Citeline Podcasts

More On These Topics From The Pink Sheet Pfizer Withdraws Oxbryta, But Overall Market Impact May Be Limited: https://pink.citeline.com/PS155302/Pfizer-Withdraws-Oxbryta-But-Overall-Market-Impact-May-Be-Limited EMA Discusses Fatal Events That Prompted Pfizer To Pull Oxbryta From Global Markets: https://pink.citeline.com/PS155296/EMA-Discusses-Fatal-Events-That-Prompted-Pfizer-To-Pull-Oxbryta-From-Global-Markets New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming: https://pink.citeline.com/PS155285/New-US-FDA-Adcomm-Trend--Approved-Cancer-Meds-Get-Another-Look-When-Competitors-Coming All Comers No More? US FDA AdComm Supports PD-L1 Threshold In Esophageal, Gastric Cancer: https://pink.citeline.com/PS155300/All-Comers-No-More-US-FDA-AdComm-Supports-PDL1-Threshold-In-Esophageal-Gastric-Cancer Pazdur Calls For 'Kumbaya’ To Standardize ImmunoOncology Biomarkers: https://pink.citeline.com/PS155298/Pazdur-Calls-For-Kumbaya-To-Standardize-ImmunoOncology-Biomarkers New AAM CEO Looking To ‘Force Multiply’ For US Generics Industry: https://pink.citeline.com/PS155294/New-AAM-CEO-Looking-To-Force-Multiply-For-US-Generics-Industry

Executive Summary: In this podcast, Andrew Warmington, Manufacturing Editor, Citeline, joins together with industry experts, Simone Secchi, R&D Process Chemist, Olon Group, and Matthieu CULIE, Head of MAB, Pierre Fabre, to discuss the challenges in the development and manufacturing of ADCs.

Emma Wille chats with oncology team director Dana Gheorghe, PhD, about the resurgence of radiopharmaceutical therapies in oncology. 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/​

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

In this podcast, Janelle Hart, Managing Editor at Citeline, teams up with industry experts Mai Yee Mishir, Senior Director of Global Regulatory Affairs, and Sally-Ann McDowell, Senior Director of Clinical Development Strategy at Advanced Clinical, to discuss the vital role of HRQoL in clinical trials. Listen now.

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

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app. Stories discussed in this episode: MindMaze, ‘A Ratio Of Luke Skywalker And R2-D2’, Navigates The DTx Galaxy Click Therapeutics Anticipates Pharma Will Begin Developing Digital Drugs From Clinical Stage Sinaptica On Precision Neuromodulation To Combat Alzheimer’s: ‘No Drug Dares Go After Moderate Patients’ DHCoE-AI-Lifecycle-Management-Plan-To-Serve-As-Playbook-For-Standards Hello Heart Says Update To Cardiovascular Health Tracker Could Benefit Women Especially

Interest in the human gut microbiome and the influence it exerts on a person’s wellbeing, from cognitive health to immunity, has been rapidly increasing in recent years. In this episode of HBW Insight's Over the Counter podcast we speak to Dublin-based food company Kerry Group about a particularly exciting, emerging area of microbiome-based wellness, postbiotics, which are defined by the International Scientific Association of Probiotics and Prebiotics (ISAPP) as a “preparation of inanimate microorganisms and/or their components that confers a health benefit on the host.” Given that postbiotics rely on inanimate ingredients, rather than live cultures as in yoghurts, they, may provide more suitable vehicles for consumer health innovation, suggests Kerry Group’s RDA senior manager of immune and joint health, Sonja Nodland. Nodland also explains what kinds of postbiotics are currently on the European market, for example for digestive and skin health and immunity, and the regulatory challenges that postbiotics share with other microbiome products in the region, such as pre- and pro-biotics. Timestamps: 2:20 Introductions 4:00 What are postbiotics? 8:30 Advantages of postbiotics for consumer health innovation 10:20 Health benefits of postbiotics 12:00 Types of postbiotics 15:20 Kerry’s postbiotic portfolio 19:00 Postbiotic regulation in the European Union 28:00 Where to start with postbiotic innovation

Audio roundup of selected biopharma industry content from Scrip over the business week ended 23 August 2024. In this episode: CMS’s price reveal better than expected?; new diabetes risk data for Zepbound; can J&J’s lung cancer combo stand up to Tagrisso?; new recruits for BioMarin leadership; and Glenmark’s shifting revenues. https://scrip.citeline.com/SC150795/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Following the recent FDA rejection of MDMA therapy for PTSD, Emma and Flora discuss the future role of psychedelics in the treatment of mental health disorders. Content warning: This episode does contain mentions of sexual assault and abuse. 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​

Keith Murphy, co-founder of Organovo, discusses the growing potential of bioprinting and how the company is using its technologies to study and develop treatments for inflammatory bowel disease (IBD).

Audio roundup of selected biopharma industry content from Scrip over the business week ended 16 August 2024. In this episode: Merck & Co. steps into CD19 bispecific space; gene therapy patients rise, but slowly; Madrigal’s Rezdiffra plans; Korean biopharma financing recovering?; and approvals to watch out for in Q3. https://scrip.citeline.com/SC150765/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things