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（複数）

「FDA's Woodcock To Supreme Court: Mifepristone Ruling Will Create 'Significant Chaos’（邦題意訳：FDA幹部、最高裁のミフェプリストン審議で「深刻な混乱」を危惧）」

https://pink.pharmaintelligence.informa.com/PS148056/FDAs-Woodcock-To-Supreme-Court-Mifepristone-Ruling-Will-Create-Significant-Chaos

「Fifth Circuit Mifepristone Ruling May Temporarily Halt Pharmacy Dispensing, Generic Approval（邦題意訳：ミフェプリストン控訴審判決、薬局販売とジェネリック承認は一時停止か）」

https://pink.pharmaintelligence.informa.com/PS148051/Fifth-Circuit-Mifepristone-Ruling-May-Temporarily-Halt-Pharmacy-Dispensing-Generic-Approval

「Will Mifepristone Be Recalled If Texas Ruling Remains In Effect? Biopharma Leaders Back FDA（邦題意訳：テキサス判決、有効ならミフェプリストンはリコール必至？　バイオ製薬社長らがFDA擁護）」

https://pink.pharmaintelligence.informa.com/PS148030/Will-Mifepristone-Be-Recalled-If-Texas-Ruling-Remains-In-Effect-Biopharma-Leaders-Back-FDA

世界の薬事規制ニュースPink Sheet（ピンクシート）とは？
https://www.citeline.com/ja-jp/products-services/regulatory-and-compliance/pink-sheet

Voice Recorder

【3分で解説  世界のファーマ】第10回 どうなるミフェプリストン承認 米国FDAが裁判に危機感 (Japanese-language podcast)

Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.

Future Governance & Oversight of the EU Medtech Regulatory System

Join Scrip's China-based editors Brian Yang and Dexter Yan in this Chinese/English podcast as they look at data presented to AACR by Chinese pharma firms and recent acquisitions of China-based companies. UK-based writer Andrew McConaghie also joins to provide his perspectives, including on the proposed US BIOSECURE Act.
https://scrip.citeline.com/SC150164/China-Biotech-Podcast-AACR-BIOSECURE-European-Perspectives

China Biotech Podcast - 26 April 2024 (Chinese and English Language)

Pulmonologist Bing Xue, MD, reviews the latest GOLD guidelines and discusses relevant topics regarding COPD treatment.

Dr. Xue Discusses Treatment Guideline Updates for COPD in This Q&A Session

Pink Sheet reporter and editors discuss the impact of FDA biosimilar promotion guidance on the future of the interchangeability designation (:34), upcoming guidance on accelerated approval for gene therapies (14:15), and partisan attacks on the agency from Capitol Hill (27:13).

More On These Topics From The Pink Sheet

Rx Advertising: Interchangeability Doesn’t Mean Clinical Superiority To Other Biosimilars, FDA Says: https://pink.citeline.com/PS150143/Rx-Advertising-Interchangeability-Doesnt-Mean-Clinical-Superiority-To-Other-Biosimilars-FDA-Says 

US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios: https://pink.citeline.com/PS150140/US-FDA-Gene-Therapy-Accelerated-Approval-Guidance-Will-Describe-Buckets-Of-Use-Scenarios 

Partisan Politics Returns To US FDA Congressional Oversight: https://pink.citeline.com/PS150114/Partisan-Politics-Returns-To-US-FDA-Congressional-Oversight

Drug Fix: US FDA Biosimilar Strategy, Gene Therapy Accelerated Approvals, FDA v. Partisan Politics

Learn how molecular technology is enhancing patient safety for CAR-T clinical trials. 

US FDA recently initiated class safety labeling changes after evaluating the safety of CAR-T cancer treatment therapies. What does this mean for developers in the CAR-T landscape? Listen to your free podcast to find out.

Listen in on the conversation as experts from Cerba discuss facilitating patient safety measures in CAR-T therapies by accurately identifying the integration of viral vectors, utilizing flow cytometry, and more.

Listen now as experts discuss answers to:  
· What patient monitoring is required by the FDA?
 · What molecular technology does Cerba use and how does it meet FDA requirements?
 · What is the importance of cytometry assays in monitoring CAR-T cells? 
· What are the opportunities for combining flow cytometry with genomic solutions? 
· What key innovations are poised to improve patient monitoring in clinical trials?

Podcast: Facilitating Patient Monitoring in CAR-T Development

2024 Global Generics & Biosimilars Awards

Audio roundup of selected biopharma industry content from Scrip over the business week ended 26 April 2024. In this episode: 2023’s top selling drugs and the COVID cliff; falling sales force Roche to reassess priorities; Phase III immunology win for Sanofi; BMS’s strong pipeline: and which companies could be acquired next.
https://scrip.citeline.com/SC150182/Quick-Listen-Scrips-Five-MustKnow-Things

Scrip's Five Must-Know Things - 30 April 2024

Flora and Emma are joined by Datamonitor’s CNS analysts Summer, Joseph, and Wen-Yu to discuss coverage from AAN.

Other platforms (in addition to SoundCloud):​

Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836​

Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz​

TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/​

Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67

April Datamonitor Podcast 2024: AAN coverage

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights key interviews with Philips’ CEO Roy Jakobs on NAM’s draft framework on AI, BD’s CTO Beth McCombs R&D initiatives and HSS spine co-chair Sheeraz Qureshi on his vision for integrating AI tech. Hannah Daniel discusses the FDA’s new initiative to create an idea lab for medical device use at home and Apple Watch’s new feature to help people with Parkinson’s disease.

Listen to the podcast via the player below:

Medtech Insight articles addressing topics discussed in this episode:

BD’s CTO Beth McCombs Discusses Key Initiatives – AI/Gen AI; DE&I Strategy; Succession Planning

HSS Spine Surgeon Sees Potential For AI Chatbots, But Not To ‘Practice Medicine’ 

Philips Portfolio Includes ‘No Single Product That Does Not Use A Type of AI,’ Says CEO and AI Thought Leader Roy Jakobs

Discreet Gait Freezing Solution Brings Therapy With The Tap Of An Apple Watch

CDHR’s AR/VR Home Space Will Serve As An ‘Idea Lab’ For Device Stakeholders

Digital Health Roundup: US FDA’s ‘Idea Lab’; Philips’ Roy Jakobs On AI Draft Framework; Apple Watch

Pink Sheet reporter and editors discuss what an upcoming listening session means for the FDA’s advisory committee reform effort (:32), the agency’s efforts to help the clinical trial modeling and simulation industry (16:22), and the UK’s MHRA plan to use artificial intelligence to assist in drug application reviews (21:05).

More On These Topics From The Pink Sheet  

US FDA Adcomm Reform: Does Listening Session Suggest No Major Near-Term Changes?: https://pink.citeline.com/PS150167/US-FDA-Adcomm-Reform-Does-Listening-Session-Suggest-No-Major-Near-Term-Changes  

US FDA Wants Advice About Advisory Committees: Try Having Some?: https://pink.citeline.com/PS154644/US-FDA-Wants-Advice-About-Advisory-Committees-Try-Having-Some 

US FDA Developing Model Master File System To Grow Modeling, Simulation Field: https://pink.citeline.com/PS154647/US-FDA-Developing-Model-Master-File-System-To-Grow-Modeling-Simulation-Field 

UK’s MHRA To Use AI In Regulatory Review Process & RWD Analysis: https://pink.citeline.com/PS154643/UKs-MHRA-To-Use-AI-In-Regulatory-Review-Process--RWD-Analysis

Drug Fix: US FDA Adcomm Reform, A Boost For Clinical Trial Modeling, AI For Drug Review

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.

【3分で解説世界のファーマ】第10回どうなるミフェプリストン承認米国FDAが裁判に危機感 (Japanese-language podcast)

Citeline

Related tracks

【3分で解説 世界のファーマ】第10回 どうなるミフェプリストン承認 米国FDAが裁判に危機感 (Japanese-language podcast)

Citeline

Related tracks

【3分で解説世界のファーマ】第10回どうなるミフェプリストン承認米国FDAが裁判に危機感 (Japanese-language podcast)