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

【3分で解説  #世界のファーマ】第25回 中国、民間保険で新薬のアクセス拡大へ

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

VC가 한발 물러설 때 바이오 기업의 대체 자금원은? (Korean-language podcast)

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]

Navigating What’s Next for Global Drug Development: What Sponsors Need to Know

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/ 

Drug Fix: US FDA Changes COVID-19 Vaccine Labeling, Reimbursement Confusion Rises

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

Scrip's Five Must-Know Things - Sept. 1, 2025

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-nhsa-releases-preliminary-innovative-drug-list-for-first-time-JOSACB66CZA6BOZNDEGFTLLWSU/

China Biopharma English-Language Podcast: China Innovative Drugs And Commercial Insurance

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.

Is It Better To Be A Sustainability ‘Shaper’ Or ‘Staller’? With PA Consulting’s Rhea Patten

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/

Drug Fix: US FDA Drops Offit, Others From Adcomms, Releases Unapproved Product Rejection Letters

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

Scrip's Five Must-Know Things - September 5, 2025

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.

From Abandonment To Opportunity In Pediatric Pharma

Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.

Is It Better To Be A Sustainability ‘Shaper’ Or ‘Staller’? With PA Consulting’s Rhea Patten

Citeline

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