Citeline Podcasts Citeline

Pink Sheet editors discuss the US FDA’s consideration of regulatory changes to promote innovative clinical trial designs (:32), an NIH proposal to require patent licensees create plans to ensure access to the commercialized product (7:29), and lawmakers longing for the days when Janet Woodcock ran the FDA’s Center for Drug Evaluation and Research (15:35).

More On These Topics From The Pink Sheet

‘Antiquated’ Regulations Slowing Adoption of Innovative Clinical Trial Approaches: https://pink.citeline.com/PS154730/Antiquated-Regulations-Slowing-Adoption-of-Innovative-Clinical-Trial-Approaches

US FDA Looking To Modernize Clinical Trial Regulations To Spur ‘Evolution’ In Research: https://pink.citeline.com/PS154721/US-FDA-Looking-To-Modernize-Clinical-Trial-Regulations-To-Spur-Evolution-In-Research

NIH Drug Patent Licensees Would Develop ‘Access Plan’ Under Proposal; Pricing Commitments Optional: https://pink.citeline.com/PS154744/NIH-Drug-Patent-Licensees-Would-Develop-Access-Plan-Under-Proposal-Pricing-Commitments-Optional

Woodcock Nostalgia: GOP Rep. Bilirakis Wants CDER To Recapture Her Flexible Approach: https://pink.citeline.com/PS154745/Woodcock-Nostalgia-GOP-Rep-Bilirakis-Wants-CDER-To-Recapture-Her-Flexible-Approach

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
「Hibernating Squirrels And Exercise In A Pill: The Next Wave of Cardiometabolic Therapies（ 邦題意訳：GLP-1を超える心代謝系治療薬のヒントは、冬眠するリスか、地道な運動か）」

（日本語版）
https://www.citeline.com/ja-jp/resources/hibernating-squirrels-and-exercise-in-a-pill
※全文の閲覧には情報の登録（無料）が必要です。

（英語版）
https://scrip.citeline.com/SC150222/Hibernating-Squirrels-And-Exercise-In-A-Pill-The-Next-Wave-of-Cardiometabolic-Therapies

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

In this episode of the In Vivo podcast, Hakim Yadi, CEO and co-founder of UK techbio company Closed Loop Medicine, discusses how his company is pairing software and predictive analytics with medications old and new to tailor drug dosing to each patient.

In this episode, HBW chats with John Hite of the leading producer responsibility organization administering three Extended Producer Responsibility laws launching next year. With a 1 July deadline to register for his PRO, Circular Action Alliance, Hite discusses steps companies should take now, how his organization will assist producers and expectations on fee collection.

빅파마 기업들의 블록버스터 신약 확보 전략에 대한 Scrip 기사를 요약한 내용입니다.
https://scrip.citeline.com/SC150256/Development-Versus-Dealmaking-How-To-Obtain-A-Blockbuster
Playlist: https://soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

In this episode, HBW Insight catches up with Albert Swane, founder and CEO of Dutch consumer healthcare firm, TheOTCLab, to talk about business strategy. Having grown the company with widely successful European OTC medical devices like Dr. Yglo, FungeX and Kidsner, Swane is perfectly placed to explain how to create and grow OTC brands. Swane also offers some sage advice on partnering, reflects on the fantastic opportunity of TheOTCLabs expanding into the US, and shares his experiences of using social media to raise the profile of the OTC industry.