Citeline Podcasts

Humira Biosimilar Landscape

Other platforms

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

일본 최대 제약바이오 R&D 허브와 한국 바이오벤처들이 세포유전자치료제 분야의 협업을 활발히 추진하고 있다는 Scrip 기사를 요약한 내용입니다.

https://scrip.citeline.com/SC149214/Japans-Largest-Biocluster-Korean-Ventures-To-Collaborate-For-Cell-And-Gene-Therapies

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: CEOs on global tensions; Roche’s new Alzheimer's contender; Sanofi eyes external deals; investors’ reactions to clinical data; and Korean licensing pitfalls

https://scrip.citeline.com/SC149308/Quick-Listen-Scrips-Five-MustKnow-Things

Pink Sheet reporters and editor discuss take-aways from the first Medicare price negotiation program public listening sessions (:35), next steps after Sarepta reported questionable top-line data for its Duchenne muscular dystrophy gene therapy Elevidys (14:45), and indications the FDA may adjust its regulatory approach to gene editing products (26:27).

More On These Topics From The Pink Sheet

Could Government Negotiated Prices Curtail Access? PBMs And Potential Perverse Incentives Dominate First Medicare Listening Session: https://pink.citeline.com/PS149097/Could-Government-Negotiated-Prices-Curtail-Access-PBMs-And-Potential-Perverse-Incentives-Dominate-First-Medicare-Listening-Session

Elevidys And The EMBARK Trial: Is Another Advisory Committee Meeting Coming? https://pink.citeline.com/PS149282/Elevidys-And-The-EMBARK-Trial-Is-Another-Advisory-Committee-Meeting-Coming

US FDA’s Confidence In Gene Editing Safety Growing Enough That Regulatory Bar May Be Lowered: https://pink.citeline.com/PS149289/US-FDAs-Confidence-In-Gene-Editing-Safety-Growing-Enough-That-Regulatory-Bar-May-Be-Lowered

Heritable Genetic Modification Debate May Ignite Again As Technology Advances: https://pink.citeline.com/PS149098/Heritable-Genetic-Modification-Debate-May-Ignite-Again-As-Technology-Advances

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

「Swiss To Introduce Parallel HTA & Regulatory Submissions, More Transparent Decisions（邦題意訳：新たな制度を導入のスイス、医薬品審査の透明性確保へ）」

https://pink.citeline.com/PS149096/Swiss-To-Introduce-Parallel-HTA--Regulatory-Submissions-More-Transparent-Decisions

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

Listen in as Citeline sits down with a regulatory and compliance expert Mai Mishir, Senior Director, Global Regulatory Affairs from Advanced Clinical. Capture new insights into the present state of regulatory as advancements in technology, a shift to patient-centricity, and the globalization of clinical trials combine to change workflows and trial design. Plan your strategy now and develop new ways to master these complexities, with information from this free podcast.

Brian Yang interviews Nasdaq-listed cell therapy developer Gracell Bio Founder and CEO William Wei Cao who discussed the plan to enter the US market through quicker turnaround, faster delivery, cost-effective and safety profile. He also discussed taking the Shanghai-based firm’s CD19 and BCMA-dual targeted therapy to the first-line treatment, allogenic CAR-T therapies, combinations, Chinese biotech going global and surviving in the current “capital winter” environment.

Brian Yang interviews Nasdaq-listed cell therapy developer Gracell Bio Founder and CEO William Wei Cao who discussed the plan to enter the US market through quicker turnaround, faster delivery, cost-effective and safety profile. He also discussed taking the Shanghai-based firm’s CD19 and BCMA-dual targeted therapy to the first-line treatment, allogenic CAR-T therapies, combinations, Chinese biotech going global and surviving in the current “capital winter” environment.

In this Chinese-language podcast, Brian Yang and Dexter Yan discuss China biotech topics including the annual IND and NDA report from Center for Drug Evaluation, ESMO’s China data and Shanghai International Biotech Industry Week.

https://scrip.citeline.com/SC149259/Chinese-Language-Podcast-ESMO-China-Data-Annual-CDE-Report-Shanghai-Biotech-Week

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: did Pfizer miss out on Roivant/Roche deal?; Padcev/Keytruda combo impresses in bladder cancer at ESMO; biggest upfront ever in Daiichi/Merck deal; Rybrevant at ESMO; and subcutaneous Leqembi could open up access.

https://scrip.citeline.com/SC149266/Quick-Listen-Scrips-Five-MustKnow-Things