Citeline Podcasts

Pink Sheet Editor-in-Chief Nielsen Hobbs, executive editor Derrick Gingery, and senior reporter Maaisha Osman discuss new FDA commissioner nominee Heidi Overton, her prospects for confirmation, and what her pick means for the agency. More On The Topic From The Pink Sheet FDA Commissioner Nominee Has The White House’s Trust. Winning Over Career Staff Is Another Matter: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-commissioner-nominee-has-the-white-houses-trust-winning-over-career-staff-is-another-matter-IIZWK46CFVHMBIZF5XM7L4PQ6U/ Trump To Nominate White House Advisor Overton As FDA Commissioner: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/outgoing-georgia-congressman-buddy-carter-eyed-for-fda-commissioner-RHIYQUYTIVGRTFEXYCHCWPG54Y/

One in ten women has endometriosis, yet treatment options remain largely unchanged for decades. Tanya Petrossian, CEO of EndoCyclic Therapeutics, explains how her company's non-hormonal peptide platform - now FDA-cleared for human trials - could finally change that.

Biopharma’s small-to-mid-cap players are stepping up as serious acquirers. David Wild and Scrip’s Jessica Merrill unpack how companies like argenx, Insmed, Jazz, Genmab, UCB, and BioMarin are using M&A to extend growth beyond their first commercial successes and what that shift means for investors, dealmaking, and the next generation of big biotechs.

Everyone in consumer health is talking about GLP-1s. While this new generation of weight loss drugs is firmly on the prescription-only side, industry is now thinking about how it can meet users’ needs for products that address side effects and the nutritional gaps that come with rapid weight loss. In this episode of HBW Insight’s Over the Counter, ALL Creative founder Beverley Law and consultant Martina Gripp – who has 25 years’ experience in industry including at Boehringer Ingelheim and Perrigo – unpick what a companion products category actually requires. We talk claims and the grey area around referencing a prescription brand, the difference between a product marketed for GLP-1 users and one that ends up being used by them, what a real evidence investment looks like from bibliographic data through to a clinical trial, and what OTC companies should be doing right now. A quick update for our listeners: HBW Insight now has its own dedicated podcast channel. To stay up to date on the latest, follow HBW Insight’s Over The Counter podcast on Spotify and Apple Podcast. You'll find the link in this episode's description. For any podcast feedback or queries, you can now reach us at [email protected]

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the important provisions of the new prescription drug and generic drug user fee commitment letters (:53), including the revenue cut coming in PDUFA VIII (7:16), as well as the new formal meeting names (13:53) and “America First” incentives (23:47) in GDUFA IV. More On These Topics From The Pink Sheet US FDA Will Start PDUFA VIII Collecting Less Revenue, But Will Fees Drop?: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-will-start-pdufa-viii-collecting-less-revenue-but-will-fees-drop-3VJC34BDRZFHHMY5N5YIODQRZ4/ Generic Drug User Fee Deal Creates Domestic-Focused Incentives, Could Lower Application Fees: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/generic-user-fee-deals-creates-domestic-focused-incentives-could-lower-application-fees-UOG7BGF2YNA3NMWHLFMM2C2BFU/ Generic Drug User Fee Agreement Streamlines Meetings, Creates ‘Complex Issue’ Goal Extension: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/generic-drug-user-fee-agreement-streamlines-meetings-creates-complex-issue-goal-extension-TZFGYWV2VNCF3M7GJWPOJZ66SI/

Biotech leaders are navigating disciplined growth, shifting global dynamics, and rising expectations across boards, partners, and clinical teams. In this opening episode, a panel of experienced biotech executives step back to discuss where the industry truly stands, the forces shaping decision‑making, and how leaders are approaching strategy, execution, and collaboration in today’s biotech landscape. Featuring: - Claire Riches, VP, Clinical Solutions, Citeline - Ross Pettit, Chief Development Officer, Kestrel Therapeutics - Carrie Melvin, Head of Clinical Operations and Data Management, Lantheus - Marrissa Volpe, SVP, Clinical Development, NervGen - Jennifer Burg, SVP, Clinical Development Operations, Axonis Therapeutics View the video series and find out more information here: https://www.citeline.com/biotech

On this episode of Strategic Intent, In Vivo’s David Wild sits down with Doug Love, President and CEO of Annexon Inc., to discuss how the company is transitioning from a platform-centric biotech into a commercial organization. Love walks through the distinct go-to-market strategies for an acute rare disease treated in hospitals versus a large chronic ophthalmology market served by retina practices, and explains how Annexon is building two dedicated commercial teams to support both launches. The conversation also covers Annexon’s oral complement inhibitor ANX1502, capital allocation priorities across late-stage and platform programs, and how most-favored-nation (MFN) pricing dynamics are influencing launch sequencing and ex‑US partnering plans.

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the impact of nationalism on the regulatory process, which entered the fray once again when news of a potential AstraZeneca-Bristol Myers Squibb merger broke (:58), as well as the US Food and Drug Administration’s IND reform pilot program (11:22), including the potentially influential role of external qualified research institutions (16:20) and the resources the pilot will require (20:29). More On These Topics From The Pink Sheet Oncology Overlap, Nationalism Cast Doubts On Potential AstraZeneca/BMS Merger: https://insights.citeline.com/pink-sheet/policy-regulation/oncology-overlap-nationalism-cast-doubts-on-potential-astrazenecabms-merger-NL65J53QYNF57GBW53AZGSYD54/ Merged AstraZeneca, BMS Would Have Deep Solid Tumor And Blood Cancer Portfolio: https://insights.citeline.com/pink-sheet/r-and-d/merged-astrazeneca-bms-would-have-deep-solid-tumor-and-blood-cancer-portfolio-IF4Z7IRHEFDIRDUAZTZP2PHEDM/ US FDA’s IND Reform Pilot Could Use External Partners To Speed Trial Set-Up: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/us-fdas-ind-reform-pilot-could-use-external-partners-to-speed-trial-set-up-7QU7Y7US4FCJRLRWZWV4CLCQBA/  

In this episode of Proof of Concept, Krishna Bulusu joins us for an honest, industry-wide look at what AI and simulation can and can't do. Having spent years in oncology data science at AstraZeneca before becoming VP of Product Innovation & Strategy at Turbine, he's seen the problem from both sides — as the big-pharma adopter deciding whether to trust these tools, and as the builder creating them. We cover how simulation is used to find and de-risk drug targets, why some AI tools get adopted while others stall, the translational gap between lab results and real patients, and the honest question of where the field is overhyped — and what would count as real proof.

Science Corp.'s PRIMA brain-computer interface receives CE mark for restoring central vision in AMD patients. Viz.ai partners with Cortechs.ai on MS tracking. AMA urges Congress to regulate mental health AI chatbots. MedLink earns Mayo Clinic Platform qualification.

How shifting perceptions and new opportunities are changing the way sponsors approach China

Generics Bulletin’s senior reporter Urtė Fultinavičiūtė launches a new interview podcast series “Off-Patent, On Record.” In the inaugural episode, Urtė is joined by Dave Wallace, executive editor at Generics Bulletin, who has been covering the off-patent drug industry as a journalist and editor for 16 years.

Consumers are turning to AI at the start of the self-care journey in growing numbers, but they do not yet trust it, the latest Better Health Report from Simon-Kucher & Partners shows. They do trust pharmacists, who can convert that trust into sales, providing crucial sales volume growth for their consumer healthcare industry partners. However, as Simon-Kucher’s Christian Danelund and Chris Rebholz explain in the latest episode of HBW Insight’s Over the Counter podcast – now also in video – pharmacists feels that support from industry has declined over recent years.

This Scrip video podcast brings together three European biotech leaders to discuss the challenges facing the sector, and what measures are needed to stop it falling behind the US and China and to create the next generation of European biotech champions.

Oncology biosimilars have already helped expand access to established biologic treatments while supporting more sustainable healthcare spending. As the market moves towards increasingly complex therapies, however, identifying viable opportunities will require more than monitoring patent expiries. In this podcast, ICON experts Colin Farquharson and Martin Lachs, discuss how scientific innovation, evolving standards of care and changing market dynamics are influencing the next generation of oncology biosimilars. This podcast explores: How oncology biosimilars are moving from proof of concept towards broader adoption The potential opportunities and challenges associated with antibody-drug conjugates and bispecific antibodies Why patent expiry alone is not enough to determine the long-term viability of an asset The factors influencing physician confidence, patient acceptance and market uptake How real-world evidence can strengthen confidence in biosimilar safety and efficacy The analytical, CMC, regulatory and market-planning capabilities sponsors should develop early

On the heels of Eli Lilly recently committing $3.3bn across two recombinase-focused deals, the question for the field is which gene editing modality, and which delivery system, will get large genetic payloads safely into the right cells. ElevateBio's chief scientific officer Amy Pooler joins In Vivo's David Wild to argue that the answer isn't one technology, but many. In this episode, Pooler walks through ElevateBio's full editing stack: AI-designed large serine recombinases, retrotransposon-based insertion, generative AI-optimized base editors, and an LNP delivery platform that has now shown re-dosing and therapeutically meaningful editing in non-human primates. She also makes the case for epigenetic editing as a potentially underappreciated modality, one that could compete with small molecules in indications where you want potency and specificity without permanently rewriting the genome. And she explains why ElevateBio, with six consecutive years of revenue growth and a 98% manufacturing batch success rate, sees its end-to-end CDMO model as uniquely positioned to turn those tools into medicines partners can actually bring to the clinic.

Generics Bulletin's editorial team discusses the recent Medicines for Europe legal and annual conferences, attended by executive editor Dave Wallace, as well as the Medicines UK conference attended by reporter Anabel Costa-Ferreira.

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the impact of the US Food and Drug Administration clarifying that journal articles written by former commissioner Martin Makary and others were not official guidance (:58). They also discuss the questions an FDA commissioner nominee could field from Senators based on the recent confirmation hearing for President Trump’s US Centers for Disease Control and Prevention and Health and Human Services Assistant Secretary for Preparedness and Response nominees (15:12). More On These Topics From The Pink Sheet US FDA Says Two Makary, Prasad Journal Articles And NPV FAQ Were Not Policy Or Guidance: https://insights.citeline.com/pink-sheet/legislation/us-fda-says-two-makary-prasad-journal-articles-and-npv-faq-were-not-policy-or-guidance-6MCDQTKVXFG7TJ7IWOT6YMW4CA/ US CDC, ASPR Nominees’ Confirmations In Question After Contentious Senate Hearing: https://insights.citeline.com/pink-sheet/agency-leadership/us-cdc-aspr-nominees-confirmations-in-question-after-contentious-senate-hearing-3TX2W6HSXRACJELUX2CYY6ICVY/

Eisai's Michael Irizarry talks to Scrip about broadening Leqembi's use with its subcutaneous version, its ongoing Phase III in treating patients before dementia symptoms appear and news from a Phase II study of it tau-targeting asset, etalanetug.

On the July 2026 edition of the Scrip Deals Podcast, Scrip Senior Writer Joseph Haas and Bruce Leuchter, CEO of Neurvati Biosciences and GRIN Therapeutics, discussed the recent trend of biopharma M&A deals valued at $1bn or greater closing quickly. Recent research showed that closing time for such deals is less than half of how long it took to close a billion-dollar acquisition during the span on 2023-2025.. Leuchter offered some insights on why this might be. Haas and Leuchter also discussed M&A activity during the just-ended second quarter of 2026.

Health literacy is a phrase you hear a lot in consumer health at the moment, but it's not always clear what people mean by it, or what a company is actually supposed to do about it. In this episode of Over the Counter, HBW Insight talks to Trevor Gore, a trustee of the Self-Care Forum who spent more than two decades at Reckitt and now looks at healthcare through behavioural science. Gore's argument is that most companies treat health literacy as a readability job, making labels and leaflets easier to follow, when the harder work is changing what people do: helping them recognize symptoms, understand risk and act on it. We discuss the three levels of health literacy, the gap between what people intend to do and what they actually do, the line between educating and promoting, and why awareness on its own buys you almost nothing. Timestamps 3:00 – Introductions 5:00 – What is health literacy? 7:00 – What has health literacy become so important? 15:30 – What are CHC companies doing well? 25:00 – The role of behavioural science 29:00 – What do you need to do now?

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the implications of potential regulations that would cement the FDA’s presumption that it can release complete response letters (:49) and effectively ban direct-to-consumer advertising (18:45), as well as a potential reorganization to create a senior FDA position in charge of all medical products (29:23). More On These Topics From The Pink Sheet US FDA To Clarify, Expand ‘Significant Discretion’ To Publish CRLs: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/us-fda-to-clarify-expand-significant-discretion-to-publish-crls-NYZ2YV2DCFD6HDJ3XTLRZPXSRY/ US FDA Moves To Eliminate ‘Adequate Provision’ For DTC Broadcast Ads: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/us-fda-moves-to-eliminate-adequate-provision-for-dtc-broadcast-ads-5Y32BOH25JEXVLE4ES2JMFHYLQ/ HHS Considering US FDA Reorganization With Medical Products Chief Overseeing Centers: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/hhs-considering-us-fda-reorganization-with-medical-products-chief-overseeing-centers-7DSI2OHYUBHXTO73OBBDJW2QQA/

Lyme disease is spreading, the last US vaccine was withdrawn in 2002, and the most recent attempt at a new one (Pfizer and Valneva's Phase III candidate) missed its primary endpoint earlier this year. Into that gap steps Tonix Pharmaceuticals with a different idea entirely: skip the vaccine and deliver the antibody directly.   In Vivo's David Wild talks to Tonix CEO Seth Lederman about TNX-4800, a fully human monoclonal antibody targeting OspA on the Lyme-causing bacterium Borrelia burgdorferi. Lederman explains why the unusual biology of OspA makes it better suited to a monoclonal approach than a traditional vaccine, how the antibody works inside the tick's midgut to kill the bacteria and block their migration before they can enter a human host, and what the Phase I data tell us about safety, dosing, and the planned two-dose seasonal regimen. He also discusses the adaptive Phase II field study Tonix is preparing for 2027, the lessons (and the lack of information) from the Valor trial, and the long-term questions around who would use this product, how it would be reimbursed, and whether the health economic case can be made for a seasonal preventive in a disease whose chronic form remains medically and politically contested.

In this podcast, Satish Reddy, chairman of Dr. Reddy's Laboratories, talks about deploying generic Revlimid gains strategically, building a diversified growth engine, what India must fix — regulatory science, risk capital and more — to become a serious innovation force, and learnings from China. 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. #pharma #biotech #India #China #funding #Supply chain #business strategy #regulation

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

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

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.