Citeline Podcasts

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年3月6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: 中小型企业考虑在最惠国待遇下拓展欧洲市场；辉瑞CEO谈FDA疫苗审批决策；人工智能时代大型药企对CRDMOs有何期待；神经科学研究资金蓄势复苏；优时比与中国达成重大合作。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-N3WEPHD34BHGBGRM5BNJPTS2NY/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended Mar.6, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – smaller companies consider European expansion under MFN; Pfizer CEO on FDA vaccine decisions; what does big pharma want from CRDMOs in AI age; neuroscience funding poised for comeback; and UCB’s big China deal. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-N3WEPHD34BHGBGRM5BNJPTS2NY/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery and Senior Editor Sue Sutter are joined by special guests Michael Rogers, former US Food and Drug Administration associate commissioner for inspections and investigations, and Douglas Stearn, former principal deputy associate commissioner in the FDA Office of Inspections and Investigations, both now at Canal Row Advisors. They talk about the current state of the agency inspection cadre and resource challenges (1:04) and offer thoughts on the FDA’s efforts to increase foreign inspections (25:24), as well as discuss the growing threat that receiving an Official Action Indicated (OAI) classification presents (35:20) and consider whether user fee goals eventually could be impacted (45:02). More On These Topics From The Pink Sheet US FDA Use of ‘Potential Official Action Indicated’ Flag Raises Concerns About Facility-Based CRLs: https://insights.citeline.com/pink-sheet/compliance/us-fda-use-of-potential-official-action-indicated-flag-raises-concerns-about-facility-based-crls-3JLUE3CW6BEIFOKQRZ5C4FKFOM/ US FDA’s Failure To Implement Key Workforce Reforms Puts Oversight At Risk, GAO Says: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-failure-to-implement-key-workforce-reforms-puts-oversight-at-risk-gao-says-B64V7RAIQNBNBI57ID5ZU3DYAE/ US FDA Remote Assessments Need Clearer Closeout Process, More Transparency, Experts Argue: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-remote-assessments-need-clearer-closeout-process-more-transparency-experts-argue-4P5UQEPW7NDLNDDQERUQY5Y56M/

The European market for probiotic dietary supplements is one of the most dynamic, but also one of the most complicated, areas of self‑care right now. Probiotics are hugely popular with consumers, widely used across Europe, and backed by an expanding body of science. But for companies trying to bring these products to market, one major obstacle remains: the European Union’s fragmented and highly restrictive regulatory environment. To help us unpack this, I’m joined on this episode of HBW Insight’s Over the Counter podcast by one of the leading experts on probiotics and the wider “biotics” category: David Pineda Ereño, managing director of DP International Consulting. In this first part of our conversation, we explore why the current international definition of “probiotic,” which currently includes the assertion that these microorganisms confer a health benefit on the host. It is this inbuilt health claim that has become such a regulatory sticking point in Europe. We discuss whether this definition could be revisited at the Codex Alimentarius level, and what that might mean for future harmonization. We also look at the growing divergence within the EU, as countries like Italy, Spain, Denmark and others move away from the European Commission’s restrictive position and allow the use of the term “probiotic” under certain conditions. Timestamps 2:00 – Introductions 4:30 – What are probiotics? 6:00 – Probiotic regulation in Europe 12:30 – Changing the definition 16:30 – The EFSA view 19:30 – EU member state divergence 22:15 – The Commission view 24:00 – What’s next? Guest Bio David Pineda Ereño is managing director of DPE International Consulting, an international consultancy firm that provides strategic and regulatory advice on the policy, regulation and trade of foods and food supplements. David has over 20 years of experience providing strategic solutions to companies, trade associations, and government bodies at national, regional, and international level, in Europe, Latin America, Asia, Middle East and Africa, and the United States.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年3月2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: Zealand首席执行官呼吁终结减肥竞赛；默沙东谈人工智能辅助研发管线；布鲁斯·莱文的CAR-T疗法故事；生物制药并购活动回暖；2025年美国IPO市场艰难。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LTCVEH6JLFGRXBOQCFW6V72NVI/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended Feb.27, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Zealand CEO calls for end to weight loss Olympics; MSD on AI-assisted pipelines; Bruce Levine’s CAR-T stories; biopharma dealmaking bounces back; and 2025 was a tough year for US IPOs. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LTCVEH6JLFGRXBOQCFW6V72NVI/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Editor-in-Chief Nielsen Hobbs and special guest Dave Wallace, executive editor of Generics Bulletin, discuss the generic industry’s future direction and priorities (:27) and the impact of recent policy moves on the biosimilar industry (12:28) following their trade association’s annual meeting, as well as US Food and Drug Administration Commissioner Martin Makary’s comment on compassionate use and the concern it may have caused industry (20:23). More On These Topics From The Pink Sheet The State Of The Off-Patent Union: AAM’s Murphy Sets Out US Achievements And Obstacles: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/the-state-of-the-off-patent-union-aams-murphy-sets-out-achievements-and-obstacles-in-us-IHJH2CZBX5GGTI6UJQVE2WO2G4/ ‘Biology Is Dirty’: HHS’s Principal Deputy Counsel On How Biosimilar Firms Can Help US FDA: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/biology-is-dirty-hhss-principal-deputy-counsel-on-how-biosimilar-firms-can-help-us-fda-2GEAUSXNMRCYNIXPS7P6IAYESE/ Makary’s Compassionate Use Comments, Later Clarified, Still May Startle Industry: https://insights.citeline.com/pink-sheet/rare-diseases/makarys-compassionate-use-comments-later-clarified-still-may-startle-industry-XPBVZ6MH7FC7JKP2XEL4ZESWSE/

Swedish biotech Affibody has spent over two decades engineering proteins 1/20th the size of a conventional monoclonal antibody — and CEO David Bejker believes they're perfectly suited to solve one of radioligand therapy's biggest problems: a dangerously narrow target space. Bejker discusses how Affibody's platform combines the selectivity of antibodies with the biodistribution flexibility of small molecules, the science behind its Albumod technology, and how its HER2 imaging and therapeutic programs are translating from animals to humans. He also digs into partnerships with AstraZeneca's respiratory unit and complement-focused Rally Bio, manufacturing advantages of E. coli-based production, and Affibody's long-term ambitions as a commercial-stage company.

특허 만료와 미국 내 약가 압박은 대형 글로벌 제약사들이 극복해야 할 과제이며, 다수 제약사가 올해 소폭의 실적 상승을 전망하고 있다는 Scrip 기사를 요약한 내용입니다. https://insights.citeline.com/scrip/drug-pricing/drug-makers-confront-headwinds-in-2026-but-mfn-doesnt-seem-like-a-big-one-YYQBO72NSNCHBE6EBPKF2GSDB4/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年2月20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: 哈德森在赛诺菲的遗产；特朗普推动美国制药投资背后的现实；拜耳的精准医疗战略与增长；今年值得关注的临床试验；以及Scrip关于人工智能与运营卓越的专题访谈。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-GO7ZGTBFEJDA5OUKAXHCTBVBDU/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended February 20, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Hudson’s legacy at Sanofi; the realities behind Trump’s US pharma investment push; Bayer’s precision medicine approach and growth; clinical trials to look out for this year; and Scrip Asks on AI and operational excellence. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-GO7ZGTBFEJDA5OUKAXHCTBVBDU/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss a series of US Food and Drug Administration proposals for user fee program changes that would advance President Trump’s priorities and the concerns they raise (:31). They also consider the impact of the agency’s decision to review Moderna’s mRNA flu vaccine application shortly after refusing to file it and using accelerated approval for one of the proposed indications (8:37), as well as ideas for sponsors wondering if their development advice is still good (25:24). More On These Topics From The Pink Sheet US FDA Proposing White House-Aligned Policies For User Fee Agreements: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-proposing-white-house-aligned-policies-for-user-fee-agreements-D5JWRDGLCFBT7CYT3FGK3JAZNI/ After Moderna Flu Vaccine, Is US FDA’s Accelerated Approval A Pathway Or A Pressure Valve?: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/after-moderna-flu-vaccine-is-us-fdas-accelerated-approval-a-pathway-or-a-pressure-valve-EWMFKFWO3BB3JA6CQHC4E3JWPA/ Moderna Flu Vaccine Debate Could Resolve With Postmarket Study, FDA’s Makary Suggests: https://insights.citeline.com/pink-sheet/vaccines/moderna-flu-vaccine-debate-could-resolve-with-postmarket-study-makary-suggests-Y3R657N2JZABRGFOSKADM33YA4/ Horse Trading? Oz, Bourla Exchange MFN Codification, Vaccine Collaboration Requests: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/horse-trading-oz-bourla-exchange-mfn-codification-vaccine-collaboration-requests-X6UDDVOSMRBSTO5WC224IN6PTE/

Renée Aguiar-Lucander, CEO of Hansa Biopharma, discussed the company’s leading asset, its journey toward US FDA approval and the trials and tribulations of completing a Phase III program.

In Part 2 of HBW Insight’s conversation with sustainability leader Steve Ramus, we dig into the practical realities shaping the future of sustainability in consumer health, from what consumers are actually willing to pay for, to why packaging, supply chains and long‑term planning remain some of the industry’s toughest challenges. Drawing on two decades of sustainability and ESG experience, Ramus explains how consumer price sensitivity varies across markets, why sustainability can ultimately make companies more efficient, and how inflation complicates the conversation. We also explore the complex world of pharmaceutical packaging — where safety, stability and regulation often collide with expectations around plastics, recyclability and waste — and why progress, though slow, cannot stall. Timestamps: 2:00 – Will consumers pay more for sustainable OTCs? 7:00 – You don’t want to be unsustainable 9:00 – ESG is good for business 10:00 – Retailer expectations 15:00 – The state of play in OTC packaging 20:00 – The challenge of replacing plastic 23:00 – The challenge of recycling 27:00 – Sustainability priorities right now 31:00 – Supply chain 32:00 – The life of a sustainability professional Guest Bio: Steve Ramus is a global sustainability and ESG executive with 20 years of experience aligning strategy with business growth, risk mitigation, and value creation. As former Vice President of Sustainability & ESG at Perrigo, he led: ESG reporting, climate strategy, responsible sourcing, human rights due diligence, packaging circularity, community engagement and other initiatives that improved ESG ratings, delivered cost savings, and generated millions in incremental revenue. Steve advanced his career within the business having led teams in both HR and Sales, prior to his roles in sustainability.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年2月13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: Scrip问答—研发创新专题；拜耳“颠覆性”中风研究成果；阿斯利康精准肿瘤学战略；吉利德首席医学官谈研发管线；印度制药领袖论创新驱动。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EP6IJB43CRG7XBFEWVVN7V3FXE/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended February 13, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Scrip Asks on R&D Innovation; Bayer’s “paradigm-changing” stroke results; AstraZeneca’s precision oncology approach; Gilead’s CMO reflects on pipeline; and India’s pharma chiefs on driving innovation. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EP6IJB43CRG7XBFEWVVN7V3FXE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the US Food and Drug Administration’s controversial decision to refuse to file Moderna’s mRNA-1010 seasonal influenza vaccine candidate, including the unusual public airing of grievances (2:10), the changing issues sparking RTF actions (5:51), the uncertainty created by the decision and how vaccine sponsors should react going forward (16:54). More On These Topics From The Pink Sheet Moderna Cites Changing Advice As US FDA Refuses To File Flu Vaccine BLA: https://insights.citeline.com/pink-sheet/vaccines/moderna-cites-changing-advice-as-us-fda-refuses-to-file-flu-vaccine-bla-SRLIEHHMOFEWFPTLYJCXFIF5FM/ HHS Defends US FDA Refusal To File Moderna’s Flu Vaccine: https://insights.citeline.com/pink-sheet/vaccines/hhs-defends-us-fda-refusal-to-file-modernas-flu-vaccine-NULTQ6P6R5C6DDXZFMZROE3HRU/

Bronchopulmonary dysplasia affects up to 90% of extremely preterm infants, yet no approved therapies exist. In this episode of the In Vivo podcast, Airway Therapeutics CEO Marc Salzberg discusses how their Phase Ib study of zelpultide alfa, a recombinant surfactant protein D, showed substantial reductions in BPD incidence and mechanical ventilation time. Salzberg explains the unique challenges of running neonatal trials, navigating regulatory pathways for vulnerable populations, and why preventing BPD could unlock broader respiratory applications. From ethics and enrollment to EMA approval and global expansion, this episode explores what it takes to develop breakthrough medicines for the smallest, most fragile patients.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年2月6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—默克寻求填补Keytruda空缺；诺华力争突破最长专利到期期； 诺和诺德预警销售额大幅下滑；辉瑞看好肥胖症治疗前景；礼来期待奥福格利普隆取得成功。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JES32O67YRBSLC6UV2JFY5KPBQ/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended February 6, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Merck looks to fill Keytruda’s shoes; Novartis aims to push through largest expiry period; Novo warns of steep sales decline; Pfizer bullish on obesity; and Lilly expects orforglipron success. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JES32O67YRBSLC6UV2JFY5KPBQ/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things