Citeline Podcasts

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/

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.

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.

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

In Vivo spoke with UK biotech CEO Catherine Pickering about developing innovative therapies for challenging cancer types, the progress of iOntura's lead asset, roginolisib, for uveal melanoma, and the strategies that have helped secure over €100m in private financing.

Introduction: Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and Senior Editor Sue Sutter discuss the impact of the 3,500 layoffs on the US Food and Drug Administration, including the areas where the agency could lose some autonomy (:28). They also consider worries that the agency’s preparations for user fee reauthorization negotiations may be slowing because of the upcoming staffing cuts (24:09).

More On These Topics From The Pink Sheet

Power Play: US FDA Likely Losing More Than Just Staff With Restructured Health Department: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/power-play-us-fda-likely-losing-more-than-just-staff-with-restructured-health-department-BT5YZ4U7WNANBEZN7OBF42LCEE/

US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-staffing-uncertainty-could-impact-upcoming-user-fee-negotiations-EAUTZOANHVB3PK6NKCLJCYTOLA/

Can New US FDA Commissioner Makary Calm Agency During Turbulent Times?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/can-new-us-fda-commissioner-makary-calm-agency-during-turbulent-times-STBAXTWCIFEGJPDYZ6LZKMRPE4/

Farideh Bischoff, chief medical officer of Heranova Lifesciences, discusses the urgent need for better diagnostic options and the latest innovations transforming care for endometriosis patients.

Europe’s self-care industry leaders, policymakers and stakeholders are heading to Warsaw, Poland between the 4th and 6th June this year for the Association of the European Self-Care Industry’s 61st Annual Meeting.

With Poland heading up the EU Council and the country being one of the largest and most self-care friendly markets in Europe, the location made sense, explains AESGP director general Jurate Švarcaite, in this episode of Over the Counter.

As always, there’s a jam-packed line up for the event, which every year sets the agenda for industry in the months to come.

Highlights for Jurate include sessions on the role of prevention in self-care and the competitiveness of European industry on the world stage.

I’m personally also looking forward to discussions about how industry will square the circle of sustainability, with medicines posing unique challenges for both regulators and manufacturers.

Sign up for AESGP’s 61st Annual Meeting: https://aesgp.eu/events/61st-aesgp-annual-meeting

Audio roundup of selected biopharma industry content from Scrip over the business week ended 21 March 2025. In this episode: Pfizer tops pharma leaderboard; AstraZeneca buys into in vivo cell therapy; Almirall looks to dominate derma spectrum; Incyte’s HS contender looks approvable; and MSD’s Williams says pharma should shorten tech adoption cycles.

https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EGD3MLOIVJDKRCE32KV376CJ5Q/

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

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss industry stakeholders’ complaints about US Food and Drug Administration productivity declines in the weeks since President Trump took office and began making changes and the potential recourse for industry (:24). They also review the expected and emerging problems with the agency requiring nearly all of its Washington, D.C.-area staff to return to in-office work at its White Oak headquarters and consider its impact on workflow going forward (15:35).

More On These Topics From The Pink Sheet

US FDA’s Speed Of Work Under Trump Quietly Raising Industry Concerns: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-speed-of-work-under-trump-quietly-raising-industry-concerns-ZWM522FIDJAO7DVAJYZRLLDFAI/

US FDA Survives First Day Of Return To In-Office Work, But True Test Upcoming: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-survives-first-day-of-return-to-in-office-work-but-true-test-upcoming-AZOWC5ITNNGGVG3TIGGWR5VMBA/

Cramped Quarters, Limited Parking And Water Concerns Await US FDA’s Return To Office: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/cramped-quarters-limited-parking-and-water-concerns-await-us-fdas-return-to-office-YWHJRM6RTZF4NJP2MZX4Y6LLQA/