Citeline Podcasts

Pink Sheet reporters and editors discuss Viatris receiving the first interchangeable biosimilar designation, CMS hearing from stakeholders about Aduhelm and other Alzheimer’s drugs, and concerns about expanding pediatric coronavirus vaccine trials to look for rare adverse events.

On this week’s podcast we highlight US Medicare reimbursement topics that industry should keep an eye on, and discuss important regulatory changes underway in the UK.

Medtech Insight articles addressing topics discussed in this episode:

• Latest Physician Fee Schedule Proposal Could Impact Companies’ Bottom Line

• Glaukos Takes Another Hit From CMS; Investors Respond Negatively As Stock Falls

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

• UK ABHI Perspectives On Enabling Regulation – Part 1: Regulatory Certainty Vital For Medtechs

• MHRA Must Seize UK Digital And Diagnostics Opportunity: ABHI Perspectives On Enabling Regulation – Part 2

• MDR Makes EU ‘Much Less Attractive’ For Start-Ups, Says Medtronic EMEA Chief

This week– J&J’s outlook for coronavirus vaccines, Cosentyx comes in strong for Novartis, Biogen’s views on Aduhelm pricing, competition in the “dustat” sector, and dealing with endemic COVID-19.

Pink Sheet reporters and editors discuss increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.

In this edition of Device Week, Medtech Insight’s Marion Webb discusses the huge number of digital health deals being done at the moment, including exciting developments in the SPAC space. UK-based reporter Barnaby Pickering talks about Angle, a British liquid diagnostics company that has developed a novel approach to liquid diagnostics.

- Exec Chat: Pear Therapeutics’ CEO Charts Future For Digital Therapeutics Following SPAC Deal - https://medtech.pharmaintelligence.informa.com/MT144127/Exec-Chat-Pear-Therapeutics-CEO-Charts-Future-For-Digital-Therapeutics-Following-SPAC-Deal

- HeartFlow Wants To Accelerate Adoption Of AI-Powered Heart Disease Test With $2.4Bn SPAC Deal - https://medtech.pharmaintelligence.informa.com/MT144222/HeartFlow-Wants-To-Accelerate-Adoption-Of-AIPowered-Heart-Disease-Test-With-24Bn-SPAC-Deal

- Angle Will Reshape Liquid Diagnostics By Capturing Circulating Tumor Cells -

https://medtech.pharmaintelligence.informa.com/MT144198/Angle-Will-Reshape-Liquid-Diagnostics-By-Capturing-Circulating-Tumor-Cells

HBW Insight talks to the Global Self Care Federation's director general, Judy Stenmark, about the impact of pandemic on global self-care industry, as well as what GSCF is doing to promote self-care in the wake of the pandemic. Marking International Self-Care Day (24 July) Stenmark tells HBW Insight's Senior Editor (EU) David Ridley about the GSCF's "Self-Care Promise" initiative, its work on producing an index to analyse the self-care readiness of national health systems, as well as ongoing projects in self-care economics and sustainability.

Davinderpreet Mangat, Pamela Spicer, Jessica Merrill, and Catherine Kelly discuss the approval of Aduhelm in Alzheimer’s disease.

Topics covered include:

• Drug development and approval - 01:45

• Pricing and commercial potential - 15:12

• National reimbursement processes - 30:55

Supporting links:

• Datamonitor’s Alzheimer’s Disease Analysis report - https://service.datamonitorhealthcare.com/hkc/disease/central-nervous-system/neurology/alzheimers-disease/disease-analysis/article209751.ece

• Biogen: Aduhelm’s Price Is Part Of Alzheimer’s ‘Evolution’ - https://scrip.pharmaintelligence.informa.com/SC144754/Biogen-Aduhelm-Price-Is-Part-Of-Alzheimers-Evolution

• Medicare Coverage Analysis Of Alzheimer’s Drugs Begins With Focus On Outcomes, Patient Eligibility - https://pink.pharmaintelligence.informa.com/PS144631/Medicare-Coverage-Analysis-Of-Alzheimers-Drugs-Begins-With-Focus-On-Outcomes-Patient-Eligibility

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

This year’s CPhI Pharma Awards will be taking place on 9th November and entries for 2021 are open! Listen to the CPhI Pharma Awards podcast in order to find out more on how the entry process works, the categories for this year and tips on how to improve your entry’s odds. The entry deadline is 6th August.

In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb and Barnaby Pickering offer a recap of Medtech Insight’s digital health coverage in June, including the record-breaking H1 digital health funding, a recap of ADA 2021 and updates on telehealth legislation.

Medtech Insight articles addressing topics discussed in this episode:

Quanta Raises $245M In Series D, Plans To Expand Into Home-Based Dialysis In US

https://medtech.pharmaintelligence.informa.com/MT144130/Quanta-Raises-245M-In-Series-D-Plans-To-Expand-Into-HomeBased-Dialysis-In-US

CMR Surgical Closes SoftBank-Led Funding Round Worth $600M

https://medtech.pharmaintelligence.informa.com/MT144132/CMR-Surgical-Closes-SoftBank-Led-Funding-Round-Worth-$600M

Pear Therapeutics Goes Public To Support Expansion Of Prescription Digital Therapeutics

https://medtech.pharmaintelligence.informa.com/MT144127/Exec-Chat-Pear-Therapeutics-CEO-Charts-Future-For-Digital-Therapeutics-Following-SPAC-Deal

ADA 2021: Encouraging Trial Data on CGMs, Insulin Pens, Digital Solutions, And More

https://medtech.pharmaintelligence.informa.com/MT144145/ADA-2021-Encouraging-Trial-Data-On-CGMs-Insulin-Pens-Digital-Solutions-And-More

Exec Chat: Dexcom Continues To Evolve Blood Glucose Measurement Market

https://medtech.pharmaintelligence.informa.com/MT144175/Exec-Chat-Dexcom-Continues-To-Evolve-Blood-Glucose-Measurement-Market

Cures 2.0 Would Circumvent CMS’ Pause On Breakthrough Payment Rule, Improve Telehealth, And More

https://medtech.pharmaintelligence.informa.com/MT144113/Cures-20-Would-Circumvent-CMS-Pause-On-Breakthrough-Payment-Rule-Improve-Telehealth-And-More

MDUFA V: Industry, FDA Tangle Over TAP Program, Agency Finances, Reinstatement Of Fifth-Year Offset Funds

https://medtech.pharmaintelligence.informa.com/MT144183/MDUFA-V-Industry-FDA-Tangle-Over-TAP-Program-Agency-Finances-Reinstatement-Of-FifthYear-Offset-Funds

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This week – pharma’s Q2 prospects; Bayer’s plans for the US launch of its CKD drug; big tobacco takes further steps into healthcare; KRAS’s emergence in oncology amid ongoing challenges; and tips for European biotech fundraising.