Pink Sheet reporters and editors discuss the FDA’s approach to psychedelic drugs (:25), whether postmarket clinical trial data from the Alzheimer’s drug Aduhelm will be published (16:32), and the FDA offering more time to find candidates for its new Genetic Metabolic Diseases Advisory Committee (27:19).

More On These Topics From The Pink Sheet

Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance: https://pink.citeline.com/PS149813/Lykos-MDMA-NDA-Leads-Upcoming-Tests-Of-US-FDAs-Psychedelics-Draft-Guidance 

For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards: https://pink.citeline.com/PS149812/For-Psychedelics-US-FDA-Is-Open-To-Creative-Thinking-But-Firm-On-Approval-Standards 

A Visual Trip Through The Psychedelic Pipeline: https://pink.citeline.com/PS149831/A-Visual-Trip-Through-The-Psychedelic-Pipeline 

Aduhelm’s Post-Marketing Studies: At Least One More Data Dump Likely Required By NIH: https://pink.citeline.com/PS149826/Aduhelms-Post-Marketing-Studies-At-Least-One-More-Data-Dump-Likely-Required-By-NIH 

New US FDA Genetic Metabolic Adcomm Needs More Candidates: https://pink.citeline.com/PS149819/New-US-FDA-Genetic-Metabolic-Adcomm-Needs-More-Candidates

Drug Fix: US FDA And Psychedelic Drugs, Aduhelm Clinical Trial Data, Adcomm Candidates

Audio roundup of selected biopharma industry content from Scrip over the business week ended 17 May 2024. In this episode: the life of a blockbuster; blockbusters by indication; gene therapy struggles; sun shines on AstraZeneca and GSK; and Korean ventures look to Japan.
https://scrip.citeline.com/SC150281/Quick-Listen-Scrips-Five-MustKnow-Things
Playlist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Five Must-Know Things - 20 May 2024

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.

How To Grow A Consumer Health Brand, With TheOTCLab’s Albert Swane

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

개발 VS 딜메이킹: 블록버스터 신약을 확보하는 방법 (Korean-language podcast)

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.

Voice Recorder

Leading PRO Discusses Plans For Administering State EPR Programs

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.

Closed Loop Medicine: Pairing Software With Drugs To Optimize Dosing

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

【3分で解説  世界のファーマ】第18回 GLP-1を超える肥満治療薬のカギとは？(Japanese-language podcast)

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

Drug Fix: Novel Clinical Trial Reg Problems, NIH Drug ‘Access Plans’, Good Ole Days Of Woodcock

Audio roundup of selected biopharma industry content from Scrip over the business week ended 24 May 2024. In this episode: Biogen’s immunology acquisition; AstraZeneca looks to cement respiratory lead; why US FTC is tough on pharma; the US election’s impact on pharma; and how new AI tools are impacting medical affairs.
https://scrip.citeline.com/SC150324/Quick-Listen-Scrips-Five-MustKnow-Things
Playlist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Five Must-Know Things - 27 May 2024

As the 15 July entry deadline for the 3rd edition of the annual Citeline Japan Awards approaches, join us in this bilingual English/Japanese podcast to learn more about the categories and event itself. (Japanese starts at 2' 25".)
English event site: https://www.citeline.com/en/awards/citelinejapanawards
Japanese event site: https://www.citeline.com/ja-jp/awards/citelinejapanawards

Citeline Japan Awards 2024 - Enter Now! (Bilingual English/Japanese)

NeuShen CEO Joan Shen discusses with Brian Yang about developing CNS drugs in China, the venture's business rationale, challenges and fundraising. She also discusses two leading assets for schizophrenia and epilepsy in first-in-human studies, as well as a gene therapy collaboration for ALS with UMass's Gao Lab.
https://scrip.citeline.com/SC150328/China-Biotech-CEO-Interview-Starting-A-CNS-Venture-In-An-Economic-Downturn
Playlist: https://on.soundcloud.com/AaFyPUxfD2RiDEis5

China Biotech CEO Interview - NeuShen's Joan Huaqiong Shen

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.

Drug Fix: US FDA And Psychedelic Drugs, Aduhelm Clinical Trial Data, Adcomm Candidates

Citeline

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