Pharma Intelligence Podcasts

Pink Sheet reporters and editors discuss the largest pharma companies’ pending applications (0:41), the FDA delaying its decision on Sarepta’s gene therapy in Duchenne muscular dystrophy (14:32), and a plan to add more temporary members to agency advisory committees (24:55) … as well as a little bit of “The Simpsons.” Read More In The Pink Sheet Everything’s Coming Up Pfizer: The Biggest Of Pharma Firms Leads Industry In Pending Applications For US FDA Approval https://pink.pharmaintelligence.informa.com/PS148271/Everythings-Coming-Up-Pfizer-The-Biggest-Of-Pharma-Firms-Leads-Industry-In-Pending-Applications-For-US-FDA-Approval Big Pharma At US FDA: A Regulatory Scorecard https://pink.pharmaintelligence.informa.com/PS148265/Big-Pharma-At-US-FDA-A-Regulatory-Scorecard Lilly Unlucky? Lilly Leads Big Pharma In US FDA Complete Response Letters https://pink.pharmaintelligence.informa.com/PS148280/Lilly-Unlucky-Lilly-Leads-Big-Pharma-In-US-FDA-Complete-Response-Letters Everybody Stumbles: US FDA Complete Response Letters To Big Pharma https://pink.pharmaintelligence.informa.com/PS148279/Everybody-Stumbles-US-FDA-Complete-Response-Letters-To-Big-Pharma Sarepta’s DMD Gene Therapy: Approval Delayed And Indication Narrowed, But Still On Track https://pink.pharmaintelligence.informa.com/PS148268/Sareptas-DMD-Gene-Therapy-Approval-Delayed-And-Indication-Narrowed-But-Still-On-Track Expect More Temporary Members Voting In US FDA Advisory Committees https://pink.pharmaintelligence.informa.com/PS148243/Expect-More-Temporary-Members-Voting-In-US-FDA-Advisory-Committees

HBW Insight catches up with our own US Executive Editor, Malcolm Spicer, to find out all about Perrigo subsidiary HRA Pharma’s Rx-to-OTC switch of its daily contraceptive, Opill. Currently under consideration by the US Food and Drug Administration after a positive recommendation from its advisory committees, Spicer draws on 30+ years of writing about the US consumer healthcare market, as well as his extensive coverage of the subject, to tell us all we need to know about this historic switch.

Quick Listen: Scrip's Five Must-Know Things https://scrip.pharmaintelligence.informa.com/SC148417/Quick-Listen-Scrips-Five-MustKnow-Things

Brian Yang and Dexter Yan discuss the latest China biotech trends and topics including recent mega-million deals between domestic biotechs and MNCs, the inaugural Asia Bio Partnering Forum and drug makers’ creative ways to financing amid lingering “capital winter”, and GLP-1 receptor agonists stepping into the spotlight and its potential to become the next hot pursuit after PD-1 in China.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb discusses how two medtech CEOs are and aren’t using ChatGPT in their businesses while Reed Miller talks about his “Cardio Conversations” podcast interviews with Quentin Blackford, CEO of iRhythm and Rob Krummen, CEO of Vektor Medical. Washington, DC-based reporter Hannah Daniel reviews highlights from the HIMSS conference and the latest updates on FDA guidances. Listen to the podcast via the player below: Medtech Insight articles addressing topics discussed in this episode: Cardio Conversations: iRhythm Prepares To Deliver ‘Standard-Of-Care’ Cardiac Monitoring Cardio Conversations: Vektor Addresses ‘Global Health Crisis’ With Arrythmia Mapping HIMSS23 Using The Metaverse To Break Down Language Barriers and Improve Diversity In Clinical Trials Tales From HIMSS23: FDA On FHIR And AI For The Voiceless Decentralized Clinical Trial Guidance Fulfills Promise, Underlies Digitization Of Healthcare Expert: FDA’s Highly Anticipated PCCP Guidance Isn’t Anything Too ‘Surprising’ How Two Medtech CEOs Are (And Aren’t) Using ChatGPT In Their Businesses

Quick Listen: Scrip's Five Must-Know Things: https://scrip.pharmaintelligence.informa.com/SC148375/Quick-Listen-Scrips-Five-MustKnow-Things

Quentin Blackford, CEO of iRhythm, talked to Medtech Insight about his company’s plans to bring its Zio long-term cardiac monitoring platform to more patients by building its evidence base and marketing in more countries outside the US. For more information on iRhythm, cardiac monitoring and ECG technologies, check out these articles at Medtech Insight. Cardio Conversations: Vektor Addresses ‘Global Health Crisis’ With Arrythmia Mapping https://medtech.pharmaintelligence.informa.com/MT147825/Cardio-Conversations-Vektor-Addresses-Global-Health-Crisis-With-Arrythmia-Mapping CMS Proposes National Payments For Long-Term Continuous Electrocardiogram Monitoring https://medtech.pharmaintelligence.informa.com/MT145597/CMS-Proposes-National-Payments-For-Long-Term-Continuous-Electrocardiogram-Monitoring FDA Clears iRhythm’s Afib-Detecting Wearable Running Software Co-Developed By Verily https://medtech.pharmaintelligence.informa.com/MT145646/FDA-Clears-iRhythms-Afib-Detecting-Wearable-Running-Software-Co-Developed-By-Verily Exec Chat: As Reimbursement Questions Get Answers, iRhythm Looks To The Future https://medtech.pharmaintelligence.informa.com/MT145401/Exec-Chat-As-Reimbursement-Questions-Get-Answers-iRhythm-Looks-To-The-Future JPM 2022: Abbott, iRhythm, Novocure, Zimmer Biomet https://medtech.pharmaintelligence.informa.com/MT144935/JPM-2022-Abbott-iRhythm-Novocure-Zimmer-Biomet Exec Chat: New iRhythm CEO Foresees Enormous Opportunity In AI For Arrhythmia Detection https://medtech.pharmaintelligence.informa.com/MT144913/Exec-Chat-New-iRhythm-CEO-Foresees-Enormous-Opportunity-In-AI-For-Arrhythmia-Detection Dexcom COO Quentin Blackford Takes CEO Job At iRhythm https://medtech.pharmaintelligence.informa.com/MT144461/Dexcom-COO-Quentin-Blackford-Takes-CEO-Job-At-iRhythm

스크립의 박재홍 동아ST R&D 총괄 부문 사장 인터뷰 기사를 요약한 내용입니다 https://scrip.pharmaintelligence.informa.com/SC148059/Dong-A-ST-Faces-New-Wave-Of-Change-As-It-Challenges-Norms

In this episode, HBW Insight speaks to the Global Self-Care Federation’s director of regulatory and scientific affairs, Padmaja Kamath, about the organisation’s sustainability work. In 2019, GSCF published its Global Charter for Environmental Sustainability, which represented, Kamath notes, the global consumer healthcare industry’s “first commitment to drive sustainable self-care.” Kamath updates us on the progress of the charter, which calls on GSCF members to pledge to make progress on one or more of three key sustainability areas: plastics and packaging, pharmaceuticals in the environment and CO2 footprint. We dive a little deeper into some specific challenges within these areas, such as recyclable blister packs and supply chain emissions, with Kamath pointing also to an upcoming GSCF webinar on the latter.

Quick Listen: Scrip's Five Must-Know Things: https://scrip.pharmaintelligence.informa.com/SC148335/Quick-Listen-Scrips-Five-MustKnow-Things

Scrip senior writer Joseph Haas overviews biopharma deal-making in 2022 and discusses the Pfizer/Seagen merger and what that may mean for pharma M&A during the remainder of 2023, with EF Hutton analyst Mike King and Mintz attorney Matt Gardella.

Joshua Sabari, MD Lung Cancer Specialist Answers Questions on Treating Patients with ES-SCLC

Maximizing The UK Medtech Opportunity In Times Of Change by Pharma Intelligence

In this episode of Medtech Connect, Medtech Insight senior regulatory writer Eliza Slawther interviews MedTech Europe’s digital lead Alexander Olbrechts about the interplay between EU medical device laws with proposed horizontal regulations that impact digital devices, such as the AI Act, the Data Act and the European Health Data Space. The importance of international harmonized standards, particularly for cybersecurity, is also discussed

Quick Listen: Scrip's Five Must-Know Things: https://scrip.pharmaintelligence.informa.com/SC148297/Quick-Listen-Scrips-Five-MustKnow-Things?utm_source=sfmc&utm_medium=email&utm_campaign=Scrip%20Weekly%20Email

In this episode, HBW Insight catches up with Bayer Consumer Health’s Daniella Foster. Foster leads on the company’s public affairs and sustainability work, and so updates us on Bayer’s progress towards its net zero goals and also its Nutrient Gap Initiative, which aims to expand access to vitamins and minerals for 50 million people in underserved communities by 2030. Foster explains the business model behind sustainability, and how the company is expanding access to self-care products in other ways, for example via Rx-to-OTC switch. We also dig a bit deeper into thorny sustainability issues like greenwashing and offsetting, with Foster offering sage advice to consumer health industry colleagues.

Quick Listen: Scrip's Five Must-Know Things https://scrip.pharmaintelligence.informa.com/SC148258/Quick-Listen-Scrips-Five-MustKnow-Things

Pink Sheet reporters and editors discuss questions about Sarepta’s Duchenne muscular dystrophy gene therapy candidate (0:32), the US FDA’s efforts to simplify the COVID-19 vaccine schedule (13:15), and industry’s ideas for Medicare price negotiation system changes (24:18). Read More In The Pink Sheet CBER Director Marks’ Intervention On Sarepta Gene Therapy Filing Decision Appears To Backfire: https://pink.pharmaintelligence.informa.com/PS148055/CBER-Director-Marks-Intervention-On-Sarepta-Gene-Therapy-Filing-Decision-Appears-To-Backfire If New COVID-19 Vaccine Recommendations Land In the United States, Do They Make Sound? https://pink.pharmaintelligence.informa.com/PS148080/If-New-COVID19-Vaccine-Recommendations-Land-In-the-United-States-Do-They-Make-Sound PhRMA’s Opening Gambit: Limiting Medicare Price Setting To The IRA's Minimum Discount: https://pink.pharmaintelligence.informa.com/PS148072/PhRMAs-Opening-Gambit-Limiting-Medicare-Price-Setting-To-The-IRAs-Minimum-Discount

CNS analysts discuss neurodegenerative disorders - Parkinson’s and Alzheimer’s disease Alzheimer’s Disease Forecast https://service.datamonitorhealthcare.com/hkc/disease/central-nervous-system/neurology/alzheimers-disease/forecast/article155358.ece Alzheimer’s Disease Analysis Report https://service.datamonitorhealthcare.com/hkc/disease/central-nervous-system/neurology/alzheimers-disease/disease-analysis/article209751.ece Parkinson’s Disease Analysis Report https://service.datamonitorhealthcare.com/hkc/disease/central-nervous-system/neurology/parkinsons-disease/disease-analysis/article218480.ece Parkinson’s Disease Forecast https://service.datamonitorhealthcare.com/hkc/disease/central-nervous-system/neurology/parkinsons-disease/forecast/article138452.ece 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

Huahui Health CSO Li Wenhui sits down with Scrip in the office to discuss many of the key issues such as, how he views antivirals development post-COVID? how the company’s hepatitis drugs differentiated from others? Given the current antivirals from Gilead among others, why Li believed that the antiviral development remains vital?