Citeline Podcasts

In this episode, HBW chats with Neil D’Souza, CEO of Makersite GmbH, a Stuttgart, Germany-based data software company that offers product data management tools that enable personal care firms to manage product sustainability, cost and compliance. D’Souza provides his take on what defines sustainable product development and how companies can use technologies such as “digital twin” product models to analyze and improve sustainability, while developing products at a faster pace.

Introduction: Pink Sheet reporter and editor discuss the FDA’s latest advertising enforcement letter, which targeted a migraine treatment TV commercial featuring Serena Williams, and its impact on drug promotion (:36), as well as the now growing list of legal cases targeting agency decisions with Chevron deference overturned (13:32).

More On These Topics From The Pink Sheet

Celebs Bring Extra Scrutiny To Advertisements, US FDA Tells AbbVie: https://pink.citeline.com/PS155225/Celebs-Bring-Extra-Scrutiny-To-Advertisements-US-FDA-Tells-AbbVie

Lilly Challenges US FDA Classification Of Obesity Drug Retatrutide, Citing Chevron Overturn: https://pink.citeline.com/PS155205/Lilly-Challenges-US-FDA-Classification-Of-Obesity-Drug-Retatrutide-Citing-Chevron-Overturn

Life After Chevron: US Supreme Court Ruling Cited In FDA Exclusivity Decision Challenges: https://pink.citeline.com/PS155211/Life-After-Chevron-US-Supreme-Court-Ruling-Cited-In-FDA-Exclusivity-Decision-Challenges

US FDA Biologics Designation As Price Protection: Lilly Charts New Course With Retatrutide: https://pink.citeline.com/PS155226/US-FDA-Biologics-Designation-As-Price-Protection-Lilly-Charts-New-Course-With-Retatrutide

Emma and Summer meet with oncology analyst Flora to discuss the therapeutic potential of exploring the tumor microenvironment.

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​

Generics Bulletin's editorial team discusses recent conferences held by Medicines for Europe and the AAM, while looking ahead to the key off-patent industry events on the calendar over the next few months and beyond.

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

「Multiple Chinese Firms Expand Global Phase III Trials To Japan（邦訳：中国企業、第三相グローバル治験の地域を続々と日本に拡大）」

 https://scrip.citeline.com/SC150842/Multiple-Chinese-Firms-Expand-Global-Phase-III-Trials-To-Japan

Playlist: https://soundcloud.com/citelinesounds/sets/japanese-language-mini

호아킨 두아토 존슨앤존슨 대표가 모건스탠리 헬스케어 컨퍼런스에서 발표한 내용입니다.

https://scrip.citeline.com/SC150846/JJ-Interested-In-Differentiated-Obesity-Assets

Playlist: https://soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Audio roundup of selected biopharma industry content from Scrip over the business week ended 6 September 2024. In this episode: J&J interested in differentiated obesity assets; Kerendia hits in heart failure; strong HERCULES data keep Sanofi’s MS plans alive; WCLC preview; and Mankind sets eyes on 5x growth.

https://scrip.citeline.com/SC150865/Quick-Listen-Scrips-Five-MustKnow-Things

Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet reporter and editors discuss the potential fallout if the US FDA’s rare pediatric disease priority review voucher program is allowed to sunset on 1 October (:30), as well as an upcoming agency advisory committee meeting on potentially banning compounding of the now withdrawn pre-term birth prevention drug Makena (18:39).

More On These Topics From The Pink Sheet

US FDA’s Rare Pediatric Voucher Program Faces Tight Deadline For Reauthorization: https://pink.citeline.com/PS155196/US-FDAs-Rare-Pediatric-Voucher-Program-Faces-Tight-Deadline-For-Reauthorization

Ipsen Outpaces Market With Lucrative Priority Review Voucher Deal: https://pink.citeline.com/PS155197/Ipsen-Outpaces-Market-With-Lucrative-Priority-Review-Voucher-Deal

Audio roundup of selected biopharma industry content from Scrip over the business week ended 30 August 2024. In this episode: summer ADC dealmaking continues apace; a look at cell therapies in Japan; Pfizer’s new US digital consumer platform; Galapagos’s US point of care CAR-T study; and Novartis partners with Lindy on biologics delivery.

https://scrip.citeline.com/SC150827/Quick-Listen-Scrips-Five-MustKnow-Things

Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet reporter and editors discuss new developments in the FDA’s plans to regulate artificial intelligence and drugs associated with it, including a new AI Council within CDER, as well as some of the unanswered questions about AI in drug development.

More On These Topics From The Pink Sheet Artificial Intelligence:

CDER’s New Council Takes Charge Of Oversight, Coordination: https://pink.citeline.com/PS155173/Artificial-Intelligence-CDERs-New-Council-Takes-Charge-Of-Oversight-Coordination AI In Drug Development: Regulatory Clarity Needed On Inspections, Human Role: https://pink.citeline.com/PS155156/AI-In-Drug-Development-Regulatory-Clarity-Needed-On-Inspections-Human-Role