Pharma Intelligence Podcasts

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

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

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

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs look at the potential consequences of the US Food and Drug Administration's upcoming crack down on direct-to-consumer advertising (:30), including the first publicly released letter, which went to AstraZeneca for a Flumist TV commercial (2:50), as well as vaccine policy and other major issues that were listed in the Make America Healthy Again Commission's Strategy Report (21:45). More On These Topics From The Pink Sheet Direct-To-Consumer Ads: Manufacturers Face ‘Cease And Desist' Orders Now, Uncertain Future: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/direct-to-consumer-ads-manufacturers-face-cease-and-desist-orders-now-uncertain-future-6XLXAWS7WJBYNPHSBRAQVTBARU/ Limited Detail In MAHA Strategy Report Could Catch Pharma Off Guard: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/limited-detail-in-maha-strategy-report-could-catch-pharma-off-guard-TVL7CCBQONA7PHCLUDJ7WTEJC4/

What makes a biotech-CRO partnership truly work? Claire Riches, VP, Clinical Solutions, Citeline, and Matt Simmons, Senior Director, Oncology Strategy, IQVIA Biotech, share the secrets behind winning biotech-CRO partnerships, covering collaboration, transparent budgeting, regulatory navigation, and recruitment strategies, with essential insights to help biotechs succeed from their first RFP to global trials. View the video series and find out more information here: https://www.citeline.com/biotech

Community based trials are reshaping clinical research, broadening patient access and accelerating timelines. Discover the drivers, challenges and future outlook.

In Vivo spoke with Annette Bakker, CEO of the Children's Tumor Foundation, a medical research foundation developing an innovative approach to reviving shelved pharmaceutical assets, resulting in the recent US FDA approval of mirdametinib, a treatment for rare tumors.

Audio roundup of selected biopharma industry content from Scrip over the business week ended September 5, 2025. In this episode: the US MASH market after Wegovy's approval; AstraZeneca and Mineralys in close hypertension race; United Therapeutics' Phase III win in IPF; Corsera aims to predict and prevent cardiovascular disease; and Ionis's RNA-targeted win in severe hypertriglyceridemia. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RKP4E4CFGFGGXBRVXTI73V27U4/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

For today's consumers, sustainability is an expectation rather than a luxury, according to PA Consulting's latest Brand Impact Index. In other words, companies that haven't invested in minimizing their brands' impact on the environment are at risk of being left behind. “But it's ok to get it wrong sometimes too,” notes PA's personalization and consumer expert, Rhea Patten, in this episode of HBW Insight's Over the Counter podcast. And maybe for smaller brands, being a staller rather than a shaper may also make strategic, short-term sense, as long as consumers can understand that sustainability is their long-term goal. Don't mis the first part of this interview with Patten, in which we discussed, among other things, what “vibes” are and how understanding this aspect of “consumer centricity” better can help consumer health companies grow their brands. Timestamps 2:00 – Do consumers still want sustainable brands? 8:00 – Will consumers forgive sustainability missteps? 10:00 – Will consumers pay more for sustainable brands? 13:00 – Is better to be a sustainability shaper or staller? 15:30 – Final thoughts Guest Bio Rhea Patten is a consumer product expert at PA Consulting, with expertise in health, beauty, and wellness. She has over 20 years' experience in leading innovation and transformation projects in the consumer products and retail sector. Passionate about bridging physical products with digital experiences, Patten helps leaders deliver solutions that drive business growth. She specializes in accelerating product innovation, with a focus on strategy, customer-centricity, and sustainability.

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the ongoing impact of the US Food and Drug Administration decision to drop vaccine expert Paul Offit and others from its advisory committee rosters (:32), as well as the substantial new detail in the latest batch of complete response letters for unapproved products that the agency released (12:47). More On These Topics From The Pink Sheet Offit's VRBPAC Departure Raises Questions About Another HHS Panel Revamp: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-paul-offit-no-longer-member-of-us-fdas-vaccine-advisory-panel-WX3X3CIP6VCARJ7BPLXNQIQ2BQ/ US FDA Compounding Advisory Panel Hit Hardest By Recent Purges: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-compounding-advisory-panel-hit-hardest-by-recent-purges-OXBD4IXGFZCIDIMB6VXSOSVP6U/ 89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/89-complete-response-letters-one-huge-leap-for-us-fda-transparency-for-unapproved-drugs-SLYA5LADMNDY3LKZ5TRUAWRRAU/

In this episode of the China Biopharma English-language Podcast, Shanghai-based senior reporter Xu Hu talks about the release for the first time by China's National Healthcare Security Administration in August of a preliminary list of innovative drugs reimbursed by commercial insurance and the key reasons that have driven this reform. Related story links: https://insights.citeline.com/pink-sheet/geography/asia/china/china-signals-commercial-insurance-biotech-and-foreign-owned-hospitals-as-policy-priorities-6WABWKHO3VCRHNSCOXGABSHTZE/ https://insights.citeline.com/pink-sheet/market-access/government-payers/china-unveils-multiple-policies-to-support-innovative-drugs-throughout-life-cycle-JFEHXBAS2ND3PGJYKOF7NB6ZCM/ https://insights.citeline.com/pink-sheet/geography/asia/china/china-signals-commercial-insurance-biotech-and-foreign-owned-hospitals-as-policy-priorities-6WABWKHO3VCRHNSCOXGABSHTZE/

Audio roundup of selected biopharma industry content from Scrip over the business week ended August 29, 2025. In this episode: Lilly's orforglipron strong in diabetic obesity; Ascletis confident in oral GLP-1 challenger; myostatin drugs progress for obesity; an interview with OneSource's CEO; and an analysis of Dupixent's pipeline-in-a-product success. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-KKZ7ZW3B2VGUBFTSLNCLIHU7QU/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss the impact of US Food and Drug Administration's COVID-19 vaccine indication changes and recission of the associated emergency use authorizations, as well as the postmarketing studies that now are required (:40), and their potential impact on access and reimbursement (12:20). More On These Topics From The Pink Sheet COVID-19 Vaccines: Pfizer Arguments To Keep EUA Failed To Persuade US FDA's Prasad: https://insights.citeline.com/pink-sheet/vaccines/covid-19-vaccines-pfizer-arguments-to-keep-eua-failed-to-persuade-us-fdas-prasad-V3X2OEBZE5HRHKO7KMMCFXBM2Q/ US FDA Updates COVID-19 Vaccine Formulations, Revokes EUAs, ACIP Use Decision Next: https://insights.citeline.com/pink-sheet/vaccines/us-fda-updates-covid-19-vaccine-formulations-revokes-euas-acip-use-decision-next-VBXJDSOA6BCOXNCA2TAH27EBJY/ A US FDA Move to Revoke Pfizer's Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions: https://insights.citeline.com/pink-sheet/vaccines/a-us-fda-move-to-revoke-pfizers-pediatric-covid-19-vaccine-eua-could-raise-supply-questions-ZX26DBENHFCOHPBGMPFPQB6REQ/ Changes In Pediatric COVID-19 Vaccine Recommendations Causing Coverage Confusion: https://insights.citeline.com/pink-sheet/vaccines/changes-in-pediatric-covid-19-vaccine-recommendations-causing-coverage-confusion-WDEYUVJXGBCGBEVBQ2I6INH554/

As global regulatory expectations evolve, biotech sponsors face growing pressure to make smarter, earlier decisions about where and how to run their trials. In this episode, Novotech experts Renita Hite (Director of Regulatory Affairs, Drug Development Consulting) and Scott Schliebner (Global Head of Drug Development Consulting) join moderator Meredith Landry to discuss how early-stage sponsors can adapt to shifting FDA initiatives, accelerated global pathways, and increasing demands for regulatory flexibility. They explore: How new FDA initiatives—like AI-driven reviews, user fee changes, and the National Priority Voucher—are reshaping IND strategy Why sponsors should design trials with global data packages in mind from day one Accelerated and early access pathways that can speed startup and market entry How CROs are evolving to help sponsors prioritize markets and build regulatory flexibility If you're planning trials for 2025 and beyond, this conversation will help you prepare for what's next—and position your program for long-term success. About This Episode This episode is the final installment (4 of 4) in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Catch up on earlier episodes: [Part 1: Navigating Regulatory Changes & Market Dynamics] [Part 2: Navigating Regulatory & Market Shifts] [Part 3: Navigating Regulatory Changes & Market Dynamics]

전통적 벤처캐피털이 점점 더 신중하고 선별적인 투자 성향으로 변하면서 바이오 기업들이 새로운 자본 조달 경로를 모색하고 있다는 Citeline의 In Vivo 기사를 요약한 내용입니다. https://insights.citeline.com/in-vivo/growth/when-vc-steps-back-finding-alternative-biotech-funding-4UN5IYJEUZD2XPLYIZ7RR7YVQY/ Playlist: https://soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 今回取り上げた記事はこちら 「China NHSA Releases Preliminary Innovative Drug List For First Time（邦訳：中国国家医療保障局、初の画期的医薬品向け償還“候補”リストを発表）」 URL:　 https://insights.citeline.com/pink-sheet/geography/asia/china/china-nhsa-releases-preliminary-innovative-drug-list-for-first-time-JOSACB66CZA6BOZNDEGFTLLWSU/ ※全文の閲覧には購読（有料）が必要です。 世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip Playlist: https://soundcloud.com/citelinesounds/sets/japanese-language-mini

Despite the recent pressure on their finances, consumers are rejecting the idea of choosing brands based on cost alone, according to PA Consulting's latest Brand Impact Index. People are prepared to pay more for brands they “vibe” with, PA suggests. But what are vibes? And how can consumer health companies tap into them? As PA personalisation and consumer expert Rhea Patten explains in this episode of HBW Insight's Over the Counter podcast, vibing with consumers means making them feel special, seen and heard, and creating communities around their needs. Timestamps: 2:00 – Introductions 3:00 – The Brand Impact Index 4:30 – This year's headline findings 6:30 – What OTC firms can learn from leading beauty and wellness brands 17:00 – What are “vibes”? 25:00 – How to build a brand community Guest Bio: Rhea Patten is a consumer product expert at PA Consulting, with expertise in health, beauty, and wellness. She has over 20 years' experience in leading innovation and transformation projects in the consumer products and retail sector. Passionate about bridging physical products with digital experiences, Patten helps leaders deliver solutions that drive business growth. She specialises in accelerating product innovation, with a focus on strategy, customer-centricity, and sustainability.

Audio roundup of selected biopharma industry content from Scrip over the business week ended August 22, 2025. In this episode: Madrigal regains MASH lead with EU Rezdiffra approval; Viking's obesity data scare investors; China assets lead GLP-1 deals; CSL and others restructure; and Indegene exec on DTP and MFN policies. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T77LV22VANAL5GNPCC2YUVLZBE/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Merck KGaA's Emre Ozcan outlines the company's systematic approach to integrating digital solutions across the care continuum in specialty pharmaceuticals, moving from technology-first to patient-need-first strategies.

Tevard Biosciences CEO Daniel Fischer discusses how engineered suppressor tRNAs enable read-through of premature stop codons to restore full-length protein production in genetic diseases. Fischer, whose daughter has Dravet syndrome, covers the company's lead programs in dilated cardiomyopathy and DMD, advantages over traditional gene therapy approaches, and the path to human proof-of-concept.

Audio roundup of selected biopharma industry content from Scrip over the business week ended August 15, 2025. In this episode: a look at the likely top drugs in 2030; Lilly CEO advocates US/Europe pricing rebalance; Insmed sees $5bn-plus market for Brinsupri; royalty deals go mainstream; Phase III win sets stage for Epkinly label expansion. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-365OXHOS2RFXHPEDQIURY6LFDI/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Audio roundup of selected biopharma industry content from Scrip over the business week ended August 8, 2025. In this episode: Trump ups pressure on MFN pricing; Pfizer says pharma working with Trump on direct sales; Sanofi says direct sales worth considering: Aurigene Oncology CEO on biotech valuations and more; and Novartis progresses pipeline-in-a-product assets. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RCXSH2B5EVCC3IIK35GXUSNZVA/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

It's been about three years since Haleon became a standalone self-care company. Since then, the firm has announced an ambitious plan to reach one billion more consumers by 2030. In this episode of HBW Insight's Over the Counter podcast, we catch up with Haleon's new UK & Ireland general manager Jo Cooper to find out what that means in practice when translated to the firm's home market. Empowering pharmacists is key to Cooper's local plans, as is exploring the opportunities suggested by the UK government's recently published list of Rx-to-OTC switches it would like to see applications for. Timestamps 2:00 – Introductions 4:00 – Becoming consumer focused 10:00 – Attracting talent into consumer health 13:00 – Translating Haleon's ambitious global growth strategy to a local context 25:00 – The importance of pharmacy 30:00 – Rx-to-OTC switch and Haleon's R&D strategy 38:00 – Unpacking Haleon's “strategic category realignment

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

In the latest episode of the In Vivo Podcast, Jeremy Skillington, CEO of Poolbeg Pharma, discussed the company's ambitious pipeline and strategic direction.

Audio roundup of selected biopharma industry content from Scrip over the business week ended August 1, 2025. In this episode: EU tariff deal leaves questions for pharma; Prasad's CBER exit could bode well for genetic medicines; Winrevair grows but Merck & Co. plans cost cuts; Novo Nordisk selects new CEO; and a look at obesity past the GLP-1s. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-AOJAANRHLNCPNNLNGVVKA3HEAE/ 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

Amid growing uncertainty in the U.S. regulatory landscape, sponsors are increasingly looking to ex-U.S. markets as a strategic way to reduce clinical trial risk and maintain momentum. In this episode, Novotech experts Renita Hite and Scott Schliebner discuss how biotech and small to mid-sized pharma companies are adapting their global trial strategies—leveraging regions like APAC and Eastern Europe for faster startups, strong data quality, and significant cost savings. They explore: -Why sponsors are increasingly looking outside the U.S. amid regulatory and political uncertainty -Key benefits of ex-U.S. regions like APAC and Eastern Europe, including speed, quality, and cost savings -Strategic considerations for integrating global sites into clinical development plans -Common pitfalls and risk mitigation strategies when operating in international markets -How ex-U.S. trials support greater flexibility and resilience heading into 2025–2026 This episode is part 3 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: Podcast Series: Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials Listen to part 2 here: Podcast Series: Navigating Regulatory & Market Shifts — CRO Perspectives on Clinical Trials

Listen to learn more about the evolving landscape of rheumatoid arthritis treatment through the lens of the patient experience. One RA patient shares her insights as Advanced Clinical discusses the results from a recent RA patient experience survey.

Healthy aging has been identified as an important trend that consumer healthcare companies need to respond to. According to founder and managing director of UK firm Prime Fifty, Max Gowland, innovating in this area requires understanding the science behind healthy aging and offering consumers specific and efficacious products, rather than catch-all solutions. In this episode of HBW Insight's Over the Counter podcast, Gowland dives into some of the science behind targeted nutrition for over fifties and explains why appearing on TV shopping channels like QVC has offered a useful way to communicate these benefits to older consumers. Timestamps: 2:00 – Introductions 5:45 – Leveraging consumer health industry experience 8:15 – Prevention is key 10:30 – Competing for shelf space 13:30 – Be a specialist not a generalist 14:30 – Selling via shopping TV 17:30 – Why science and quality is important in healthy aging supplementation 24:00 – Addressing musculoskeletal health 32:00 – Getting your claims right 36:00 – What's next for Prime Fifty Guest Bio: Max Gowland is a PhD-qualified biochemist with over 40 years' experience in health and nutrition. He is a leading expert on shaping the nation on providing supplements for 50+ and his focus includes helping support longevity through supplementation to support bone health, skin, hair, nails and more. Having worked with many large companies, Gowland founded Prime Fifty focusing on healthy ageing and currently serves as Chief Scientific Officer at FutureYou Cambridge. Gowland regularly appears on QVC and at industry events to promote evidence-based nutritional support for midlife and beyond.

Audio roundup of selected biopharma industry content from Scrip over the business week ended July 25, 2025. In this episode: Sanofi's Vicebio buy; Sarepta halts US Elevidys shipments; Novartis warning over Europe; US CRL for Genentech's Columvi; and an interview with Novavax. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-U4IN5X7DRVFLVIBJ4Q72VTAJUY/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the issues awaiting George Tidmarsh, the new director of the US Food and Drug Administration's Center for Drug Evaluation and Research (:24), as well as the next steps for the agency and Sarepta amid the ongoing problems with its gene therapy Elevidys (delandistrogene moxeparvovec) (23:49). More On These Topics From The Pink Sheet Will Tidmarsh's Industry Experience Translate As US FDA's Chief Drug Regulator?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-news-pharma-ceo-george-tidmarsh-named-director-of-us-fdas-drug-center-2HXJJCPAIVB2RFNGDDU5NZVNQQ/ Business Background Of New CDER Director George Tidmarsh: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/business-background-of-new-cder-director-george-tidmarsh-BROCYQDUYFE3LIQDJ2JNBDWD6Y/ US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-cancer-reviewers-heading-for-the-exits-potentially-impacting-review-timelines-YMOFTXDFDZBGVGBIKFXHJY5XTY/ US FDA's Biologics Center Departures Grew Before More Than 100 RIFs Exited: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-biologics-center-departures-grew-before-more-than-100-rifs-exited-2LR3ZFYOBND3DLIWXSFFWWLFYE/ After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next?: https://insights.citeline.com/pink-sheet/product-reviews/post-marketing-regulation-and-studies/after-sarepta-reversed-course-on-elevidys-could-an-adcomm-be-next-ZA5ODQB3DJF4LBDFODMB52DM3M/ Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/us-fda-asks-sarepta-to-stop-elevidys-shipments-after-third-death-linked-to-gene-therapy-vector-GLJ2YJDJGNBPLD3SSKKE6UVM34/

MoonLake Immunotherapeutics is racing ahead in the biotech space with its innovative nanobody SLK and a transformative $500m non-dilutive financing deal. Its CEO and CFO discuss with In Vivo the company's rapid clinical progress, financial strategy and ambitions to reshape inflammatory disease.

Audio roundup of selected biopharma industry content from Scrip over the business week ended July 18, 2025. In this episode: – J&J delivers in Q2 despite Stelara drop; Sarepta cuts jobs as Elevidys slumps; AI is inevitable but needs to be applied appropriately; China's mid-cap companies thrive; and a look behind Glenmark's landmark trispecific deal. Article links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HYQOHZ42CNCQRPF6HCKGLTHUKM/ 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

Scrip discusses the latest M&A activity and trends with CEO Shawn Titcomb of Allele Capital and Cheryl Reicin, a partner focused on international life sciences activity at Mintz.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss why Center for Biologics Evaluation and Research Director Vinay Prasad cited an unproven theory alleging politics influenced the 2020 COVID-19 vaccine emergency use authorizations to justify his decision to overrule reviewers on more recent indication updates (:35). They also consider the impact of hundreds of staff departures after the US Food and Drug Administration's reduction-in-force was allowed to proceed, including 600 in the Center for Drug Evaluation and Research (20:14). More On These Topics From The Pink Sheet Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/prasad-cites-unproven-theory-defending-his-covid-19-vaccine-decisions-QFAGD35QOFA5VCZS4WXDPCNWV4/ US FDA's Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-drugs-center-lost-hundreds-of-staff-through-june-with-600-rifs-coming-GYSWOX6RIZEXTK5LZ4KWF3PPDY/

Join Meredith Landry, Managing Editor of Citeline's Custom Content, 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 at the annual BIO conference in Boston, Tom offers a sharp and timely look at the state of RNA therapeutics and shares how innovation in delivery technologies, regulatory strategy, and partnership models is shaping the next generation of RNA-based medicines. With Novotech's deep experience in the space, Tom provides actionable insights for biotech leaders looking to position their RNA programs for long-term success.

In this week's Digital Health Roundup, MedTech Insight's Marion Webb discusses her interview with Johns Hopkins researcher Axel Krieger who published study findings on autonomous surgery. Brian Bossetta highlights new FDA cybersecurity guidance and Medtronic's partnership with IRCAD to train surgeons on robots. Shubham Singh highlights his interviews with OpenWater on stroke and EnsoData on sleep. Natasha Barrow discusses FDA approval challenges with Flow Neuroscience's CEO. Tags: robotics, robotic surgery, FDA, cybersecurity, cardiology, neurology, leadership interviews, neurostimulation, commercial, medtech.

The latest episode of the In Vivo podcast features an interview Edward Ahn, CEO of Medipost, a Korean company that has developed stem cell therapies from cord blood, on how they are working across regulatory markets to provide a novel treatment for degenerative diseases.

Astellas is doubling down on gene therapy while others retreat. Richard Wilson, SVP at Astellas Gene Therapies, joins In Vivo to discuss why the company believes AAV technology will transform medicine despite current industry headwinds.

Audio roundup of selected biopharma industry content from Scrip over the business week ended July 11, 2025. In this episode: Merck & Co's Verona acquisition; venture funding plummets in Q2; how Teva is expanding innovation; Apogee's Phase II eczema win; and a look at India's wave of licensing. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-TJX4YBGD5JDSHGRUTLYHWO2JMU/ 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

Originally developed to treat diabetes, GLP-1 agonists have been found to suppress appetite and reduce calorie intake, fueling their growing popularity as obesity drugs. According to JP Morgan, the total number of GLP-1 users in the US may reach 30m by 2030, or around 9% of the population. But what is the opportunity for the consumer health industry? According to Kerry Group's scientific director Mathieu Millette, there are two main areas that companies could target. Firstly, there are the pre-and post-GLP phases, when consumers may want natural GLP-1 alternatives to help them lose weight or maintain the weight loss achieved on the drug. And secondly, during use, consumer health products can help address some of the unwanted side-effects of GLP-1s, for example gastrointestinal issues. Of course, as Millette tells HBW insight in this episode of the Over the Counter podcast, marketers also need to be mindful of the regulatory environment around health claims, especially in the EU. Timestamps 2:20 – Introductions 3:30 – What are GLP-1 agonists? 8:50 – What's the opportunity for consumer health companies? 16:00 – Is this a European trend as well? 17:40 – Health claims: the regulatory environment 25:00 – Natural GLP-1 alternatives Guest Bio Mathieu Millette is scientific director for Bio-K Plus International and RDA director for digestive health within Kerry Group's proactive health division. Millette leads a team of talented scientists dedicated to elucidating the mechanisms of action of probiotics and to understanding the interactions between beneficial microorganisms, the gut microbiome, and the gastrointestinal tract. Millette is also associate professor at INRS-IAF, a member of the Association of Microbiologists of Quebec and is highly involved with the International Probiotic Association.

올해 제약바이오 M&A 가 다소 주춤할 것으로 전망되고 있지만, 재정난을 겪고 있는 의약품 개발업체들이 자금조달의 대안을 찾으면서 잠재적 매물이 넘쳐나고 있다는 Scrip의 BIO USA 기사를 요약한 내용입니다. https://insights.citeline.com/scrip/conferences/bio/bio-deal-trends-financial-market-stress-creates-transactional-opportunities-IL5W6U4BSZD6RPQ53EHG7HNTJ4/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

The latest episode of the In Vivo podcast features an interview with Phil L'Huillier, who discusses the inclusion of Scancell's melanoma cancer vaccine on the NHS Cancer Vaccine Launch Pad, and how 2025 could be a pivotal year for the cancer vaccine field as a whole.

Ying Tam, Chief Scientific Officer at Acuitas Therapeutics, discusses the company's role in delivering the first personalized CRISPR gene editing treatment to an infant with CPS-1, achieving treatment in just six months from diagnosis. Tam shares insights on evolving lipid nanoparticle technology beyond COVID vaccines, including LNPs that allow for next-generation immune-targeting delivery that is 10x more potent, and progress in delivering genetic medicines to stem cells and solid tumors. He also addresses the challenges of repeat dosing, a new biodegradable LNP formulation, and expanding genetic medicine beyond the liver to treat blood disorders and cancer.

The latest episode of the In Vivo podcast features an conversation with Agnès Arbat, CEO and co-founder of Barcelona-based biotech company OxoLife, which is pioneering a novel approach to addressing female infertility.

According to a recently published study by Bayer Consumer Health, being poor makes it more likely that you will suffer from self-treatable health conditions. But it also means you will find it harder to take advantage of self-care solutions. In this episode of the Over the Counter podcast, HBW Insight speaks to Bayer Consumer Health's global medical access lead Emese Csoke about the issues that the study raises for the self-care industry, not least how widening access to self-care solutions can be balanced with equity with regards to affordability. For Csoke, ways forward include partnerships between public and private sector stakeholders and investments in digital self-care. Timestamps 2:00 – Introductions 2:50 – Bayer Consumer Health's RISE initiative 4:00 – Self-care is hardest for those who need it most 5:45 – Implications for the consumer health industry 8:20 – Self-care's “double burden” 10:15 – Profit vs people? 16:30 – Public-private partnerships 19:00 – Digital self-care 22:40 – Impact of RISE so far Guest Bio Emese Csoke is currently serving as global strategy director for regulatory, medical, safety, quality, and compliance at Bayer Consumer Health. In this role, she plays a pivotal part in advancing health equity by designing and implementing strategic initiatives that expand access to self-care. Emese led the creation of the strategic pillar RISE – the Research Initiative for Self-care Equity – and authored a peer-reviewed publication on the impact of socioeconomic determinants on health outcomes for self-care conditions. As a lead on Bayer's “dynamic shared ownership” model, Csoke is also driving force behind organizational transformation and innovation. Csoke holds a PharmD and a degree in Clinical Development Science from Semmelweis University and is certified as a medical science translator.

Audio roundup of selected biopharma industry content from Scrip over the business week ended July 4, 2025. In this episode: AbbVie's big autoimmune CAR-T play; In Vivo CAR-T interest grows; China deal perspectives from BIO; global pharma interest in Korea undeterred; and a look at the biggest drug sales disappointments. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-Y77FXMFAIFEVFK75G5QUSNSBOY/ 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

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 Snapshot Of India's Pharma Manufacturing Network Amid ‘Trumponomics'（邦訳：インド、医薬品製造ネットワークの現在地　「トランプ経済政策」の最中で） https://insights.citeline.com/scrip/focus-on-asia/india/snapshot-of-indias-pharma-manufacturing-network-amid-trumponomics-4NDNAVYZW5CPZIKDIZHDRXCJ6A/ ※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

How is venture philanthropy revolutionizing Alzheimer's drug discovery? We sit down with Karen Harris, CFO at the Alzheimer's Drug Discovery Foundation, to explore their game-changing approach to funding early-stage research. With $370M+ awarded to 765+ programs globally, the ADDF operates like a VC firm—using convertible debt and preferred equity to accelerate breakthrough treatments. Topics: Venture philanthropy vs traditional grants Shift from amyloid to combination therapies Blood-based biomarkers & precision medicine NIH funding cuts impact on research ecosystem Karen brings 20+ years investment banking experience to discuss how strategic capital is changing Alzheimer's research.

In the first episode of this new China Biopharma English-language mini podcast, Shanghai-based senior reporter Xu Hu looks at the main directions in which obesity drug developers are moving, Chinese pharma firms' position in the global race for muscle-preserving weight loss drugs and China's challenge in matching accessible drugs with well-guided weight loss. Related story links: https://insights.citeline.com/scrip/r-and-d/chinese-developers-showcase-potentially-differentiated-weight-loss-assets-at-ada-TGCGQMCVBFHS7LNTWM6YDPEC3I/; https://insights.citeline.com/in-vivo/global-vision/chinese-firms-build-obesity-clinical-pipeline-but-face-wider-hurdles-KX5GZJDC2NGKRDO6VUU7HROF4Y/

Summer Colling and Emma Wille speak with oncology experts Nkiru Ibeanu, Neha Anand, Anna Simmons and David Dahan about the 2025 American Society of Clinical Oncology (ASCO) conference. Deeper coverage is available through Datamonitor Healthcare