Citeline Podcasts

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the reasons US Food and Drug Administration Commissioner Martin Makary could have helped negotiate the Most Favored Nation drug pricing deal with Astra Zeneca (:30) and the deal’s potential impact on the 340B program (16:35). They also consider the Justice Department’s alternative interpretation of off-label promotion regulations and the effect on the scientific exchange of information about drugs (19:16). More On These Topics From The Pink Sheet US FDA Commissioner’s Involvement In AstraZeneca Pricing Deal Raises Ethical, Legal Questions: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/us-fda-commissioners-involvement-in-astrazeneca-pricing-deal-raises-ethical-legal-questions-IJV4LMTDA5E65KCOFQUQM76GCA/ EMD Serono IVF Candidate Among First US FDA Priority Voucher Recipients As Part Of MFN Deal: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/emd-serono-ivf-candidate-among-first-us-fda-priority-voucher-recipients-as-part-of-mfn-deal-LKHA6VRTKRE6DJERGNCWCGMBF4/ Manufacturer Most Favored Nation Deals: How They Could Be Protected From 340B: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/manufacturer-most-favored-nation-deals-how-they-could-be-protected-from-340b-FALSG7GHM5GQBFN3I5SPERJIYU/ Off-Label Promotion: DOJ May Take New Look At Scientific Information Exchange: https://insights.citeline.com/pink-sheet/legalandip/litigation/off-label-promotion-doj-may-take-new-look-at-scientific-information-exchange-R62PQJFQTRBCVGCZE57GWM3Q3Q/

Adalvo: Exploring European B2B Pharma’s Next Steps by Citeline

Join host David Wild as he speaks with Stacie Bell, chief clinical research officer at Lupus Therapeutics, about the dramatic transformation happening in lupus drug development. From a field once avoided by pharma companies to one generating unprecedented excitement, Bell discusses how her organization's 62-center network is revolutionizing clinical trials through patient engagement and scientific innovation. Learn about promising oral therapies, Genentech's cancer drug Gazyva under FDA review for lupus nephritis, cell therapy approaches offering potential long-term remission and how combination treatments may become the new standard. Bell shares insights on overcoming clinical trial barriers, advancing biomarker research and ensuring representative participation from lupus communities. A must-listen for anyone interested in autoimmune disease research, clinical development innovation, and patient-centered drug development.

In Vivo spoke with Emma Johnson, CEO of Essential Pharma, to discuss the company's strategic priorities and plans for growth as it expands its portfolio in rare diseases.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年10月10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: 生物制药融资重燃乐观情绪；CAR-T疗法适应症扩大将考验医疗体系承载力；高德美在皮肤科领域表现超出预期；安进推出面向患者的Repatha直接销售计划；Datroway在乳腺癌领域取得生存期突破。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JZ326HAB2ZHB7E3Z5PNIUBITQQ/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 10, 2025. In this episode: biopharma financing regaining optimism; larger CAR-T indications to strain healthcare capacity; Galderma punching above weight in dermatology; Amgen’s direct-to-patient Repatha program; and Datroway’s survival success in breast cancer. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JZ326HAB2ZHB7E3Z5PNIUBITQQ/ 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

Cereno Scientific CEO Sten Sörensen discusses how his company is repurposing a 60-year-old epilepsy drug as a potential game-changer for pulmonary arterial hypertension and idiopathic pulmonary fibrosis. Learn about their promising Phase IIa results that showed improved heart function and reduced mortality risk, the FDA fast track designation they recently received, and their strategy for advancing two rare disease programs toward pivotal trials. A fascinating look at drug repurposing, epigenetic modulation, and the challenges of developing therapies for high unmet need patient populations.

Listen now as Citeline speaks with top executives from Perceptive to understand eClinical’s major reset and what it means for the future of clinical trials. Learn more about IRT’s evolving role, lessons learned, and how tech will rule the data-driven trials of the future.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年10月3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: 辉瑞暗箱操作美国定价协议；日本药品关税政策引发争议；美国直供患者计划持续扩张；诺华瑞美布替尼获首次批准；葛兰素史克首席执行官即将卸任。 https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-NYTAMV4KPFCB3PSCCQMKIF2CEA/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Celebrating Europe’s Consumer Health Best Practice, With AESGP’s Luis Rhodes Baiao The Association of the European Self-Care Industry, or AESGP, has launched a digital platform that brings together inspiring self-care initiatives from across Europe. Launched to coincide with International Self-Care Day 2025, AESGP’s Self-Care Insight and Inspire platform showcases national-level initiatives led or supported by the consumer health industry in collaboration with healthcare professionals, sectoral associations, and public authorities. In this episode of the Over the Counter podcast, AESGP governmental and public affairs manager, Luis Rhodes Baiao, tells HBW Insight about the background behind the platform and pulls out some of his favourite examples. Timestamps 2:00 – Introductions 5:15 – AESGP’s Self-Care Insight and Inspire platform 14:30 – Luis’s favourite examples 17:30 – Public reaction to the campaign 18:50 – Next steps 20:30 – How to get involved Guest Bio Luis Rhodes Baiao is governmental and public affairs Manager at AESGP. Before, he was policy advisor to a Portuguese Member of the European Parliament on the Committee for Environment, Public Health and Food Safety (ENVI), during the mandate 2014 to 2019. He is currently also vice-president of the General Assembly of the Association Public Affairs Portugal (PAPT).

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 3, 2025. In this episode: Pfizer’s backroom US pricing deal; confusion over Japan’s pharma tariffs; more direct-to-patient schemes in the US; first approval for Novartis’s remibrutinib; and GSK’s CEO to step down. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-NYTAMV4KPFCB3PSCCQMKIF2CEA/ 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 editors Sue Sutter and Cathy Kelly consider the impact of the government shutdown on the US Food and Drug Administration, as well as industry (:21), and discuss the future of drug pricing after Pfizer completes its deal with the White House to embrace its Most Favored Nation plan (10:29). More On These Topics From The Pink Sheet Shutdown Approaches: US FDA Would Retain Most Of Recently Trimmed Staff: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/shutdown-approaches-us-fda-would-retain-most-of-recently-trimmed-staff-DTVAHLBI5VGZBPHD76TLNDIBGU/ Shutdown Day One: US FDA Hiring, MFN Demos Delayed?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/shutdown-day-one-us-fda-hiring-mfn-demos-delayed-7LGCITF2WVCJNEVUTWZV5MOZSE/ Closing The Gap? Pfizer Will Set Same US, Foreign Launch Prices In MFN Deal: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/closing-the-gap-pfizer-will-set-same-us-foreign-launch-prices-in-mfn-deal-ZRSNU56KTFGRBBX4Y5OJKLFV6Y/ Questions Persist About How Pfizer’s US Agreement Lowers Prices: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/questions-persist-about-how-pfizers-us-agreement-lowers-prices-T2TEWMKVMVHGJHPXDKIFDF2GWA/

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年9月26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：辉瑞通过收购Metsera重返肥胖治疗领域；罗氏勾勒肥胖治疗战略蓝图；UniQure公司亨廷顿病基因疗法取得积极进展；百时美施贵宝计划在英国采用美国定价策略推广Cobenfy；疫苗质疑情绪影响商业化前景。 https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HCVAK32IGREDHMH5D4I3RFY6AA/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended September 26, 2025. In this episode: Pfizer jumps back into obesity with Metsera bid; Roche maps out its obesity ambitions; UniQure’s encouraging gene therapy results for Huntington’s; BMS plans US pricing for Cobenfy in the UK; and vaccine skepticism affects vaccine commercial prospects. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HCVAK32IGREDHMH5D4I3RFY6AA/ 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

Generics Bulletin editor Dave Wallace talks to John Murphy III, president and CEO of the US Association for Accessible Medicines, about the association's latest annual savings report and key topics affecting the US off-patent market.

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 「EFPIA Rallies EU To Shield Innovative Drugs After US Tariff Cap Is Confirmed（邦訳：欧州製薬団体、医薬品への米国関税適用に反発　EUへ対策を要請）」 URL:　 https://insights.citeline.com/pink-sheet/compliance/manufacturing/efpia-rallies-eu-to-shield-innovative-drugs-after-us-tariff-cap-is-confirmed-HYZJDK4S7NGT3FUEBA5AFSYYT4/ Playlist: soundcloud.com/citelinesounds/sets/japanese-language-mini

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年9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。 本期内容——GSK在特朗普访英期间宣布美国投资计划； 礼来公司对英国实验室投资三思而后行；解析中国研发与并购热潮；再生元CEO谈被忽视的重磅产品；阿斯利康COPD试验受挫。 https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-D4VJFG2XNJGAJEFGSXNEQUA3BU/ China Webinar sign up: https://www.citeline.com/en/events/china-transforming-pharma Playlist: https://on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended September 19, 2025. In this episode: GSK announces US investments during Trump’s UK visit; Lilly thinks twice about UK lab investment; analyzing the rise in China R&D and deals; Regeneron CEO on his company’s ignored blockbusters; and AstraZeneca’s COPD trial failure. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-D4VJFG2XNJGAJEFGSXNEQUA3BU/ Sign up for China R&D webinar: https://www.citeline.com/en/events/china-transforming-pharma 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

Hear from ICROM CEO Pierfrancesco Morosini and HOLODIAG GM Pierric Marchand as they discuss how the company is advancing HPAPI development, solid-state science, and flexible CDMO services. Topics include OEB5/6 capabilities, a new kilo-scale unit, and the impact of electron diffraction on drug development.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年9月12日当周的生物制药行业的商业动态。 本期要闻——诺和诺德裁员9000人；诺华心脏病业务板块交易焕新； 强生Inlexto获批；Summit公司ivonescimab面临挑战；FDA严打直接面向消费者广告。 https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XQF6667ICBDMTFBCUCNYBZUJZY/ 本期节目采用人工智能文本转语音及语音仿真技术制作。