Scrip’s Five Must-Know Things – 13 September 2021 by Citeline

Pink Sheet reporters and editors discuss new developments in US drug pricing reform, FDA considering mandatory opioid prescriber education again, and including China in the agency’s international parallel review initiative, Project Orbis.

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

Pink Sheet reporters and editors consider the leadership shake-up at the FDA Office of Vaccines Research and Review, the COVID-19 vaccine booster shot debate, and the impact of new safety measures for several JAK inhibitors.

Davinderpreet Mangat, David Dahan, and Ellie Davenport discuss new developments in the diffuse large B-cell lymphoma (DLBCL) and melanoma space.

Topics covered include:

• DLBCL – CAR-T therapies: 1:23

• DLBCL – Polivy: 12:40

• Melanoma – Lifileucel: 20:20

• Melanoma – Keytruda: 27:25

Supporting links:

https://service.datamonitorhealthcare.com/hkc/disease/oncology/lymphoma/diffuse-large-B-cell-lymphoma/

https://service.datamonitorhealthcare.com/hkc/disease/oncology/skin-cancer/malignant-melanoma/disease-analysis/article223365.ece

https://www.biomedtracker.com/EventDetail.cfm?EventID=416767

https://www.biomedtracker.com/EventDetail.cfm?EventID=418078

https://www.biomedtracker.com/EventDetail.cfm?EventID=422214

https://www.biomedtracker.com/EventDetail.cfm?EventID=421354

https://www.biomedtracker.com/EventDetail.cfm?EventID=421183

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

In this week’s podcast, Marion Webb discusses the future of robotic surgery and Barnaby Pickering breaks down the trauma fixation device 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, TuneIn, Spotify Podcasts and via smart speakers if one of these platforms has been set up as your default podcast provider.

Medtech Insight: articles addressing topics discussed in this episode:

Market Intel: Robotic Surgery Holds Great Promise, But Is Not Quite There Yet

Exec Chat: AAOS 2021 Outgoing President Bosco Discusses Hot-Button Issues – Inpatient-Only List, Pre-Authorization, New Tech

Amulet IDE Trial Supports Abbott’s New LAA Closure Device

Infographic: Fracture Fixation Devices Market Projected A Return To Steady Growth

Zimmer Biomet, Canary Medical Win FDA De Novo For First Smart Knee Implant

Scrip’s Five Must-Know Things – 30 August 2021 by Citeline

In both the US and EU, we are seeing a push for large-scale cosmetics regulation, with the Personal Care Products Safety Act and European Green Deal respectively. For HBW Insight executive editor Ryan Nelson, this raises questions about what and whom it will serve ultimately, particularly when compared with the burdens being levied on industry and the repressive effects on small business, free competition, and innovation.

On this week’s podcast we discuss the US agency’s final regulation on the intended use of products, which device makers must follow beginning on 1 September.

Medtech Insight articles addressing topics discussed in this episode:

• FDA Widens Scope In Considering Evidence For Off-Label Use

In this month’s podcast, Medtech Insight's Reed Miller and Marion Webb provide a recap of our digital health coverage in July, including start-ups that grabbed new funding, product launches and regulatory clearances.

Listen to the podcast via the player below:

Medtech Insight articles addressing topics discussed in this episode:

Exec Chat: New CEO of Digital Therapeutics Alliance Says Reimbursement Remains Big Issue

Handheld Ultrasound Developer Exo Raised $200M In Series C

Babson Diagnostics Plans To Deliver What Theranos Could Not

Spire Health Closed A $38M Financing Round To Expand Commercialization Of Respiratory Remote Patient Monitoring Platform

Signifier Medical Technologies Raises $35M In Series D

Happify Health Launches Prescription Digital Therapeutics To Treat Depression Or Anxiety

HeartFlow Wants To Accelerate Adoption Of Al-Powered Heart Disease Test With $24Bn SPAC Deal

Carrot’s Pivot Breath Sensor Helps Motivate Smokers To Quit

Paige Obtains NHSx Award Allowing It To Launch AI Prostate Test

Biden Admin Looks To Broaden Telehealth, Increase Access To Mental Health Care

For more information on Medtech Insight and to start a free trial, click here:

http://bit.ly/2w7LnlR