Citeline Podcasts

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs look at the potential consequences of the US Food and Drug Administration’s upcoming crack down on direct-to-consumer advertising (:30), including the first publicly released letter, which went to AstraZeneca for a Flumist TV commercial (2:50), as well as vaccine policy and other major issues that were listed in the Make America Healthy Again Commission’s Strategy Report (21:45). More On These Topics From The Pink Sheet Direct-To-Consumer Ads: Manufacturers Face ‘Cease And Desist’ Orders Now, Uncertain Future: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/direct-to-consumer-ads-manufacturers-face-cease-and-desist-orders-now-uncertain-future-6XLXAWS7WJBYNPHSBRAQVTBARU/ Limited Detail In MAHA Strategy Report Could Catch Pharma Off Guard: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/limited-detail-in-maha-strategy-report-could-catch-pharma-off-guard-TVL7CCBQONA7PHCLUDJ7WTEJC4/

What makes a biotech-CRO partnership truly work? Claire Riches, VP, Clinical Solutions, Citeline, and Matt Simmons, Senior Director, Oncology Strategy, IQVIA Biotech, share the secrets behind winning biotech-CRO partnerships, covering collaboration, transparent budgeting, regulatory navigation, and recruitment strategies, with essential insights to help biotechs succeed from their first RFP to global trials. View the video series and find out more information here: https://www.citeline.com/biotech

Community based trials are reshaping clinical research, broadening patient access and accelerating timelines. Discover the drivers, challenges and future outlook.

In Vivo spoke with Annette Bakker, CEO of the Children’s Tumor Foundation, a medical research foundation developing an innovative approach to reviving shelved pharmaceutical assets, resulting in the recent US FDA approval of mirdametinib, a treatment for rare tumors.

Audio roundup of selected biopharma industry content from Scrip over the business week ended September 5, 2025. In this episode: the US MASH market after Wegovy’s approval; AstraZeneca and Mineralys in close hypertension race; United Therapeutics’ Phase III win in IPF; Corsera aims to predict and prevent cardiovascular disease; and Ionis’s RNA-targeted win in severe hypertriglyceridemia. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RKP4E4CFGFGGXBRVXTI73V27U4/ 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

For today’s consumers, sustainability is an expectation rather than a luxury, according to PA Consulting’s latest Brand Impact Index. In other words, companies that haven’t invested in minimizing their brands’ impact on the environment are at risk of being left behind. “But it’s ok to get it wrong sometimes too,” notes PA’s personalization and consumer expert, Rhea Patten, in this episode of HBW Insight’s Over the Counter podcast. And maybe for smaller brands, being a staller rather than a shaper may also make strategic, short-term sense, as long as consumers can understand that sustainability is their long-term goal. Don’t mis the first part of this interview with Patten, in which we discussed, among other things, what “vibes” are and how understanding this aspect of “consumer centricity” better can help consumer health companies grow their brands. Timestamps 2:00 – Do consumers still want sustainable brands? 8:00 – Will consumers forgive sustainability missteps? 10:00 – Will consumers pay more for sustainable brands? 13:00 – Is better to be a sustainability shaper or staller? 15:30 – Final thoughts Guest Bio Rhea Patten is a consumer product expert at PA Consulting, with expertise in health, beauty, and wellness. She has over 20 years’ experience in leading innovation and transformation projects in the consumer products and retail sector. Passionate about bridging physical products with digital experiences, Patten helps leaders deliver solutions that drive business growth. She specializes in accelerating product innovation, with a focus on strategy, customer-centricity, and sustainability.

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the ongoing impact of the US Food and Drug Administration decision to drop vaccine expert Paul Offit and others from its advisory committee rosters (:32), as well as the substantial new detail in the latest batch of complete response letters for unapproved products that the agency released (12:47). More On These Topics From The Pink Sheet Offit’s VRBPAC Departure Raises Questions About Another HHS Panel Revamp: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-paul-offit-no-longer-member-of-us-fdas-vaccine-advisory-panel-WX3X3CIP6VCARJ7BPLXNQIQ2BQ/ US FDA Compounding Advisory Panel Hit Hardest By Recent Purges: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-compounding-advisory-panel-hit-hardest-by-recent-purges-OXBD4IXGFZCIDIMB6VXSOSVP6U/ 89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/89-complete-response-letters-one-huge-leap-for-us-fda-transparency-for-unapproved-drugs-SLYA5LADMNDY3LKZ5TRUAWRRAU/

In this episode of the China Biopharma English-language Podcast, Shanghai-based senior reporter Xu Hu talks about the release for the first time by China’s National Healthcare Security Administration in August of a preliminary list of innovative drugs reimbursed by commercial insurance and the key reasons that have driven this reform. Related story links: https://insights.citeline.com/pink-sheet/geography/asia/china/china-signals-commercial-insurance-biotech-and-foreign-owned-hospitals-as-policy-priorities-6WABWKHO3VCRHNSCOXGABSHTZE/ https://insights.citeline.com/pink-sheet/market-access/government-payers/china-unveils-multiple-policies-to-support-innovative-drugs-throughout-life-cycle-JFEHXBAS2ND3PGJYKOF7NB6ZCM/ https://insights.citeline.com/pink-sheet/geography/asia/china/china-signals-commercial-insurance-biotech-and-foreign-owned-hospitals-as-policy-priorities-6WABWKHO3VCRHNSCOXGABSHTZE/

Audio roundup of selected biopharma industry content from Scrip over the business week ended August 29, 2025. In this episode: Lilly’s orforglipron strong in diabetic obesity; Ascletis confident in oral GLP-1 challenger; myostatin drugs progress for obesity; an interview with OneSource’s CEO; and an analysis of Dupixent’s pipeline-in-a-product success. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-KKZ7ZW3B2VGUBFTSLNCLIHU7QU/ 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

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss the impact of US Food and Drug Administration’s COVID-19 vaccine indication changes and recission of the associated emergency use authorizations, as well as the postmarketing studies that now are required (:40), and their potential impact on access and reimbursement (12:20). More On These Topics From The Pink Sheet COVID-19 Vaccines: Pfizer Arguments To Keep EUA Failed To Persuade US FDA’s Prasad: https://insights.citeline.com/pink-sheet/vaccines/covid-19-vaccines-pfizer-arguments-to-keep-eua-failed-to-persuade-us-fdas-prasad-V3X2OEBZE5HRHKO7KMMCFXBM2Q/ US FDA Updates COVID-19 Vaccine Formulations, Revokes EUAs, ACIP Use Decision Next: https://insights.citeline.com/pink-sheet/vaccines/us-fda-updates-covid-19-vaccine-formulations-revokes-euas-acip-use-decision-next-VBXJDSOA6BCOXNCA2TAH27EBJY/ A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions: https://insights.citeline.com/pink-sheet/vaccines/a-us-fda-move-to-revoke-pfizers-pediatric-covid-19-vaccine-eua-could-raise-supply-questions-ZX26DBENHFCOHPBGMPFPQB6REQ/ Changes In Pediatric COVID-19 Vaccine Recommendations Causing Coverage Confusion: https://insights.citeline.com/pink-sheet/vaccines/changes-in-pediatric-covid-19-vaccine-recommendations-causing-coverage-confusion-WDEYUVJXGBCGBEVBQ2I6INH554/

As global regulatory expectations evolve, biotech sponsors face growing pressure to make smarter, earlier decisions about where and how to run their trials. In this episode, Novotech experts Renita Hite (Director of Regulatory Affairs, Drug Development Consulting) and Scott Schliebner (Global Head of Drug Development Consulting) join moderator Meredith Landry to discuss how early-stage sponsors can adapt to shifting FDA initiatives, accelerated global pathways, and increasing demands for regulatory flexibility. They explore: How new FDA initiatives—like AI-driven reviews, user fee changes, and the National Priority Voucher—are reshaping IND strategy Why sponsors should design trials with global data packages in mind from day one Accelerated and early access pathways that can speed startup and market entry How CROs are evolving to help sponsors prioritize markets and build regulatory flexibility If you’re planning trials for 2025 and beyond, this conversation will help you prepare for what’s next—and position your program for long-term success. About This Episode This episode is the final installment (4 of 4) in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Catch up on earlier episodes: [Part 1: Navigating Regulatory Changes & Market Dynamics] [Part 2: Navigating Regulatory & Market Shifts] [Part 3: Navigating Regulatory Changes & Market Dynamics]

전통적 벤처캐피털이 점점 더 신중하고 선별적인 투자 성향으로 변하면서 바이오 기업들이 새로운 자본 조달 경로를 모색하고 있다는 Citeline의 In Vivo 기사를 요약한 내용입니다. https://insights.citeline.com/in-vivo/growth/when-vc-steps-back-finding-alternative-biotech-funding-4UN5IYJEUZD2XPLYIZ7RR7YVQY/ Playlist: https://soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

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 「China NHSA Releases Preliminary Innovative Drug List For First Time（邦訳：中国国家医療保障局、初の画期的医薬品向け償還“候補”リストを発表）」 URL: https://insights.citeline.com/pink-sheet/geography/asia/china/china-nhsa-releases-preliminary-innovative-drug-list-for-first-time-JOSACB66CZA6BOZNDEGFTLLWSU/ ※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 Playlist: https://soundcloud.com/citelinesounds/sets/japanese-language-mini

Despite the recent pressure on their finances, consumers are rejecting the idea of choosing brands based on cost alone, according to PA Consulting’s latest Brand Impact Index. People are prepared to pay more for brands they “vibe” with, PA suggests. But what are vibes? And how can consumer health companies tap into them? As PA personalisation and consumer expert Rhea Patten explains in this episode of HBW Insight’s Over the Counter podcast, vibing with consumers means making them feel special, seen and heard, and creating communities around their needs. Timestamps: 2:00 – Introductions 3:00 – The Brand Impact Index 4:30 – This year’s headline findings 6:30 – What OTC firms can learn from leading beauty and wellness brands 17:00 – What are “vibes”? 25:00 – How to build a brand community Guest Bio: Rhea Patten is a consumer product expert at PA Consulting, with expertise in health, beauty, and wellness. She has over 20 years’ experience in leading innovation and transformation projects in the consumer products and retail sector. Passionate about bridging physical products with digital experiences, Patten helps leaders deliver solutions that drive business growth. She specialises in accelerating product innovation, with a focus on strategy, customer-centricity, and sustainability.

Audio roundup of selected biopharma industry content from Scrip over the business week ended August 22, 2025. In this episode: Madrigal regains MASH lead with EU Rezdiffra approval; Viking’s obesity data scare investors; China assets lead GLP-1 deals; CSL and others restructure; and Indegene exec on DTP and MFN policies. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T77LV22VANAL5GNPCC2YUVLZBE/ 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

Merck KGaA's Emre Ozcan outlines the company's systematic approach to integrating digital solutions across the care continuum in specialty pharmaceuticals, moving from technology-first to patient-need-first strategies.

Tevard Biosciences CEO Daniel Fischer discusses how engineered suppressor tRNAs enable read-through of premature stop codons to restore full-length protein production in genetic diseases. Fischer, whose daughter has Dravet syndrome, covers the company's lead programs in dilated cardiomyopathy and DMD, advantages over traditional gene therapy approaches, and the path to human proof-of-concept.

Audio roundup of selected biopharma industry content from Scrip over the business week ended August 15, 2025. In this episode: a look at the likely top drugs in 2030; Lilly CEO advocates US/Europe pricing rebalance; Insmed sees $5bn-plus market for Brinsupri; royalty deals go mainstream; Phase III win sets stage for Epkinly label expansion. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-365OXHOS2RFXHPEDQIURY6LFDI/ 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

Audio roundup of selected biopharma industry content from Scrip over the business week ended August 8, 2025. In this episode: Trump ups pressure on MFN pricing; Pfizer says pharma working with Trump on direct sales; Sanofi says direct sales worth considering: Aurigene Oncology CEO on biotech valuations and more; and Novartis progresses pipeline-in-a-product assets. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RCXSH2B5EVCC3IIK35GXUSNZVA/ 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

It’s been about three years since Haleon became a standalone self-care company. Since then, the firm has announced an ambitious plan to reach one billion more consumers by 2030. In this episode of HBW Insight’s Over the Counter podcast, we catch up with Haleon’s new UK & Ireland general manager Jo Cooper to find out what that means in practice when translated to the firm’s home market. Empowering pharmacists is key to Cooper’s local plans, as is exploring the opportunities suggested by the UK government’s recently published list of Rx-to-OTC switches it would like to see applications for. Timestamps 2:00 – Introductions 4:00 – Becoming consumer focused 10:00 – Attracting talent into consumer health 13:00 – Translating Haleon’s ambitious global growth strategy to a local context 25:00 – The importance of pharmacy 30:00 – Rx-to-OTC switch and Haleon’s R&D strategy 38:00 – Unpacking Haleon’s “strategic category realignment