Citeline Podcasts

In this episode, HBW Insight’s US and EU Managing Editors Malcolm Spicer and Tom Gallen analyse Q3 OTC business trends, including why the biggest pharmaceutical companies in the world are spinning out their consumer health businesses to create new, publicly listed standalone firms and what's causing the supply chain troubles that are driving up OTC product prices.

Pink Sheet reporters and editors discuss the authorization of COVID-19 vaccine booster shots for all adults, Aduhelm’s impact on Medicare Part B and rejection by EMA, and the nomination of ex-FDA commissioner Robert Califf for another term.

In this edition of Device Week, Medtech Insight’s Reed Miller chats to Marion Webb about the recent announcement that Johnson & Johnson will split into two separate businesses – one focusing on medical products, and the other focusing on consumer. Reed and Barnaby also discuss recent results from the UK’s 100,000 Genome project, and how its analysis partner, Congenica, hopes to deliver personalized medicine through widescale genomic testing

Medtech Insight articles addressing topics discussed in this episode:

J&J To Split Consumer From Medtech and Pharmaceutical Businesses – Creating Two Companies To Unlock More Value, Growth, Innovation - https://medtech.pharmaintelligence.informa.com/MT144717/JJ-To-Split-Consumer-From-Medtech-and-Pharmaceutical-Businesses--Creating-Two-Companies-To-Unlock-More-Value-Growth-Innovation

- Congenica Tries To Bring Clarity To Personalized Medicine For Rare Diseases -https://medtech.pharmaintelligence.informa.com/MT144723/Congenica-Tries-To-Bring-Clarity-To-Personalized-Medicine-For-Rare-Diseases

In this episode of Speaking Of Medtech we discuss the regulatory side of digital health – that is, the US FDA side of digital – and some of the more important related policies and activities that are going on at the agency right now.

Medtech Insight articles addressing topics discussed in this episode:

• What Does ‘Digital’ Mean For FDA’s Device Center? - https://medtech.pharmaintelligence.informa.com/MT144553/What-Does-Digital-Mean-For-FDAs-Device-Center

Scrip’s Five Must-Know Things – 15 November 2021 by Citeline

On this week’s podcast: The US FDA finally issued a draft guidance for medical software in the premarket space, while an agency panel meeting focused on the safety of graft stents.

Medtech Insight articles addressing topics discussed in this episode:

• FDA’s SaMD/SiMD Guidance Could Mean Documentation Headaches For Some Software Makers, Attorney Says

• Bleeding Risks Still A Concern For Patients With Endologix Stent Grafts: FDA Advisory Panel

In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb and Ferdous (Danny) Al-Faruque provide a recap of our digital health coverage in October including updates on the digital therapeutics sector and FDA guidance documents.

Medtech Insight articles addressing topics discussed in this episode:

https://medtech.pharmaintelligence.informa.com/MT144573/Pear-Therapeutics-Obtains-First-Medicaid-Coverage-For-PDTs

https://medtech.pharmaintelligence.informa.com/MT144574/PDT-Company-Better-Therapeutics-Ready-To-Go-Public-With-SPAC-Deal

https://medtech.pharmaintelligence.informa.com/MT144614/CTAs-Standards-For-Digital-Therapeutics-Clears-Up-Industry-Confusion

https://medtech.pharmaintelligence.informa.com/MT144620/Cardiovascular-CatchUp-TAVR-Withstands-Delta-Virus-So-Far-Stereotaxis-Robot-Succeeds-In-Trial

https://medtech.pharmaintelligence.informa.com/MT144568/FDA-Clears-Withings-Smart-Watch-For-Detecting-AF-and-Measuring-Blood-Oxygen

https://medtech.pharmaintelligence.informa.com/MT144610/Market-Intel-Lessons-Learned-From-COVID-19-A-Global-Perspective-On-Digital-Health-Transformation

https://medtech.pharmaintelligence.informa.com/MT144628/23andMe-Acquires-Telehealth-Company-Lemonaid-Health-For-$400M

https://medtech.pharmaintelligence.informa.com/MT144629/FDA-Guidance-Priorities-For-FY-2022-Include-Transitioning-EUAs-List-Includes-CDS-Software-Again

https://medtech.pharmaintelligence.informa.com/MT144650/US-UK-Canada-Agree-On-Good-Machine-Learning-Practices

https://medtech.pharmaintelligence.informa.com/MT144625/Notified-Bodies-Group-New-Euro-AI-Regs-Could-Cause-Undue-Burdens

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In this episode, HBW Insight Senior Editor David Ridley chats with Bayer’s Daniella Foster about the emerging self-care movement. Daniella is global vice president and Head of Public Affairs, Science & Sustainability for Bayer Consumer Health. We dive deep into what is driving the self-care movement and some of the challenges industry faces in building this movement in a purposeful way as we come out of the pandemic.

Scrip’s Five Must-Know Things – 8 November 2021 by Citeline

Pink Sheet reporters and editors discuss the congressional agreement to allow Medicare drug pricing negotiations, the authorization of the Pfizer/BioNTech vaccine for children age 5 to 11, and the departure of the US FDA’s Chief Scientist.