Citeline Podcasts

트럼프 미 대통령의 재당선과 지정학적 불안요소가 제약바이오 시장과 기업에 어떤 영향을 미칠까? Scrip의 전문가 설문조사 기사를 요약한 내용입니다.

https://insights.citeline.com/scrip/scrip-asks/scrip-asks-what-does-2025-hold-for-biopharma-part-3-impacts-of-political-change-in-us-and-beyond-CKTDR3BC2JBU5O6MUHDAKXGXHU/

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

Audio roundup of selected biopharma industry content from Scrip over the business week ended 7 February 2025. In this episode: Novo outlines CagriSema strategy; Pfizer is back in the deal game; Vertex’s pain drug faces opportunities and headwinds; uncertain times for Korean pharma; and a view on women’s health at JPM.

https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-Y37SM5W2TZDXNE26O3W6E33TZE/

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

Creativity can sometimes be about discovering what in retrospect seems obvious, like shoes that are shaped to fit our feet, marketing expert Beverley Law tells HBW Insight in the first episode of this season’s Over the Counter podcast. But this often requires stepping out of established approaches and patterns of thinking, she points out, which tend to characterise innovation in the consumer health industry. Law offers some tips to help firms think outside the box, including being brave, benchmarking against the fast-moving consumer goods industry, and including regulatory experts much earlier on in the process.

Introduction: Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the many commitments Robert F. Kennedy Jr. gave Sen. Bill Cassidy, R-LA, to secure his vote to move his Health and Human Services Secretary nomination to the Senate floor (:25). They also consider the slow restoration of some US Food and Drug Administration public communications and the impact of HHS postponing activities not deemed “mission-critical” (10:36).

More On These Topics From The Pink Sheet

HHS Nominee Kennedy’s Behind-The-Scenes Vaccine Reassurances Win Senate Swing Vote: https://insights.citeline.com/pink-sheet/vaccines/hhs-nominee-kennedys-behind-the-scenes-vaccine-reassurances-win-senate-swing-vote-F45HDCJQJJDIDKJOFXYODP6DJQ/

Kennedy Would Issue Trial Diversity Guidance, But Not Necessarily Roll Back All Anti-DEI Actions: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/diversity-and-inclusion/kennedy-would-issue-trial-diversity-guidance-but-not-necessarily-roll-back-all-anti-dei-actions-4SDSMJ5V7NFPHKVUX5XYBMRMEE/

FDA Communications In Flux As HHS Assesses Mission-Critical Activities: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-communications-in-flux-as-hhs-assesses-mission-critical-activities-H5UQ7BRSSZBVJDJBAXSVTDLIR4/

As US FDA Communications Freeze Thaws, Approvals Accumulate: https://insights.citeline.com/pink-sheet/product-reviews/approvals/as-us-fda-communications-freeze-thaws-approvals-accumulate-JA4WVLHMGJEZDHYB7LRNZAOYT4/

Harness Therapeutics' CEO talked to In Vivo about the company's scientific strategy, and its plans for expansion and partnering in the neurodegeneration space.

Audio roundup of selected biopharma industry content from Scrip over the business week ended 31 January 2025. In this episode: biopharma VC fundraising recovers; Daiichi Sankyo’s big year ahead; Akero’s promising MASH results; ADCs attract new investments in China; and Scrip Asks on AI and data science.

https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-D3ODXZGPURHZFJKT7MTVZ3AUWI/

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

Release date:

27 January 2025

Summer Colling and Emma Wille speak with epidemiologists Ridwaan Ibrahim and Lucia Rodriguez-Garcia about the recent ISPOR conference. Ridwaan and Lucia discuss where they see new technologies like AI fitting into the epidemiology space as well as the advantages and disadvantages of using AI to analyze large volumes of real world data.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss the effect of Acting US Food and Drug Administration Commissioner Sara Brenner’s use of MAHA in her introductory memo (:35), the issues that emerged during MAHA founder and Health and Human Services Secretary nominee Robert F. Kennedy Jr.’s Senate confirmation hearings (7:22), return to office plans for senior FDA staff (14:27), and postponed meetings and other impacts of the Trump Administration’s freeze on agency communications (19:30).

More On These Topics From The Pink Sheet

US FDA Acting Commissioner Tells Staff She’s Ready To MAHA: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-acting-commissioner-tells-staff-shes-ready-to-maha-D3VJ2JORKVEC5MKJNBRNY2XAOE/

Beyond Vaccines: Kennedy’s Anti-Pharma Side On Display At Senate Hearings: https://insights.citeline.com/pink-sheet/agency-leadership/beyond-vaccines-kennedys-anti-pharma-side-on-display-at-senate-hearings-EATXNW5MNBATFDTUWSIDDO6RDA/

Will Republican Senator’s Concerns About Kennedy’s Vaccine Views Endanger Nomination?: https://insights.citeline.com/pink-sheet/vaccines/will-republican-senators-concerns-about-kennedys-vaccine-views-endanger-nomination-ZQMM3G6NIFAQ7NPS2WF6F22PFE/

Medicare Price Negotiation Will Continue Under Trump With Possible ‘Improvements’: https://insights.citeline.com/pink-sheet/geography/north-america/united-states/medicare-price-negotiation-will-continue-under-trump-with-possible-improvements-BD6JAB25KZDLXO7MCVDCTLEESE/

US FDA Senior Staff Return To Office In February, Next Steps for Schedule F Reclassification: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-senior-staff-return-to-office-in-february-next-steps-for-schedule-f-reclassification-ETI5TGY5XRACLA76GCYY2PEZ74/

US FDA Opioids Adcomm Postponed; Are Communications Freeze, Travel Ban To Blame?: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-opioids-adcomm-postponed-are-communications-freeze-travel-ban-to-blame-H4WQ4DLAJBD5HOZAWBCSRDBTIA/

Approvals The US FDA Is Not Talking About: A Communication Freeze Calendar: https://insights.citeline.com/pink-sheet/product-reviews/approvals-the-us-fda-is-not-talking-about-a-communication-freeze-calendar-DHS4X56LNNFELPXQ6JAZSGJMGA/

Audio roundup of selected biopharma industry content from Scrip over the business week ended 24 January 2025. In this episode: semaglutide in 2027 Medicare price negotiations; J&J expects revenue growth despite challenges; Roche’s China Accelerator makes progress; Scrip Asks about the impact of political change; and Datroway’s US approval in breast cancer.

https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-3VZEWOJZWZHEPJGE6T2L4HOKPA/

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

Pink Sheet reporter and editors try to answer some emerging questions about the US Food and Drug Administration now that President Donald Trump has taken office. They discuss the FDA’s acting leadership (:43), an ongoing communications freeze (7:45), along with the hiring freeze and travel ban (20:49). They also discuss the impact of several executive orders on the US Centers for Medicare and Medicaid Services (26:23) and try to put the entire week’s events into perspective (33:40).

Editor’s Note: This episode was recorded prior to Sara Brenner being officially named acting FDA commissioner, but the discussion about other aspects of the presidential transition still is relevant.

More On These Topics From The Pink Sheet

Who’s Running The US FDA? Interim Team May Not Have Assumed Control: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/whos-running-the-us-fda-interim-team-may-not-have-assumed-control-S5HIPYKBZNFY3J2VHNJRY4JDYQ/

Deciphering Trump’s Executive Order On Medicare, Medicaid Payment Models: https://insights.citeline.com/pink-sheet/market-access/government-payers/medicare/deciphering-trumps-executive-order-on-medicare-medicaid-payment-models-MEWAWGHDNVES3IHTJJUJNAZJVI/

US FDA’s Trump Transition Relatively Smooth, Except For Diversity, Equity Work: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/diversity-and-inclusion/us-fdas-trump-transition-relatively-smooth-except-for-diversity-equity-work-V367EFJBVRGLBIVJ7VGWIYUSJ4/