Citeline Podcasts

트럼프의 관세 조치에 따른 미국시장 영향과 글로벌 빅파마들의 반응에 대한 Scrip 기사를 요약한 내용입니다.

https://insights.citeline.com/scrip/business/manufacturing/as-trumps-ups-the-ante-on-tariffs-reactions-are-mixed-7WMIGZ3O5JHF7AJSICVLRUE3GY/

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

Audio roundup of selected biopharma industry content from Scrip over the business week ended 28 February 2025. In this episode: which big companies face the least LOE hit?; IPOs rise in 2024; Pfizer cuts last AAV gene therapy program; balance and focus suggested for globalizing Chinese firms; and Scrip Asks on therapeutic area advances.

https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-4RXPQH4B5NBJ3AM7SFMPROUJ2U/

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

The consumer healthcare industry is changing. Companies are separating from their pharmaceutical parents and brands are shifting from therapeutic solutions to preventative health and wellness options. These shifts bring a number of challenges for OTC firms, notes AdverCheck managing director James Walmsley in the second part of his chat with HBW. For example, it is much more difficult to get science-backed claims for food supplements approved, he points out. With firms now also becoming standalone consumer health entities, there is no longer a direct pipeline of off-patent prescription medicines available for Rx-to-OTC switch, he observes. We may, therefore, see a new generation of switch-focused self-care companies and partnerships emerging.

Keywords: Innovation, AdverCheck, OTC medicines, Consumer Health, Rx-to-OTC switch

Timeline

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs, as well as Medtech Insight Managing Editor Elizabeth Orr, discuss the US Food and Drug Administration’s decision to call back many workers that were laid off and the next steps for the Trump Administration’s effort to reduce the size of the federal government (:29), the FDA decision to cancel an upcoming Vaccines and Related Biological Products Advisory Committee meeting on strain selection for the 2025-2026 flu vaccine (12:42), and the motives for Eli Lilly’s plan to increase domestic manufacturing (23:18).

More On These Topics From The Pink Sheet

Drug Reviewers And Legal Staff Among Those Called Back to US FDA, But Why?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/drug-reviewers-and-legal-staff-among-those-called-back-to-us-fda-but-why-YWONQYDHARESFLLY26YEP6RIHI/

DOGE-ing US FDA: Three Scenarios For What Comes Next: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/doge-ing-us-fda-three-scenarios-for-what-comes-next-XUDLPX3WNNH55JCHOMTOS2NXBA/

Breaking: US FDA Cancels Upcoming Adcomm Discussing 2025-2026 Flu Vaccine: https://insights.citeline.com/pink-sheet/vaccines/breaking-us-fda-cancels-upcoming-adcomm-discussing-2025-2026-flu-vaccine-AGBZQHYGZFHZLOK2PU5CCKBNK4/

Lilly $27Bn US Manufacturing Investment Linked To Trump’s Tariff, Tax Agenda: https://insights.citeline.com/pink-sheet/compliance/manufacturing/lilly-27bn-us-manufacturing-investment-linked-to-trumps-tariff-tax-agenda-FN55MQ3V75EU5J42TIYTFLTH4Q/

Audio roundup of selected biopharma industry content from Scrip over the business week ended 21 February 2025. In this episode: 2025’S biggest launches; 2024 deal metrics declined; GSK’s meningococcal vaccine; Arcus’s kidney cancer results; and Novartis on its India hub.

https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-2Y543BULOJEOTHMZLB5ATXRVPU/

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

UK law prohibits the advertising of prescription-only medicines. Nevertheless, some online pharmacies are marketing Rx drugs from “skinny jabs” to high strength eczema treatments, essentially selling prescription medicines directly to consumers, explains AdverCheck managing director James Walmsley. While regulators are cracking down on illegal practices, the growing market for prescription medicines is increasingly impinging on traditional consumer healthcare categories, Walmsley warns. In this episode of Over the Counter, we get to the bottom of this fascinating issue and outline what firms need to know.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs, as well as Medtech Insight Managing Editor Elizabeth Orr and HBW Insight Managing Editor Malcolm Spicer, discuss the most up-to-date information on the layoffs at the US Food and Drug Administration that were instituted by the Trump Administration (:42). They also consider the layoffs’ impact on the drug, device and consumer health divisions, including application review and facility inspections, as well as industry’s response to them (17:58).

More On These Topics From The Pink Sheet

US FDA Staff Cuts: Biopharma Industry Braces For Impact, But First Wants Clarity On Losses: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-staff-cuts-biopharma-industry-braces-for-impact-but-first-wants-clarity-on-losses-C45JIJX7IRD5FON2BNNKHTTBZU/

CMS Layoffs Broader Than Reports Indicate, Former Administrator Brooks-LaSure Says: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/cms-layoffs-broader-than-reports-indicate-former-administrator-brooks-lasure-says-A6XEKATFPRFXZCHSD7VDKO53HA/

Weekend US FDA Layoffs Cost Device Center Many AI And Digital Health Staffers: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/weekend-us-fda-purge-costs-device-center-many-ai-and-digital-health-staffers-VSCWD67JAJARTP7S3EZYB6KSIQ/

US FDA Food Safety Leader Resigns In Protest Of White House-Ordered Layoffs: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-food-safety-leader-resigns-in-protest-of-white-house-ordered-layoffs-ZJSIV3VWTNBB7MPGPOV7TUWWJU/

FDA Cosmetics Office Braces For Agency-Wide Staff Cuts; MoCRA Implementation Likely Delayed: https://insights.citeline.com/hbw-insight/beauty/policy-and-regulation/fda-cosmetics-office-braces-for-agency-wide-staff-cuts-mocra-implementation-likely-delayed-5CNPONAL2JBGRIOVLTPSISLCFY/

PhRMA Still All In For Trump Despite Chaos Hitting US Health Sector: https://insights.citeline.com/pink-sheet/market-access/phrma-still-all-in-for-trump-despite-chaos-hitting-us-health-sector-MSNPGI66H5AABGVJVGG2MLNZIA/

Audio roundup of selected biopharma industry content from Scrip over the business week ended 14 February 2025. In this episode: delayed take-off for M&A?; Bain to acquire Mitsubishi Tanabe; clinical trials to look out for; how to work with Trump; and mid-cap biopharma winners and losers.

https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-PYWFIZWE2FH2LIZUT4BDHGBZHQ/

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

Pink Sheet Executive Editor Derrick Gingery, Editor-in-Chief Nielsen Hobbs, and special guest Michael McCaughan of Prevision Policy look at new Health and Human Services Secretary Robert F. Kennedy Jr.’s first assignment, a presidential commission on reducing chronic disease (:29), as well as former US Food and Drug Administration Commissioner Scott Gottlieb’s suggestion that industry extend the existing user fee program rather than negotiate a new agreement in the current political environment (13:30). They also discuss the impact of President Trump’s executive order mandating a reduction in force across the federal government on the US Food and Drug Administration and communications questions affecting the agency’s advisory committee schedule (25:16).

More On These Topics From The Pink Sheet

Commission Led By HHS Secretary Kennedy Will Probe ‘Threats’ To Children, Including Medicines: https://insights.citeline.com/pink-sheet/agency-leadership/commission-led-by-hhs-secretary-kennedy-will-probe-threats-to-children-including-medicines-Q5YF65T23JEOXDWQ7I72X556KQ/

Bracing For RFK At HHS: Vaccine Safety Commission Likely First Step: https://insights.citeline.com/pink-sheet/agency-leadership/bracing-for-rfk-at-hhs-vaccine-safety-commission-likely-first-step-O5XKOSVYYVE7RMQUAIHZ4I2OLY/

User Fees: Industry Should Push For Extension Of Current Agreement In Reconciliation Bill, Gottlieb Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/user-fees-industry-should-push-for-extension-of-current-agreement-in-reconciliation-bill-gottlieb-says-YOWZW2CMSZA4BDP23MR2FLQJB4/

Could PDUFA VIII Align With Trump’s Efficiency Emphasis?: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/could-pdufa-viii-align-with-trumps-efficiency-emphasis-5WGLRU6N2FG4XABILEMHBYDXYI/

US FDA Advisory Committee Freeze Raises Concerns Of Delayed, More Controversial Approvals: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-advisory-committee-freeze-raises-concerns-of-delayed-more-controversial-approvals-CWT2HOAQ3JBHNCMKSSOOXVAYYU/

‘This Is Not Good For Business’: Trump’s Workforce Shakeups Could Harm Industry: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/this-is-not-good-for-business-trumps-workforce-shakeups-could-harm-industry-JJTMQ5RXOFDC7DQDVIZ3S2NJG4/

Citeline’s expert panel of reporters and analysts unpack the biggest deals, trends, and innovations from the JP Morgan Healthcare Conference. Discover what these developments mean for you and the future of the industry in 2025 and beyond.