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المحتوى المقدم من Citeline. يتم تحميل جميع محتويات البودكاست بما في ذلك الحلقات والرسومات وأوصاف البودكاست وتقديمها مباشرة بواسطة Citeline أو شريك منصة البودكاست الخاص بهم. إذا كنت تعتقد أن شخصًا ما يستخدم عملك المحمي بحقوق الطبع والنشر دون إذنك، فيمكنك اتباع العملية الموضحة هنا https://ar.player.fm/legal.
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The So What from BCG


1 Re-Recruiting and Other New HR Strategies You Can’t Ignore 18:09
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HR is no longer just about managing people—it’s about shaping the future of work. Jens Baier, BCG’s HR transformation expert, discusses how AI and shifting employee expectations are forcing companies to rethink talent strategies. From re-recruiting to upskilling employees, HR must adapt to a rapidly changing landscape. Learn More: Jens Baier: https://on.bcg.com/41ca7Gv BCG on People Strategy: https://on.bcg.com/3QtAjro Decoding Global Talent: https://on.bcg.com/4gUC4IT…
Drug Fix: Concerns and Questions As Trump Administration Takes Control Of US FDA
Manage episode 462992107 series 2877522
المحتوى المقدم من Citeline. يتم تحميل جميع محتويات البودكاست بما في ذلك الحلقات والرسومات وأوصاف البودكاست وتقديمها مباشرة بواسطة Citeline أو شريك منصة البودكاست الخاص بهم. إذا كنت تعتقد أن شخصًا ما يستخدم عملك المحمي بحقوق الطبع والنشر دون إذنك، فيمكنك اتباع العملية الموضحة هنا https://ar.player.fm/legal.
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/
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Manage episode 462992107 series 2877522
المحتوى المقدم من Citeline. يتم تحميل جميع محتويات البودكاست بما في ذلك الحلقات والرسومات وأوصاف البودكاست وتقديمها مباشرة بواسطة Citeline أو شريك منصة البودكاست الخاص بهم. إذا كنت تعتقد أن شخصًا ما يستخدم عملك المحمي بحقوق الطبع والنشر دون إذنك، فيمكنك اتباع العملية الموضحة هنا https://ar.player.fm/legal.
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/
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Citeline Podcasts

1 The Challenge Of Innovating In A Changing OTC Industry With AdverCheck’s James Walmsley 24:35
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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…
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Citeline Podcasts

1 Scrip's Five Must-Know Things - 3 March 2025 15:51
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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…
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Citeline Podcasts

1 Drug Fix: Laid Off US FDA Staff Called Back, Vaccine Adcomm Cancelled, Lilly’s Manufacturing Push 32:31
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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/…
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Citeline Podcasts

1 Scrip's Five Must-Know Things - 25 February 2025 16:22
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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…
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Citeline Podcasts

1 Why OTC Firms Should Care About Rx Advertising, With AdverCheck’s James Walmsley 27:52
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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.…
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Citeline Podcasts

1 Drug Fix: Understanding the US FDA Layoffs And Their Impact On Industry 27:54
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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/…
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Citeline Podcasts

1 Scrip's Five Must-Know Things - 18 February 2025 15:07
15:07
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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…
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Citeline Podcasts

1 Drug Fix: RFK’s First Actions, Pitch To Extend Current US FDA User Fee Agreement, More Trump Impacts 32:44
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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/…
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Citeline Podcasts

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.
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Citeline Podcasts

1 Scrip이 묻다... 2025년 제약바이오 산업의 미래는? 세계 정치 변화의 영향 (Korean-language podcast) 4:26
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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…
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Citeline Podcasts

1 Getting Creative In Consumer Health, With All Creative’s Beverley Law 32:00
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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.…
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Citeline Podcasts

1 Scrip's Five Must-Know Things - 10 February 2025 14:47
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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…
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Citeline Podcasts

1 Drug Fix: Kennedy’s Assurances To Gain HHS Nod, US FDA Coms Freeze Continues Thawing 17:33
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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/…
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Citeline Podcasts

1 Harness Therapeutics CEO Talks Somatic Expansion for Neurodegeneration 21:13
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Harness Therapeutics' CEO talked to In Vivo about the company's scientific strategy, and its plans for expansion and partnering in the neurodegeneration space.
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Citeline Podcasts

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…
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