Join us for an insightful Q&A session with Dr. Vega, where we delve into the groundbreaking world of Multi-Cancer Early Detection (MCED) and the future of cancer detection.

In this episode, In Vivo speaks to Bruce Leuchter, CEO of Neurvati Neurosciences, about ways clinical drug development in rare neurologic diseases is being held back and what can be done to make the process more efficient and successful.

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 

「Clinical Trial Diversity Plans: Early Oncology Experience Shows More Work Needed, US FDA Says（邦題意訳：FDA、被験者の多様性を義務化へ　がん治験では課題も）」 

https://pink.citeline.com/PS149444/Clinical-Trial-Diversity-Plans-Early-Oncology-Experience-Shows-More-Work-Needed-US-FDA-Says

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

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to King & Spalding’s Eric Henry about the year’s most influential digital health regulations in the US and EU, and what we may have missed in all the excitement.

In this podcast Scrip looks at the some upcoming clinical catalysts for biopharma, judged by the size of the sales forecasts at stake. Companies including Sanofi, Cytokinetics, Corcept and Inventiva stand to gain – or lose.

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: first ever gene editing FDA nod; US FTC ruffles pharma’s feathers; AstraZeneca pays to play in RSV; Syndax leukemia drug makes splash at ASH; BMS bets big on Chinese ADC.

https://scrip.citeline.com/SC149527/Quick-Listen-Scrips-Five-MustKnow-Things

Pink Sheet reporters and editors in the US and Europe consider the growth and impact of Project Orbis after a year in which two major regulators joined the program, but several countries did not keep up with the US approval pace.

More On These Topics From The Pink Sheet

Project Orbis 2023: FDA Approves Six New Cancer Drugs, But Partner Nations Lag Behind: https://pink.citeline.com/PS149452/Project-Orbis-2023-FDA-Approves-Six-New-Cancer-Drugs-But-Partner-Nations-Lag-Behind

Project Orbis: More Cancer Drugs Available In Scotland Than England: https://pink.citeline.com/PS149063/Project-Orbis-More-Cancer-Drugs-Available-In-Scotland-Than-England

EMA Will Observe Project Orbis In Effort To Increase Collaboration: https://pink.citeline.com/PS148458/EMA-Will-Observe-Project-Orbis-In-Effort-To-Increase-Collaboration

US FDA Eyes Project Orbis-Type Approach For Cell And Gene Therapies: https://pink.citeline.com/PS147730/US-FDA-Eyes-Project-Orbis-Type-Approach-For-Cell-And-Gene-Therapies

Brian Yang and Dexter Yan discuss Biokin/BMS's ADC deal, WuXi Biologics' share price drop, BlissBio's recent developments and Pfizer's divestment of Prevenar 13 commercial rights in China to a Chinese local partner.

https://scrip.citeline.com/SC149497/Chinese-Language-Podcast-BiokinBMS-Deal-Developments-At-Pfizer-BlissBio-WuXi-Biologics

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: another acquisition for AbbVie; Roche buys into the obesity market; J&J’s oral immunology push; oral incretins advance; and AstraZeneca on Chinese innovation.

https://scrip.citeline.com/SC149480/Quick-Listen-Scrips-Five-MustKnow-Things

In this episode, HBW Insight speaks to Aurélie Perrichet, regional director, Europe at the International Fragrance Association. We discussed the implications of planned revisions to the European Commission’s Classification, Labeling and Packaging (CLP) regulation, which may re-categorize biological materials as mixtures, from their current status as substances. Perrichet also speculated how the proposed change could reduce the number of available essential oils and other types of fragrance and flavor materials available.