Citeline Podcasts
1,366 episodes - English - Latest episode: 2 days ago - ★★★★★ - 24 ratingsCiteline 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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Episodes
Scrip’s Five Must-Know Things – 4 September 2023
September 04, 2023 03:59 - 15 minutes - 20.9 MBAudio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: US Medicare price negotiations get soft landing; Medicare negotiations and patent cliff acceleration; Novo Nordisk steps into heart failure; PCSK9s and the convenience battle; and an investor’s view of Korean biotech potential. https://scrip.pharmaintelligence.informa.com/SC148990/Quick-Listen-Scrips-Five-MustKnow-Things
Digital Health Roundup: VR, AI Trends In Rehabilitation; Cybersecurity Regulations; Medicare Updates
September 01, 2023 22:47 - 7 minutes - 3.53 MBSummary: In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights VR, AI and other high tech trends in rehabilitation and gait training. Hannah Daniel discusses cybersecurity updates such as the new NIST published draft for an updated version of the Cybersecurity Framework, a recent report by Health-ISAC, and an interview with MedCrypt’s Naomi Schwartz about the upcoming FDA cybersecurity regulations for premarket approvals. Medtech Insight articles addressing topics...
Drug Fix: What We Learned From The First Medicare Price Negotiation List, Pepaxto Withdrawal Update
September 01, 2023 17:27 - 39 minutes - 23.5 MBPink Sheet reporters and editors consider lessons and next steps after the first list of drugs subject to Medicare price negotiations was released (:34) and discuss Oncopeptides’ Pepaxto facing withdrawal under the US FDA’s new and potentially faster process (22:44). More On The Medicare Price Negotiation List From The Pink Sheet Litigation Against Medicare Price Negotiation Gains Four Potential New Plaintiffs: https://pink.pharmaintelligence.informa.com/PS148778/Litigation-Against-Medicare...
China Biotech CEO Interview with Hua Medicine’s Li Chen
September 01, 2023 07:17 - 36 minutes - 15.3 MBHua Medicine’s founder and CEO Li Chen discusses with host Brian Yang about its new product launch for dorzagliatin, glucokinase activator for type 2 diabetes in China, partnership with Bayer, and plans to get reimbursed through National Reimbursement Drug List. https://scrip.pharmaintelligence.informa.com/SC148981/Hua-Medicines-Chen-On-Product-Launch-Bayer-Partnership-And-Reimbursement
Emergex CEO Questions mRNA Vaccines Against ‘Wuhan Virus’, Works On Universal Vaccines
August 31, 2023 00:51 - 37 minutes - 23.3 MBScrip’s senior editor Vibha Ravi speaks with Dr Thomas Rademacher, Emergex CEO and ex-research director at the University of Oxford, about the myth of the “Wuhan virus” and why synthetic T-cell adaptive vaccines are expected to be superior to RNA/mRNA ones. Novel delivery mechanisms like patches and microneedles are part of the UK-based clinical-stage biotech’s plan to make universal coronavirus and influenza vaccines affordable and effective as it seeks to partner governments. https://scrip....
Podcast: Operationalizing Decentralized Clinical Trials
August 30, 2023 15:31 - 15 minutes - 7.56 MBListen in as experts from Advanced Clinical discuss the evolution of the decentralized clinical trial model and what it means in a post-COVID landscape. Experts from Advanced Clinical share their thoughts on the benefits, challenges, management considerations, and outlook for such trials in this short podcast, packed with operational insights.
How To Be A Consumer Health Leader, With BSS Consulting’s Birgit Schuhbauer
August 29, 2023 10:15 - 34 minutes - 79.6 MBIn this episode, HBW Insight talks to BSS Consulting’s Birgit Schuhbauer about her stellar career in consumer healthcare. Up until recently, Schuhbauer was global vice president for Johnson & Johnson’s Self Care Franchise and president of the Association of the European Self-Care Industry. Now setting up on her own, Schuhbauer reflects on her career highlights, what it takes to be a leader in OTC and on her role as the AESGP’s first female president during a time of unprecedented change.
Fourth Time Lucky: How Mithra’s Novel Estrogen E4 Is Disrupting The Women’s Health Market
August 29, 2023 08:41 - 33 minutes - 15 MBMithra is shaking up the stagnant women’s health market with a brand new estrogenic compound. E4, or estetrol, is a natural estrogen produced by the human fetus during pregnancy, and could represent a major breakthrough in contraceptive and menopause care.
Scrip’s Five Must-Know Things – 28 August 2023
August 28, 2023 03:39 - 14 minutes - 32.5 MBAudio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Roche’s TIGIT data leak; Regeneron gets important US approvals; COVID subvariant vaccine progress; Pfizer’s RSV vaccine extended approval; and Japan recommends lecanemab for Alzheimer’s. https://scrip.pharmaintelligence.informa.com/SC148952/Quick-Listen-Scrips-Five-MustKnow-Things
China Biotech Podcast - August 2023 (Chinese-language)
August 24, 2023 07:52 - 14 minutes - 6.23 MBIn this Chinese-language podcast, Brian Yang and Dexter Yan discuss the latest hot topics in August in China’s biotech sector, which include a massive anti-corruption campaign and PD-1 inhibitor antibody development and approval prospects in the US. https://scrip.pharmaintelligence.informa.com/SC148929/ChineseLanguage-Podcast-AntiCorruption-Campaign-PD1-Going-Global
Scrip’s Five Must-Know Things – 21 August 2023
August 21, 2023 02:58 - 16 minutes - 38 MBAudio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: a look at global executive compensation; Pfizer’s new myeloma approval; Merck and Sichuan trump ADC breast cancer success; combo Alzheimer’s therapies in Eisai’s pipeline; and an overview of the state of gene therapy. https://scrip.pharmaintelligence.informa.com/SC148914/Quick-Listen-Scrips-Five-MustKnow-Things
Drug Fix: Medicare Price Negotiation List Preview, Mifepristone Ruling, AZ Sales Aid Warning Letter
August 18, 2023 17:01 - 30 minutes - 19.4 MBPink Sheet reporters and editor discuss a projected list of drugs that could be eligible for the first round of Medicare price negotiations (:40), the future of mifepristone access after the latest court decision (9:24), and AstraZeneca receiving the first US FDA drug promotion warning letter in more than a year (21:55). More On These Topics From The Pink Sheet Medicare Price Negotiation List Remains A Puzzle, Even For Those That Are (Probably) On It: https://pink.pharmaintelligence.informa...
UK OTC Marketing Awards Judge On What Makes A Standout Entry, With PAGB's Michelle Riddalls
August 14, 2023 10:02 - 18 minutes - 41.7 MBIn this special episode, we speak to PAGB CEO Michelle Riddalls about being a UK OTC Marketing Awards judge and what makes a good entry in her extensive experience. Having spent two decades working in some of the largest OTC companies in the world, and now heading up the UK’s OTC industry association that literally checks marketing campaigns before they go out, Riddalls is well placed to be able to give advice to companies working on their entries right now. Making entries UK-specific, data-d...
Scrip’s Five Must-Know Things – 14 August 2023
August 14, 2023 03:28 - 14 minutes - 34 MBAudio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Wegovy’s solid new trial results; Lilly’s sales swing back; nothing off the table for new Bayer boss; new compliance crackdown in China; and McKinsey on AI. https://scrip.pharmaintelligence.informa.com/SC148876/Quick-Listen-Scrips-Five-MustKnow-Things
Drug Fix: Wegovy’s CV Benefits, Mifepristone And Water Contamination, US FDA Back To The Office?
August 11, 2023 18:37 - 33 minutes - 19.9 MBPink Sheet reporters and editors discuss the impact of a study showing cardiovascular benefits for the weight loss drug Wegovy (:45), another attempt to restrict mifepristone access (16:15), and a new threat to the US FDA’s hybrid work policy (26:35). More On These Topics From The Pink Sheet Wegovy’s Cardiovascular Benefits May Improve, But Not Transform, Insurance Coverage In Obesity: https://pink.pharmaintelligence.informa.com/PS148672/Wegovys-Cardiovascular-Benefits-May-Improve-But-Not...
【3分で解説 世界のファーマ】第13回 薬価めぐり違憲訴訟へ 米国、インフレ抑制法 (Japanese-language podcast)
August 09, 2023 01:02 - 3 minutes - 7.8 MB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 「 Tracking Industry’s Lawsuits Against IRA’s Medicare Price Negotiations（邦題意訳：アメリカ反インフレ法 薬価をめぐる法廷闘争の現在地）」 https://scrip.pharmaintelligence.informa.com/SC148794/Tracking-Industrys-Lawsuits-Against-IRAs-Medicare-Price-Negotiations 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
What Happens To Software As A Medical Device Under The EU AI Act? With Bristows’ Jamie Hatzel
August 07, 2023 09:28 - 27 minutes - 63 MBIn the second part of HBW Insight’s chat with Bristows digital health regulatory expert Jamie Hatzel, we talk about artificial intelligence. Specifically, we discuss what happens to Software as a Medical Device within incoming EU artificial intelligence legislation, which has now entered trilogue negotiations. Issues such as the meaning of “high risk” within the proposed AI Act, in contrast to its meaning in the existing Medical Device Regulations, highlight the importance for manufacturers i...
Scrip’s Five Must-Know Things – 31 July 2023
August 07, 2023 06:25 - 14 minutes - 33.8 MBAudio roundup of selected biopharma industry content from Scrip over the past business week. https://scrip.pharmaintelligence.informa.com/SC148825/Quick-Listen-Scrips-Five-MustKnow-Things
Drug Fix Special: Assessing US FDA Advisory Committee Reform Proposals
August 04, 2023 14:49 - 51 minutes - 30.8 MBPink Sheet reporters and editors and special guests from 3D Communications, a firm that helps sponsors prepare for advisory committee meetings, dig into the pros and cons of issues such as eliminating or reducing advisory committee votes (1:15), creating more time for committee discussion (10:25), committee member preparation (19:25), adding more temporary members (25:35), and in-person versus virtual meetings (30:45). They also discuss industry’s reaction to the reform campaign (39:10) and a...
How The Eudamed Medical Device Database Is Progressing Slowly But Surely And the Challenges Ahead
August 04, 2023 11:15 - 18 minutes - 8.85 MBHow The Eudamed Medical Device Database Is Progressing Slowly But Surely And the Challenges Ahead
일본 항암제, CNS 치료제, 미국시장서 높은 허가가능성 보여 (Korean-language podcast)
August 03, 2023 23:07 - 4 minutes - 9.49 MBCiteline의 최신 연구보고서에 따르면 미국시장에서 대형 일본제약사들의 항암제, CNS 치료제 허가가능성이 상대적으로 높은 것으로 나타났다. 어떤 요인이 작용했을까? (Scrip 기사를 요약한 내용입니다) https://scrip.pharmaintelligence.informa.com/SC148677/Whats-Behind-Japan-Firms-Higher-Approval-Rates-In-Challenging-Oncology-CNS-Areas
Medtech Connect Episode 8: Exploring Regulatory Differences In The EU And US
August 03, 2023 19:19 - 13 minutes - 10.1 MBIn this episode of Medtech Connect, EU Senior Reporter Eliza Slawther and US Reporter Hannah Daniel explore the similarities and differences between EU and US regulations for digital health products in this mid-season recap episode. We talk about cybersecurity legislation, reimbursement of digital health products, and current AI regulations, so if you are looking for a bird’s eye view of regulations in these two places, this is the episode for you.
CEO Of Cell Therapy Firm Stempeutics Talks Partnerships In Japan, Changes In India Trials Regulation
July 28, 2023 06:36 - 34 minutes - 22 MBScrip’s Mumbai-based senior editor Vibha Ravi speaks with Dr B N Manohar, CEO of Indian cell and gene therapy firm Stempeutics Research. The company counts Cipla as an investor and has partnered with both Cipla and Alkem Labs for the marketing of cell therapy Stempeucel. This became the first patented cell therapy platform to be approved for commercial use in India, for knee osteoarthritis and critical limb ischemia. Manohar talks about these and other topics including plans and strategy.
China Biotech Podcast - July 2023 (Chinese language)
July 28, 2023 06:20 - 35 minutes - 21.9 MBBrian Yang, Dexter Yan and guest Jin Wang discuss trending biotech topics including recent antibody deals, China biotech innovation and underlying drivers as well as the outlook for the sector, in this Chinese-language podcast. Other topics include BioNTech’s recent China R&D collaborations and COVID-19 vaccine developments.
Digital Health Roundup: What’s Hot On Investment; Diabetes; AI
July 27, 2023 19:26 - 12 minutes - 5.56 MBIn this month’s Digital Health Roundup, Medtech Insight’s Marion Webb looks back at ADA 2023 highlights and her interviews with diabetes company execs. Reed Miller discusses his Cardio Conversation with Volta Medical and Hannah Daniel discusses the FDA’s Clinical Decision Support Software final guidance. Listen to the podcast via the player below: Medtech Insight articles addressing topics discussed in this episode: Diabetes, ADA 2023 Better Therapeutics Plans Diabetes PDT Launch Followin...
A Digital Marketplace Aims To Make Asset Acquisition Frictionless
July 27, 2023 15:31 - 20 minutes - 10.7 MB9xchange CEO Anat Naschitz and Benevolent AI's Matthew Fujisawa spoke with In Vivo about how they are trying to make selling and buying pharma assets more efficient through a digital marketplace and AI.
What's ‘Software As A Medical Device’ And How Is It Regulated In The EU? With Bristows’ Jamie Hatzel
July 24, 2023 09:31 - 27 minutes - 62.2 MBDigitalisation is a hot topic in consumer health, and “digital health” covers a broad spectrum of applications, from wellness apps to virtual reality therapeutics. In this episode, HBW Insight speaks to regulatory expert Jamie Hatzel to get some clarity on “software as a medical device” – a subset of medical device regulatory frameworks within which many digital health applications are classified. In the first part of a two-part podcast, Hatzel briefly outlines the UK and EU regulatory approa...
Building Your Early Phase Clinical Data, From Protocol to Regulatory Submission
July 20, 2023 16:30 - 15 minutes - 36 MBExplore best practices for gathering, preparing, and managing data for clinical Phase I clinical trials from start to finish.
The Advantages of Conducting Early-Phase Clinical Research in Canada
July 20, 2023 16:27 - 23 minutes - 52.7 MBLearn about the cost- and time-saving benefits of basing early phase and first in human clinical trials in Canada.
Key Considerations as You Move From Discovery to Preclinical to Clinical
July 20, 2023 16:23 - 14 minutes - 33.8 MBListen in as experts discuss the advantages of an integrated approach supporting drug development from discovery to commercialization.
Meeting Milestones Through Effective Biotech Trial Strategies Episode 2
July 20, 2023 16:01 - 16 minutes - 7.41 MBExplore the latest trends in biotech funding, the strategies for successful alignment with investment priorities, and the supportive role of CROs in the process.
Meeting Milestones Through Effective Biotech Trial Strategies Episode 1
July 20, 2023 15:58 - 19 minutes - 8.79 MBDiscover the key challenges facing clinical trial delivery and the current trends and solutions required to optimize efficiency and enhance results.
Will A ‘Netflix’ Model Solve Antibiotic Reimbursement Challenges And Spur R&D?
July 19, 2023 11:07 - 33 minutes - 13.3 MBIn Vivo executive editor Lucie Ellis-Taitt and Infex CEO Peter Jackson explore the current state of antimicrobial resistance in the UK, and worldwide. They discuss the potential of a new “Netflix” style subscription model in the UK for antibiotic reimbursement, as well as future challenges for biotechs in the anti-infectives space.
How Downturn In Demand For EU Medtech Regulatory Talent Is Starting To Improve
July 18, 2023 08:04 - 25 minutes - 15.2 MBMedtech Insight's Amanda Maxell interviews Elena Kyria, Elemed founder and CEO, to find out how the impact of the EU's Medical Device and IVD Regulations are affecting recruitment and how AI is changing the landscape. Kyria gave some in-depth insights into how the talent market is reacting to broader political and financial challenges too.
Scrip’s Five Must-Know Things – 18 July 2023
July 18, 2023 03:55 - 15 minutes - 35.4 MBAudio roundup of selected biopharma industry content from Scrip over the past business week. Quick Listen: Scrip's Five Must-Know Things https://scrip.pharmaintelligence.informa.com/SC148715/Quick-Listen-Scrips-Five-MustKnow-Things
Q&A with Retina Specialist
July 14, 2023 12:30 - 9 minutes - 13.2 MBDr. Avni Finn, retina specialist affiliated with Vanderbilt Eye Institute shares her experiences with new modalities and ways to optimize/personalize nAMD treatment in both Treatment Naïve and Switch patients. Click here to listen to the podcast.
MDR Amending Regulation Eases Stress Of EU Medtech Stakeholders As Processes Improve
July 12, 2023 11:48 - 31 minutes - 14.3 MBBSI's Graeme Tunbridge, Qserve's Gert Bos and TUV SUD's Andreas Stange talk with Medtech Insight's Amanda Maxwell about how the recent amending regulation to the EU's Medical Device Regulation has changed the EU medtech regulatory landscape.
【3分で解説 世界のファーマ】第12回 ChatGPT、製薬業界でも実証実験 (Japanese-language podcast)
July 10, 2023 23:53 - 3 minutes - 7.38 MB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 「 ChatGPT Unleashed: Generative AI Use Cases Taking Off In Pharma （邦題意訳：解き放たれる生成AI 製薬業界でも事例相次ぐ）」 https://scrip.pharmaintelligence.informa.com/SC148508/ChatGPT-Unleashed-Generative-AI-Use-Cases-Taking-Off-In-Pharma 世界の製薬業界ニュース Scrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip
Q&A with Bladder Cancer Specialist
July 10, 2023 03:44 - 5 minutes - 8.22 MBDr. Matthew Galsky, Director of GU Medical Oncology, The Tisch Cancer Institute, Mount Sinai, New York discusses clinical trial data and RWE in assessing treatment options for patients with high-risk urothelial carcinoma. Click here to listen to the podcast.
Scrip’s Five Must-Know Things – 10 July 2023
July 10, 2023 01:50 - 16 minutes - 36.8 MBAudio roundup of selected content from Scrip over the past business week. Quick Listen: Scrip's Five Must-Know Things: https://scrip.pharmaintelligence.informa.com/SC148667/Quick-Listen-Scrips-Five-MustKnow-Things
Prescription Slimming Drugs And Their OTC Alternatives, With OptiBiotix’s Stephen O’Hara
July 07, 2023 13:51 - 28 minutes - 66.1 MBIn this episode we explore the recent consumer trend for prescription weight loss drugs like Novo Nordisk's Wegovy with gut health expert Stephen O’Hara. As CEO of microbiome specialists OptiBiotix Health, O’Hara points to over-the-counter alternatives like prebiotic food supplements and medical devices, which may offer similar hunger-reducing benefits without the side effects associated with these drugs, which are designed for clinically obese patients. By successfully negotiating health cla...
이모코그, 치매 디지털치료제의 기준을 세우다 (Korean-language podcast)
July 07, 2023 04:40 - 3 minutes - 7.69 MB노유헌 이모코그 공동대표의 Scrip 인터뷰 기사를 요약한 내용입니다. https://scrip.pharmaintelligence.informa.com/SC148400/Emocog-Setting-The-Standard-For-Cognitive-Decline-DTx-in-Korea
Cardio Conversations: Volta Has Big Ambitions For AI In EP
July 06, 2023 22:41 - 16 minutes - 14.5 MBIn this edition of Cardio Conversations, Medtech Insight talked to Théophile Mohr Durdez, the CEO and co-founder of Volta Medical, a Marseille based company applying artificial intelligence to electrophysiology. Volta has raised over €70m and is sponsoring TAILORED-AF to evaluate its atrial fibrillation ablation guided by its VXI decision-support software. More on AI and electrophysiology from Medtech Insight: https://medtech.pharmaintelligence.informa.com/MT147825/Cardio-Conversations-Vekt...
No Valid excuses For Manufacturers To Delay IVD Regulation Applications
July 05, 2023 11:43 - 36 minutes - 17 MBTwo leading notified body experts, BSI’s Graeme Tunbridge, and TÜV SÜD’s Andreas Stange, in addition to consultant Gert Bos, once head of BSI notified body medtech services, joined Medtech Insight’s Amanda Maxwell to examine what impact the IVDR amending regulation, published some 18 months ago, has had on manufacturer applications to notified bodies. They revealed that the hyper around backlogs at notified bodies is exaggerated and not an excuse for inaction. The content of this podcast is ...
Medtech Connect Episode 7: Decentralized Clinical Trials
July 03, 2023 20:52 - 20 minutes - 17.3 MBIn this episode, Medtech Insight spoke to three decentralized clinical trial experts at Hogan Lovells: partner Kristin Zielinski Duggan, partner Blake Wilson and associate Stephanie Agu. We discussed the ins and outs of the draft, what pieces of the guidance still might need clarification, and how they expect to see the industry change as DCTS become mainstream.
Scrip’s Five Must-Know Things – 3 July 2023
July 03, 2023 07:13 - 14 minutes - 33.7 MBAudio roundup of selected content from Scrip over the past business week. https://scrip.pharmaintelligence.informa.com/SC148645/Quick-Listen-Scrips-Five-MustKnow-Things
China Biotech Podcast - 30 June 2023
June 30, 2023 08:47 - 20 minutes - 14.1 MBBrian Yang and Dexter Yan discuss the latest China biotech trends and hot topics.
Digital Health Round-Up: DTA 2023 Highlights; Pear Assets; Medtronic’s Spin-Off; New Business
June 28, 2023 18:53 - 10 minutes - 4.7 MBIn this month’s Digital Health Roundup, Medtech Insight’s Marion Webb and Hannah Daniel discuss highlights from their DTA Summit coverage in Washington. Reed Miller talked to Frank Chan, the president of Medtronic’s Patient Monitoring, about plans for the patient monitoring as an independent company and Bayer AG’s new business unit focusing on digital health. Listen to the podcast via the player below: Medtech Insight articles addressing topics discussed in this episode: Digital Therapeutic...
Scrip’s Five Must-Know Things – 26 June 2023
June 26, 2023 07:01 - 14 minutes - 34.3 MBAudio roundup of selected content from Scrip over the past business week. Quick Listen: Scrip's Five Must-Know Things: https://scrip.pharmaintelligence.informa.com/SC148608/Quick-Listen-Scrips-Five-MustKnow-Things?utm_source=sfmc&utm_medium=email&utm_campaign=Scrip%20Weekly%20Email
What You Need To Know About The EU Green Claims Directive, With PHD’s Jo Stephenson
June 24, 2023 23:12 - 38 minutes - 89 MBIn this episode, HBW Insight looks at yet another piece of EU sustainability legislation, this time the Green Claims Code. Sustainability expert Jo Stephenson, managing director of PHD Marketing, explains the background to the legislation, which proposes detailed rules for companies that wish to make environmental claims. Although companies are not required to make green claims, and may choose not to given these stricter rules, Stephenson points out that companies will soon be required to rec...