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Citeline Podcasts

1,366 episodes - English - Latest episode: 3 days ago - ★★★★★ - 24 ratings

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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Episodes

Speaking Of Medtech, Ep. 6: 2022 Predictions For FDA’s Device Center

January 20, 2022 16:07 - 27 minutes - 15.1 MB

In this episode of Speaking Of Medtech we’re breaking out the crystal ball to give a few predictions of what could be in store this year for industry and the FDA’s Center for Devices and Radiological Health. From the ongoing COVID-19 pandemic to digital devices and facility inspections, there’s a lot of ground to cover. Medtech Insight article addressing topics discussed in this episode: • Happy New Year! (I Think?): Some 2022 Predictions For FDA’s Device Center - https://medtech.pharmaintell...

Report Digest – Tackling The Liquid Biopsy For Oncology Market With An Expert

January 20, 2022 14:28 - 10 minutes - 6.25 MB

In this first edition of “Report Digest,” UK-based reporter Barnaby Pickering discusses the liquid biopsy for oncology market with analyst, Phil Greenfield. The two discuss the main market drivers, and exactly what experts think will occur in the sector in future years. For more information, take a look at Meddevicetracker’s report, here - https://www.meddevicetracker.com/ReportDetail.cfm?ReportID=477

Scrip’s Five Must-Know Things – 17 January 2022

January 17, 2022 02:07 - 12 minutes - 18.5 MB

Scrip’s Five Must-Know Things – 17 January 2022 by Citeline

Device Week, 14 January 2022 – Battle For The Right To Repair Devices Heats Up In US States

January 14, 2022 22:42 - 8 minutes - 6.23 MB

On this week’s podcast: From Hawaii to Missouri to Florida, the medtech industry and third-party servicers are duking it out in state legislatures over who has the right to repair and service medical devices. Medtech Insight articles addressing topics discussed in this episode: • Right To Repair Proponents Gearing Up To Fight In State Legislatures Again

Pink Sheet Podcast: Aduhelm Medicare Coverage, Fewer FDA Adcomms, Domestic Drug Production Effort

January 14, 2022 17:28 - 39 minutes - 25 MB

Pink Sheet reporter and editors discuss the CMS coverage decision for Biogen and Eisai’s Alzheimer’s treatment Aduhelm, the FDA conducting fewer advisory committee meetings in 2021 and the Defense Department’s efforts to increase domestic drug production.

Scrip’s Five Must-Know Things – 11 January 2022

January 11, 2022 02:16 - 13 minutes - 19.3 MB

Scrip’s Five Must-Know Things – 11 January 2022 by Citeline

Greening The Global OTC Industry With AESGP/GSCF's Jurate Švarcaite

January 10, 2022 11:02 - 30 minutes - 22.8 MB

In this episode, HBW Insight speaks to director general of the Association of the European Self-Care Industry (AESGP) and board member of the Global Self-Care Federation, Jurate Švarcaite. As a member of the GSCF board, Jurate has been involved in the creation of the association’s recently launched Charter for Environmentally Sustainable Self-Care, which it describes as the “first industry-wide climate action resolution issued by the consumer health sector.” Jurate tells us all about the stor...

Device Week 7 January 2022 – CES Review: Abbott Pushes Wearables; Start-Ups Galore

January 07, 2022 21:46 - 6 minutes - 12.1 MB

In the first Device Week podcast of 2022, Medtech Insight editor Marion Webb reviews the medtech highlights from CES, the world’s biggest technology convention. Listen to the podcast via the player below: The archive of Device Week and the rest of Informa Pharma Intelligence’s podcasts are available on the Informa Pharma Intelligence channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn, Spotify Podcasts and via smart speakers if one of these platforms has been set up as your def...

RSV forecast podcast

December 22, 2021 15:03 - 18 minutes - 11.4 MB

Davinderpreet Mangat discusses the forecast for the RSV market. Supporting links: RSV forecast https://service.datamonitorhealthcare.com/hkc/disease/infectious-diseases/vaccines/respiratory-syncytial-virus-prevention/forecast/article133448.ece RSV disease analysis report https://service.datamonitorhealthcare.com/hkc/disease/infectious-diseases/vaccines/respiratory-syncytial-virus-prevention/disease-analysis/article220186.ece Other platforms: Apple Podcasts -   https://podcasts.apple.com/us/...

Skin Diseases Podcast

December 22, 2021 14:08 - 41 minutes - 24.3 MB

Podcast description Davinderpreet Mangat, Pamela Spicer, and Kevin Grogan discuss the skin disease landscape (atopic dermatitis and psoriasis). Topics covered include: • Atopic Dermatitis - 01:00 • Psoriasis – 25:00 Supporting links: • Datamonitor’s Atopic dermatitis disease analysis report - https://service.datamonitorhealthcare.com/hkc/disease/immunology-and-inflammation/dermatology/atopic-dermatitis/disease-analysis/article232260.ece • Datamonitor’s Psoriasis disease analysis report - http...

Ocugen Founder-CEO Musunuri on mutation-agnostic gene therapy and COVID-19 vaccine plans

December 22, 2021 00:16 - 43 minutes - 23.7 MB

Ocugen’s founder and CEO Shankar Musunuri speaks to Scrip about his company’s mutation-agnostic gene therapy candidate OCU-400, a commercial agreement with CanSino Biologics and plans for a bridging study of partner Bharat Biotech’s COVID-19 vaccine Covaxin post a US FDA clinical hold.

No Greenwashing: Navigating The UK Green Claims Code, with PHD Marketing's Jo Stephenson

December 20, 2021 10:18 - 29 minutes - 21.6 MB

How can self-care companies operating in the UK avoid 'greenwashing' when making environmental claims for their OTC brands? In this episode, HBW Insight's David Ridley speaks to PHD Marketing managing director Jo Stephenson about the new UK Green Claims Code, and how OTC firms can navigate this new guidance on making claims for 'eco-friendly' products. We also chat about the wider implications of sustainability for the consumer healthcare industry, with advice for companies small and large fo...

Scrip’s Five Must-Know Things – 20 December 2021

December 20, 2021 04:08 - 13 minutes - 20.4 MB

Scrip’s Five Must-Know Things – 20 December 2021 by Citeline

Pink Sheet Podcast: Califf Confirmation Hearing, COVID-19 vaccine changes, Cancer Drugs From China

December 17, 2021 17:49 - 39 minutes - 23.6 MB

Pink Sheet reporters and editors discuss US FDA commissioner nominee Robert Califf’s Senate confirmation hearing, new COVID-19 vaccine recommendations from the US CDC, and issues related to US approval of China-developed cancer drugs.

Device Week, 17 December 2021 – Califf’s Senate Hearing; Medtronic And BrainsGate’s Woes

December 16, 2021 22:56 - 13 minutes - 5.78 MB

On this week’s podcast: Robert Califf goes through his first round nomination hearing in the US Senate, Medtronic and BrainsGate hits their own snags, and the US FDA defines counterfeit products under its new authorities.

COVID-19 Continues To Shape MTI 100 Entering 2022

December 15, 2021 22:32 - 14 minutes - 26.4 MB

In this special podcast, Medtech Insight commercial/R&D editor Reed Miller talks to In Vivo executive editor Ashley Yeo about the annual MTI 100 list and the major trends facing the top medtech companies entering the third year of the pandemic. Related articles: https://medtech.pharmaintelligence.informa.com/datasets/company-rankings-2022 https://medtech.pharmaintelligence.informa.com/MT144758/MTI-100-Review-Medtechs-Drive-To-Keep-The-Status-Quo-In-A-Year-Like-No-Other https://medtech.pharm...

Device Week, Dec 10, 2021 – Early Alzheimer’s Diagnostic, And Cardiac Pacing Breakthroughs

December 10, 2021 12:43 - 7 minutes - 4.57 MB

In this edition of Device Week, Medtech Insight’s Marion Webb talks to UK-based reporter Barnaby Pickering about Cognetivity’s FDA approved diagnostic tool for Alzheimer’s. The company hopes that by providing earlier diagnosis, cost savings in the trillions of dollars can be made. Reed Miller also discusses Boston Scientific’s new “Modular” cardiac rhythm management system. They launched the trial of their Modular system that includes both a subcutaneous ICD and a leadless pacemaker, with po...

Digital Health Roundup – A Season For Interviews, New Frontiers, AI, Cybersecurity

December 07, 2021 23:12 - 20 minutes - 21.8 MB

In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb, Ferdous (Danny) Al-Faruque and Barnaby Pickering provide a recap of our digital health coverage in November including interviews with Medtronic, Abbott and Congenica, partnerships and launches, and AI and cybersecurity announcements. Medtech Insight articles addressing topics discussed in this episode: Congenica Tries To Bring Clarity To Personalized Medicine For Rare Diseases https://medtech.pharmaintelligence.informa.com...

Speaking Of Medtech, Ep. 5: MDUFA V User-Fee Negotiations

December 07, 2021 20:37 - 26 minutes - 18.7 MB

In this episode of Speaking Of Medtech we discuss the Medical Device User Fee Amendments, or MDUFA, the negotiations for which come around every five years. The MDUFA V talks between industry and the US FDA appear with the inevitability of an unloved season – it seems no one is ever terribly excited to engage in the user-fee process. Here, we break things down. Medtech Insight articles addressing topics discussed in this episode: FDA Official: Uptick In PMA, 510(k) Applications Calls For Mor...

Addressing the UK's Post-Pandemic Sleep Crisis, with Perrigo VP Neil Lister

December 07, 2021 10:08 - 18 minutes - 13.8 MB

Nearly three quarters of the UK adults suffer from sleep problems, yet the majority of them do not seek help. In this episode, HBW Insight's Senio Editor, Europe, David Ridley, speaks to Perrigo VP and PAGB president Neil Lister about what consumer healthcare companies can do to help sleep-deprived British consumers. We talk about UK sleep brand Nytol-owner Perrigo's new report, State of the Market Report on Sleep, and how adjacencies in the OTC sleep category offer opportunities for self-car...

Scrip’s Five Must-Know Things – 6 December 2021

December 06, 2021 02:10 - 13 minutes - 18.9 MB

Scrip’s Five Must-Know Things – 6 December 2021 by Citeline

Pink Sheet Podcast: Woodcock’s Legacy, Merck’s Oral COVID-19 Pill, 340B Case At Supreme Court

December 03, 2021 18:04 - 36 minutes - 23.2 MB

Pink Sheet reporters and editor review Acting Commissioner Janet Woodcock’s long career at the US FDA and update Robert Califf’s confirmation process, consider the advisory committee decision on Merck’s oral COVID-19 treatment, and discuss an under-the-radar case on 340B policy at the US Supreme Court.

Device Week, 3 December 2021 – What Do The New Eudamed Modules Mean for Medtech?

December 03, 2021 17:42 - 8 minutes - 4.47 MB

In this week’s podcast, EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union, including recent module updates and compliance expectations for the Eudamed database.

APAC Podcast: Policies Play Out Against Pandemic, Corporate Activity Remains Strong

December 01, 2021 03:25 - 42 minutes - 31.6 MB

APAC Podcast: Policies Play Out Against Pandemic, Corporate Activity Remains Strong by Citeline

Scrip’s Five Must-Know Things – 29 November 2021

November 29, 2021 03:09 - 15 minutes - 22.9 MB

Scrip’s Five Must-Know Things – 29 November 2021 by Citeline

Podcast: How To Protect Yourself When Your AI Makes Mistakes?

November 23, 2021 20:51 - 27 minutes - 20.2 MB

Medtech Insight spoke with Sidley Austin attorneys about the future of medical device AI negligence litigation and what manufacturers can do to protect themselves.

Over The Counter 22 November 2021: CHC Spin Outs, Supply Chain Issues And Other Q3 Business Trends

November 22, 2021 10:01 - 41 minutes - 30.7 MB

In this episode, HBW Insight’s US and EU Managing Editors Malcolm Spicer and Tom Gallen analyse Q3 OTC business trends, including why the biggest pharmaceutical companies in the world are spinning out their consumer health businesses to create new, publicly listed standalone firms and what's causing the supply chain troubles that are driving up OTC product prices.

Pink Sheet Podcast: COVID-19 Boosters For Adults, Aduhelm And Part B, Califf For FDA Commissioner

November 19, 2021 17:07 - 41 minutes - 26.1 MB

Pink Sheet reporters and editors discuss the authorization of COVID-19 vaccine booster shots for all adults, Aduhelm’s impact on Medicare Part B and rejection by EMA, and the nomination of ex-FDA commissioner Robert Califf for another term.

Device Week, Nov. 19, 2021 – J&J Break Up And Genomic Diagnostics

November 19, 2021 13:04 - 8 minutes - 4.73 MB

In this edition of Device Week, Medtech Insight’s Reed Miller chats to Marion Webb about the recent announcement that Johnson & Johnson will split into two separate businesses – one focusing on medical products, and the other focusing on consumer. Reed and Barnaby also discuss recent results from the UK’s 100,000 Genome project, and how its analysis partner, Congenica, hopes to deliver personalized medicine through widescale genomic testing Medtech Insight articles addressing topics discusse...

Speaking Of Medtech, Ep. 4: FDA’s Regulation Of Digital Devices

November 19, 2021 12:55 - 19 minutes - 13.4 MB

In this episode of Speaking Of Medtech we discuss the regulatory side of digital health – that is, the US FDA side of digital – and some of the more important related policies and activities that are going on at the agency right now. Medtech Insight articles addressing topics discussed in this episode: • What Does ‘Digital’ Mean For FDA’s Device Center? - https://medtech.pharmaintelligence.informa.com/MT144553/What-Does-Digital-Mean-For-FDAs-Device-Center

Scrip’s Five Must-Know Things – 15 November 2021

November 15, 2021 02:35 - 14 minutes - 21.3 MB

Scrip’s Five Must-Know Things – 15 November 2021 by Citeline

Device Week, 11 November 2021–Long-Awaited Software Guidance Released; FDA Panel Talks Stent Safety

November 11, 2021 21:06 - 9 minutes - 7.22 MB

On this week’s podcast: The US FDA finally issued a draft guidance for medical software in the premarket space, while an agency panel meeting focused on the safety of graft stents. Medtech Insight articles addressing topics discussed in this episode: • FDA’s SaMD/SiMD Guidance Could Mean Documentation Headaches For Some Software Makers, Attorney Says • Bleeding Risks Still A Concern For Patients With Endologix Stent Grafts: FDA Advisory Panel

Digital Health Roundup – Digital Therapeutics Standards, Coverage; FDA’s Software Guidance

November 09, 2021 20:31 - 8 minutes - 5.82 MB

In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb and Ferdous (Danny) Al-Faruque provide a recap of our digital health coverage in October including updates on the digital therapeutics sector and FDA guidance documents. Medtech Insight articles addressing topics discussed in this episode: https://medtech.pharmaintelligence.informa.com/MT144573/Pear-Therapeutics-Obtains-First-Medicaid-Coverage-For-PDTs https://medtech.pharmaintelligence.informa.com/MT144574/PDT-Company-Bette...

What’s Next For The Global Self-Care Movement? With Bayer Consumer Health’s Daniella Foster

November 08, 2021 11:05 - 31 minutes - 23.4 MB

In this episode, HBW Insight Senior Editor David Ridley chats with Bayer’s Daniella Foster about the emerging self-care movement. Daniella is global vice president and Head of Public Affairs, Science & Sustainability for Bayer Consumer Health. We dive deep into what is driving the self-care movement and some of the challenges industry faces in building this movement in a purposeful way as we come out of the pandemic.

Scrip’s Five Must-Know Things – 8 November 2021

November 08, 2021 03:13 - 13 minutes - 19.8 MB

Scrip’s Five Must-Know Things – 8 November 2021 by Citeline

Pink Sheet Podcast: Drug Price Negotiations, Kids COVID Vaccine Deployed, FDA Chief Scientist Leaves

November 05, 2021 15:30 - 34 minutes - 21.7 MB

Pink Sheet reporters and editors discuss the congressional agreement to allow Medicare drug pricing negotiations, the authorization of the Pfizer/BioNTech vaccine for children age 5 to 11, and the departure of the US FDA’s Chief Scientist.

Device Week, 4 November 2021 – Analysis On CEO Post-Pandemic Views, SPACs, Medtronic

November 04, 2021 22:42 - 12 minutes - 9.07 MB

In this week’s podcast, Medtech Insight's US Commercial manager Reed Miller provides an overview of Medtronic’s “refreshed brand” on environmental, social and governance targets. Managing editor Marion Webb highlights her deep-dive pieces on CEO post-pandemic perspectives while UK-based reporter Barnaby Pickering provides an analyst perspective on price targets following poor SPAC reception. Listen to the podcast via the player below: Medtech Insight articles addressing topics discussed in...

Speaking Of Medtech, Ep. 3: FDA Quality System Regulation Harmonization

November 03, 2021 20:25 - 17 minutes - 12.5 MB

In this episode of Speaking Of Medtech we talk about arguably one of the biggest regulatory changes to come down the pike in decades: the ongoing harmonization of the US FDA’s QSR, which is going to broadly change the way the agency handles medical device quality oversight. Medtech Insight articles addressing topics discussed in this episode: • QSR Author Says FDA – Not Industry – Will Need Most Time To Adapt To New Quality System Reg • QSR Q&A: 5 Top Medtech Experts Answer 6 Burning Question...

Scrip’s Five Must-Know Things – 1 November 2021

November 01, 2021 03:28 - 12 minutes - 18.5 MB

Scrip’s Five Must-Know Things – 1 November 2021 by Citeline

Device Week, 29 October 2021 – FDA Breast Implant Rules & Favored Guidance List

October 29, 2021 18:33 - 10 minutes - 7.27 MB

On this week’s podcast: The US FDA put some teeth to its regulation of the implants by issuing several new mandates, including a requirement that surgeons warn patients about the risks of the devices prior to surgery. Also this week the agency released its annual list of priority guidance documents. Medtech Insight articles addressing topics discussed in this episode: • FDA Strengthens Safety Requirements For Breast Implants https://medtech.pharmaintelligence.informa.com/MT144648/FDA-Strength...

Pink Sheet Podcast: Kids’ COVID-19 Vaccines, Merck Shares COVID Pill, Accelerated Approval Problems

October 29, 2021 16:18 - 30 minutes - 19 MB

Pink Sheet reporters and editors discuss the issues that could arise when the COVID-19 vaccines are given to children age 5 to 11, Merck’s agreement to share the license for its proposed oral COVID-19 treatment, and problems for a sponsor blocked by an accelerated approval conversion to full approval.

Boehringer Ingelheim India Chief On Strategy, Jardiance Challenge, Gender Balance In Pharma

October 27, 2021 05:23 - 30 minutes - 22.6 MB

Boehringer Ingelheim India Chief On Strategy, Jardiance Challenge, Gender Balance In Pharma by Citeline

Scrip’s Five Must-Know Things – 26 October 2021

October 26, 2021 02:25 - 13 minutes - 20.8 MB

Scrip’s Five Must-Know Things – 26 October 2021 by Citeline

Building A Global Self-Care Movement With GSCF's Heiko Schipper

October 25, 2021 09:22 - 33 minutes - 25 MB

Following the publication of its Self-Care Readiness Index, HBW Insight's David Ridley speaks to Global Self-Care Federation chair Heiko Schipper about what it takes to build a worldwide movement for self-care. We also discuss how industry players like Bayer Consumer Health - which Schipper heads up as division president - can contribute, for example as 'truth leaders' in an age of misinformation and public mistrust and as partners for community pharmacy, which still has an important role to ...

Device Week, 21 October 2021 - Post-Pandemic Perspectives; Good And Bad News For Medtronic

October 21, 2021 21:00 - 9 minutes - 17.7 MB

In this edition of Device Week, Medtech Insight’s Reed Miller discusses some important news from Medtronic and Marion Webb reviews the first of two feature articles on the impact of the pandemic on the medtech industry around the world. Listen to the podcast via the player below: The archive of Device Week and the rest of Informa Pharma Intelligence’s podcasts are available on the Informa Pharma Intelligence channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn, Spotify Podcasts an...

Speaking Of Medtech, Ep. 2 – Breakthrough Medical Devices

October 20, 2021 20:28 - 20 minutes - 14.2 MB

In this episode of our new deep-dive podcast Speaking Of Medtech, former US FDA device center compliance chief Steve Silverman and Medtech Insight executive editor Shawn M. Schmitt talk about the agency’s Breakthrough Devices Program – what it is, how it operates, how device makers can take full advantage of the pathway, and more. Medtech Insight articles addressing topics discussed in this episode: • Breathing Easy: ALung CEO Talks Novel Hemolung Device, FDA's Breakthrough Pathway, Landmark ...

HIV Treatment & PrEP – long acting agents

October 18, 2021 11:11 - 39 minutes - 23.4 MB

Davinderpreet Mangat and Shardha Millington discuss the current and future role of long-acting agents in HIV treatment and PrEP. Topics covered include: HIV treatment – 4:30 HIV PrEP – 22:45 Supporting links: https://service.datamonitorhealthcare.com/hkc/disease/infectious-diseases/viral-infections/hiv-pre-exposure-prophylaxis-hiv-prep/disease-analysis/article225313.ece https://service.datamonitorhealthcare.com/hkc/disease/infectious-diseases/viral-infections/human-immunodeficiency-viru...

Scrip’s Five Must-Know Things – 18 October 2021

October 18, 2021 02:42 - 12 minutes - 16.3 MB

Scrip’s Five Must-Know Things – 18 October 2021 by Citeline

Device Week, 13 October 2021 – Spotlight On The Latest Medtech-Industry News From The EU

October 13, 2021 20:42 - 10 minutes - 5.93 MB

In this week’s podcast, EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union. Topics include discussion of ISO 13485, ongoing industry concerns with MDR implementation, and the Eudamed database expansion.

Digital Health Roundup, 12 October 2021 – Record-Breaking Funding; FDA, AAOS 2021

October 12, 2021 23:45 - 5 minutes - 4 MB

In this month’s podcast, Medtech Insight's Reed Miller and Marion Webb provide a recap of our digital health coverage in August and September, including start-ups that grabbed new funding, news from AAOS 2021 and regulatory news. Medtech Insight articles addressing topics discussed in this episode: Akili Pays $37.5M To License Tali’s Tech For Early Childhood Attention Impairments https://medtech.pharmaintelligence.informa.com/MT144365/Akili-Pays-375M-To-License-Talis-Tech-For-Early-Childhoo...

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