Audio roundup of selected biopharma industry content from Scrip over the business week ended 28 March 2025. In this episode: Merck & Co. licenses Hengrui’s lipid lowerer; Novo gets United’s triple G obesity drug; J&J plans major US manufacturing investments; approval for GSK’s novel antibiotic; and a call for more aggressive Korean M&A activity. 
https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-7API33OTGJELXGC7RGOH2KK2G4/

This episode was produced with the help of AI text-to-voice and voice emulation tools.

Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Five Must-Know Things - 31 March 2025

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her interview with Gary Guthart, CEO of Intuitive Surgical about the new da Vinci 5 surgical robot and the future of robotics in surgery. Brian Bossetta talks about the recently FDA-cleared patient monitoring system that sends vital signs directly to clinician staff. Elizabeth Orr discusses an FDA warning letter to Exer Labs and Shubham Singh discusses Roche’s new NGS Prototype, expected to challenge Illumina.

Digital Health Roundup: Intuitive CEO Exec Chat, Patient Monitoring, Exer Labs Woes, Roche New NGS Prototype

OSE Immunotherapeutics' CEO Nicolas Poirier talks about the company's IL-7 receptor agonist, lusvertikimab, recent data presented at The European Crohn's and Colitis Organization congress, commercialization and development strategy and the future of IBD therapy. 

CEO Nicolas Poirier on OSE Immunotherapeutics Latest IL-7 Data

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss the impact of the 1 April reduction-in-force on the US Food and Drug Administration, which targeted about 3,500 employees (:30). They also consider how and whether service levels will change (13:28), and new Commissioner Martin Makary’s first address to the drastically smaller staff the day after the RIF was announced (29:22).

More On These Topics From The Pink Sheet

Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-layoffs-us-likely-to-lose-its-first-approver-advantage-5C37YQ73DNBEFF7SHRYV4MJUIA/ 

Are Bigger Ad Policy Changes Coming After US FDA’s Drug Promotion Office Hit Hard By Layoffs?: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/are-bigger-ad-policy-changes-coming-after-us-fdas-drug-promotion-office-hit-hard-by-layoffs-FQLHKJ4GWRCXLEIZCEMX37SUYU/ 

Dramatic HHS Layoffs A Response To ‘Existential Crisis,’ Kennedy Advisor Argues: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/dramatic-hhs-layoffs-a-response-to-existential-crisis-kennedy-advisor-argues-XZKO5PJF6RHGHLABD2TZY7K2N4/ 

CDRH Staff Cuts Focus On Administrative Workers, Spare Reviewers: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/cdrh-staff-cuts-focus-on-administrative-workers-spare-reviewers-DL3L63CAGFGYTDAICFSXG5JP34/ 

Makary Pledges To Uphold Gold Standard Science, But First Address Confuses Some US FDA Staff: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/makary-pledges-to-uphold-gold-standard-science-but-first-address-confuses-some-us-fda-staff-WE7A5TQARBHX3MS6LGDIQT5CRY/

US FDA Restructuring May Be Next After Drugs Center Loses More Than 1,000 People: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-restructuring-may-be-next-after-drugs-center-loses-more-than-1000-people-HOZ7IYGEC5BYBMNNUPAT2TBNI4/

Drug Fix: Understanding The US FDA Reduction-In-Force And Its Long-Term Impact

Audio roundup of selected biopharma industry content from Scrip over the business week ended 4 April 2025. In this episode: pharma dodges tariffs for now; Marks’s departure from FDA rattles industry; Phase 2b win for AstraZeneca’s oral PCSK9; Hengrui renews global Phase 3 push; and Novo’s new cardio results for semaglutide. 
https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-MPJF4YP4NFAQ5JEDFBEIW62LBE/

This episode was produced with the help of AI text-to-voice and voice emulation tools.

Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Five Must-Know Things - 7 April 2025

Exerting maximum influence on stakeholders, helping companies navigate regulatory complexity and promoting industry best practice are three big jobs that the UK consumer healthcare industry association, PAGB, has set itself for the next five years. 
In the last five years, PAGB has made significant headway with UK government, reports PAGB CEO Michelle Riddalls, establishing the economic and social value of self-care and ensuring that self-care is part of the UK’s national healthcare strategy.  
Rx-to-OTC switch has been a major area of success, Michelle notes in this episode of the Over the Counter podcast. The Department of Health and Social Care recently published a list of switches it would like to see applications for, and PAGB is now facilitating members to take advantage of this opportunity. 
But there’s always more work to be done. Switch involves significant risk, which PAGB is trying to reduce through further work with policy makers, and with a new government, the association must ensure that self-care remains high up on the agenda for politicians. 
Given the breadth of PAGB’s work discussed by Michelle, we have split this episode into two, so watch out for the second part in two weeks’ time on your favourite podcast provider and on Citeline’s HBW Insight. 

Timestamps
2:10 – Introductions
2:40 – PAGB’s new five-year strategy
5:40 – Evolution not revolution
8:00 – Self-care and UK government policy
10:30 – Quantifying the value of self-care
12:30 – Lobbying around AMR and OTCs
16:00 – Rx-to-OTC switch in the UK
24:00 – The power of brands

Guest Bio
Michelle Riddalls OBE is Chief Executive Officer of PAGB, the consumer healthcare association, which represents the manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements in the UK.
Prior to joining PAGB, Michelle was Director of Regulatory Affairs for the Northern European Cluster at Pfizer Consumer Healthcare, where she was integral in the highly successful POM to GSL reclassification of Nexium Control and the Viagra Connect POM to P switch.  
Michelle has been recognised across a number of industry awards, including the Women in Trade Powerlist in 2024, and was awarded an OBE for outstanding services to consumer health in the King’s 2025 New Year Honours.

Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

미국이 수입 의약품에 관세를 부과할 가능성은 여전하지만, 트럼프의 최근 발표로 인해 이를 시행하는 데 시간이 더 걸릴 수 있다는 Pink Sheet (Citeline Regulatory) 기사를 요약한 내용입니다.

https://insights.citeline.com/pink-sheet/compliance/distribution-supply-chain/pharma-still-nervous-while-riding-trumps-tariff-rollercoaster-DFQMWLGXSZBS3K34UY2OE6TUVA/

Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

 

미국 관세 롤러코스터에 제약업계는 여전히 불안 (Korean-language podcast)

Audio roundup of selected biopharma industry content from Scrip over the business week ended 11 April 2025. In this episode: Trump’s tariff rollercoaster; regulatory, economic uncertainties hang over Q1 earnings; IPOs rise in Q1 but may slow; Chinese deal-making matures; and AstraZeneca talks about Chinese innovation. 
https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-X3YNW3ZLVZABLNFILQHNH6FPAE/

This episode was produced with the help of AI text-to-voice and voice emulation tools.

Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Five Must-Know Things - 14 April 2025

Summary:
At the heart of any successful self-care business is a portfolio of recognizable and trusted consumer health brands. These brands could play a key role in unlocking the potential of digital self-care in the UK, suggests Michelle Riddalls, in this second part of her Over the Counter interview. As PAGB CEO, Michelle has seen first had how the UK consumer health industry has been transformed, for example also by Brexit. Has the UK’s exit from the EU realised the promises of innovation unleashed from bureaucracy? Not so far, Michelle reflects, but it might be too soon to tell. What she can predict is that with its new five-year strategy, PAGB will remain dedicated to supporting UK firms in navigating a continuously evolving industry landscape. 

Timestamps
2:00 – Digital consumer health in the UK
7:00 – The power of brands
12:00 – Brexit, promise realised? 
20:00 – What’s next for the UK OTC industry?

Guest Bio
Michelle Riddalls OBE is Chief Executive Officer of PAGB, the consumer healthcare association, which represents the manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements in the UK.
Prior to joining PAGB, Michelle was Director of Regulatory Affairs for the Northern European Cluster at Pfizer Consumer Healthcare, where she was integral in the highly successful POM to GSL reclassification of Nexium Control and the Viagra Connect POM to P switch.  
Michelle has been recognised across a number of industry awards, including the Women in Trade Powerlist in 2024, and was awarded an OBE for outstanding services to consumer health in the King’s 2025 New Year Honours.


Brands, Brexit And New Self-Care Business Models, With PAGB’s Michelle Riddalls

Audio roundup of selected biopharma industry content from Scrip over the business week ended 18 April 2025. In this episode: Trump’s drug pricing executive order; J&J says taxes, not tariffs, influence US manufacturing; Pfizer discontinuation sparks M&A speculation; US tariffs and manufacturing concentration; and tariffs’ pressures on pharma’s complex supply chain. 
https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ROAXNELATJBXDMNSHISARWARPY/

This episode was produced with the help of AI text-to-voice and voice emulation tools.

Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Five Must-Know Things - 21 April 2025

This week, "Gray Sheet" reporters and editors discuss FDA's device user fee negotiation public meeting, role of combination products and personalized medicine during the negotiations, an upcoming workshop on robotically-assisted surgical devices, safety communication addressing off-label use of the Lariat suture device, Medicare payment proposals, and Medtronic addresses "never event" with acquisition.

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Device Week Podcast – Episode 6

Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.

Device Week Podcast – Episode 6

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