Scrip’s Five Must-Know Things – 28 February 2022 by Citeline

Pink Sheet reporters and editors discuss changes to the standard for some COVID-19 treatment emergency use authorizations, late-coming COVID-19 vaccines and their potential effect on the market, and an upcoming HHS biosimilar use and cost study.

Afrigen Chief On mRNA Vaccine Candidate, IP Hoops, Market-Shaping Efforts by Citeline

In this edition of Device Week, Medtech Insight’s Reed Miller chats with UK-based reporter Barnaby Pickering about Abbott’s recent supplementary premarket submission to its CardioMEMS platform, recent safety data for Dexcom’s G7 continuous glucose monitor, and where KPMG expects life sciences investment to be focused in 2022.

Medtech Insight articles addressing topics discussed in this episode:

-Abbott Hopes To Prevent Heart Failure Hospitalizations With New CardioMEMS HF Labeling - https://medtech.pharmaintelligence.informa.com/MT145103/Abbott-Hopes-To-Prevent-Heart-Failure-Hospitalizations-With-New-CardioMEMS-HF-Labeling

-KPMG Speaks On What 2022 Medtech Investment May Look Like

-Dexcom Shows Off More G7 Data - https://medtech.pharmaintelligence.informa.com/MT145078/KPMG-Speaks-On-What-2022-Medtech-Investment-May-Look-Like

US-based biotech Lactocore Group’s CEO and co-founder Anton Malyshev talks to Scrip on milk-derived, novel peptides that hold potential as safe and effective treatments for a range of common psychiatric, metabolic and cognitive disorders.

Lead asset LCGA-17 with indications for mental health conditions, like anxiety and post-traumatic stress disorder, is at the pre-Investigational New Drug stage and could have the unique advantage of intranasal administration. Another asset can regulate appetite, with potential to treat obesity and type-2 diabetes and a third could find use as adjunct or complimentary therapy for Parkinson’s disease.

In this month’s podcast, Medtech Insight's Reed Miller reports on IBM Watson Health’s divestiture, Barnaby Pickering discusses his Exec Chat with Bloom Diagnostics, autonomous robots and Philips’ ultrasound game. Al-Faruque (Danny) Ferdous highlights the latest digital health regulatory news.

Listen to the podcast via the player below:

Medtech Insight articles addressing topics discussed in this episode:

Exec Chat: Bloom Diagnostics’ Chair Discusses The Future Of At-Home Lateral Flow Testing

Philips Steps Up Ultrasound Game With Lumify 4.0

Minute Insight: Can Robots Do Surgery Without Human Help?

IBM Divests Watson Health Assets To Focus On Cloud And AI Businesses

Experts: New Cybersecurity Standard Goes Beyond What US And Other Regulators Require

FDA Continues To Down-Classify Digital Health Apps With New Cardio App Rule

Scrip’s Five Must-Know Things – 21 February 2022 by Citeline

Pink Sheet reporters and editors consider Robert Califf’s priorities now that he is FDA commissioner, what sponsors can learn from the sintilimab advisory committee meeting, and the latest generics news from a major (and in-person) trade association conference.

In this episode of Speaking Of Medtech we’re talking real-world evidence and real-world data – what it is, who’s using it, and why the medtech industry and the US FDA are so keen to collect it.

Medtech Insight articles addressing topics discussed in this episode:

AdvaMed Asks US FDA To Add Causality, RWE To Safety-Reporting Draft Guidance (https://medtech.pharmaintelligence.informa.com/MT144840/AdvaMed-Asks-US-FDA-To-Add-Causality-RWE-To-SafetyReporting-Draft-Guidance)

Real-World Evidence Deemed Essential For Breakthrough Designations (https://medtech.pharmaintelligence.informa.com/MT144525/Real-World-Evidence-Deemed-Essential-For-Breakthrough-Designations)

FDA Doc Bemoans ‘Dearth’ Of Pediatric Devices, Says Real-World Data Could ‘Make A Difference’ (https://medtech.pharmaintelligence.informa.com/MT144492/FDA-Doc-Bemoans-Dearth-Of-Pediatric-Devices-Says-RealWorld-Data-Could-Make-A-Difference)

Woodcock: Use Of Real-World Evidence Still Brings ‘A Lot Of Problems’ (https://medtech.pharmaintelligence.informa.com/MT144008/Woodcock-Use-Of-Real-World-Evidence-Still-Brings-A-Lot-Of-Problems)

When the White House Office of Management and Budget, or OMB, sent the US FDA’s draft harmonized Quality System Regulation back to the agency after only 35 days of review, it raised some eyebrows in industry. Check out what experts are saying about the reg review time frame in this week’s podcast.

Medtech Insight articles addressing topics discussed in this episode:

• Too Slow, Too Fast, Or Just Right? Experts Weigh In On OMB’s 35-Day Review Of FDA’s Draft QSR

• OMB Completes Review Of FDA’s Draft Harmonized Quality System Regulation

• At Long Last, FDA Sends Draft Harmonized Quality System Regulation To OMB For Review