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Join Scrip editors Mandy Jackson and Mary Jo Laffler and Pink Sheet editor Sarah Karlin-Smith as they discuss the general mood at the recent BIO International Convention in Boston and around the current US economic and biopharma policy environment in general, along with other key topics at BIO including vaccines, deal and financing and the rise of China's innovation. https://insights.citeline.com/scrip/conferences/bio/post-bio-podcast-thoughts-from-the-frontlines-ID7TBPASUFG4HKFSH56TK44DUM/ https://insights.citeline.com/pink-sheet/conferences/bio/post-bio-podcast-thoughts-from-the-frontlines-VGDKPJ2QQRBV5B6TY36ROPKE4Q/ Time stamps (0:45) Economic and policy environment in the US (2:50) BIO leadership surprisingly open about the industry's challenges, and willingness to call out Trump government (4:20) Most-favored nation policy proposal: storm in a teacup or existential threat (7:57) DTC sales: new opportunities to sidestep middlemen? GLP-1s leading the way (10:52) Impact of FDA staff cuts and changes on regulatory practices and policy, and on biopharma companies (16:47) Reaction of vaccine companies, health providers, insurers and other stakeholders to ACIP panel dismissal and policy uncertainty (22:27) Climate for biopharma dealmaking and financing; demand for assets (27:28) Advice for startups in challenging times (29:49) China's biopharma industry in the ascendant (33:27) Rare diseases policy, regulation and industry focus (38:15) Priorities for BIO
The FDA's Diversity Action Plan guidance underwent several changes in recent months—with the draft guidance taken down, restored, and then pulled again—creating uncertainty for sponsors planning Phase III and pivotal trials across all therapeutic areas. With the final guidance expected by June 26, CRO regulatory leaders reflected on how companies can manage this evolving environment. They explored: The impact of the FDA's changing Diversity Action Plan guidance on sponsors' trial planning How companies adapted strategies to maintain inclusivity goals amid shifting regulatory priorities Broader implications for trial design, pipeline strategies, and sponsor approaches in the global drug development landscape This episode is part 2 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. Stay tuned for the next episode, where we'll continue exploring the key forces shaping the future of clinical trials. Listen to part 1 here: https://insights.citeline.com/scrip/partnered-content/podcast-series-navigating-regulatory-changes-market-dynamics-cro-perspectives-on-the-future-of-clinical-trials-26Q4Q35N6BHTZGLHIKHK6V2NXY/
The race for new therapies is more intense than ever. This episode uncovers how biotech and pharma use competitive intelligence, AI, and data to outsmart rivals and change the game. Small Biotechs, Big Decisions is a limited podcast series exploring the challenges and opportunities facing emerging biotech companies, hosted by Daniel Chancellor, VP of Thought Leadership at Norstella, and Claire Riches, VP of Clinical Solutions at Citeline, a leading provider of life sciences data and insights. View the video series and find out more information here: https://www.citeline.com/biotech
Audio roundup of selected biopharma industry content from Scrip over the business week ended June 20, 2025. In this episode: US policies in spotlight at BIO; Lilly's Verve acquisition; UroGen's bladder cancer approval; Ireland's biopharma talent; and Korea proposes new AI R&D project. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-VYWYRS37HJH6HNRZJHNGCWVSNM/ 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
관세와 무역 장벽의 출현, 정책 변화 등으로 올해 유럽 바이오기업들의 자금조달이 쉽지 않은 상황이라는 In Vivo 기사를 요약한 내용입니다. https://insights.citeline.com/in-vivo/market-intelligence/the-360-degrees-of-european-biotech-financing-in-2025-KZUNCOS3GZAYLBPGFTLJUBY7SY/ Join Seoul-based Scrip and Pink Sheet editor Jung Won Shin in this Korean-language mini podcast on recent biopharma industry topics. Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini
Devika Wood, CEO of Brain+, explains the importance of developing health tech solutions for dementia and the growing need to both raise awareness and improve overall access to nondrug interventions like CST.
The European Commission has put forward a series of proposals designed to simplify European Union sustainability rules and boost the region's competitiveness. As a result, application dates for EU due diligence and sustainability reporting requirements have been delayed by two years. Other proposals such as reducing the frequency of reporting and narrowing the scope of supply chains are still subject to trilogue negotiation. In the first of two Over the Counter episodes, CEN Group director Jasper Crone returns to the podcast to explain what might change, where he thinks this is all coming from and why companies should consider getting ready for new sustainability reporting rules even if they are no longer directly affected. Timestamps: 2:00 – Introductions 4:30 – EU sustainability reporting regulation recap 7:20 – Omnibus simplification package 12:00 – Simplification, or confusion? 19:00 – Where's this all coming from? 23:30 – Why sustainability reporting is still good for business 25:40 – What's all this got to do with competitiveness? Guest Bio: Jasper Crone is a Director at CEN-ESG, a corporate sustainability consultancy which helps businesses maximise their corporate sustainability potential, improving performance and ESG disclosure. Crone leads on several client teams, covering the implementation of internal controls and sustainability data, setting sustainability and net zero targets and developing programmes for implementation and operationalisation of objectives. He is experienced in sustainability reporting and the CEN-ESG assists clients with all aspects of sustainability reporting, whether regulatory, investor or customer driven. He brings a range of skills from 20 years of experience in the financial markets, in both the investment banking and investment management industries. He has a BSc in Biology from University of Bristol and is a CFA charter holder. You can contact Jasper via email: jasper@cen-esg.com
Audio roundup of selected biopharma industry content from Scrip over the business week ended 13 June 2025. In this episode: breaking down big pharma's executive pay; US vaccine panel upheaval; Merck's RSV approval; MFN and Japan; and the future of Pfizer and Arvinas's partnership. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-BC44NPMNMNGMXP5X4STR4ZAFU4/ 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 Francesca Bruce, Senior Editor Cathy Kelly and Editor-in-Chief Nielsen Hobbs consider European officials' opinions of President Trump's Most Favored Nation drug pricing proposal (:29), the uncertainty the plan has created and could create for the pharmaceutical industry (22:48), as well as its potential impact on the both sides of the Atlantic Ocean (27:42). More On These Topics From The Pink Sheet ‘Brainless' US MFN Policy Could Drive Pharma Investment To Europe: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/brainless-us-mfn-policy-could-drive-pharma-investment-to-europe-Z3FC7WBPKNF2LLG4YVZK3RBDUA/ US ‘Most Favored Nation' Pricing Could be Game Changer for Drug Access In Germany: https://insights.citeline.com/pink-sheet/geography/europe/us-most-favored-nation-pricing-could-be-game-changer-for-drug-access-in-germany-XFXD72XUSBE7VNLRMRSRQQGU5Q/ US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine': https://insights.citeline.com/pink-sheet/geography/europe/us-most-favored-nations-policy-higher-drug-spending-in-germany-is-difficult-to-imagine-QYQGDAMNH5A3HK4YWHUYFJCWME/ Could EU Collective Procurement Counter US Most Favored Nation Policy?: https://insights.citeline.com/pink-sheet/could-eu-collective-procurement-counter-us-most-favored-nation-policy-WPQOHPWQ3NF55NYDKT5KMU7AEY/ US ‘Most Favored Nations' Drug Pricing Policy Will Jeopardize Innovation In Europe: https://insights.citeline.com/pink-sheet/us-most-favored-nations-drug-pricing-policy-will-jeopardize-innovation-in-europe-TR52C5V6GVDSJBOTCEJ7T74FB4/ New Pricing Agreements And Greater Transparency: What A US MFN Policy Could Mean For France: https://insights.citeline.com/pink-sheet/risk-sharing-agreements-greater-transparency-in-pricing-what-us-most-favored-nations-policy-could-OYEHJIF6LJCQZDL6VJHATV77JA/ Crisis Or Opportunity? US MFN Policy Could Test Japan's Appetite For Reforms: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/crisis-or-opportunity-us-mfn-policy-could-test-japans-appetite-for-reforms-3OTVRHXSOFFIJARSNHPWZ7SBJ4/
The 14 July entry deadline for the Citeline Japan Awards 2025 in Tokyo on 21 October is fast approaching! Join Ian Haydock and Lisa Takagi in this bilingual mini podcast as they outline the event and the various Award categories. (Japanese starts at 2:20.) More information on categories, entry criteria, table bookings and sponsorship opportunities here: English: https://www.citeline.com/en/awards/citelinejapanawards) Japanese: https://www.citeline.com/ja-jp/awards/citelinejapanawards)
With FDA bottlenecks growing, biotech is looking beyond borders. In this final episode, we explore how companies are rethinking trials, embracing real-world data, and building a new path to approval.
The race for new therapies is more intense than ever. This episode uncovers how biotech and pharma use intelligence, AI, and data to outsmart rivals and change the game.
In a tough market, biotech is racing to change the rules. This episode reveals how AI, real-world data, and strategic partnerships are reshaping drug development. Is reinvention biotech's last hope?
In this first episode of the series, small biotech companies are facing tough times, shrinking funding and uncertain futures. But beneath the surface, quiet forces of innovation and resilience are rising. We explore how these sparks of hope might just light the way to a new breakthrough.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 6 June 2025. In this episode: Sanofi's Blueprint buy; AstraZeneca's breast cancer resistance results at ASCO; BMS and BioNTech's big bispecific deal; Kymera's Dupixent in a pill; and Degron's CEO on pipeline and strategy. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T5ID4HF465BXFGAH7C6OOSEGTA/ 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 discuss why seemingly routine comments from Vinay Prasad, director of the US Food and Drug Administration's Center for Biologics Evaluation and Research, that he would stay away from daily review decisions were notable (:26), as well as the impact of proposed FDA budget cuts by the White House and the House of Representatives (17:16). More On These Topics From The Pink Sheet Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors: https://insights.citeline.com/pink-sheet/rare-diseases/prasad-says-involvement-in-us-fda-product-approvals-will-mirror-prior-cber-directors-KF4LJWX5U5DLBMSM6D4YFL7ZOA/ To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/to-compete-with-china-us-fda-must-deregulate-early-gene-therapy-studies-car-t-inventor-says-VDVXZGZIJZFHHNGGQXYILBI7RM/ FDA's FY 2026 Budget Request Lacks New Policy Proposals: https://insights.citeline.com/pink-sheet/legislation/fdas-fy-2026-budget-request-lacks-new-policy-proposals-WV3LE2AYBRAC7LIYJEU4WZDNGU/ User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/user-fee-funded-staff-would-drop-in-fy-2026-us-fda-budget-TQZMEB57V5GELNPMYGTY5BEGOY/ House Gives US FDA More Non-User Fee Funds Than Requested: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/house-gives-us-fda-more-non-user-fee-funds-than-requested-PCQZCBHOB5ARPICMJJQ6VYIJ5M/
Summer Colling speaks with Emma Wille about the symptoms, diagnosis, and treatment landscape of Sjögren's disease, highlighting the latest research and developments.
In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.
Flagship Pioneering senior partner Raj Panjabi discusses shifting healthcare from reactive treatment to AI-powered prediction and prevention of disease before symptoms emerge. Note: Raj Panjabi was mistakenly introduced as CEO-partner in the interview. His correct title is senior partner.
SGLT2 Inhibitors Cardiovascular and Safety Outcomes in Chronic Diseases by Citeline
Plant-Based Diet Improves Outcomes in Metastatic Breast Cancer by Citeline
Generics Bulletin editors Dave Wallace and Dean Rudge discuss the Global Generics & Biosimilars Awards 2025, providing all the key details of the event coming up in Frankfurt this October, along with tips on how to make the most of your entries and opportunities to get more involved with the event.
Join Andrew Warmington, Manufacturing Editor at Citeline, in conversation with Tom Hickey, Director of Therapeutic Strategy at Novotech, a global full-service clinical CRO dedicated to accelerating the development of advanced and novel therapeutics. In this episode, recorded live at the European Association for the Study of the Liver Congress (EASL) in Amsterdam, Tom shares invaluable insights into the evolving landscape of hepatology clinical trials and the unique challenges and opportunities shaping the field today. Listen now to stay ahead in the dynamic world of clinical trials.
An expert from ISACA shares her insights into medtech's Voluntary Improvement Program (VIP), a collaboration among participants, ISACA, MDIC, and US FDA formed to enhance patient safety and product quality in medical device manufacturing. Listen to learn more about attaining measurable improvements with the VIP.
Largely driven by community pharmacy footfall, France's self-care market is dynamic and characterized by high levels of innovation, according to French self-care industry association, NèreS. As NèreS' executive director Luc Besançon explains in this episode of HBW Insight's Over the Counter podcast, much of this is down to the tireless work of the association. Renaming self-care products as first-line or “premier recours” (first-line) products, identifying medicines that are available OTC in other countries that could be switched in France and quantifying the impact that the revised Urban Wastewater Treatment Directive would have on access to medicines are all strands of NèreS' pathbreaking recent work. Timestamps 2:20 – Introductions 3:00 – France's self-care market 7:50 – Innovation in supplements and devices 11:00 – “Premiere recourse” products 13:00 – Driving reclassification 18:00 – Harmonising Rx-to-OTC switch across Europe 20:00 – Switch environment in France 26:00 – Impact of Urban Wastewater Treatment Directive in France 33:00 – Who should pay? 37:00 – NèreS priorities for 2025
Audio roundup of selected biopharma industry content from Scrip over the business week ended 30 May 2025. In this episode: a preview of major ASCO readouts; Roivant stays patient in deals; Lilly diversifies pain pipeline with SiteOne acquisition; Nucala gets US COPD nod; and women in Indian pharma. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-L4LQVHCXLRFEDBOU657R5SEMJY/ 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 consider the potential comments that US Food and Drug Administration Commissioner Martin Makary and other senior agency leaders could receive during their pharma CEO listening tour (:30), as well as the impact of Health and Human Services Secretary Robert F. Kennedy Jr.'s decision to change US Centers for Disease Control and Prevention policy and no longer recommend healthy children and pregnant women receive COVID-19 vaccines (15:47). More On These Topics From The Pink Sheet US FDA Makary's Pharma CEO Tour Goes Against Transparency Rhetoric: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-makarys-pharma-ceo-tour-goes-against-transparency-rhetoric-3E5RP5IATVD73DRPQHZPSTHKRA/ HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role: https://insights.citeline.com/pink-sheet/vaccines/hhs-rescinds-covid-19-vaccine-advice-usurping-us-cdc-role-YNFI7TU5CFGERIGFG7ISOJ4X5Q/
The uncertainty surrounding changes at the FDA and other market dynamics is reshaping the global drug development landscape. In this webinar, CRO regulatory leaders will summarize the collective experience of the biotech companies we've spoken to recently. We will explore: • The impact of the FDA leadership changes, staffing cuts, and return to office mandates in reshaping regulatory priorities. • Trends we're observing from biotech sponsors on the decision of whether or not to keep trials in the US. • The broader implications for industry investment, pipeline prioritization strategies, and international responses. This episode is part 1 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. Stay tuned for the next episode, where we'll continue exploring the key forces shaping the future of clinical trials.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 23 May 2025. In this episode: Novo Nordisk's CEO forced out; quantifying biopharma's contribution to the US economy; a history of MASH deals; lift for AstraZeneca's asthma ambitions; and major Japanese firms see US revenue growth. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XJZXECGBDRDJLCM6FBOJSZNPK4/ 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 consider the limited label that Novavax received for its new COVID-19 vaccine Nuvaxovid, the impact of the new COVID-19 vaccine development policy announced by the US Food and Drug Administration and additional upcoming indicators of the evolving policy. More On These Topics From The Pink Sheet Novavax's COVID-19 Vaccine Label Narrowed After Political Officials Intervened: https://insights.citeline.com/pink-sheet/vaccines/novavaxs-covid-19-vaccine-label-narrowed-after-political-officials-intervened-56OPC7DJ6NCXFLQYGE27SVTEH4/ Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy: https://insights.citeline.com/pink-sheet/vaccines/legal-process-problems-may-plague-new-us-fda-covid-19-vaccine-policy-HAUDHEREXZCA5DAZ47HZ6L544U/ Observational, Retrospective Trials Could Retest Vaccines, HHS' Kennedy Says: https://insights.citeline.com/pink-sheet/vaccines/observational-retrospective-trials-could-retest-vaccines-hhs-kennedy-says-BOFKDMMHGVDNXKXMFEILOXAH4E/ US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems: https://insights.citeline.com/pink-sheet/vaccines/us-fda-covid-19-booster-strategy-may-not-be-as-controversial-as-it-seems-ZEAHMHE5LJB6HLBT2WRZW4L3AY/ US FDA Punts On New COVID-19 Framework's Impact On Fall Shots: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-punts-on-new-covid-19-frameworks-impact-on-fall-shots-QSB6OPEB4ZCEFLS36JG3Y7XSPE/
Mikkel Wandahl Pederson, CEO and chief scientific officer at Commit Biologics, discussed the company's mission to harness the powerful complement system for the treatment of serious diseases.
바이오기업 가치상승으로 일부 딜 (deal)의 경우 빅파마의 투자수익률 (ROI)이 거의 없는 상황이지만, 특정 전략으로 성공 가능성을 높일 수 있다는 Scrip 기사를 요약한 내용입니다. https://insights.citeline.com/scrip/business/deals/biopharma-deals-roi-has-fallen-and-market-instability-could-make-it-worse-MV7Z55MUW5EB7CWVF6JYKHZWUA/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini
While few doubt the opportunity represented by real-world evidence, some concerns remain about its validity compared to traditional forms of clinical evidence, particularly among regulators. To address these concerns, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, suggests that incorporating some elements of traditional trials, such as randomization, is a good way to persuade regulators that RWE can be used for consumer health innovation, for example in generating new claims or supporting Rx-to-OTC switch. Looking forward, Spitzer is excited about the ways in which digital health tools and artificial intelligence can be used to expand the scope of RWE as well as drive personalization for consumers. Timestamps: 3:00 - Addressing concerns about RWE's scientific rigour and validity 12:00 – Regulators' views of RWE, particularly for consumer health 16:00 – Use of RWE for Rx-to-OTC switch 22:00 – The future of RWE Guest Bio: Volker Spitzer has more than 30 years of R&D experience spanning the consumer health sector, ingredients industry, and academia. Beginning his career as a professor in pharmaceutical sciences, he ascended to global positions encompassing R&D, innovation, licensing/M&A, and medical marketing at firms like Roche, DSM Nutritional Products, and Bayer. Since October 2017, Spitzer has been affiliated with IQVIA Consumer Health, serving as the vice president for global R&D and RWE Services. His purview primarily includes clinical research, RWE, virtual trials, and the burgeoning field of digital health. He has penned over 80 scientific publications, whitepapers and textbooks centered on science and innovation.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 16 May 2025. In this episode: Trump's executive order more rhetoric than action; industry grapples with Trump pricing plan; Hengrui set for this year's biggest IPO; Sanofi's exec's advice to biotechs; and biotech deal return on investment falls. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-D4WWGRDN7VB3BB2KULQYTQFKJM/ 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
在本期中国生物技术播客中，Dexter Yan回顾了他在4月的美国癌症研究协会年会（AACR）举办前和再鼎医药总裁及全球肿瘤研发负责人Rafael Amado的采访。Amado在采访中详细阐述再鼎在AACR展示的两个临床前项目，分别是PD-1/IL-12 双抗和靶向LRRC15的抗体偶联药物（ADC）。Dexter还采访到Arbele的创始人和CEO John Luk，请他介绍Arbele在钙粘蛋白17（CDH17）靶点研发上的最新进展和心得体会。最后Dexter回顾了4月维升药业和映恩生物在香港交易所首次上市的情况。 此外，Xu Hu分享了她最近撰写的有关中国企业研发肠促胰岛素类体重管理药物的综述。除此之外，Xu点评了中国药监局最近公布的有关药品试验数据保护的征求意见稿。
Audio roundup of selected biopharma industry content from Scrip over the business week ended 9 May 2025. In this episode: industry makes its case to Trump; Sarepta slammed by double blow; Chinese firms build obesity pipeline; Swiss biopharma staying strong; and Merck & Co looks to immunology and ophthalmology. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HVFSXCWENFCU7FLRVPHK3P4WFU/ 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 Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider early excitement and concern about Vinay Prasad's potential impact on product development as director of the US Food and Drug Administration's Center for Biologics Evaluation and Research (:20). They also consider the consequences of the FDA missing product-specific guidance publication deadlines (14:59) and its potential impact on the upcoming user fee reauthorization negotiations (20:00). More On These Topics From The Pink Sheet Tougher Approval Standards May Follow Vinay Prasad's Appointment To Lead US FDA's CBER: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tougher-approval-standards-may-follow-vinay-prasads-appointment-to-lead-us-fdas-cber-WEULXI5EJRE43BWU752PGDGE44/ US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/us-fda-guidance-roadblock-writing-continues-but-publication-has-slowed-or-stopped-TZF4DMPEMVHT3JJPRUX7LJJIHU/
Audio roundup of selected biopharma industry content from Scrip over the business week ended 2 May 2025. In this episode: AstraZeneca CEO cautions Europe; Pfizer CEO optimistic on US tariffs, pricing; Merck & Co reassures on pipeline; Merck KGaA buys SpringWorks; and Akeso explains ivonescimab overall survival data. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LV7ZA2GKQVHEZDZYYNZFKYQZ74/ 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
The potential for real world evidence (RWE) is huge, according to enthusiasts, but to the uninitiated it can seem like a complicated and forbidding subject. In this Over the Counter double episode, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, makes understanding real world evidence easy. We start with the basics, with what it is and what companies need to know about it, and what the key difference is with randomised control trials. Many companies are already using real world evidence, Volker notes, and he extracts some key lessons for companies interested in trying it out based on his extensive experience working with industry on such projects. Timestamps 2:00 – Introductions 4:00 – What is real world evidence? 5:00 – Can RWE and clinical trials complement each other? 10:00 – Why RWE is particularly attractive today 14:00 – Don't reinvent the wheel 18:00 – Why is this important for consumer health companies? 25:00 – Why RWE is often a good value option, especially for SMEs 33:00 – Applications of RWE in consumer health Guest Bio Volker Spitzer has more than 30 years of R&D experience spanning the consumer health sector, ingredients industry, and academia. Beginning his career as a professor in pharmaceutical sciences, he ascended to global positions encompassing R&D, innovation, licensing/M&A, and medical marketing at firms like Roche, DSM Nutritional Products, and Bayer. Since October 2017, Volker has been affiliated with IQVIA Consumer Health, serving as the vice president for global R&D and RWE Services. His purview primarily includes clinical research, RWE, virtual trials, and the burgeoning field of digital health. He has penned over 80 scientific publications, whitepapers and textbooks centered on science and innovation.
Anil Matai, director general, Organization of Pharmaceutical Producers of India, discusses the evolving intellectual property landscape in India post the 2024 amendments and long-standing sticking points including Section 3(d) of India's patent regulations and regulatory data protection. Big pharma's experience when it comes to the Bolar provision and the impact of geopolitical shifts on innovation were some of the other topics he touched on.
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor in Chief Nielsen Hobbs consider the impact of FDA Commissioner Martin Makary directing one of his assistants to take over the review of Novavax's COVID-19 vaccine (:40), as well as how states or courts could respond (19:19). They also discuss several announcements of missed user fee deadlines and whether FDA layoffs could have contributed (28:33). More On These Topics From The Pink Sheet Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review: https://insights.citeline.com/pink-sheet/vaccines/political-official-pushing-novavax-to-conduct-covid-19-vaccine-postmarket-rct-BZTIWKSTK5G77BUQGGD3G2IOFY/ How States And Courts Could Insulate America From An Anti-Vaccine Executive Branch: https://insights.citeline.com/pink-sheet/vaccines/how-states-and-courts-could-insulate-america-from-an-anti-vaccine-executive-branch-DARDVWDMLVFCHM6DE75AJQHSBQ/ US FDA Commissioner's Office Plans Involvement In Many Approvals In Potential Major Change: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioners-office-plans-involvement-in-many-approvals-in-potential-major-change-JFPWOQ2VF5D2JAFKXKGK54REZU/ US FDA Miss On Stealth's Elamipretide Boosts Signal Of Broader Delays Due To Staff Cuts: https://insights.citeline.com/pink-sheet/product-reviews/us-fda-miss-on-stealths-elamipretide-boosts-signal-of-broader-delays-due-to-staff-cuts-5ITZREGXX5H75ID6IL4Q2MHKBE/
Scrip senior writer Joseph Haas discusses the potential impact of the recent FDA staff cuts with attorneys Andrew Goodman of Paul Hastings LLP and Alan Minsk of Arnall Golden Gregory, as well as Naya Therapeutics CEO Daniel Teper
In this episode, we recap the key takeaways from BIO-Europe 2025, held in Milan, Italy, in March 2025, with Trajko Spasenovski, Vice President of Strategic Account Management at Evaluate, and Carolyn Hall, Senior Director of Content and Thought Leadership Marketing at Evaluate. After the conference, Citeline's Managing Editor, Meredith Landry, spoke with them about their experience there and what they learned about trends in early-stage deal-making, emerging areas like cardiovascular and rare disease therapies, and the expanding role of AI in R&D. Trajko and Carolyn also shared how conferences like BIO-Europe help Norstella and its clients forge meaningful partnerships, uncover market needs, and accelerate the path to life-saving therapies through data-driven insights and strategic collaboration.
Emma Wille and Summer Colling discuss the 2025 American Academy of Neurology (AAN) conference with CNS and I&I analysts Wen-Yu Huang, Joseph Jacob and Istafa Armughan.
Aragen Life Sciences's CEO Manni Kantipudi - also former CIO of Intel Asia - speaks with Citeline's senior editor Vibha Ravi about the changing global supply chain dynamics as the industry watches a ticking time bomb of US tariffs on pharmaceuticals. Impacts on Indian CRDMOs of the US-China trade war, budget cuts at US NIH and lower funding for biotechs are discussed.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 25 April 2025. In this episode: 2024's top-selling drugs; two CEOs call for higher Europe drug prices; diabetes trial win for Lilly's orforglipron; BMS trial failure in schizophrenia; and an analysis of alliance deal-making last year. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-6L5MDUXZ5BGHJHLZFILGLH6ZT4/ 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 the departures of several senior leaders in the US Food and Drug Administration's facility inspection group, Office of Generic Drugs and Office of Prescription Drug Promotion (:26). They also consider Commissioner Martin Makary's intent to combine the agency's many adverse event databases (14:52), his idea for a new approval pathway based on a “plausible mechanism” (26:25) and the seemingly increasing influence of politics at the agency despite his declarations that the FDA is apolitical (36:16). More On These Topics From The Pink Sheet US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-retirements-continue-unabated-with-drug-inspectorate-leaders-former-chief-counsel-JRKHCHZHMBC4RLRJRBDTSIP7E4/ FDA Leadership Shuffle Continues: Lowell Zeta Returns As OPDP, OGD Leaders Depart: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-leadership-shuffle-continues-lowell-zeta-returns-as-opdp-ogd-leaders-depart-FONMRWR37VGAFL2JJ5S27QIU2E/ US FDA's Makary Floats Vague ‘Plausible Mechanism' Approval Pathway For Rare Diseases: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/us-fdas-makary-floats-vague-plausible-mechanism-approval-pathway-for-rare-diseases-RJJJCPDUDFHINMPDE5VK4OFDVQ/ US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioner-makary-wants-to-combine-adverse-event-reporting-systems-UJ4QUEM72ZC25J7JHAC3LAKKKA/ Political Influence And The US FDA: A New Era?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/political-influence-and-the-us-fda-a-new-era-SL6ZBNKHNVFEXCLQLCYTDJIETQ/
Ochre Bio co-founder and CSO Quin Wills spoke with In Vivo about the UK-based company's novel approach to finding and validating RNA therapies for chronic liver diseases.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 18 April 2025. In this episode: Trump's drug pricing executive order; J&J says taxes, not tariffs, influence US manufacturing; Pfizer discontinuation sparks M&A speculation; US tariffs and manufacturing concentration; and tariffs' pressures on pharma's complex supply chain. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ROAXNELATJBXDMNSHISARWARPY/ 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
Summary: At the heart of any successful self-care business is a portfolio of recognizable and trusted consumer health brands. These brands could play a key role in unlocking the potential of digital self-care in the UK, suggests Michelle Riddalls, in this second part of her Over the Counter interview. As PAGB CEO, Michelle has seen first had how the UK consumer health industry has been transformed, for example also by Brexit. Has the UK's exit from the EU realised the promises of innovation unleashed from bureaucracy? Not so far, Michelle reflects, but it might be too soon to tell. What she can predict is that with its new five-year strategy, PAGB will remain dedicated to supporting UK firms in navigating a continuously evolving industry landscape. Timestamps 2:00 – Digital consumer health in the UK 7:00 – The power of brands 12:00 – Brexit, promise realised? 20:00 – What's next for the UK OTC industry? Guest Bio Michelle Riddalls OBE is Chief Executive Officer of PAGB, the consumer healthcare association, which represents the manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements in the UK. Prior to joining PAGB, Michelle was Director of Regulatory Affairs for the Northern European Cluster at Pfizer Consumer Healthcare, where she was integral in the highly successful POM to GSL reclassification of Nexium Control and the Viagra Connect POM to P switch. Michelle has been recognised across a number of industry awards, including the Women in Trade Powerlist in 2024, and was awarded an OBE for outstanding services to consumer health in the King's 2025 New Year Honours.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 11 April 2025. In this episode: Trump's tariff rollercoaster; regulatory, economic uncertainties hang over Q1 earnings; IPOs rise in Q1 but may slow; Chinese deal-making matures; and AstraZeneca talks about Chinese innovation. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-X3YNW3ZLVZABLNFILQHNH6FPAE/ 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
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