Pink Sheet Podcast: FDA Implements Coronavirus Containment Plan
Pink Sheet reporter and editor discuss the implications of the FDA decision to cancel meetings and postpone inspections, as well as its new Type 2 Diabetes drug development guidance.
12 Mar 2020
A Chat With Immuno-oncology Trailblazer Exec Dan Chen
In the last decade, anti-PD-1/L1 checkpoint inhibitors have been revolutionary in oncology, but while the impact has been dramatic, many patients still do not respond. Dan Chen, M.D., Ph.D., former global head of the cancer immunotherapy franchise at oncology leader Roche/Genentech, talks to Scrip and Pink Sheet journalist Emily Hayes about the cancer immunity cycle, lessons learned from trials of combinations of drugs and more. Recorded onsite at the ASCO-SITC Clinical Immuno-Oncology Symposium in San Francisco on March 1, 2019.
5 Mar 2019
Pink Sheet Regulatory Podcast Episode 5
Pink Sheet Regulatory Podcast Episode 5 by Informa
11 Jun 2019
FDA’s Patel Discusses Pre-Cert Working Model
US FDA released a working model for their digital health pre-certification program as part of a broader Digital Health Action Plan. FDA's Bakul Patel spoke to Medtech Insight about what the agency is hoping to achieve with the new model.
26 Apr 2018
Most Popular Podcasts
Device Week, 14 June 2019: Genomic Spy Games?
In this week's Medtech Insight podcast, executive editor Shawn M. Schmitt and senior reporter Sue Darcey discuss recent reporting on efforts by US senators to control and stop Chinese researchers in the US from using their research jobs at the National Institutes of Health, and at American medical colleges and universities, to steal genomic data and share it with the Chinese government.Medtech Insight articles addressing topics discussed in this episode:• US Senators Ask HHS IG To Investigate CMS Genetic Test Payments To Chinese Firms (https://medtech.pharmaintelligence.informa.com/MT125235/US-Senators-Ask-HHS-IG-To-Investigate-CMS-Genetic-Test-Payments-To-Chinese-Firms)• Sen. Cornyn Plans Bill To Secure US Genomic Research From Foreign 'Interference, Espionage And Exfiltration' (https://medtech.pharmaintelligence.informa.com/MT125225/Sen-Cornyn-Plans-Bill-To-Secure-US-Genomic-Research-From-Foreign-Interference-Espionage-And-Exfiltra)
14 Jun 2019
Innovations in Market Access: High-Impact Practices for a New Era of Transformational Medicine
In Vivo discusses ways to enhance the visibility of the market access function in biopharma with two leaders of a 20-company initiative to promote best practices in the field: Indranil Bagchi, Senior Vice-President, Global Value and Access, Novartis Oncology; and Srikant Vaidyanathan, Senior Partner and Managing Director, the Boston Consulting Group.
27 Mar 2019
Pink Sheet Pharma Regulatory Podcast: Zolgensma Data Manipulation, ICER's Assessment of DMD Drugs
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.
15 Aug 2019
Philips CEO On Future Of AI
Frans van Houten, CEO of Philips, talked about the future of AI and what his company is doing to be a part of it. He spoke with Medtech Insight at the World Medical Innovation Forum.
18 Apr 2019
Device Week, Dec. 20, 2017 – Medtech Regulatory Landscape In 2018
On this week's podcast, David Filmore discusses with Shawn M. Schmitt some of important dynamics that will impact medtech regulations globally in 2018, with a focus on the US, Europe and Asia. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.Medtech Insight content addressed in this episode:Interactive Timeline: Global Regulatory Deadlines: http://bit.ly/2An8xn8 5 Ongoing US FDA Device Center Pilot Programs: A Listing: http://bit.ly/2kmlx71 A No-Predicate 510(k) Future? Pending US FDA Policy Might Forge A Path: http://bit.ly/2BAuVLT Expert Panel: How Manufacturers Are Paying For Notified Body Struggles: http://bit.ly/2iuUMfp Brexit Roundup: UK Medtech Balancing On A Fault Line: http://bit.ly/2D9qvvS India Settles On Classifications For Nearly 600 Devices, IVDs: http://bit.ly/2B1hVhe Malaysia Moves: Asian Medtech Associations Regulatory Networking November 2017, Part I: http://bit.ly/2AY4nCX
20 Dec 2017
Device Week, July 6, 2018–Clinical Data Presentations At ADA;Big Deals From GE, Novartis, Bio-Techne
In this edition of Device Week, Medtech Insight editor Marion Webb reports on the American Diabetes Association conference in Orlando and editor Reed Miller runs down the latest corporate restructuring news.For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlRmMedtech Insight articles addressing topics discussed in this episode:ADA2018: Insulet Reports Positive Clinical Results For Omnipod Horizon, Limited Market Release Of Dashhttps://bit.ly/2J0Ajd4ADA2018: Senseonics' Implantable CGM Beats Abbott, Dexcom In Head-To-Head Study – But Is Methodology Flawed?https://bit.ly/2lXXBr6ADA2018: Medtronic Touts Power of Artificial Intelligence, New Pediatric Indication, Payer Guarantee Programhttps://bit.ly/2KNXZGBGE Spins Off Healthcare As Part Of Major Reorganizationhttps://bit.ly/2tylKbJBio-Techne Makes Big Push Into Liquid Biopsy With Exosome Acquisitionhttps://bit.ly/2NuiJBZNovartis Sees The Light And Plumps For Alcon Spin-Offhttps://bit.ly/2u9qxjo
5 Jul 2018
Generics Bulletin Editor Discusses Industry Trends
Informa Pharma Intelligence’s head of content Mike Ward and Generics Bulletin editor Aidan Fry discuss how US market pressures are making life tough for the generics industry.
28 Jun 2018
Device Week, April 19, 2018 – FDA Safety Plan, Cybersecurity, Pivotal Clinical Trial
In this week’s Medtech Insight podcast, we discuss US FDA Commissioner Scott Gottlieb’s big plan to boost medical device safety and quality, important news regarding cybersecurity, and the latest on a Medtronic clinical trial.
19 Apr 2018
Pink Sheet Regulatory Podcast
Pink Sheet Regulatory Podcast by Informa
17 May 2019
Pink Sheet Pharma Regulatory Podcast: Breaking Down The Biggest Stories Of 2019
Pink Sheet reporters recap the biggest pharma regulatory stories of 2019 and their impact on 2020, including the government shutdown, the FDA commissioner carousel and the Zolgensma data manipulation scandal.
9 Jan 2020
Device Week, 18 March 2020 – Cancelled Surgeries, New Medtech Alliances
In this episode of our weekly podcast, Medtech Insight's managing editor Marion Webb talks with deputy editor Reed Miller about her story on US hospitals cancelling elective surgeries to preserve critical resources in response to COVID-19 and joining forces with medtechs to find rapid technological solutions to keep patients and caregivers healthy. Listen to the podcast via the player below:US Hospitals Cancel Elective Surgeries; Team Up With Medtechs To Find Remote-Monitoring Solutionshttps://medtech.pharmaintelligence.informa.com/MT126406/US-Hospitals-Cancel-Elective-Surgeries-Team-Up-With-Medtechs-To-Find-RemoteMonitoring-SolutionsFormer FDA Chief Urges Manufacturers To Shift Gears In Coronavirus Effortshttps://medtech.pharmaintelligence.informa.com/MT126396/Former-FDA-Chief-Urges-Manufacturers-To-Shift-Gears-In-Coronavirus-EffortsCOVID-19: FDA Expands Overseas Inspections Freeze Through Aprilhttps://medtech.pharmaintelligence.informa.com/MT126388/COVID19-FDA-Expands-Overseas-Inspections-Freeze-Through-AprilFor more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
18 Mar 2020
Podcast: Accelerating Cancer Drug Development - From Target to Patients
Alderley Park, one of the UK's leading bio and life science campuses, has just hosted a new conference, Accelerating Cancer Drug Development - From Target to Patients. At the event Mike Ward spoke to two of SMEs based at the site in Cheshire about the challenges of growing a business in the oncology supply chain.
12 Mar 2018
Device Week, Jan. 11, 2019 – A New Plan From NHS In A Period Of UK Uncertainty
On this week's podcast, Ashley Yeo talks about a the "Long Term Plan" for the UK's health-care system published by the country's NHS this week, and the implications of Brexit. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.Medtech Insight articles addressing topics discussed in this episode:NHS' New Plan: 'Long-Termism' Is Also Needed In Adoption And Spread Of Technology In UK: https://bit.ly/2D61q6T ABHI 30: NHS Long-Term Plan Promises Diagnosis And Tech Uptake Boost For Industry And Patients: https://bit.ly/2FsOoSoBrexit At The 11th Hour: UK Refreshes No-Deal Guidance For Medtech : https://bit.ly/2RJyfib
11 Jan 2019
Pink Sheet Pharma Regulatory Podcast: FDA Panels Deliver Shocking Verdicts On Twirla, Makena
Pink Sheet reporters discuss the implications from recent US FDA advisory committee meetings for Agile's contraceptive patch Twirla and AMAG’s preterm birth drug Makena.
31 Oct 2019