease R&D, the evolving landscape of genomics and genetic therapies, and the challenges around the biopharma industry’s narrow focus on only 5-10% of rare diseases.

This podcast brings you highlights from Scrip Awards 2025, including wins for AstraZeneca, Syndax, Akeso and Summit Therapeutics and the Lifetime Achievement Award for Flagship Pioneering's Noubar Afeyan.

Emma Wille and Summer Colling speak with ophthalmology expert, Joseph Jacob, to discuss the latest developments in dry age-related macular degeneration (dry AMD), including current treatments, emerging therapies, regulatory challenges, and the unmet needs shaping the future of patient care.

Scrip senior writer Joseph Haas and PwC analyst Roel Van den Akker look back on biopharma sector dealmaking in 2025, why deal values rose from 2024's lows, and look ahead to what the trends mean heading into 2026 in this latest edition of the Scrip M&A Podcast.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年12月12日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本期聚焦美国血液学会（ASH）会议五大关键成果：Jaypirca有望成为一线疗法；Kite公司Anito-cel在多发性骨髓瘤领域的进展；新一代CAR-T疗法；Kelownia公司CAR-T疗法的早期体内数据；以及诺华公司ianalumab在ITP治疗中的潜力。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RFOOY2665REEZEN5SMJ2GW27EY/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended December 12, 2025. This week, a focus on five key results from the American Society of Hematology (ASH) meeting – Jaypirca headed for the front line; Kite’s Anito-cel in multiple myeloma; next-generation CAR-T approaches; Kelownia’s early in vivo CAR-T data; and Novartis’s ianalumab’s potential in ITP. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RFOOY2665REEZEN5SMJ2GW27EY/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年12月5日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本次要闻: 特朗普在英国药品定价谈判中获胜；诺和诺德阐释司美格鲁肽治疗阿尔茨海默病的依据；强生与诺华达成年度最大并购交易；CAR-T疗法成效参差分析；阿克索制药的伊沃尼西马布后续目标。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-UZSVLBBSQRAKNJC7GDZWILMAT4/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended December 5, 2025. In this episode: Trump’s UK drug pricing win; Novo explains semaglutide Alzheimer's rationale; J&J and Novartis on this year’s biggest M&A deals; a look at the mixed performance of CAR-Ts; and Akeso’s goals beyond ivonescimab. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-UZSVLBBSQRAKNJC7GDZWILMAT4/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug resistance derails even the most advanced cancer treatments, but what if we could restore sensitivity to existing therapies instead of starting over? Neil Bhowmick, chief scientific officer at Kairos Pharma, joins In Vivo to discuss how his company is tackling resistance in oncology. We explore the company's lead asset, ENV-105, which is showing over 13 months of progression-free survival in Phase II prostate cancer trials by resensitizing tumors to hormone therapy, with significantly lower toxicity than standard alternatives like chemotherapy or radiopharmaceuticals. Bhowmick explains the complex biology behind different resistance mechanisms, shares early data on GITR-modulating therapies designed to expand T cell populations for immunotherapy, and discusses their approach to developing companion biomarkers for patient selection. We also dive into the clinical and commercial rationale for combination approaches and what milestones to watch in the coming year.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs break down the pending retirement of Center for Drug Evaluation and Research Director Richard Pazdur and appointment of Tracy Beth Høeg as the interim replacement (4:51), including the potential impact on sponsors (15:46). They also discuss whether Høeg will take time to learn CDER operations before making changes (19:38), as well as the possibility of yet another CDER director being hired in the coming weeks or months (23:18). More On These Topics From The Pink Sheet US FDA Faces Another Leadership Crisis As Drugs Center Director Richard Pazdur Retires: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-us-fda-cder-director-richard-pazdur-retiring-SUPZZ4JEQ5GVHEEH4RPDLCNIBY/ Tracy Beth Høeg Named New Acting US FDA CDER Director: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tracy-beth-hoeg-named-new-acting-us-fda-cder-director-3AYJZJAMBVG6HNPX3FJ7IBCDHQ/ US FDA Sending Pazdur Back To Oncology Office: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-sending-pazdur-back-to-oncology-office-KVBDIDT2RVF4JAZ7FCZHN46XXU/

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 今回取り上げた記事はこちら 「The Rise of China Biopharma – Five Themes In 2025（邦訳：中国バイオファーマの勃興　2025年注目のテーマ5つとは）」 URL: https://insights.citeline.com/scrip/r-and-d/clinical-trials/the-rise-of-china-biopharma-five-themes-in-2025-GEB2XLG3CNDONIO5HE4S2FZOVI/ ※全文の閲覧には購読（有料）が必要です。 世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年11月28日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本次要闻: 2027年医保降价幅度或低于CMS预期；赛尔安泰在DLL3肺癌ADC竞赛中领先；强生抗tau阿尔茨海默病药物posdinemab二期试验失败；拜耳阿苏德克赛安三期中风试验意外获胜；辉瑞/安斯泰来Padcev膀胱癌研究首获重大突破。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-R4RCDF2RXVGVHPEX2WQ7A3JVKU/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX