Pharma Intelligence Podcasts

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年10月24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。 本期聚焦柏林欧洲医学肿瘤学会会议的新成果：Enhertu在早期乳腺癌中的应用；Padcev/Keytruda在膀胱癌领域的突破；Pluvicto的III期试验成功；Trodelvy与Datroway在乳腺癌治疗领域的较量；默克公司为乳腺癌治疗带来新希望。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EWX3A6U4TBE5NPDYXHIJSWDO3A/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 24, 2025. In this episode we focus on the most significant results presented at the European Society for Medical Oncology meeting in Berlin: Enhertu in early-stage breast cancer; Padcev/Keytruda in bladder cancer; Phase III wins for Pluvicto; Trodelvy and Datroway in breast cancer tussle; and Merck & Co. raises hopes in breast cancer. . Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EWX3A6U4TBE5NPDYXHIJSWDO3A/ 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, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs explain the reasons for the US Food and Drug Administration's planned “Simple Reform” of its inspection group, including the move away from specialized teams (:44). They also consider industry's current thinking on best practices for navigating the agency's new position on direct-to-consumer ad regulation (18:45). More On These Topics From The Pink Sheet US FDA Plans Move Back To More Generalist Inspectorate: https://insights.citeline.com/pink-sheet/compliance/us-fda-plans-move-back-to-more-generalist-inspectorate-5V3573KXHFAJXH6LVC6NSXW37M/ Industry Rethinking Visual Elements And Quality-Of-Life Claims After US FDA Drug Ad Crackdown: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/industry-rethinking-visual-elements-and-quality-of-life-claims-after-us-fda-drug-ad-crackdown-WMXPANFVC5B55GZZQ6IWJG4FRE/ US FDA Ad/Promo Crackdown Letters Came From OPDP Staff, Not Artificial Intelligence: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/us-fda-adpromo-crackdown-letters-came-from-opdp-staff-not-artificial-intelligence-RKTSXQ5ZV5BPJD4DXGAOS5SS5Q/

Biotech funding is tougher than ever, but some companies still win big. Join Claire Riches, VP, Clinical Solutions, Citeline and Alistair McDonald, CEO of Worldwide Clinical Trials as they reveal insider strategies for securing investors, navigating partnerships, and turning innovative science into real-world success. View the video series and find out more information here: https://www.citeline.com/biotech

As the potential of in vivo CAR-T therapy moves closer to clinical reality, biotech innovators are reimagining what's possible in autoimmune disease. With groundbreaking scientific advances and evolving regulatory perspectives, this next generation of cell therapy could redefine how immune-mediated conditions are treated. In this episode, Pete Robinson, Therapeutic Strategy Director, Novotech, joins Meredith Landry, Managing Editor, Custom Content, Citeline, to discuss how in vivo CAR-T is opening new possibilities for autoimmune therapies—and what it will take to translate early promise into patient impact. They explore: • The breakthrough potential of in vivo CAR-T—and what could make it a true game-changer for autoimmune disorders • Key developments and considerations to realize clinical success • Global landscape for early phase clinical trials

Hear experts Matthieu Culié and Alessandro Agosti as they discuss how Olon stands out in a competitive landscape through its fully integrated end-to-end ADC manufacturing expertise, global operations, impurity control and strategic facilities.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年10月17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: 大型药企仍看好细胞与基因疗法前景；ESMO会议关注焦点；科伦制药TROP2抗体药物偶联物创全球首例；强生预期与白宫政策保持一致；BioFuture会议揭示行业不确定性。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ADAR4VZIGRFIFCOMXI7UTZS76U/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 17, 2025. In this episode: big pharma still sees value in cell and gene therapy; what to look out for at ESMO; world first for Kelun's TROP2 ADC; J&J expects alignment with White House policies; industry uncertainties aired at BioFuture meeting. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ADAR4VZIGRFIFCOMXI7UTZS76U/ 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 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.

Listen now: Adalvo – advancing pharma with private equity and an asset-light model

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。

Audio roundup of selected biopharma industry content from Scrip over the business week ended September 12, 2025. In this episode: Novo Nordisk cuts 9,000 jobs; deals freshen up Novartis's cardio franchise; J&J's Inlexto approval; Summit's ivonescimab challenges; and FDA's DTC ad crackdown. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XQF6667ICBDMTFBCUCNYBZUJZY/ 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, 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

Dr Murali Ramachandra, CEO of Aurigene Oncology, talks to Anju Ghangurde about the tough biotech funding environment, promising pipeline assets including a CAR-T cell therapy in Phase II and ‘hybrid' manufacturing options, besides outcome-based reimbursement models. The promise of bispecifics and multispecifics in oncology, including Chinese biotech Akeso's PD-1/VEGF bispecific antibody, are some of the other topics he discussed.