Citeline Podcasts

Pink Sheet reporter explains the increased pressure on the FDA now that a coronavirus vaccine booster plan is in place, the surprising results of a survey of agency advisory committee members, and the recalculation of FY 2022 PDUFA fees.

In this week’s podcast, Medtech Insight's US Commercial manager Reed Miller provides an overview of Abbott’s Amplatzer Amulet, which was approved by the US FDA for preventing thrombus embolization in patients with nonvalvular atrial fibrillation. Managing editor Marion Webb discusses Zimmer Biomet’s FDA clearance of its Rosa robotic surgery platform for total hip replacement and the intensifying competition in the rising surgical robotics market.

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As the entry deadline (1 September) for the UK OTC Marketing Awards approaches, HBW Insight Senior Editor David Ridley talks to multi-award-winning agency Satellite PR's Pauline Kent about how to put together a winning entry.

Scrip’s Five Must-Know Things – 16 August 2021 by Citeline

In this week’s podcast, we take a look at the concerns a US FDA advisory panel recently expressed about Keystone Heart’s TriGUARD 3, then discuss some expert predictions on the FDA’s hotly anticipated Quality System Regulations (QSR) rewrite.

Pink Sheet reporters and editors discuss Bluebird Bio’s decision to pull is gene therapy business from Europe, Eli Lilly potentially pushing regulatory boundaries with its Olympic TV spots, and the CMS decision to scrap the Trump Administration’s most favored nation rule.

Scrip’s Five Must-Know Things – 10 August 2021 by Citeline

Pink Sheet reporters and editor discuss the inspector general assessment of the US FDA’s approval of Aduhelm as well as the accelerated approval program, the FDA race to finish its review of the Pfizer/BioNTech COVID-19 vaccine BLA, and the lack of agency advisory committee meetings.

In this edition of Device Week, Medtech Insight’s Barnaby Pickering discusses a market intelligence report about robotically assisted surgery. Reed Miller discusses exciting mergers in the medtech space, paying focus to a company looking to image damage to the heart in order to spot potential heart attacks before they happen.

Medtech Insight articles addressing topics discussed in this episode:

- Market Intel: Expanding Applications And Improved Offerings To Drive Robotically Assisted Surgery Market - https://medtech.pharmaintelligence.informa.com/MT144294/Market-Intel-Expanding-Applications-And-Improved-Offerings-To-Drive-Robotically-Assisted-Surgery-Market

Scrip Podcast: Sanofi India Chief, Ex-GSK Exec Discuss Pharma’s Digitization Journey by Citeline