Pharma Intelligence Podcasts

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年3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: 今年将有众多重磅药物失去市场主导地位; 司美格鲁肽在印度的命运；跨国药企不再满足于单纯的中国授权； Almirall瞄准中国皮肤科资产；欧盟被敦促恢复生物制药竞争力。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-KZ6RVPJK6BAADJKFNBUNOTMB6M/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended Mar.13, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – many blockbusters to fade this year: semaglutide's India reckoning; multinationals look beyond simple China licensing; Almirall eyes China dermatology assets; EU urged to restore biopharma competitiveness. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-KZ6RVPJK6BAADJKFNBUNOTMB6M/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, and Editor-in-Chief Nielsen Hobbs discuss the next steps after a federal judge ruled the reconstitution of the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP), as well as recent changes to the childhood vaccine schedule, likely violated the law (:32). They also consider the responses to the decision from some controversial committee members (9:06) and prior ACIP priorities that now are delayed (14:50). More On These Topics From The Pink Sheet Federal Court Halts US CDC Vaccine Panel Appointments, Immunization Schedule Changes: https://insights.citeline.com/pink-sheet/vaccines/breaking-judge-stops-us-cdc-childhood-immunization-changes-acip-appointments-RBZR2RZY2BEU3IOXQT2MDBKKFM/ Fantasy Agenda: The ACIP Meeting That Could Have Been: https://insights.citeline.com/pink-sheet/vaccines/fantasy-agenda-the-acip-meeting-that-could-have-been-S4P2UO3G4FBOBAJGJUWRZ6IO6M/ Mail Not Enough? US FDA Considers New In-Home Opioid Disposal Requirements: https://insights.citeline.com/pink-sheet/product-reviews/post-marketing-regulation-and-studies/mail-not-enough-us-fda-considers-new-in-home-opioid-disposal-requirements-W3VJOHOHYZCMZK4THBCE2GKKCY/

What does it take to move from concept to commercial vaccine manufacturing at speed without compromising quality or compliance? In this conversation, leaders from Alfasigma's CDMO arm, Morpho, share a detailed look at how they approached a complex vaccine technology transfer, from facility upgrades to regulatory approval. The discussion offers a grounded perspective on execution, coordination, and capability building in today's evolving CDMO landscape. This podcast explores: • The role of facility design, sterile manufacturing, and cold chain expansion • Why flexibility in equipment and formats matters for biological products • Approaches to contamination control and aseptic processing • Coordinating engineering, quality, and regulatory teams under tight timelines • What this project reveals about broader CDMO trends, from personalization to speed and sustainability

최근 미국의 BIO 투자자 및 성장 서밋에서 투자자들은 초기 단계 신경과학 분야의 자금 조달 환경이 여전히 어렵지만, 이 분야에 대한 관심이 높아지고 있다는 징후가 보인다고 말했습니다. Scrip이 취재한 내용을 요약했습니다. AI 기반 텍스트 음성 변환 및 음성 모방 도구의 도움을 받아 제작되었습니다. Story link: https://insights.citeline.com/scrip/business/financing/neuroscience-drug-development-funding-poised-for-a-comeback-GEVK5NDEFRBSBKNEP67XY7QW6A/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

The final week of February saw the AAM hold its Access! 2026 annual conference in Miami and Medicines for Europe hold its annual regulatory and scientific affairs conference in Amsterdam. Generics Bulletin was there at both events and our reporters discuss the key takeaways in our latest podcast.

Probiotics remain one of the fastest‑growing segments in consumer health, but companies still face the challenge of operating in a fragmented claims environment, building credible brands, and communicating benefits to increasingly savvy consumers. In part two of HBW Insight's interview with probiotics expert, David Pineda Ereno, we explore how leading players are finding ways through this complexity: from launching strategically in more permissive markets like Italy and France, to using umbrella brands and authorised nutrient claims to support probiotic innovation. Finally, we turn to postbiotics, a newer but fast‑developing area that could open up additional commercial opportunities. With their stability and easier formulation, postbiotics are gaining traction — but they bring their own regulatory considerations too 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 US.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年3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: 罗氏的吉雷德斯特兰特（giredestrant）III期试验遭遇挫折；BioNTech创始人退出公司； 伊普森将撤回Tazverik；拜耳面临困境；以及UCB的Bimzelx再获利好。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LMR3CRGKRFDWLHTOSBRDCRM7GE/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended Mar.13, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Roche faces giredestrant Phase III setback; founders exit BioNTech; Ipsen to withdraw Tazverik; tough times for Bayer; and another boost for UCB's Bimzelx. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LMR3CRGKRFDWLHTOSBRDCRM7GE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman and Editor-in-Chief Nielsen Hobbs discuss potential directions for the US Food and Drug Administration's Center for Biologics Evaluation and Research after the departure of Director Vinay Prasad (:32), including similarities between the center's leadership issues and the staffing problems in the Harry Potter saga's Hogwarts School of Witchcraft and Wizardry (7:48), as well as the potential policy implications (10:11). They also discuss the contributions of the agency's Real-Time Oncology Review (RTOR) pilot program to the quick reviews of two Commissioner's National Priority Voucher (CNPV) awardees (17:19). More On These Topics From The Pink Sheet US FDA's Vinay Prasad, Controversial CBER Director, Leaving In April: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-vinay-prasad-controversial-cber-director-leaving-in-april-DJO7ACE73RCNTLZKQWCN2S26LM/ US FDA's CNPV Approvals Ride RTOR Pilot's Coattails: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/us-fdas-cnpv-approvals-ride-rtor-pilots-coattails-3HEGU5MDWJEG7OYHSZQR6TE5NM/

What if a drug could kill cancer cells broadly, spare the immune system and then train it to keep fighting, without triggering resistance? That's the promise behind the ELANE pathway, a mechanism discovered not from a hypothesis but from studying fundamental biology in patients. In this episode of the In Vivo Podcast, Court Turner, CEO and co-founder of Onchilles Pharma, and Lev Becker, CSO and scientific founder, discuss how a neutrophil elastase-based mechanism is being translated into N17350, a first-in-class intratumoral agent targeting solid tumours including head and neck, skin and breast cancers. With $40m raised, GMP manufacturing of thousands of clinical doses completed, a US IND approved, and a first-in-human study underway in Australia, Onchilles is moving from "stubborn optimism" to clinical execution. Court and Lev discuss the dual mechanism that sets N17350 apart from both traditional chemotherapy and immunotherapy, why histone H1 functions as a universal tumour vulnerability rather than a conventional biomarker, and how they're thinking about combinations, partnering and the eventual value story for payers.

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 60, 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

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the impact of new data showing US Food and Drug Administration hiring increasing, but net employee losses continuing (1:13), including how the issue could be reflected in the user fee program going forward (7:40) and where the strains will emerge as the agency continues to navigate its workload (11:43). More On These Topics From The Pink Sheet US FDA's Drugs, Biologics Centers See Increased Hiring, But Not Enough To Overcome Departures: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-drugs-biologics-centers-see-increased-hiring-but-not-enough-to-overcome-departures-XGMD6U2QHFGULBLCBTRCBWATNQ/ PDUFA VIII: Industry Proposes Funding Changes To Reflect ‘Realistic Ability To Hire Staff': https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/pdufa-viii-industry-proposes-funding-changes-to-reflect-realistic-ability-to-hire-staff-AALJBBI5BJEKLEBGIRFL6ZKDQA/ 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/ A Strong Year For US FDA Approvals, But Warning Lights Flashing: https://insights.citeline.com/pink-sheet/product-reviews/approvals/a-strong-year-for-us-fda-approvals-but-warning-lights-flashing-OEYQQ4RRDVHEVPAFYXPQ4LRHOA/

With the European Union rolling back parts of its Green Deal — including scaling back major legislation such as the Corporate Sustainability Reporting Directive and the Corporate Sustainability Due Diligence Directive — and the US splintering into state‑by‑state sustainability mandates, global OTC companies are facing a fresh wave of uncertainty around their sustainability strategies. It's no surprise, then, that many are acting and investing more cautiously. But for sustainability expert Steve Ramus, formerly VP for Sustainability & ESG at Perrigo, now is precisely when leadership matters most. Sustainability teams, he argues, should be helping their executives and boards see that doing the “right” thing is also the competitive thing. Companies that keep moving through the uncertainty, he says, will be faster, leaner and far better prepared than those waiting on the sidelines. Timestamps: 3:00 – Introductions 4:50 – The state of sustainability in consumer health 9:00 – The business case for sustainability 14:30 – Where are we heading? 17:20 – Making the case for sustainability within companies 20:30 – The chilling effect of uncertainty

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年1月30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—阿斯利康宣布重大中国投资计划；诺华高管警示早期临床试验竞争压力；中国生物科技企业借IPO筹资海外试验；默克公司谈成功交易；深度解析印欧自由贸易协定。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T7BHL2UUN5DY3ENU5ZRTCY7YIE/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 30, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – AstraZeneca's big China investment pledge; Novartis exec's warning on early trial competitiveness; Chinese biotechs tap IPOs to fund foreign trials; Merck & Co on winning deals; and breaking down the India-EU free trade agreement. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T7BHL2UUN5DY3ENU5ZRTCY7YIE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss details recently unearthed about the role center directors play in the Commissioner's National Priority Voucher review process and the influence they could have over the review division (:32). They also discuss the CNPV Review Council's membership (16:58) and the program's resource needs (27:28). More On These Topics From The Pink Sheet US FDA CNPV Reviews Clarified: Center Director Approval Recommendations Not Binding, HHS Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/us-fda-cnpv-reviews-clarified-center-director-approval-recommendations-not-binding-hhs-says-GRCFLKAPVZCWPGPT3I36B2WXI4/ FDA Voucher Program Approvals Will Come From Product Centers, But Ambiguity Lingers: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/fda-voucher-program-approvals-will-come-from-product-centers-but-ambiguity-lingers-KBX2KFYONBEEVF4AJN3PV2AH4A/ US FDA Adds Facility Data To Commissioner's Priority Voucher Pre-Submission Requirements: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/us-fda-adds-facility-data-to-commissioners-priority-voucher-pre-submission-requirements-2XYJICOLOFBUNJVOTSXFNXSBSE/

Tim Lu, CEO of Senti Bio, joins In Vivo to discuss how programmable cell therapies are solving oncology's targeting problem. Lu explains the logic-gated approach behind SENTI-202, an allogeneic CAR-NK therapy for relapsed/refractory AML that achieved 50% response rates in Phase 1 while avoiding the dose-limiting toxicities that have plagued other AML cell therapies. We cover the Phase 1 ASH 2025 data showing 39% complete remission rates (all MRD-negative) with 7.6-month median duration, the rationale for using NK cells over T cells, and why synthetic biology's three-target logic gates can distinguish cancer from healthy bone marrow cells. Lu also discusses plans for pivotal trials following RMAT designation, expansion into solid tumors, and where biotech innovation is accelerating versus where clinical translation bottlenecks remain. For biopharma professionals tracking cell therapy innovation, synthetic biology applications, and AML treatment advances.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年1月23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—强生肿瘤业务前景；葛兰素史克收购Rapt交易；2026年最受期待的新药上市；摩根大通乐观的财务展望；以及Scrip对竞争格局的深度解析。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RQH7ZGCHCBHZXOVSG7V53XIV54/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 23, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – J&J's oncology prospects; GSK's Rapt deal; 2026's biggest expected launches; optimistic financial outlook at JPM; and Scrip Asks about the competitive dynamics landscape. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RQH7ZGCHCBHZXOVSG7V53XIV54/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip senior editor Jessica Merrill, Scrip US managing editor Mandy Jackson and In Vivo senior reporter David Wild discuss trends and topics from interviews and presentations at the J.P. Morgan Healthcare Conference and Biotech Showcase.

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Managing Editor Bridget Silverman and Editor-in-Chief Nielsen Hobbs consider the US Food and Drug Administration's average speed of a novel drug application review in 2025 (:34), including the loss of so-called “fast approvals” (5:33) and how reviewers managed to ignore the distractions caused by the changes (7:35). They also consider whether the layoffs and other departures will impact the review system in 2026 (11:16). More On These Topics From The Pink Sheet Average Metrics In A Turbulent Year: US FDA's 2025 Median Review Times Match PDUFA Goals: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/average-metrics-in-a-turbulent-year-us-fdas-2025-median-review-times-match-pdufa-goals-FOEPKT27UFAHPDS36HKJFOHOQE/ It's About Time: US FDA's Review Speed For Novel Approvals In 2025: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/its-about-time-us-fdas-review-speed-for-novel-approvals-in-2025-6LMDCANRRZGWTIDSRKFVXCJRPY/ US FDA's 2025 Staffing Turmoil Will Create 2026 Application Review Challenges: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-2025-staffing-turmoil-will-create-2026-application-review-challenges-AJIE7WRQ2ZFS7IOR5PA3OWFE2M/

Antti Vuolanto, CEO of Herantis Pharma, discusses the significant unmet need in Parkinson's disease and outlines Phase II plans for the company's lead asset HER-096.

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 「Novartis Sounds Alarm Bell On Global Trade Policy（邦訳：ノバルティスが警鐘を鳴らす　自国第一主義の貿易政策めぐり）」 Article link: https://insights.citeline.com/scrip/drug-pricing/novartis-sounds-alarm-bell-on-global-trade-policy-GRXGDPFNE5E2VNHXZMK67CYEFI/ 公開書簡のURLはこちら Open Letter: https://www.novartis.com/sites/novartis_com/files/letter-to-global-governments.pdf?utm_campaign=pharmalittle&utm_medium=email&_hsenc=p2ANqtz--ND6BAwNYOXJlpATFKTFHmMTF6pv7a_72Ft7BD6JemCR-91pUUsDLTiRGjuqtDcyqTBbMVLBh_0RmYh8063YZw3HoWfPAwsgK6z1yCvjYrBnwAY4g&_hsmi=398727134&utm_content=398727134&utm_source=hs_email ※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1月16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—摩根大通弥漫乐观情绪；Scrip探析2026年资本配置与并购趋势；安永指出中国并购增长值得关注；礼来收购Ventyx引发对NLRP3抑制剂的热议；诺和诺德基金会助力欧洲初创企业。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XE634WMH7FHA3AHR4MPJ65VOQM/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 16, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – optimism reigns at J.P. Morgan; Scrip Asks what 2026 holds for capital allocation and dealmaking; EY says keep eye on China as deals grow; Lilly's Ventyx buyout raises NLRP3 inhibitor interest; and Novo Nordisk Foundation backs Europe startups. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XE634WMH7FHA3AHR4MPJ65VOQM/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs consider the many concerns Richard Pazdur and others raised about the US Food and Drug Administration's Commissioner's National Priority Voucher Program (CNPV) (:37), including potential legal issues (10:35), as well as the possibility of releasing the full action package for an unapproved application, given the resources that likely would be required (18:16). More On These Topics From The Pink Sheet Commissioner's National Priority Voucher Program Reflects US FDA Review Politicization, Pazdur Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/commissioners-national-priority-voucher-program-reflects-us-fda-review-politicization-pazdur-says-A43CKFRDVBHTLESE6IQE6JXLGM/ US FDA Gauging Impact, Resource Use In Commissioner's Voucher Pilot As Concerns Grow: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-gauging-impact-resource-use-in-commissioners-voucher-pilot-as-concerns-grow-7WQB3TOQERGXJPAIV5465GOBLM/ With Unapproved Drug Complete Response Letters Now Public, Are Action Packages Next?: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/with-unapproved-drug-complete-response-letters-now-public-are-action-packages-next-S4Y5ANUYE5DOTC7YVTALA3GPIE/

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年1月9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—口服版Wegovy在美国上市； 2025年中盘股最大催化剂；去年小盘股转型与僵尸股清算；去年上市新药面临的商业逆风；以及中国企业全球三期临床动态。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ZV4GVVROYBEN7I6DQBOMQ3A3XE/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip의 2026년 글로벌 제약바이오 산업 전망 (1부: 자본배분과 딜메이킹)을 요약한내용입니다. https://insights.citeline.com/scrip/scrip-asks/scrip-asks-what-does-2026-hold-for-biopharma-part-1-capital-allocation-and-dealmaking-U3B4EUN3GZGNXM6QI3ZGXVMNZY/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 9, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – oral Wegovy launches in the US; the biggest mid-cap catalysts in 2025; small cap pivots and zombie killers last year; commercial headwinds for last year's launches; and a look at Chinese firms' global Phase III activity. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ZV4GVVROYBEN7I6DQBOMQ3A3XE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

PreVision Policy Founding Member Michael McCaughan joins Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs to discuss the career and legacy of Richard Pazdur, the long-time head of the US Food and Drug Administration's oncology drug review division and Oncology Center of Excellence. They consider his brief stint as Center for Drug Evaluation and Research director and decision to retire (:55), his impact on oncology (4:36), as well as reflect on his famous “Pazdur Moments” (18:41), the future of legacy programs like Project Orbis (28:52), and whether the FDA can find another leader like him (33:54). More On These Topics From The Pink Sheet US FDA's Richard Pazdur: Appreciating An Extraordinary Career: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-richard-pazdur-appreciating-an-extraordinary-career-YD2GBQ7WOZHM5BNAKWJF4OQVFM/ Modernizing Accelerated Approval: One Of Pazdur's Biggest Legacies: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/modernizing-accelerated-approval-one-of-pazdurs-biggest-legacies-4QPXDRZ7SNBE7EUOG5VWWILGDY/

Intranasal vaccines are back in the spotlight as highly pathogenic avian influenza spreads among birds and spills over into mammals, including recent cases in dairy and poultry workers. In this episode of In Vivo, senior pharma and biotech reporter David Wild talks with Chad Costley, CEO of BlueWillow Biologics and Meagan Deming, an infectious disease researcher at the University of Maryland School of Medicine about a novel intranasal recombinant H5 flu vaccine that aims to stop infection at the gate by building mucosal immunity in the nose. They discuss recent Phase I data, pandemic‑flu preparedness, BARDA/NIH funding realities, and how BlueWillow's NanoVax platform could extend to other major respiratory threats, including TB.