Citeline Podcasts

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Managing Editor Bridget Silverman and Editor-in-Chief Nielsen Hobbs consider the US Food and Drug Administration’s average speed of a novel drug application review in 2025 (:34), including the loss of so-called “fast approvals” (5:33) and how reviewers managed to ignore the distractions caused by the changes (7:35). They also consider whether the layoffs and other departures will impact the review system in 2026 (11:16).

More On These Topics From The Pink Sheet

Average Metrics In A Turbulent Year: US FDA’s 2025 Median Review Times Match PDUFA Goals: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/average-metrics-in-a-turbulent-year-us-fdas-2025-median-review-times-match-pdufa-goals-FOEPKT27UFAHPDS36HKJFOHOQE/

It’s About Time: US FDA’s Review Speed For Novel Approvals In 2025: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/its-about-time-us-fdas-review-speed-for-novel-approvals-in-2025-6LMDCANRRZGWTIDSRKFVXCJRPY/

US FDA’s 2025 Staffing Turmoil Will Create 2026 Application Review Challenges: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-2025-staffing-turmoil-will-create-2026-application-review-challenges-AJIE7WRQ2ZFS7IOR5PA3OWFE2M/

Antti Vuolanto, CEO of Herantis Pharma, discusses the significant unmet need in Parkinson’s disease and outlines Phase II plans for the company’s lead asset HER-096.

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

「Novartis Sounds Alarm Bell On Global Trade Policy（邦訳：ノバルティスが警鐘を鳴らす　自国第一主義の貿易政策めぐり）」

Article link: https://insights.citeline.com/scrip/drug-pricing/novartis-sounds-alarm-bell-on-global-trade-policy-GRXGDPFNE5E2VNHXZMK67CYEFI/

公開書簡のURLはこちら

Open Letter: https://www.novartis.com/sites/novartis_com/files/letter-to-global-governments.pdf?utm_campaign=pharmalittle&utm_medium=email&_hsenc=p2ANqtz--ND6BAwNYOXJlpATFKTFHmMTF6pv7a_72Ft7BD6JemCR-91pUUsDLTiRGjuqtDcyqTBbMVLBh_0RmYh8063YZw3HoWfPAwsgK6z1yCvjYrBnwAY4g&_hsmi=398727134&utm_content=398727134&utm_source=hs_email

※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2026年1月16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—摩根大通弥漫乐观情绪；Scrip探析2026年资本配置与并购趋势；安永指出中国并购增长值得关注；礼来收购Ventyx引发对NLRP3抑制剂的热议；诺和诺德基金会助力欧洲初创企业。

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XE634WMH7FHA3AHR4MPJ65VOQM/

Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 16, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools.

This time – optimism reigns at J.P. Morgan; Scrip Asks what 2026 holds for capital allocation and dealmaking; EY says keep eye on China as deals grow; Lilly’s Ventyx buyout raises NLRP3 inhibitor interest; and Novo Nordisk Foundation backs Europe startups.

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XE634WMH7FHA3AHR4MPJ65VOQM/

Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

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/