本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年10月24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。

本期聚焦柏林欧洲医学肿瘤学会会议的新成果：Enhertu在早期乳腺癌中的应用；Padcev/Keytruda在膀胱癌领域的突破；Pluvicto的III期试验成功；Trodelvy与Datroway在乳腺癌治疗领域的较量；默克公司为乳腺癌治疗带来新希望。

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EWX3A6U4TBE5NPDYXHIJSWDO3A/

Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 24, 2025. In this episode we focus on the most significant results presented at the European Society for Medical Oncology meeting in Berlin: Enhertu in early-stage breast cancer; Padcev/Keytruda in bladder cancer; Phase III wins for Pluvicto; Trodelvy and Datroway in breast cancer tussle; and Merck & Co. raises hopes in breast cancer. .

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EWX3A6U4TBE5NPDYXHIJSWDO3A/

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 explain the reasons for the US Food and Drug Administration’s planned “Simple Reform” of its inspection group, including the move away from specialized teams (:44). They also consider industry’s current thinking on best practices for navigating the agency’s new position on direct-to-consumer ad regulation (18:45).

More On These Topics From The Pink Sheet

US FDA Plans Move Back To More Generalist Inspectorate: https://insights.citeline.com/pink-sheet/compliance/us-fda-plans-move-back-to-more-generalist-inspectorate-5V3573KXHFAJXH6LVC6NSXW37M/

Industry Rethinking Visual Elements And Quality-Of-Life Claims After US FDA Drug Ad Crackdown: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/industry-rethinking-visual-elements-and-quality-of-life-claims-after-us-fda-drug-ad-crackdown-WMXPANFVC5B55GZZQ6IWJG4FRE/

US FDA Ad/Promo Crackdown Letters Came From OPDP Staff, Not Artificial Intelligence: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/us-fda-adpromo-crackdown-letters-came-from-opdp-staff-not-artificial-intelligence-RKTSXQ5ZV5BPJD4DXGAOS5SS5Q/

Biotech funding is tougher than ever, but some companies still win big. Join Claire Riches, VP, Clinical Solutions, Citeline and Alistair McDonald, CEO of Worldwide Clinical Trials as they reveal insider strategies for securing investors, navigating partnerships, and turning innovative science into real-world success.

View the video series and find out more information here: https://www.citeline.com/biotech

As the potential of in vivo CAR-T therapy moves closer to clinical reality, biotech innovators are reimagining what’s possible in autoimmune disease. With groundbreaking scientific advances and evolving regulatory perspectives, this next generation of cell therapy could redefine how immune-mediated conditions are treated.

In this episode, Pete Robinson, Therapeutic Strategy Director, Novotech, joins Meredith Landry, Managing Editor, Custom Content, Citeline, to discuss how in vivo CAR-T is opening new possibilities for autoimmune therapies—and what it will take to translate early promise into patient impact.

They explore:

• The breakthrough potential of in vivo CAR-T—and what could make it a true game-changer for autoimmune disorders

• Key developments and considerations to realize clinical success

• Global landscape for early phase clinical trials

Hear experts Matthieu Culié and Alessandro Agosti as they discuss how Olon stands out in a competitive landscape through its fully integrated end-to-end ADC manufacturing expertise, global operations, impurity control and strategic facilities.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年10月17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。

本次要闻: 大型药企仍看好细胞与基因疗法前景；ESMO会议关注焦点；科伦制药TROP2抗体药物偶联物创全球首例；强生预期与白宫政策保持一致；BioFuture会议揭示行业不确定性。

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ADAR4VZIGRFIFCOMXI7UTZS76U/

Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 17, 2025. In this episode: big pharma still sees value in cell and gene therapy; what to look out for at ESMO; world first for Kelun’s TROP2 ADC; J&J expects alignment with White House policies; industry uncertainties aired at BioFuture meeting.

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ADAR4VZIGRFIFCOMXI7UTZS76U/

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 reasons US Food and Drug Administration Commissioner Martin Makary could have helped negotiate the Most Favored Nation drug pricing deal with Astra Zeneca (:30) and the deal’s potential impact on the 340B program (16:35). They also consider the Justice Department’s alternative interpretation of off-label promotion regulations and the effect on the scientific exchange of information about drugs (19:16).

More On These Topics From The Pink Sheet

US FDA Commissioner’s Involvement In AstraZeneca Pricing Deal Raises Ethical, Legal Questions: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/us-fda-commissioners-involvement-in-astrazeneca-pricing-deal-raises-ethical-legal-questions-IJV4LMTDA5E65KCOFQUQM76GCA/

EMD Serono IVF Candidate Among First US FDA Priority Voucher Recipients As Part Of MFN Deal: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/emd-serono-ivf-candidate-among-first-us-fda-priority-voucher-recipients-as-part-of-mfn-deal-LKHA6VRTKRE6DJERGNCWCGMBF4/

Manufacturer Most Favored Nation Deals: How They Could Be Protected From 340B: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/manufacturer-most-favored-nation-deals-how-they-could-be-protected-from-340b-FALSG7GHM5GQBFN3I5SPERJIYU/

Off-Label Promotion: DOJ May Take New Look At Scientific Information Exchange: https://insights.citeline.com/pink-sheet/legalandip/litigation/off-label-promotion-doj-may-take-new-look-at-scientific-information-exchange-R62PQJFQTRBCVGCZE57GWM3Q3Q/

Adalvo: Exploring European B2B Pharma’s Next Steps by Citeline