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We’re the world’s leading provider of drug, device, company, clinical trial and market intelligence in the competitive pharma and medtech markets.

We’re the world’s leading provider of drug, device, company, clinical trial and market intelligence in the competitive pharma and medtech markets.
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United States

Description:

We’re the world’s leading provider of drug, device, company, clinical trial and market intelligence in the competitive pharma and medtech markets.

Language:

English


Episodes

OTC Podcast Recording 2020

10/15/2019
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Get the most out of your entry into the 2020 OTC Marketing Awards with our latest podcast. Listen to find out more about the categories and how to enter.

Duration:00:06:25

Device Week, 11 October 2019 – Total Recall: The Latest On Corrections & Removals

10/11/2019
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On this week’s podcast, executive editor Shawn M. Schmitt and senior reporter Elizabeth Orr delve into recent news on medical device recalls, including tips and advice from US FDA officials, and a report about a new app that scans products and gives detailed safety and recall information. Medtech Insight articles addressing topics discussed in this episode: • 'SoomSafety': How A Real-Life Recall Scare Led A Father To Develop A Free App That Gives Detailed Device Safety Info...

Duration:00:10:39

Celltrion’s Subcutaneous Infliximab And The Future Of Biosimilars

10/11/2019
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Celltrion’s Subcutaneous Infliximab And The Future Of Biosimilars by Informa

Duration:00:20:04

Device Week, 4 October 2019 – Demant Group Recovers From Cyber-Attack; TCT Conference Highlights

10/4/2019
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In this edition of Device Week, reporter Catherine Longworth provides an update on how Demant Group is recovering from a ransomware attack that forced the Danish hearing aid manufacturer to shut down its IT systems. Deputy editor Reed Miller reviews the highlights from the clinical trial presentations at the recent Transcatheter Cardiovascular Therapeutics conference in San Francisco. Listen to the podcast via the player below: Medtech Insight articles addressing topics discussed in this...

Duration:00:06:19

Makena's Accelerated Approval At Stake, Woodcock On Biobetters And Singulair's Safety Issues

10/3/2019
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Pink Sheet reporters discuss the potential withdrawal of Makena’s accelerated approval, CDER director Janet Woodcock’s remarks on the development of biobetters and the advisory committee meeting on the neuropsychiatric events safety risk for Merck’s Singulair.

Duration:00:16:17

Device Week, 27 September 2019 – Guidance, Guidance Everywhere...

9/27/2019
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The US FDA has been furiously releasing a boatload of updated, draft and new guidance documents over the past month. On this week’s podcast, we discuss three of them, related to clinical decision support (CDS) software, Humanitarian Use Devices (HUD) and Humanitarian Device Exemption (HDE). Medtech Insight articles addressing topics discussed in this episode: • Industry Optimistic About Second CDS Draft Guidance; FDA Releases More Final Software Guidances • New FDA Guidance Expands HUD...

Duration:00:07:31

FDA Launches Project Orbis, Mulls Expansion Of ADFs And Touts Rare Disease Cures Accelerator

9/20/2019
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Pink Sheet reporters discuss the US FDA's launch of its Project Orbis collaboration, the agency's call for comments on the development of abuse-deterrent formulations for central nervous system stimulants and the new Rare Disease Cures Accelerator.

Duration:00:15:33

Device Week, Sept. 20, 2019 – Medtech Giants Sign Major Diabetes Partnerships

9/20/2019
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Device Week, Sept. 20, 2019 – Medtech Giants Sign Major Diabetes Partnerships by Informa

Duration:00:10:06

Device Week, 13 September 2019 – Feathering The NESTcc

9/13/2019
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In this week’s Medtech Insight podcast, senior reporter Elizabeth Orr gives the skinny on the latest developments surrounding the National Evaluation System for health Technology Coordinating Center, or NESTcc. Medtech Insight article addressing topics discussed in this episode: • NESTcc Updates On Projects, Prepares For Winter Launch https://medtech.pharmaintelligence.informa.com/MT125627/NESTcc-Updates-On-Projects-Prepares-For-Winter-Launch

Duration:00:07:20

AI Technology And Navigating The HIPAA Minefield

9/12/2019
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DLA Piper’s Danny Tobey recently spoke with Medtech Insight about how patient privacy regulations under HIPAA may impact medtech products that use AI technology. He notes depending on the case, some companies may need to comply with HIPAA for one business division but not another based on how they are set up.

Duration:00:20:41

Opioid Litigation And Approvals, Rare Disease Legalese In Focus

9/12/2019
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Pink Sheet Reporters discuss Purdue Pharma's pending settlement on the opioid crisis, the FDA's review of future opioid applications and a proposal to better describe rare disease flexibility.

Duration:00:12:38

Device Week, 6 September, 2019 – Connected Health Summit's Digital Health Focus;

9/6/2019
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In this edition of Device Week, Medtech Insight's deputy editor Reed Miller chats with managing editor Marion Webb about her digital health coverage at the recent Connected Health Summit in San Diego. And London, UK-based senior reporter Catherine Longworth talks about her visit with Intuitive Surgical at their new training suite in Oxford. Listen to the podcast via the player below: Medtech Insight articles addressing topics discussed in this episode: Smart Homes, AI-Assisted Devices, Home...

Duration:00:08:26

Sharpless On His Future And Zolgensma's Problems, Mylan's Insulin Complete Response

9/6/2019
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Pink Sheet reporters discuss Acting FDA Commissioner Norman Sharpless' future, his comments on the Zolgensma data manipulation scandal, and a setback in Mylan's efforts to move a follow-on insulin application.

Duration:00:26:25

Ed Cox Departs FDA, J&J Loses Opioid Lawsuit And Industry Comments On Clinical Study Reports

8/30/2019
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Pink Sheet reporters discuss Ed Cox's departure from the FDA to Regeneron, Johnson & Johnson's defeat in an opioid lawsuit and industry comments on the FDA's proposal to release clinical study reports.

Duration:00:19:10

Device Week, 30 August 2019: Desperately Seeking Quality Assurance Professionals

8/30/2019
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In this week’s Medtech Insight podcast, executive editor Shawn M. Schmitt explains how an ongoing "Quality as a Career" initiative from the Medical Device Innovation Consortium (MDIC) is aiming to train the next generation of QA experts. Medtech Insight articles addressing topics discussed in this episode: • Quality Desert: How An Academic Minor In Quality Could Be The Key To Quenching Industry's Thirst For QA Professionals • Device Firms Struggle To Find Qualified Quality Assurance...

Duration:00:09:21

Golodirsen Rebuffed and DTC Ad Lawsuit Revamped

8/22/2019
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Pink Sheet reporters discuss the complete response letter for Sarepta's Duchenne muscular dystrophy drug golodirsen, the Trump administration's appeal of the DTC list price court ruling and the new Business Roundtable statement of purpose.

Duration:00:18:23

Pink Sheet Pharma Regulatory Podcast: Zolgensma Data Manipulation, ICER's Assessment of DMD Drugs

8/15/2019
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Pink Sheet reporters assess the implications of the Zolgensma data manipulation announcement, ICER’s findings on the net health benefits of DMD drugs, and the LPAD approval of Pretomanid.

Duration:00:19:54

Device WeekDevice Week, 8 August 2019 – AACC Recap; MDisrupt Helps Investors Navigate Medtech

8/15/2019
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In this edition of Device Week, Medtech Insight managing editor Marion Webb reports on her discussions with diagnostic company executives at the recent American Association for Clinical Chemistry meeting in Anaheim. Senior reporter Catherine Longworth previews her feature on MDisrupt, a new company that touts itself as the world’s first medical diligence company for the healthcare industry. Medtech Insight articles discussing topics discussed in this episode: Exec Chat: Deepak Nath,...

Duration:00:07:56

Device Week 9, Aug. 2019: Concerns Over Cardiac Devices, US FDA Drops User Fees

8/8/2019
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Medtech Insight senior reporters discuss the latest safety concerns over cardiac devices such as drug-eluting stents and implantable cardioverter defibrillators. They also cha about the agency’s recently released user fee rates and how they’ve increased historically.

Duration:00:08:58

Pink Sheet Pharma Regulatory Podcast: Drug Importation and FY 2020 User Fees

8/2/2019
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Pink Sheet reporters ask critical questions about the new drug importation framework and assess the FY 2020 US FDA user fee rates.

Duration:00:22:33