Audio roundup of selected content from Scrip over the past business week.

Quick Listen: Scrip's Five Must-Know Things

https://scrip.pharmaintelligence.informa.com/SC148580/Quick-Listen-Scrips-Five-MustKnow-Things

Pink Sheet reporters and editors consider the upcoming COVID-19 vaccination campaign (:37), the virtue of advisory committees with only a few members (19:42), and the first FDA drug advertising untitled letter in a year (25:08).

Read More In The Pink Sheet

COVID Vaccines: XBB Strain Easy Call, But Disagreements Abound Between FDA, Advisors On Logistics

https://pink.pharmaintelligence.informa.com/PS148385/COVID-Vaccines-XBB-Strain-Easy-Call-But-Disagreements-Abound-Between-FDA-Advisors-On-Logistics

Are US FDA Advisory Committees Too Big? Lecanemab Shows Benefit Of Thinking Small

https://pink.pharmaintelligence.informa.com/PS148382/Are-US-FDA-Advisory-Committees-Too-Big-Lecanemab-Shows-Benefit-Of-Thinking-Small

With First Advertising Letter In 12 Months, US FDA Goes After Xeris’s Webpage Promotion Of Recorlev

https://pink.pharmaintelligence.informa.com/PS148371/With-First-Advertising-Letter-In-12-Months-US-FDA-Goes-After-Xeriss-Webpage-Promotion-Of-Recorlev

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：「US FDA Complete Response Letter Rates Vary With Sponsor Size（邦題意訳：「大企業ほど承認申請に強い」説、過去2年分のデータで証明される）」

https://pink.pharmaintelligence.informa.com/PS148291/US-FDA-Complete-Response-Letter-Rates-Vary-With-Sponsor-Size

「US FDA’s Review Landscape」

https://infogram.com/1p2jr9d6k7y9wwf0n01yyqn6peirmzd65me

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

Quick Listen: Scrip's Five Must-Know Things

Audio roundup of selected stories from Scrip's global team over the previous business week.

https://scrip.pharmaintelligence.informa.com/SC148538/Quick-Listen-Scrips-Five-MustKnow-Things

Guest speaker Leon Tang, founder of InScienceWeTrust BioAdvisors, along with Brian Yang in Beijing and Dexter Yan in Shanghai, discuss some of the stand-outs of the ASCO 2023 meeting in this special episode of a Chinese-language podcast.

Accompanying Scrip article: https://scrip.pharmaintelligence.informa.com/SC148528/Chinese-Language-Podcast-ASCO

Over The Counter 9 June 2023: Embracing AI/AR Evolution In Beauty, While Navigating Its Hurdles by Citeline

In this episode, MedTech Insight regulatory reporter speaks to Erez Kaminski, CEO and founder of Ketryx, which assists clients in creating FDA-regulated software. He updates us on the latest and greatest in digital health regulations, including PCCPs, decentralized clinical trials and AI/ML software. We talk about some of the challenges and opportunities that often arise from these regulations and Erez shares a personal story about why the safety of medical devices matters so much to him.

점점 더 많은 미국과 아시아계 제약바이오 기업들이 스위스에 EU 본부를 설립하고 있는 배경에 대한 Scrip 기사를 요약한 내용입니다.

https://scrip.pharmaintelligence.informa.com/SC148478/From-Hengrui-To-Moderna-Why-More-Biotech-Companies-Are-Creating-Swiss-Hubs

Quick Listen: Scrip's Five Must-Know Things

https://scrip.pharmaintelligence.informa.com/SC148490/Quick-Listen-Scrips-Five-MustKnow-Things

Pink Sheet reporters and editors discuss CMS’s latest coverage announcement for Alzheimer’s drugs and the VA’s approach to the issue (0:29), the FDA’s new one-page patient medication information document (15:55), international convergence on COVID-19 vaccine strain selection (24:48), and Novavax’s place in the vaccine toolbox going forward (28:21).

Read More In The Pink Sheet

Medicare Registry Plan For Alzheimer’s Drugs Pairs CMS Web Portal With Health System Efforts

https://pink.pharmaintelligence.informa.com/PS148313/Medicare-Registry-Plan-For-Alzheimers-Drugs-Pairs-CMS-Web-Portal-With-Health-System-Efforts

The US VA And Alzheimer’s: A Misunderstood Decision

https://pink.pharmaintelligence.informa.com/PS148214/The-US-VA-And-Alzheimers-A-Misunderstood-Decision

One-Page Patient Medication Information Document Moves Forward Under Proposed Rule

https://pink.pharmaintelligence.informa.com/PS148298/One-Page-Patient-Medication-Information-Document-Moves-Forward-Under-Proposed-Rule

International Regulators Focus On Omicron XBB For Monovalent COVID-19 Vaccine

https://pink.pharmaintelligence.informa.com/PS148301/International-Regulators-Focus-On-Omicron-XBB-For-Monovalent-COVID-19-Vaccine

Novavax Readying Multiple COVID-19 Vaccine Candidates To Ensure Fall Availability

https://pink.pharmaintelligence.informa.com/PS148261/Novavax-Readying-Multiple-COVID-19-Vaccine-Candidates-To-Ensure-Fall-Availability