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Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.
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Pink Sheet reporters and editors discuss Pfizer’s abrupt decision to withdraw Oxbryta (:32), the US FDA’s Oncologic Drugs Advisory Committee bringing sponsors of approved products back to discuss labeling changes while competitors are pending (10:46), and the new CEO of a generic industry trade association (27:34).More On These Topics From The Pink…
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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.Oleh Citeline
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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/aHR0cHM6Ly9mZWVkcy5zb3VuZ…
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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.…
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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 tec…
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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 T…
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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/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU…
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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-JapanPlaylist: https://soundcloud.com/citeli…
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호아킨 두아토 존슨앤존슨 대표가 모건스탠리 헬스케어 컨퍼런스에서 발표한 내용입니다.https://scrip.citeline.com/SC150846/JJ-Interested-In-Differentiated-Obesity-AssetsPlaylist: https://soundcloud.com/citelinesounds/sets/korean-language-biopharma-miniOleh Citeline
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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…
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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 Top…
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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://sc…
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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 Char…
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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 reco…
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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 wellnes…
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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.…
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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 Podcas…
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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/SC1507…
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Pink Sheet reporter and editors discuss the take-aways from the landmark first Medicare negotiated drug prices and what additional information remains outstanding.More On These Topics From The Pink SheetMedicare Negotiation Announcement: Discounts From List Price Up To 79%, But Net Savings Unclear: https://pink.citeline.com/PS155128/Medicare-Negoti…
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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What To Look Out For At ESC 2024https://scrip.citeline.com/SC150740/What-To-Look-Out-For-At-ESC-2024Oleh Citeline
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Compliance with environmental sustainability goals is no longer optional for medtech companies serving global healthcare markets. Thermo Fisher has made it a mission to be a leader in thought and actions in meeting Scope 1, 2 and 3 needs. Corporate VP and head of sustainability Meron Mathias explains the company's sustainability aims and methods, f…
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Audio roundup of selected biopharma industry content from Scrip over the business week ended 9 August 2024. In this episode: Amgen positions for obesity and diabetes; BMS returns TIGIT asset in pipeline reshuffle; is Kerendia the next jewel in Bayer’s crown?; Japan pharma firms cut jobs; and Sun Pharma seeks GLP-1 partner.https://scrip.citeline.com…
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Since becoming a standalone consumer health company, Haleon has been driving awareness of public health issues such as chronic pain and children’s oral health. In this episode of Over the Counter, HBW Insight catches up with Haleon vice president and general manager Great Britain and Ireland Bas Vorsteveld, to find out more about why having a purpo…
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Pink Sheet reporter and editors discuss former Surgeon General Jerome Adams’ views on how the FDA can better ensure clinical trial diversity (:27), questions about approving a new drug that would be used with a standard of care regimen that is off-label (15:00), and the agency beginning to schedule fully in-person advisory committee meetings (24:03…
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올해 상반기 일라이 릴리와 노보 노디스크의 주가가 가장 높은 상승세를 보인 반면, BMS와 길리어드의 주가는 가장 큰 폭으로 하락했습니다. Scrip의 글로벌 제약주 동향 기사를 요약한 내용입니다.https://scrip.citeline.com/SC150593/Obesity-Rules-Large-Cap-Stocks-In-First-Half-Of-2024Oleh Citeline
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Audio roundup of selected biopharma industry content from Scrip over the business week ended 2 August 2024. In this episode: Pfizer bullish on its oral GLP-1; BMS’s rising confidence about Medicare pricing of Eliquis; more long term data for Leqembi; NewAmsterdam’s CETP inhibitor shows promise; and a look at Mankind’s Bharat Serums buy.https://scri…
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Pink Sheet reporter and editors discuss the US FDA drug approval decisions that could arrive in August (:34), a trial design issue that could ensnare BMS’ Opdivo along with AstraZeneca’s Imfinzi (10:11), and the EMA potentially asking all sponsors to provide raw clinical data as part of application reviews (33:14).More On These Topics From The Pink…
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COPD expert Wen-Yu discusses what the entrance of biologics might mean for the COPD treatment landscape and shares a sneak peek from her upcoming patient-based forecast.Other platforms (in addition to SoundCloud):​Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836​Google Podcasts - https://podcasts.goo…
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Consumers are expecting more and more from health and wellness brands, PA Consulting’s latest Brand Impact Index shows. Consumer health brands that link wellness to the sanctuary of the home do particularly well, explains PA consumer product expert Rhea Patten, on the latest episode of HBW Insight’s Over the Counter podcast. But do consumers expect…
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Audio roundup of selected biopharma industry content from Scrip over the business week ended 26 July 2024. In this episode: Narasimhan plays the long game; Merck & Co’s RSV contender; Mounjaro’s China approval; the mid-cap rising stars; and AI could add billions in drug revenues.https://scrip.citeline.com/SC150656/Quick-Listen-Scrips-Five-MustKnow-…
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Editors from the Pink Sheet and Medtech Insight discuss the retirement of Jeff Shuren (:35), PBM executives again appearing unscathed after another Capitol Hill appearance (10:12), and the growing push to ensure the FDA’s rare pediatric disease priority review voucher program is renewed (20:41).More On These Topics From The Pink SheetShuren Steps D…
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In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights AI discussions at the HLTH Europe conference and an interview with Motif Neurotech's CEO Jacob Robinson. Elizabeth Orr discusses DeepWell DTx's newly launched VR game for treating stress-related hypertension and anxiety. Natasha Barrow provides an overview of Digital M…
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Audio roundup of selected biopharma industry content from Scrip over the business week ended 19 July 2024. In this episode: J&J’s Spravato on track for blockbuster status; US uptake of Rezzdifra held up by payers; CNS drugs are surprisingly valuable; obesity rules large cap stocks; and Legend buyout rumors validate China biotech.https://scrip.citel…
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In this episode, Medtech Insight senior reporter Hannah Daniel speaks to DJ Fang, chief operating officer and co-founder of Pure Global. Pure Global uses AI to help device manufacturers navigate global regulations, and we talk about clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on some Chinese…
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Pink Sheet reporter and editors discuss the impact of a US and EU drug approvals analysis that found the US FDA still clears many novel products first, including most new cell and gene therapies and cancer treatments.More On This Topics From The Pink SheetPharma Looks To America First: US FDA Holds Overwhelming Lead Over EMA In Novel Approvals: htt…
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신테카바이오 조해경 사장은 Scrip과의 인터뷰에서 국내 AI 신약 개발 현황을 글로벌 흐름와 비교하고, 국내외 경쟁에서 살아남기 위해 국내업계가 해야 할 일에 대해 이야기했습니다.https://scrip.citeline.com/SC150336/Korea-Looks-To-Close-Gap-In-AI-Drug-Development-CapabilitiesOleh Citeline
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Audio roundup of selected biopharma industry content from Scrip over the business week ended 12 July 2024. In this episode: Q1’s top 10 drugs; Pfizer’s R&D leadership succession; Lilly bolsters IBD pipeline; first half deal volume up but value down; and EU firms’ China sentiment plummets.https://scrip.citeline.com/SC150587/Quick-Listen-Scrips-Five-…
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In this episode, HBW chats with Michael Washburn, principal at Washburn Consulting, on how producers of single-use packaging subject to extended producer responsibility laws rolling out in Oregon, Colorado and California next year can tackle the tedious work of collecting data on packaging materials.…
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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’s Cell-Gene Therapy Office Head Wants Sponsors To Seek Out Meetings( 邦題意訳:米国FDAの細胞遺伝子治療室長「もっと面談を」企業に求める理由は)」 (英語版)https://pink.citeline.com/PS154749/US-FDAs-Cell-Gene-Therapy-Office-Head-Wants-Sponsors-To-Seek-Out-Meetings※全文の…
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Audio roundup of selected biopharma industry content from Scrip over the business week ended 5 July 2024. In this episode: US approval for Lilly’s Alzheimer's contender; the challenges and rewards of late-stage ADCs; Eisai regains control of ADC from BMS; RSV vaccine developers hit by declining expectations; and an interview with Amgen’s Ian Thomps…
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