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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

Device Week, 9 July 2021 – Dexcom Interview; ADA Update

July 09, 2021 17:47 - 6 minutes - 11.2 MB

In this week’s podcast, Medtech Insight editors Marion Webb and Reed Miller discuss the latest news from the American Diabetes Association conference as well as an interview with Dexcom CEO Kevin Sayer about the company’s strategy in the blood glucose measurement market. 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 and TuneIn - and also now on Spotify P...

Pink Sheet Podcast: Aduhelm Label Change, First Half Drug Approvals, FTC Investigative Power

July 09, 2021 16:12 - 29 minutes - 19 MB

Pink Sheet reporters and editors discuss the implications of Aduhelm’s updated indication, CDER’s new drug approvals in the first half of 2021, and an FTC policy change that will make investigating pharma easier.

Scrip’s Five Must-Know Things – 5 July 2021

July 05, 2021 02:46 - 13 minutes - 21.9 MB

Scrip’s Five Must-Know Things – 5 July 2021 by Pharma Intelligence

Device Week, 2 July 2021 – Shuren Interview Highlights and Supreme Court Update

July 02, 2021 20:49 - 9 minutes - 5.46 MB

In this week’s podcast, senior reporter Ferdous Al-Faruque discusses the most interesting tidbits from his recent interview with US FDA device center chief Jeff Shuren, and managing editor Elizabeth Orr offers updates on what two recent Supreme Court patent decisions could mean for medtech.

Pink Sheet Podcast: US FDA Thoughts on Aduhelm, Stephen Hahn Interview, Potential Adcom Reforms

July 02, 2021 16:24 - 40 minutes - 25.7 MB

Pink Sheet reporters and editors discuss new Aduhelm documents explaining the FDA’s views on the accelerated approval, comments from the former FDA commissioner on his tenure and future, and options for improving advisory committee meetings.

Datamonitor Podcast, ASCO 2021 0

June 29, 2021 08:21 - 12.4 MB

David Dahan, Ellie Davenport, Tom Tyler and Zachary McLellan discuss the 2021 ASCO conference. Topics covered include: CheckMate 648 trial, Opdivo in Esophageal Cancer - 00:47 VISION trial, 177Lu-PSMA-617 in Prostate Cancer – 08:20 RELATIVTY-047 trial, Relatlimab and Opdivo in Melanoma – 15:36 CARTITUDE-1 trial, Cilta-cel in Multiple Myeloma – 19:45 ELEVATE-RR trial, Calquence vs. Imbruvica in Chronic Lymphocytic Leukemia – 26:01

Datamonitor Podcast, ASCO 2021

June 29, 2021 08:21 - 31 minutes - 12.4 MB

David Dahan, Ellie Davenport, Tom Tyler and Zachary McLellan discuss the 2021 ASCO conference. Topics covered include: CheckMate 648 trial, Opdivo in Esophageal Cancer - 00:47 VISION trial, 177Lu-PSMA-617 in Prostate Cancer – 08:20 RELATIVTY-047 trial, Relatlimab and Opdivo in Melanoma – 15:36 CARTITUDE-1 trial, Cilta-cel in Multiple Myeloma – 19:45 ELEVATE-RR trial, Calquence vs. Imbruvica in Chronic Lymphocytic Leukemia – 26:01

A Chat With Shuren: FDA Device Center Chief Worried About Staffing; Talks MDUFA V, Pandemic, More

June 28, 2021 21:43 - 18 minutes - 14.7 MB

The head of the US agency’s device center spoke with Medtech Insight in a wide-ranging interview about his priorities for the future, the nuances of the MDUFA V user-fee negotiations, how COVID-19 has changed the agency, and more.

Over The Counter, 28 June 2021: The Promise Of Digital Health, with PAGB's Michelle Riddalls

June 28, 2021 10:38 - 41 minutes - 30.3 MB

In this bonus edition of HBW Insight's new 'Over The Counter' podcast, David Ridley (Senior Editor, EU), speaks to the PAGB's Michelle Riddalls about the association's upcoming Digital Week event (5th to 9th July) and the promise of digitalization for the UK consumer healthcare industry. In this wide-ranging interview, we discuss how digital adoption by industry and consumers has been accelerated by the pandemic, as well as the opportunities and challenges of the recent e-commerce boom and ho...

Scrip’s Five Must-Know Things – 28 June 2021

June 28, 2021 01:36 - 12 minutes - 20.1 MB

Scrip’s Five Must-Know Things – 28 June 2021 by Pharma Intelligence

Device Week, 25 June 2021 – Major SPAC; Novel Heart Pump; And Breakthrough Device Designation

June 25, 2021 12:30 - 10 minutes - 19.3 MB

In this edition of Device Week, Medtech Insight's UK-based reporter Barnaby Pickering provides an insight into Procyrion’s novel device for decongesting cardiorenal syndrome patients. US Commercial and R&D manager, Reed Miller, highlights details on Pear Therapeutics’ recent SPAC acquisition, and managing editor, Marion Webb, discusses two companies that received types of approval for novel devices. Medtech Insight articles discussed in this week’s episode: Onward Secures FDA Breakthrough...

Over The Counter, 22 June 2021: CBD In Europe, What's Going On? With Canna Consultants' Steve Oliver

June 22, 2021 16:05 - 36 minutes - 26.4 MB

In this edition of HBW Insight's new 'Over The Counter' podcast, David Ridley (Senior Editor, EU), talks to Canna Consultants' Steve Oliver about the current state of CBD regulation in the UK and European Union. Specifically, we discuss what is going on with the hundreds of CBD novel food applications submitted to the UK Food Standards Agency and why only four synthetic CBD novel food applications have been validated by the European Commission so far. We also speculate about the possibility o...

Scrip Interview With Kaja Natland, Asia Pacific Head, Organon

June 22, 2021 01:04 - 24 minutes - 34.3 MB

Podcast Time Stamps 00:08 Introduction 01:01 The spin-off from Merck: The world needs a company like Organon 03:13 Taking a broad view on women’s health - beyond reproductive health 05:24 Wall of Voices – Listening to the needs and challenges of women 10:32 Partnering and Inorganic Growth 12:51 The cultural fit for alliances 14:06 Majority-female board of directors 15:50 Renewed focus on established products portfolio, life cycle management 19:07 Biosimilars franchise 21:30 Putting women...

Scrip’s Five Must-Know Things – 21 June 2021

June 21, 2021 02:25 - 12 minutes - 21.6 MB

Scrip’s Five Must-Know Things – 21 June 2021 by Pharma Intelligence

Device Week, 18 June 2021 – MDUFA V Update; FDA’s Shuren Speaks; Harmonized QS Reg Almost Here?

June 18, 2021 19:19 - 8 minutes - 15.9 MB

On this week’s podcast we give an update on the Medical Device User Fee Amendments (MDUFA V) process. We also discuss US FDA device center director Jeff Shuren’s comments about pre-submission meetings and IVD submissions during a recent podcast interview with AdvaMed. Finally, we discuss the FDA’s latest scheduling of the release of its draft harmonized Quality System Regulation, due out this month. Medtech Insight articles addressing topics discussed in this episode: • MDUFA V: FDA Proposes...

Pink Sheet Podcast: Adcoms Too Emotional, Pushing Gene Therapy Science, Congress Gets UFA Update

June 18, 2021 17:20 - 22 minutes - 14.1 MB

Pink Sheet reporter and editors discuss whether emotion could be removed from US FDA advisory committees, adverse events and advancing science in gene therapy development, and Capitol Hill’s interest in the ongoing user fee negotiations.

Digital Health Roundup, 17 June 2021 – Surgeons’ New ‘AR’ Tools, Digital Pill, Verily FDA Setback

June 17, 2021 22:24 - 6 minutes - 12 MB

In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb, Barnaby Pickering and Danny Al-Faruque offer a recap of our digital health coverage in May and early June, including the latest Market Intel on the “Future of Surgery” focusing on immersive technologies, an interview with the author of “The Digital Pill” and US FDA news on Verily, Cognoa and cybersecurity standards. Listen to the podcast via the player below: Market Intel: How Augmented, Mixed And Virtual Reality Unveils ...

ABHI’s Kennedy and Brown discuss UK regulatory needs

June 17, 2021 14:11 - 20 minutes - 38.2 MB

Outside the EU, the UK is setting its own regulatory standards and has a remit to promote innovation, leverage international best practice, listen more closely to the patent voice and raise safety standards. Industry watches developments closely.

Over The Counter, 14 June 2021 – Vitamin D, Immunity And COVID-19, With Professor Martin Hewison

June 14, 2021 14:10 - 36 minutes - 27 MB

In this edition of HBW Insight's new 'Over The Counter' podcast, David Ridley (Senior Editor, EU) talks to University of Birmingham professor Martin Hewison about vitamin D's immunity benefits, whether it can help prevent infection with or lessen the effects of COVID-19 and what industry can do to help researchers unlock the potential of this trending dietary supplement ingredient.

Scrip’s Five Must-Know Things – 14 June 2021

June 14, 2021 02:27 - 12 minutes - 20.5 MB

Scrip’s Five Must-Know Things – 14 June 2021 by Pharma Intelligence

Device Week, 9 June 2021 – ATTD Medtronic Update; CVRx IPO

June 09, 2021 22:16 - 6 minutes - 11.8 MB

In this week’s podcast, Medtech Insight's UK-based reporter Barnaby Pickering provides an update on Medtronic’s MiniMed 780G insulin pump cost-savings study, presented at the Advances Technologies & Treatments for Diabetes (ATTD) conference. US Commercial and R&D manager, Reed Miller, highlights details on CVRx’s recent IPO. Medtech Insight articles addressing topics discussed in this episode: ATTD 2021: Despite High Upfront Cost, Medtronic’s 780G Could Offer Cost Savings https://medtech.ph...

2021 Citeline Awards Podcast

June 07, 2021 14:12 - 13 minutes - 6.9 MB

2021 Citeline Awards Podcast by Pharma Intelligence

Scrip Interview With Dr Senthil Sockalingam, IQVIA Biotech Japan-Asia Pacific

June 07, 2021 07:08 - 29 minutes - 26.7 MB

Podcast Time Stamps: 00:08 Introduction 00:58 IQVIA Biotech’s Latest Expansion In Japan/Asia Pacific 04:40 Diverse APAC Region, Oncology/Immunology Focus Of Biotechs, Partnering Models 11:53 Pandemic-Driven Virtualization Of Trials, Site Contracting Timelines 17:57 Digital Launch Efforts, Democratization Of Healthcare Providers’ Access To Information 21:25 Evolving Patient Journey 24:16 AI In Drug Development,Treatment

Scrip’s Five Must-Know Things – 7 June 2021

June 07, 2021 02:47 - 13 minutes - 22.3 MB

Scrip’s Five Must-Know Things – 7 June 2021 by Pharma Intelligence

Device Week, 4 June 2021 – Medtronic Pulls HeartWare, Biden Releases Budget Proposal

June 04, 2021 21:24 - 7 minutes - 3.25 MB

This week’s podcast highlights Medtech Insight’s coverage of Medtronic's decision to pull its HeartWare Ventricular Assist Device from the market and the implications as well as Biden's proposed budget to increase funding for the US FDA.

Pink Sheet Podcast: Cell Therapy Enforcement Discretion Ends, Inspection Normalcy, FDA Hiring Boom

June 04, 2021 15:23 - 22 minutes - 14.6 MB

Pink Sheet reporters and editors discuss the end of stem cell clinic enforcement discretion, the US FDA’s projection that inspections will return to normal levels in FY 2022, and improved hiring in CDER.

Datamonitor Podcast, 28th May 2021 – COVID-19

June 04, 2021 14:35 - 32 minutes - 15.5 MB

Davinderpreet Mangat, Michael Haydock, and Andrew McConaghie discuss next-generation COVID-19 vaccines.

Covid-19 & hemophilia

June 03, 2021 13:03 - 22.6 MB

Davinderpreet Mangat, Michael Haydock, and Andrew McConaghie discuss COVID-19 vaccines and hemophilia A & B gene therapies. Topics covered in this episode include: • COVID-19 next-generation vaccines (0:58) • Hemophilia A & B gene therapies (32:40)

Datamonitor Podcast, 28th May 2021 – COVID-19 and hemophilia

June 03, 2021 13:03 - 49 minutes - 22.6 MB

Davinderpreet Mangat, Michael Haydock, and Andrew McConaghie discuss COVID-19 vaccines and hemophilia A & B gene therapies. Topics covered in this episode include: • COVID-19 next-generation vaccines (0:58) • Hemophilia A & B gene therapies (32:40)

Scrip’s Five Must-Know Things – 31 May 2021

May 31, 2021 02:27 - 12 minutes - 21.7 MB

Scrip’s Five Must-Know Things – 31 May 2021 by Pharma Intelligence

Device Week, 28 May 2021 – Diabetes Device Market Update

May 28, 2021 17:22 - 5 minutes - 9.44 MB

This week’s podcast highlights Medtech Insight’s latest Market Intelligence report on continuous glucose monitors, a rapidly growing sector driven by innovation and patients’ demand for easier-to-use devices.

Scrip’s Five Must-Know Things – 24 May 2021

May 24, 2021 02:33 - 12 minutes - 22.3 MB

Scrip’s Five Must-Know Things – 24 May 2021 by Pharma Intelligence

Device Week, 21 May 2021 – QSR Harmonization, Recalls and More In Medcon Spotlight

May 21, 2021 20:30 - 13 minutes - 6.93 MB

In this week’s podcast, managing editor Elizabeth Orr and executive editor Shawn Schmitt discuss breaking news out of this year’s Medcon conference, sponsored by the FDA and Xavier University. Key topics include QSR harmonization, class II recalls, the new Inspectional Affairs Council, and the breakthrough pathway.

Pink Sheet Podcast: Emergent On Capitol Hill, Second Cures Bill, US FDA’s Public Sponsor Rebuke

May 21, 2021 16:24 - 34 minutes - 22.4 MB

Pink Sheet reporters and editors discuss Emergent BioSolutions’ congressional appearance, plans for the next 21st Century Cures bill, and the FDA’s statement on the clinical trials for CytoDyn’s investigational COVID-19 therapy.

The MHRA and the Post-EU Route Ahead For UK Devices

May 21, 2021 16:20 - 32 minutes - 38.4 MB

How the UK can manage its own device regulatory affairs outside the EU – either alone or with partners on selected areas of work.

Digital Health Roundup, April 2021: Digital Trends In OR, Clinical Trials, Remote Monitoring

May 19, 2021 20:05 - 5 minutes - 10.6 MB

In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb and Barnaby Pickering offer a recap of Medtech Insight’s digital health coverage in April, including the digital transformation in the OR and clinical trials as well as remote monitoring. For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR Medtech Insight articles addressing topics discussed in this episode: Market Intel: Medtechs, Surgeons Embrace ‘Virtual Operating Theater...

How To Win A Scrip Award 2021

May 19, 2021 11:00 - 4 minutes - 3.29 MB

How To Win A Scrip Award 2021 by Pharma Intelligence

HBW Insight Podcast: COVID-19 Holds Back European Consumer Health Majors In Q1

May 17, 2021 09:28 - 19 minutes - 14.7 MB

HBW Insight editors discuss the latest European consumer healthcare industry news. This week, Tom Gallen and David Ridley look at the Q1 financial results of four major Europe-based OTC players - GSK, Sanofi, Bayer and Reckitt - to analyse the impact that the coronavirus is still having on the region's consumer healthcare industry. An almost non-existent cough and cold season, due to lockdown measures, and last year's stockpiling of OTC drugs, have led to double-digit decreases in Q1 sales. A...

Scrip’s Five Must-Know Things – 17 May 2021

May 17, 2021 01:57 - 11 minutes - 20.5 MB

Scrip’s Five Must-Know Things – 17 May 2021 by Pharma Intelligence

Pink Sheet Podcast: COVID Vaccine In Kids, CMS Drug Pricing Moves, Standard Care In Clinical Trials

May 14, 2021 17:17 - 34 minutes - 22.5 MB

Pink Sheet reporters and editors discuss the US FDA decision to lower the eligibility age for the Pfizer/BioNTech COVID-19 vaccine, CMS drug pricing project plans, and mid-stream standard of care changes in drug development.

Device Week, May. 14 2021 – AdvaMed Conference And Innovative Brain Monitoring Technology

May 14, 2021 10:32 - 7 minutes - 6.49 MB

In this edition of Device Week, Medtech Insight’s Marion Webb discusses AdvaMed’s Medtech Conference Hosted last week, where issues regarding the mesh between medtech and consumer tech were discussed. Reporter Barnaby Pickering talks about a company he recently covered, Cumulus Neuroscience, and its innovative work in clinical trial monitoring. For more information on Medtech Insight and to start a free trial, click here: http://bit.y/2w7LnlR Medtech Insight articles addressing topics discu...

The Pharmaprojects’ Pharma R&D Annual Review 2021

May 10, 2021 14:43 - 15 minutes - 10.9 MB

The podcast takes a look at the story behind the Pharmaprojects’ Pharma R&D Annual Review 2021

Scrip’s Five Must-Know Things – 10 May 2021

May 10, 2021 01:45 - 11 minutes - 19.9 MB

Scrip’s Five Must-Know Things – 10 May 2021 by Pharma Intelligence

Device Week, 7 May 2021 – New MDUFA, Old Disagreements

May 07, 2021 20:19 - 8 minutes - 11.8 MB

In this week’s podcast, senior reporter Ferdous Al-Faruque gives an early look at how user fee negotiations between the FDA and industry groups for MDUFA V are unfolding. As in the past, the parties are at odds over how much industry should pay, and what the FDA is using the money for.

Pink Sheet Podcast: COVID-19 Vaccine IP Waivers, Pandemic Delayed Inspections, CAR-T Reimbursement

May 07, 2021 16:11 - 29 minutes - 18.9 MB

Pink Sheet reporters and editors discuss the potential for the US and other governments to waive IP protections for COVID-19 vaccines, the FDA’s inspection backlog during the pandemic, and potential reimbursement changes for CAR-T therapies.

Pink Sheet Podcast: US FDA Accelerated Approval Adcomm, Drug Pricing, COVID-19 Help For India

April 30, 2021 17:36 - 38 minutes - 24.5 MB

Pink Sheet reporters and editors discuss the three-day US FDA advisory committee review of several oncology accelerated approvals, President Biden’s speech to Congress and its impact on drug pricing legislation, as well as the implications of the US helping India battle its COVID-19 surge.

Device Week, 28 April 2021 – Innovative Technologies In Diabetes, Future Of Surgery

April 28, 2021 21:48 - 7 minutes - 13.8 MB

In this week’s podcast, Medtech Insight's Barnaby Pickering features Finnish start-up GlucoModicum, which created a way to measure blood glucose levels without using needles. Managing editor Marion Webb discusses her latest Market Intel, which highlights three companies that developed technologies to help surgeons collaborate with remote surgical experts, including medical device specialists. Listen to the podcast via the player below: Start-Up Spotlight: GlucoModicum Hopes To Market Disru...

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

April 26, 2021 02:52 - 12 minutes - 22 MB

Scrip’s Five Must-Know Things – 26 April 2021 by Pharma Intelligence

Device Week, 23 April 2021 – SCOTUS Hears Major Patent Case, USPTO Encourages COVID-19 Patents

April 23, 2021 21:17 - 7 minutes - 3.12 MB

In this week’s podcast, Medtech Insight managing editor Elizabeth Orr discussed the implications for medtech patent law from the US Supreme Court’ Minerva Surgical v. Hologic Inc. case. Ferdous Al-Faruque outlined the USPTO’s efforts to encourage inventors to file for COVID-19 product patents.

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

April 20, 2021 02:26 - 11 minutes - 19.9 MB

Scrip’s Five Must-Know Things – 20 April 2021 by Pharma Intelligence

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