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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 Democratic Wins In Congress Will Fuel MFN, FDA Oversight, May Advance Bipartisan Legislation https://insights.citeline.com/pink-sheet/legislation/elections/democratic-wins-in-congress-will-fuel-mfn-fda-oversight-may-advance-bipartisan-legislation-KGXTFNXCYBE3XGLKI6XX47WNHI/ Another Midterm Wave Coming? US FDA Chief Counsel Announces Departure https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/another-midterm-wave-coming-us-fda-chief-counsel-announces-departure-INESSWGPL5A6NE7VGWCD6JQ3AE/ US FDA Acting Chief Of Staff Sees Stable User Fee Path Despite Democrats’ Capitol Hill Takeover https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-acting-chief-of-staff-sees-stable-user-fee-path-despite-democrats-capitol-hill-takeover-FOLLZZTLH5CNDK2NEI5V4Z3VKI/ This and all our other podcasts are available on the Scrip channel on Apple Podcasts, and Spotify Podcasts and on TuneIn. Scrip YouTube Podcasts: https://www.youtube.com/@scrip-commercial/podcasts Pink Sheet YouTube Podcasts: https://www.youtube.com/@pinkSheet-regulatory-n/podcasts Any comments? [email protected]

For emerging biotech companies, development success is often measured by clinical milestones, safety, and efficacy. However, demonstrating an asset’s value extends beyond regulatory approval. Understanding patient needs and treatment experiences, as well as evolving stakeholder expectations, early in development plays an important role in shaping a more informed evidence strategy. In this podcast, Ashwin Rai, Director of Data Science and Advanced Analytics, and Gale Harding, Senior Research Leader, from the PPD clinical research business of Thermo Fisher Scientific, discuss how integrating real-world data and patient-centered insights earlier in development can help developers address evidence gaps, inform critical decisions, and build a stronger foundation for demonstrating treatment value. What the Podcast Explores • Why evidence planning should begin early in asset development, rather than closer to commercialization • How real-world data can help identify unmet needs, understand patient journeys, and inform development decisions, and why more data doesn’t necessarily mean better data • The importance of capturing patient experiences and outcomes beyond traditional clinical endpoints • How patient-centered research can help address evidence gaps and strengthen an asset’s value story • Why evidence strategies must evolve alongside changing stakeholder expectations and development priorities

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Senior Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs consider the impact of the Health and Human Services Department’s temporary order allowing compounding of unapproved peptides on the drug industry (1:58), including whether stakeholder could use the precedent to gain access to other products (4:05). They also analyze HHS’ dismissal of US Food and Drug Administration safety concerns (11:28). In addition, the group discusses the Pharmaceutical Research and Manufacturers of America’s opposition to releasing complete response letters and the future of legislative efforts to codify the practice (19:52). More On These Topics From The Pink Sheet HHS Peptide Policy Brushes Off US FDA Safety Concerns As Hypothetical: https://insights.citeline.com/pink-sheet/compliance/manufacturing/hhs-allows-compounding-of-six-unapproved-peptides-UEKWZWETHFG4XJXTVA4VUNE3PU/ Peptides Compounding Would ‘Undermine’ US FDA Drug Approval Process, Ex-Agency Official Argues: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/peptides-compounding-would-undermine-us-fda-drug-approval-process-ex-agency-official-argues-7RZQLE3HJ5B4FMB3AUREB5LUZU/ US FDA’s Complete Response Letter Postings A Gift To Chinese Competitors, PhRMA Says: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/us-fdas-complete-response-letter-postings-a-gift-to-chinese-competitors-phrma-says-IJ2VETAAGND5NH6CXWADH3R6TU/

In this episode of Strategic Intent, Partner at Sofinnova Partners, David Evans discusses his transition from Roche Venture Fund, different investments strategies, general market analysis across Europe and US, as well as growing therapeutics area trends within biotech.

Ahead of the awards presentation on Dec 2, the Scrip Awards podcast speaks to Mathai Mammen, CEO of Parabilis, one of the shortlisted companies for Biotech of The Year.

Disease-modifying Alzheimer’s treatments have arrived, but diagnosing the right patients at scale is still a major bottleneck. In this episode of Strategic Intent, Marion Webb (MedTech Insight) speaks with Dr. Soeren Mattke, research professor of economics at USC, director of the Brain Health Observatory, and member of the scientific advisory board of ALZpath, about how FDA-cleared blood tests are changing the picture. They cover why amyloid PET scans and spinal taps struggle to scale, how p-tau217 blood tests work and who makes them, and how primary care doctors can use them to prioritize patients and better prepare referrals to overstretched neurologists. They also discuss test limitations, including false positives and the potential of misdiagnosis when patients have other diseases like kidney disease and obesity, why screening people without symptoms isn’t recommended yet, and the economics: roughly $5,000 for a PET scan versus about $125 for a Medicare-reimbursed blood test. Follow the In Vivo podcast on Apple Podcasts and Spotify to stay ahead of what’s shaping life sciences next.

In the latest episode of Off-Patent, On Record, Generics Bulletin’s senior reporter Urtė Fultinavičiūtė talks to the International Generic and Biosimilar medicines Association’s secretary general Ana Gaunt to mark the start of Global Biosimilars Week, a worldwide awareness and education campaign spotlighting the importance of biosimilars.

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the reasons Iilun Murphy, director of the US Food and Drug Administration’s Office of Generic Drugs, decided to step down (:53) and whether the move should concern senior agency officials (2:51). They also consider the FDA’s plan to create a fit-for-purpose rare disease approval framework (12:19), how it will connect with the agency’s litany of programs for the products (14:52) and the potential difficulties of systematizing regulatory flexibility (18:22).   More On These Topics From The Pink Sheet US FDA Generic Drugs Office Director Steps Down Amid ‘Political Pressure,’ Admin Burden: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/us-fda-generic-drugs-office-director-steps-down-amid-political-pressure-admin-burden-RSIU23LDWZETDO5XYPAAPCIKVM/ US FDA’s Rare Disease Framework Envisions Systematic Regulatory Flexibility: https://insights.citeline.com/pink-sheet/rare-diseases/us-fdas-rare-disease-framework-envisions-systematic-regulatory-flexibility-CKPMVFWBEVF3DNERAJBZZ23EYA/ US FDA Eyes Adaptive Rare Disease Framework To Replace Piecemeal Flexibilities: https://insights.citeline.com/pink-sheet/rare-diseases/us-fda-eyes-adaptive-rare-disease-framework-to-replace-piecemeal-flexibilities-JU2IHKV76ZHYXDZQBW23BE3FRI/

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年10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。本周内容包括：中国带来的竞争威胁；第三季度并购活动降温；新型肺炎球菌疫苗竞争者；西班牙生物技术公司的战略；以及盐野义制药20亿美元的收购案。Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ZCXOSRSNEBCARAW4DUWENVCPSQ/ 向听众们简要更新一下：Scrip现在已在Spotify和Apple Podcasts上开设了专属播客频道。Feedback: [email protected]

In this month's podcast, Shubham Singh discusses BD’s $19bn US investment deal for tariff relief; Brian Bossetta, NET Recovery’s stimulant-use device; George Underwood, Reset Health’s GLP-1 adherence data; and Marion Webb, Hillary Lin’s evidence-based longevity care;

Join us for an audio catch-up on the major events in the global biopharma industry over the past week, as reported by Scrip’s global team, in this podcast version of Five Must-Know Things. This episode covers insights for the business week ended Oct. 9, 2026. This time—China’s competitive threat; M&As cool off in Q3; new pneumococcal vaccine contender; strategy for Spanish biotechs; and Shionogi’s $2bn acquisition.  This and all our other podcasts are available on the Scrip channel on Apple Podcasts, and Spotify Podcastsand on TuneIn.

Can a celebrity campaign still work for a drug company when the FDA is watching every word? In this episode of Strategic Intent, Frank Watanabe, CEO of Arcutis Biotherapeutics, discusses the company’s latest brand awareness push and what it takes to commercialize a topical dermatology drug in an increasingly scrutinized promotional environment.​​ Commercial strategies, ad campaigns, dermatology

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Senior Reporter Maaisha Osman discuss the drama unfolding at the US Food and Drug Administration related to a Health and Human Services Department plan to temporarily allow some compounding of unapproved peptides (:52). They also consider the impact of the FDA’s intent to acknowledge individual NDA and BLA filings (13:00) and whether the policy will have to endure legal challenges (26:48), as well as the potential clinical trial requirements for the psychedelic ibogaine and their potential impact on product development (28:27). More On These Topics From The Pink Sheet US FDA Staff Push Back Against Trump Administration Interim Peptide Dispensing Order: ⁠https://insights.citeline.com/pink-sheet/product-reviews/approvals/us-fda-staff-push-back-against-trump-administration-interim-peptide-dispensing-order-KE3EBXDBNBDKBJBSOBF772HUAY/⁠ Transparency Growing: US FDA Plans Reg Allowing NDA, BLA Filing Disclosure: ⁠https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/transparency-growing-us-fda-plans-reg-allowing-nda-bla-filing-disclosure-5OR6R4R54VFWRBCUKXJOSVMXZQ/⁠ US FDA Signals Cardiac Safety Monitoring Will Be Ibogaine’s Regulatory Hurdle: ⁠https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/us-fda-signals-cardiac-safety-monitoring-will-be-ibogaines-regulatory-hurdle-LGD2YI6EW5GPLBWHUDM3FMUIT4/

In the third episode of Off-Patent, On Record, Generics Bulletin’s senior reporter Urtė Fultinavičiūtė is joined by Sandoz’s head of IP Julia Pike to analyze the European intellectual property system, how it compares to the US, and the financial decisions behind litigation for off-patent companies. For any podcast feedback or queries, you can now reach us at [email protected].

In this Strategic Intent episode, In Vivo speaks with Ken Getz, executive director of the Tufts CSDD and research professor at the Tufts University School of Medicine, and Pamela Tanaerts, CMO and CSO at Medable, to discuss promising data from an AI Clinical Monitoring Agent.