Citeline Podcasts

The science around the microbiome is moving fast, consumers are clearly interested, and yet the category still runs into some long-standing problems in the European Union, not least the inconsistent way the word “probiotic” itself is treated across the region. In this episode of HBW Insight’s Over the Counter podcast, we talk to Rosanna Pecere, Executive Director of IPA Europe, the European office of the International Probiotics Association. Rosanna tells us about a socioeconomic assessment that the association has recently published, which tries to put a figure on what probiotics are actually worth to society. According to the report, round €10bn could be potentially saved with probiotic use, which Pecere says is probably on the conservative side. We talk about where that value comes from, from digestive and respiratory health through to mental wellbeing, and why the regulatory gap in the EU is holding so much of it back. Timestamps 2:30 – Introductions 4:00 – IPA Europe’s Socio Economic Impact Assessment 5:50 – Key Findings 8:20 – Why are probiotics so valuable? 10:00 – What is holding probiotics back? 11:00 – What would a different regulatory approach look like? 12:00 – Why should consumers care? 13:00 – What’s next?

비만 치료제 시장의 급성장과 일라이 릴리의 티르제파티드가 주도하는 가운데, 이벨류에이트(Evaluate)의 2026 월드 프리뷰(World Preview) 보고서에 따르면 제약 업계는 향후 몇 년 동안 새로운 매출 기록을 경신할 전망입니다(AI 기반 텍스트 음성 변환 및 음성 모방 도구의 도움을 받아 제작되었습니다) https://insights.citeline.com/scrip/market-intelligence/top-drugs/pharma-sales-to-top-2-trillion-as-the-big-drug-era-beds-in-45U226OSGNDG7PJN5YILAL2KDU/

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年6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: 中国交易主导BIO大会热门话题；制药企业瞄准2万亿美元销售额；Apogee助力艾伯维实现愿景；桑加莫申请破产；以及对韦伯在武田制药任职期间的回顾。 向听众们简要更新一下：Scrip现在已在Spotify和Apple Podcasts上开设了专属播客频道。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-3KJHBFYFL5CBPK346JNITNJKTA/

Audio roundup of selected biopharma industry content from Scrip over the business week ended June 26, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time–China deal controls a hot BIO topic; pharma eyes $2tn in sales; Apogee helps AbbVie achieve vision; Sangamo files for bankruptcy; and a review of Weber’s time at Takeda.    Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-3KJHBFYFL5CBPK346JNITNJKTA/ A quick update for our listeners: Scrip now has its own dedicated podcast channel on Spotify and Apple Podcasts.​ ​Be sure to subscribe to get all episodes.

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs discuss the potential impact of the US Food and Drug Administration’s new updated guidance describing the one-trial plus confirmatory evidence standard for effectiveness (:47) and the significance of advancing yet another priority of former Commissioner Martin Makary (6:47). They also talk about the details of the agency’s planned pilot program to streamline IND clearances, including questions about the program’s feasibility. (14:08). More On These Topics From The Pink Sheet US FDA Rewrites Effectiveness Playbook, Positions Single-Pivotal-Trial Pathway As New Normal: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/us-fda-rewrites-effectiveness-playbook-positions-single-pivotal-trial-pathway-as-new-normal-XUVWF3SKQNANDMY4IW5SXTJZYE/ US FDA IND Reform Pilot Would Let ‘Qualified’ Outside Institutions Give Advice To Speed Approval: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/us-fda-ind-reform-pilot-would-let-qualified-outside-institutions-give-advice-to-speed-approval-RIPFHRJUERCULKXWCQMXW3PX3M/

Clinical operations plays a decisive role in execution quality, data integrity, cost control, and development speed, yet it is often treated as a cost centre rather than a strategic function. In this episode, Claire Riches, VP, Clinical Solutions, Citeline is joined by Executive Consultant, Clinical Development Operations to discuss why clinical operations must be elevated into board‑level conversations. Together, they explore how clinops drives value, manages risk, and shapes long‑term development strategy, and what boards and executives need to understand to make better, more informed decisions. View the video series and find out more information here: https://www.citeline.com/biotech

In this episode of the China biopharma English-language podcast, Xu Hu talks about China’s drug regulator finalizing trial data protection measures for drugs registered in the country, and some of the impacts these may have on future licensing deals involving the China market and company strategies in managing product lifecycle and market access in China. Here are links to the stories this episode is based on: Impact Of China’s New Data Protection On Deals, Corporate Strategies; China Finalizes Data Protection Periods; China Plans Clinical Data Protection By Product Category For First Time

Pancreatic cancer has the lowest survival rate of any major cancer — just 13%, largely because it's so hard to catch early. Changing that takes more than a lab breakthrough. It takes the unglamorous infrastructure to collect, track, and safeguard patient samples across dozens of institutions, reliably enough that researchers can trust what they find. In this episode, host Krishna talks with Margaret Caspler, President and CEO of the PRECEDE Foundation — a consortium of more than 65 academic medical centers working to raise pancreatic cancer survival from 13% to 50% — and Kathi Shea, Chief Client Solutions Officer for Repository at Azenta Life Sciences, who has spent three decades in biorepository science. Together they explore why early detection has lagged, what it takes to run a biospecimen network at scale, and how a public-private partnership can do what neither side could alone. Follow Medtech Insight to stay ahead of every shift in the device and diagnostics landscape.

This debut video episode of the In Vivo podcast examines the successes and pitfalls of the commercial launch of Yescarta (axicabtagene ciloleucel), Kite Pharma’s CAR-T therapy for relapsed/refractory large B-cell lymphoma. David Wild, senior reporter at In Vivo, is joined by Harris Kaplan, who consulted on the launch and conducted interviews with physicians, nurses, and hospital administrators before and after it, and is managing partner of Litmys, a life sciences commercial strategy consulting firm; Diane Parks, who led the Yescarta launch for Kite; and Jim Haag, a patient who received CAR-T therapy. It's a candid, unfiltered look at the gap between what innovation promises and what the healthcare system actually delivers. Here are some of Harris Kaplan’s contributed articles for In Vivo: Commercialization 3.0: Achieving New Product Success In Health Care’s New Era Commercialization 3.0: Recognizing And Managing The Human Side Of Change Physician Behavioral Inertia: Innovation’s Greatest Enemy

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年6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。 本期要闻: 辉瑞公司阐明肿瘤学发展方向；2026年国际生物技术大会（BIO 2026）的重点议题；GLP-1药物获取问题给肥胖症研究带来困扰；来自巴西的GLP-1药物使用洞察；以及第一季度销量前十的药物。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-VFPFSBHMSVH33HNSZ6ND3ST45Q/

Audio roundup of selected biopharma industry content from Scrip over the business week ended June 19, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time–Pfizer lays out oncology direction; key topics at BIO 2026; GLP-1 access causes problems for obesity studies; GLP-1 use insights from Brazil; and Q1’s top 10 drugs. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-VFPFSBHMSVH33HNSZ6ND3ST45Q/

The Generics Bulletin Podcast: Probing The Patent Monopoly With I-MAK’s Tahir Amin Description: Generics Bulletin senior reporter Urtė Fultinavičiūtė talks to Tahir Amin, co-founder and CEO of I-MAK, about the current intellectual property system that curtails off-patent drug competition and global health equity.

AI, Philips, Healthtech, Future Health Index 2026

Prevention has moved to the centre of UK health policy, with the NHS 10-year plan promising a decisive shift away from treatment. The financial case for getting there is less widely understood. In this episode of the Over the Counter Podcast, HBW Insight's David Ridley speaks to Liz Hampson, life sciences and health innovation advisory partner at Deloitte, about the firm's recent work on the socioeconomic value of prevention. Hampson explains why every pound invested in prevention returns an estimated £9.20, why early intervention pays off most, and how rising out-of-pocket spending risks creating a two-tier system. The conversation also covers the gender health gap in prevention, the underused role of community pharmacy, and Hampson's argument that health literacy is where consumer health companies can make the greatest difference.

Pink Sheet Editor-in-Chief Nielsen Hobbs, Senior Editor Sue Sutter, and Senior Reporter Maaisha Osman discuss the Pentagon's decision to list WuXi Apptec as a “Chinese military company” (0:58), FDA’s latest adverting enforcement letters (13:02), and the agency’s thoughts on the risks and benefits of relying on AI for regulatory activities (21:16). More on these topics from the Pink Sheet: Pentagon Chinese Company Designations Resurface Pharma Supply Chain Concerns https://insights.citeline.com/pink-sheet/compliance/distribution-supply-chain/pentagon-chinese-company-designations-resurface-pharma-supply-chain-concerns-BMG2DWJI4NDA3DD3SYHIWXLTZI/ US Legislation Targets US-China Dealmaking Amid Fears Of Ceding Biotech Leadership https://insights.citeline.com/pink-sheet/legislation/us-legislation-targets-us-china-dealmaking-amid-fears-of-ceding-biotech-leadership-54FLFUBN7RELHO6WC7RN5OINYY/ BIOSECURE Legal Lifeline Available For Pharma Companies Using WuXi AppTec … For Now https://insights.citeline.com/pink-sheet/compliance/distribution-supply-chain/biosecure-legal-lifeline-available-for-pharma-companies-using-wuxi-apptec-for-now-KAD42FTHIJAT3AWS6OJMJHFM4M/ Pentagon Cleared WuXi AppTec Once. Now It Is Being Sued for Changing Its Mind. https://insights.citeline.com/pink-sheet/compliance/manufacturing/pentagon-cleared-wuxi-apptec-once-now-it-is-being-sued-for-changing-its-mind-XVGIQA3LIFEBZAG6AS6EMENHF4/ Recent US FDA Ad/Promo Untitled Letters Citing More Email, Internet Issues, Less DTC TV Spots https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/recent-us-fda-adpromo-untitled-letters-citing-more-email-internet-issues-less-dtc-tv-spots-X2QUB5LZBRCRLNPGOJZJQMEIWU/ Unapproved Uses Safe Harbor Codified In Revised US FDA Payor Communications Guidance https://insights.citeline.com/pink-sheet/market-access/government-payers/unapproved-uses-safe-harbor-codified-in-revised-us-fda-payor-communications-guidance-GFHTVUWW7NBH3P2MT6GZL5JLJ4/ US FDA Says AI Played Supporting, Summarizing Role In Fast BLA Review https://insights.citeline.com/pink-sheet/product-reviews/us-fda-says-ai-played-supporting-summarizing-role-in-fast-bla-review-EKFWWY5SGZFVPL6PVKJVHJOVBQ/ Acting CDER Director Warns AI Over-Reliance Will Trigger GMP Violations https://insights.citeline.com/pink-sheet/advanced-technologies/ai/acting-cder-director-warns-ai-over-reliance-will-trigger-gmp-violations-7UO5KN7SJJBBLPQT7SLT3SWCJI/

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：「US Drug Shortages Ease But Discontinuations Surge, Asia Supply Chain Risks Run Deep（邦訳：米国の医薬品不足は緩和も撤退数は増加、アジア由来の深いサプライチェーンリスク）」URL: https://insights.citeline.com/scrip/focus-on-asia/india/us-drug-shortages-ease-but-discontinuations-surge-asia-supply-chain-risks-run-deep-QTQCO6KNOBG25HXMVNV5HX5NM4/「US Tariffs And Manufacturing Concentration: Double-Edged Sword?（邦訳：米国の関税政策と製造の集中は諸刃の剣か？）」URL: https://insights.citeline.com/scrip/focus-on-asia/india/us-tariffs-and-manufacturing-concentration-double-edged-sword-5HPZCB6UY5EWZMK7QGJLJHS7IE/アメリカ薬局方　最新のVML（脆弱性薬品リスト）はこちらhttps://www.usp.org/sites/default/files/usp/document/public-policy/vulnerable-medicines-list-2025.pdf※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？https://www.citeline.com/ja-jp/products-services/commercialization/scrip

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年6月12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: 礼来探索Zepbound在自身免疫性疾病中的应用；阿斯利康在心血管风险管理（CVRM）领域推行互联互通战略； 阿斯利康将口服GLP-1药物推进至III期；勃林格殷格翰凭借survodutide致力于实现高质量减重；以及葛兰素史克通过收购Nuvalent扩大其肿瘤学版图。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LLJSGYAJJ5EO3J5JMQYNNNSCMU/

Audio roundup of selected biopharma industry content from Scrip over the business week ended June 12, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time–Lilly explores Zepbound in autoimmune disorders; AstraZeneca pursues interconnected strategy in CVRM; AstraZeneca moving oral GLP-1 into Phase III; Boehringer pursues quality weight loss with survodutide; and GSK scales oncology ambitions with Nuvalent buy.   Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LLJSGYAJJ5EO3J5JMQYNNNSCMU/

Flagship Pioneering의 안드레 안도니안 아시아태평양 의장과 이병건 한국 담당 특별고문은 Scrip과의 인터뷰에서 새로운 파트너십을 모색하고, 자사의 기업 설립 모델을 국내 바이오 생태계에 적용하는 등 한국 시장 진출 전략을 공유했습니다.(AI 기반 텍스트 음성 변환 및 음성 모방 도구의 도움을 받아 제작되었습니다) Story link: https://insights.citeline.com/scrip/leadership/interviews/flagship-eyes-long-term-partnerships-biopharma-ecosystem-growth-in-korea-3IPE7SDKWNBATHEO7C4J5RHOGI/

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年6月5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: Revolution公司的daraxonrasib在ASCO大会上引发轰动；默克公司（Merck & Co.）阐述其肿瘤学愿景；美国立法者对中美交易感到不满；ADA大会上的肥胖症治疗新挑战；以及2025年大型制药公司CEO薪酬回升。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-UH6HET2LLNGUJBCSJ3UA2KLGCQ/

Audio roundup of selected biopharma industry content from Scrip over the business week ended May 29, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – can GLP-1s help in cancer; Novartis on its cardiovascular strategy; Lilly’s retatrutide looks promising in obesity; Lilly’s raises cell and gene therapy bet; and the business impact of China’s new data protections. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-QIUHRJ2UTNCIXB4T2CVZPNXG24/

Audio roundup of selected biopharma industry content from Scrip over the business week ended June 5, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Revolution’s daraxonrasib makes splash at ASCO; Merck & Co. lays out oncology vision; US legislators bristle over US-China deals; obesity challengers at ADA; and big pharma CEO pay rebounds in 2025. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-UH6HET2LLNGUJBCSJ3UA2KLGCQ/

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs, as well as Generics Bulletin Executive Editor David Wallace, consider the implications of the US Supreme Court decision upholding the skinny labeling system (:37), including how the generic industry will adapt going forward (9:02). They also discuss the stakeholder comments the US Food and Drug Administration received during a public hearing on the National Priority Voucher and their potential impact on the program’s future (10:50). More On These Topics From The Pink Sheet US Supreme Court Retains Skinny Labeling System, Backs Hikma Over Amarin: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/us-supreme-court-retains-skinny-labeling-system-backs-hikma-over-amarin-4LH4TCR2OVHPBPVMUTN4HGRQCE/ Stakeholders Want Clearer Eligibility Criteria For US FDA’s National Priority Voucher Program: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/stakeholders-want-clearer-eligibility-criteria-for-us-fdas-national-priority-voucher-program-LWGMZFB3VZAUHOZIRCPFWH4JCU/ NPV Program Facing Legal Durability Questions As Public Meeting Impacting Its Future Approaches: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/cnpv-program-facing-legal-durability-questions-amid-loper-bright-decision-YUZ6E4VAJZFYBOEWMRSWRSRAFI/ Grading US FDA’s National Priority Voucher Program After One Year: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/grading-us-fdas-national-priority-voucher-program-after-one-year-UXYNFYXDGFFH7L6WXG7TMRZPEQ/ CNPV Public Meeting Questions: US FDA Seeks Talking Points Before Confirming Speakers: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/cnpv-public-meeting-questions-us-fda-seeks-talking-points-before-confirming-speakers-NOZ3QRCLZZCI5K7EXYWKKP7PFY/

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年5月29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: GLP-1受体激动剂能否辅助抗癌；诺华公司的心血管战略；礼来公司的雷塔鲁肽在肥胖症治疗方面前景可期；礼来公司加大对细胞与基因疗法的投入；以及中国新数据保护法规对商业领域的影响。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-QIUHRJ2UTNCIXB4T2CVZPNXG24/

Interventional cardiologist and Soley Therapeutics CEO Yerem Yeghiazarians joins In Vivo’s David Wild to unpack how decoding cell stress with live‑cell imaging and AI is driving a new oncology pipeline, and what it takes to build a platform‑plus‑pipeline biotech while still practicing medicine.

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the potential impact a mandated nondisclosure agreement could have on US Food and Drug Administration activities and its employees (:34), as well as the changes the agency’s hiring push caused to user fee reauthorization efforts (13:50). More On These Topics From The Pink Sheet Proposed Government Nondisclosure Agreement Could Include US FDA Pre-Decisional Memos: https://insights.citeline.com/pink-sheet/product-reviews/proposed-government-nondisclosure-agreement-could-include-us-fda-pre-decisional-memos-BTEWGHSQBZGVDCXOCH77CDU7LU/ US FDA Hiring Push Threatens Industry Efforts To Contain, Lower User Fees: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-hiring-push-threatens-industry-efforts-to-contain-lower-user-fees-X5GTZH4JEVD3NPREWLMWKCVB6Q/

Audio roundup of selected biopharma industry content from Scrip over the business week ended May 22, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – industry grapples with MFN fallout; rapid early trials fuel China deals; AbbVie looks to grow in neuroscience; is circular DNA the next big thing?; and a flunk for Regeneron’s fianlimab. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-I3FWWY2VRBAJND24H372L2CGIY/

"Biotechs are running increasingly complex clinical trials with lean teams, tight budgets, and growing pressure to deliver faster results. In this episode, Claire Riches, VP, Clinical Solutions, Citeline is joined by Carrie Melvin, Head of Clinical Operations and Data Management, Lantheus to explore how smarter outsourcing, stronger CRO partnerships, and patient‑focused trial design can improve execution, control costs, and reduce operational risk, while avoiding unnecessary burden on sites and participants. View the video series and find out more information here: https://www.citeline.com/biotech"

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年5月22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: 行业正努力应对最惠国待遇政策带来的影响；早期临床试验进展迅速推动中国市场合作；艾伯维（AbbVie）寻求在神经科学领域扩张；环状DNA会是下一个重大突破吗？；以及Regeneron公司的fianlimab遭遇挫折。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-I3FWWY2VRBAJND24H372L2CGIY/

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the impact of the US Food and Drug Administration’s purge of multiple center directors and other senior executives in the wake of Commissioner Martin Makary’s resignation (:34). They also discuss the agency’s potential new direction and the initial comments of some of its new leaders (15:12). More On These Topics From The Pink Sheet US FDA’s Real-Time Clinical Trial Pilot Seeks Expansion As Chief Architect Departs: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/us-fdas-real-time-clinical-trial-pilot-seeks-expansion-as-chief-architect-departs-VOTFGD45X5DZXGCAMNJU2AKN6M/ Acting CDER Director Warns AI Over-Reliance Will Trigger GMP Violations: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/acting-cder-director-warns-ai-over-reliance-will-trigger-gmp-violations-7UO5KN7SJJBBLPQT7SLT3SWCJI/ US FDA Chief AI Officer Departs, But Ousted Chief Of Staff, Acting CBER Director Staying: https://insights.citeline.com/pink-sheet/geography/north-america/united-states/ousted-us-fda-chief-of-staff-acting-cber-director-will-stay-after-leadership-shake-up-HXJONIRQ5VAVVNWDKHK7Z2BA2E/ 13 Center Directors Across CDER, CBER In 17 Months … And Counting: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/13-center-directors-across-cder-cber-in-17-months-and-counting-WFYVLZPFOBEN3IICCDM5LSKWZU/ Diamantas Extends Olive Branch To US FDA Staff Amid Senior Leader Shake-Up: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-tracy-beth-hoeg-expected-to-depart-cder-CUQUEBUE3BHZ3G52UW4I7SM6BE/

MHRA’s Rob Reid spoke to Ashley Yeo at MTF 2026 on issues affecting UK and Great Britain medtech regulation

As biotech models evolve, boards, clinical leaders, and investors are being forced to rethink how value is created. In this episode, Claire Riches, VP, Clinical Solutions, Citeline is joined by Ross Pettit, Chief Development Officer, Kestrel Therapeutics, to explore how leaner operating models, sharper board governance, ROI‑driven clinical decisions, and the rapid rise of China’s biotech ecosystem are redefining what “modern biotech” looks like today. #biotech #drugdevelopment #clinicaltrials #clinicaldevelopment #biotechstrategy #biotechleadership #clinicaloperations #ROI #ChinaBiotech  View the video series and find out more information here: https://www.citeline.com/biotech

As global clinical development strategies evolve, Europe is emerging as a critical hub for scientific innovation, operational agility, and patient recruitment — reshaping its role in the future of clinical trials. In this episode, Scott Davis, Vice President of Clinical Services at Novotech, joins Andrew Warmington from Citeline to explore how sponsors are rethinking Europe’s place in global development programs amid shifting geopolitical, regulatory, and operational dynamics. They discuss: ·       Why Europe continues to lead through scientific expertise and clinical innovation ·       How sponsors are optimizing trial design, startup, and recruitment strategies across the region ·       The growing importance of flexible CRO–sponsor partnerships in global development ·       How Europe complements the US and APAC in modern clinical trial strategies ·       What regulatory evolution and operational change could mean for Europe’s future competitiveness Tune in to hear how Europe is adapting to a rapidly changing clinical landscape and why the region is poised to play an even greater role in the future of global clinical trials.

Ovid Therapeutics Chairman Jeremy Levin talks with Scrip about how the US should view its biotech sector as a strategic national asset and urges the venture capital sector to place more emphasis on supporting early and innovative science.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年5月15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: 葛兰素史克（GSK）强化下游肥胖症战略；诺和诺德（Novo）在早期肥胖症口服药市场占据优势； 罗氏对瑞士的支持面临压力；恒瑞与百时美施贵宝达成重大研发联盟；PCSK9药物Lerochol在美国以更低的直接成本上市。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HHL7OZN4TBH43HXIIRB2G7BYUI/

Audio roundup of selected biopharma industry content from Scrip over the business week ended May 15, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – GSK bolsters downstream obesity strategy; Novo winning early obesity pill market; Roche’s support for Switzerland under strain; Hengrui and BMS strike huge R&D alliance; PCSK9 drug Lerochol launched in US at lower direct cost. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HHL7OZN4TBH43HXIIRB2G7BYUI/

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter, Editor-in-Chief Nielsen Hobbs, as well as special guest Mike McCaughan, founding member of Prevision Policy, discuss the circumstances and mistakes that lead to Martin Makary’s resignation as head of the US Food and Drug Administration (:38), his achievements during his short term (21:56), the agency’s way forward (29:12) and the pressure on the Trump Administration pick the correct replacement (36:35).   #pharma #business More On These Topics From The Pink Sheet Makary’s Exit Resurrects Questions About US FDA’s Direction Under Trump Administration: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/makary-goes-embattled-us-fda-commissioner-resigns-amid-white-house-special-interest-anger-L4P6P4OSWJHB3GFOIMKVPWQTFU/ PhRMA CEO Backs Parts Of Makary’s US FDA Agenda As Diamantas’ Onboarding Continues: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/phrma-ceo-backs-parts-of-makarys-us-fda-agenda-as-diamantas-onboarding-continues-4UOZPQZOEJEWDEWB7CYMN5VL5M/ What Does Declining Average Commissioner Term Length Say About US FDA’s Future?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/what-does-declining-average-commissioner-term-length-say-about-us-fdas-future-LUWPQ4AW4BGQPPK3EKYCQ6D5OQ/ Trump Plan To Oust Makary Clouds Future Of ‘Bold Reforms’ At US FDA: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/trump-plans-to-oust-makary-clouds-future-of-bold-reforms-at-us-fda-AJNPZFEHNFEOXG4J7DJMO4E7QI/

The MHRA’s spring 2026 CE-marking consultation, the progress of UK medtech statutory instruments and the European Commission’s proposed revision of the MDR and IVDR were top of mind for the Association of British HealthTech Industries' Steve Lee as he did the rounds – and the panels – at the MedTech Forum 2026.

Generics Bulletin's editorial team discusses the recent Medicines for Europe biosimilars conference, attended by deputy editor Dean Rudge; while editor Dave Wallace talks about the latest big deals in biosimilars and what is behind them.

Kurma Partners has closed BioFund IV at €215m — its largest fund to date, but roughly €35m short of its initial target. For partner Amanda Gett-Chaperot, that gap is more than a fundraising footnote: it points to a structural problem that has long constrained European biotech's ability to build at US scale. Tags: Venture capital, European biotech, Fundraising, Exits, Early-stage investment

Arcutis Biotherapeutics' CEO Frank Watanabe joins In Vivo’s David Wild to talk about building a patient‑first culture and turning a three‑person startup into a commercial‑stage immunodermatology company. He explains how Zoryve (roflumilast) is reshaping care in chronic inflammatory skin diseases, why Arcutis is pushing beyond dermatology offices into primary care and pediatrics, and how new assets like ARQ‑234 fit into the company’s long‑term growth strategy. The conversation also covers leadership lessons from Watanabe’s time in the US Navy Reserves, his practice of speaking directly with frontline employees and his perspective on capital markets and policy decisions that will shape the future of dermatology innovation. #biotech #dermatology #immunodermatology #pharma #drugdevelopment #leadershi

In the latest episode of HBW Insight's Over the Counter podcast, Volker Spitzer, vice-president, global R&D/RWE services at IQVIA Consumer Health, returns to examine the implications of agentic AI for the consumer health industry – a topic he and colleagues explore in a recently published white paper. Unlike the large language models now familiar to most consumers, agentic AI operates with persistent memory, cross-platform autonomy, and the ability to act on a user's behalf over time, functioning less like a search tool and more like a continuous personal health advisor. In the first of this two-part conversation, we discuss important questions, such as: Can AI systems can yet be trusted to guide health decisions reliably? What is the role of the pharmacist in this evolution of health information technology? Is the existing product-focused regulatory framework equipped to govern a technology that operates as a dynamic, personalized recommendation engine rather than a fixed promotional claim? Part two – published in two weeks’ time on HBW Insight – will address the commercial implications, including what the rise of agentic AI means for marketing strategy, industry readiness, and brand risk.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年5月8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: 诺和诺德抢占早期口服减肥药市场；葛兰素史克（GSK）交易强化其下游减肥药战略；辉瑞因Vyndamax和解协议前景转好； 中国主导创纪录的新药上市；以及强生公司放弃两款淋巴瘤CAR-T疗法。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-IEFP6L4BNNCFTNMAXVIX54E6CQ/

Audio roundup of selected biopharma industry content from Scrip over the business week ended May 8, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Novo winning early oral obesity market; GSK deal bolsters downstream obesity strategy; brighter Pfizer outlook due to Vyndamax settlements; China dominates record novel drug launches; and J&J drops two lymphoma CAR-Ts.   Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-IEFP6L4BNNCFTNMAXVIX54E6CQ/

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs consider the increasing pressure on US Food and Drug Administration Commissioner Martin Makary to resign and its long-term impact on the agency (:34). They also discuss Makary’s comments on patient anecdotes influencing regulatory decisions on psychedelic drugs and his new AI-enabled one-day facility inspection program (12:14), criticism of Makary’s Commissioner’s National Priority Voucher Program (18:49), and his intent to hire 3,000 new scientists (23:12). #pharma #business More On These Topics From The Pink Sheet Psychedelic Testimonials Alone Cannot Meet Legal Approval Standard, US FDA’s Makary Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/psychedelic-testimonials-alone-cannot-meet-legal-approval-standard-us-fdas-makary-says-OCRVXBPRMJAR3I5LCSA7QER724/ US FDA Piloting AI-Enabled One-Day Inspections To Expand Oversight, Improve Efficiency: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-piloting-ai-enabled-one-day-inspections-to-expand-oversight-improve-efficiency-ULUXK3SYFVF4ZDHYTA4QWXNDJE/ US FDA Hiring 3,000 Scientists To Power Sweeping Reform Agenda, Makary Says: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-hiring-3000-scientists-to-power-sweeping-reform-agenda-makary-says-HCDJTHZFUFBSZL5C2DKCG7FPAE/ US FDA Limits Some Staff Performance Awards, In Part Because Funds Are Insufficient: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-limits-some-staff-performance-awards-in-part-because-funds-are-insufficient-YMV4DDERO5A5LO5AOSORPXWDGE/

BioWales Podcast: Getting Medtech Right In A Small Country Maximizing The Tailwind From BioWales 2026 Gwyn Tudor, head of the MediWales forum, lays out the challenges, opportunities and funding on offer for healthtech founders who make Wales part of their strategic plan. For healthtech companies looking to move from start-up to manufacturing and scale-up, Wales can be an attractive location, with its quality manufacturing facilities, expertise and often lower costs than in other parts of the UK. That was one of the messages from Gwyn Tudor, chief executive of the Cardiff-based MediWales forum, “the independent life sciences network for Wales”, as he opened the BioWales in London 2026 conference and exhibition. Interviewed by In Vivo for his take on the current commercial and innovation climate for healthtech companies considering operations in Wales, he said that adoption of new technologies by NHS Wales can be just as much of a challenge as in England. He added that NHS Wales is an accessible partner and there is “always a conversation to be had in Wales about new technology and innovation.” Companies can access potential partners, supply chains and peer support through MediWales and events like MediWales Connects. Tudor said: “Building relationships to reduce friction and move projects faster by helping people work together in a less transactional, more relationship-based approach is a clear characteristic of Wales.” Its life sciences ecosystem of 288 companies, 12,000 employees and annual sales output of £2.5bn sales value from medtech, diagnostics, wound healing, regenerative medicine and cell therapy is relatively small on an international scale. But it punches above its weight in medtech and diagnostics, Tudor told delegates at the bustling BioWales event, explaining in this In Vivo podcast his goal of “keeping all life sciences stakeholders in the room to come up with solutions.” That includes the healthcare provider, he said.

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter, Editor-in-Chief Nielsen Hobbs and Generics Bulletin Executive Editor Dave Wallace discuss US Food and Drug Administration Commissioner Martin Makary’s appointment of Katherine Szarama as acting Center for Biologics Evaluation and Research director and the updated timeline for find a permanent director (:33), as well as and Makary’s approach compared to the recent Center for Drug Evaluation and Research leadership change (4:39). They also consider the impact of the US Supreme Court’s review of the generic drug skinny label policy (10:54). #pharma #business More On These Topics From The Pink Sheet Alternate Leadership Strategy: Deputy Director Szarama Is Acting US FDA Biologics Center Chief: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/alternate-leadership-strategy-deputy-director-szarama-is-acting-us-fda-biologics-center-chief-P6ZJLJY7YBDUXCG6DMWNYNIHUI/ US FDA’s Makary Expects To Name Permanent CBER Director Within Weeks As Prasad Departs: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fdas-makary-expects-to-name-permanent-cber-director-within-weeks-as-prasad-departs-37ZOLQT6FNDARGPMZOE2EI2DPE/ Skinny Label At SCOTUS: Could Generics Maintain Carve-Out Authority No Matter The Decision?: ⁠https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/skinny-label-at-scotus-could-generics-maintain-carve-out-authority-no-matter-the-decision-54CTMA7XSBGIFF7WOYPGA26PGM/

Salvatore Viscomi, CEO and co-founder of Carna Health, discussed the company's pivotal work to combat the global crisis of chronic kidney disease (CKD).