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Citeline PodcastsDrug Fix: Understanding the US FDA’s CDER Leadership ShufflePink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs break down the pending retirement of Center for Drug Evaluation and Research Director Richard Pazdur and appointment of Tracy Beth Høeg as the interim replacement (4:51), including the potential impact on sponsors (15:46). They also discuss whether Høeg will take time to learn CDER operations before making changes (19:38), as well as the possibility of yet another CDER director being hired in the coming weeks or months (23:18). More On These Topics From The Pink Sheet US FDA Faces Another Leadership Crisis As Drugs Center Director Richard Pazdur Re...
2025-12-0528 minCiteline Podcasts
Citeline PodcastsDrug Fix: Examining George Tidmarsh’s Departure As Head Of US FDA’s Drug CenterPink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs take a deep dive into the circumstances of George Tidmarsh’s departure as director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (:30). They also consider the long-term impact on the agency (11:50) and try to place it in context compared to other crises in its history (31:24). More On These Topics From The Pink Sheet Breaking: George Tidmarsh Out As US FDA Drug Center Director: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-george-tidmarsh-out-as-us-fda-drug-center-director-MI2NEWEM6ZFP7GP66ZQJL76N2Q/ ...
2025-11-0735 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA Streamlines Biosimilar Development Requirements, Clarifies Inspection ReformPink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the impact of the US Food and Drug Administration announcement that a comparative efficacy study is no longer a prerequisite for biosimilar approval (:35), as well as the upcoming guidance stating the interchangeability switching study requirement will be dropped (11:25). They also discuss agency efforts to clarify the intent of the upcoming inspection force “Simple Reform” (15:13). More On These Topics From The Pink Sheet US FDA’s Makary Wants Lower Biosimilar Launch Prices As Clinical Study Mandate Changed: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/us-fdas-makary-wants-lower-biosimilar-launch-prices-as-clinical-study-mandate-changed-5ARJRC6QYBBMT...
2025-10-3123 minCiteline Podcasts
Citeline PodcastsDrug Fix: Another FDA Inspection Reorg, Industry Navigating New DTC LandscapePink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs explain the reasons for the US Food and Drug Administration’s planned “Simple Reform” of its inspection group, including the move away from specialized teams (:44). They also consider industry’s current thinking on best practices for navigating the agency’s new position on direct-to-consumer ad regulation (18:45). More On These Topics From The Pink Sheet US FDA Plans Move Back To More Generalist Inspectorate: https://insights.citeline.com/pink-sheet/compliance/us-fda-plans-move-back-to-more-generalist-inspectorate-5V3573KXHFAJXH6LVC6NSXW37M/ Industry Rethinking Visual Elements And Quality-Of-Life Claims After US F...
2025-10-2439 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA Involved In Astra Zeneca’s Drug Pricing Deal, DOJ’s Off-Label Promotion PolicyPink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the reasons US Food and Drug Administration Commissioner Martin Makary could have helped negotiate the Most Favored Nation drug pricing deal with Astra Zeneca (:30) and the deal’s potential impact on the 340B program (16:35). They also consider the Justice Department’s alternative interpretation of off-label promotion regulations and the effect on the scientific exchange of information about drugs (19:16). More On These Topics From The Pink Sheet US FDA Commissioner’s Involvement In AstraZeneca Pricing Deal Raises Ethical, Legal Questions: https://insights.citeline.com/pink-sheet/market-access/pricin...
2025-10-1729 minCiteline Podcasts
Citeline PodcastsDrug Fix: Government Shutdown’s Impact On US FDA, Pfizer Inks Drug Pricing DealPink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and senior editors Sue Sutter and Cathy Kelly consider the impact of the government shutdown on the US Food and Drug Administration, as well as industry (:21), and discuss the future of drug pricing after Pfizer completes its deal with the White House to embrace its Most Favored Nation plan (10:29). More On These Topics From The Pink Sheet Shutdown Approaches: US FDA Would Retain Most Of Recently Trimmed Staff: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/shutdown-approaches-us-fda-would-retain-most-of-recently-trimmed-staff-DTVAHLBI5VGZBPHD76TLNDIBGU/ Shutdown Day One: US FDA Hiring, MFN Demos Delayed?: https://insights.citeline...
2025-10-0324 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA Drops Offit, Others From Adcomms, Releases Unapproved Product Rejection LettersPink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the ongoing impact of the US Food and Drug Administration decision to drop vaccine expert Paul Offit and others from its advisory committee rosters (:32), as well as the substantial new detail in the latest batch of complete response letters for unapproved products that the agency released (12:47). More On These Topics From The Pink Sheet Offit’s VRBPAC Departure Raises Questions About Another HHS Panel Revamp: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-paul-offit-no-longer-member-of-us-fdas-vaccine-advisory-panel-WX3X3CIP6VCARJ7BPLXNQIQ2BQ/ US FDA Compounding Ad...
2025-09-0534 minCiteline Podcasts
Citeline PodcastsChina Biopharma English-Language Podcast: China Innovative Drugs And Commercial InsuranceIn this episode of the China Biopharma English-language Podcast, Shanghai-based senior reporter Xu Hu talks about the release for the first time by China’s National Healthcare Security Administration in August of a preliminary list of innovative drugs reimbursed by commercial insurance and the key reasons that have driven this reform. Related story links: https://insights.citeline.com/pink-sheet/geography/asia/china/china-signals-commercial-insurance-biotech-and-foreign-owned-hospitals-as-policy-priorities-6WABWKHO3VCRHNSCOXGABSHTZE/ https://insights.citeline.com/pink-sheet/market-access/government-payers/china-unveils-multiple-policies-to-support-innovative-drugs-throughout-life-cycle-JFEHXBAS2ND3PGJYKOF7NB6ZCM/ https://insights.citeline.com/pink-sheet/geography/asia/china/china-nhsa-releases-preliminary-innovative-drug-list-for-first-time-JOSACB66CZA6BOZNDEGFTLLWSU/
2025-09-0208 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA Changes COVID-19 Vaccine Labeling, Reimbursement Confusion RisesPink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss the impact of US Food and Drug Administration’s COVID-19 vaccine indication changes and recission of the associated emergency use authorizations, as well as the postmarketing studies that now are required (:40), and their potential impact on access and reimbursement (12:20). More On These Topics From The Pink Sheet COVID-19 Vaccines: Pfizer Arguments To Keep EUA Failed To Persuade US FDA’s Prasad: https://insights.citeline.com/pink-sheet/vaccines/covid-19-vaccines-pfizer-arguments-to-keep-eua-failed-to-persuade-us-fdas-prasad-V3X2OEBZE5HRHKO7KMMCFXBM2Q/ US FDA Updates COVID-19 Vaccine Formulations, Revokes EUAs, ACIP Use Deci...
2025-08-2922 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-OffPink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the issues awaiting George Tidmarsh, the new director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (:24), as well as the next steps for the agency and Sarepta amid the ongoing problems with its gene therapy Elevidys (delandistrogene moxeparvovec) (23:49). More On These Topics From The Pink Sheet Will Tidmarsh’s Industry Experience Translate As US FDA’s Chief Drug Regulator?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-news-pharma-ceo-george-tidmarsh-named-director-of-us-fdas-drug-center-2HXJJCPAIVB2RFNGDDU5NZVNQQ/ Business Background Of New CDER Director George Tidmarsh: https://insigh...
2025-07-2536 minCiteline Podcasts
Citeline PodcastsDrug Fix: CBER Director’s Political Spin On COVID-19 Vaccines And US FDA RIFs FinalizedPink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss why Center for Biologics Evaluation and Research Director Vinay Prasad cited an unproven theory alleging politics influenced the 2020 COVID-19 vaccine emergency use authorizations to justify his decision to overrule reviewers on more recent indication updates (:35). They also consider the impact of hundreds of staff departures after the US Food and Drug Administration’s reduction-in-force was allowed to proceed, including 600 in the Center for Drug Evaluation and Research (20:14). More On These Topics From The Pink Sheet Prasad Cites Unproven Theory Defending His CO...
2025-07-1828 minCiteline Podcasts
Citeline Podcasts【3分で解説 世界のファーマ】第24回 トランプ関税 製薬大国インドへの影響 (Japanese-language podcast)世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 今回取り上げた記事はこちら Snapshot Of India’s Pharma Manufacturing Network Amid ‘Trumponomics’（邦訳：インド、医薬品製造ネットワークの現在地　「トランプ経済政策」の最中で） https://insights.citeline.com/scrip/focus-on-asia/india/snapshot-of-indias-pharma-manufacturing-network-amid-trumponomics-4NDNAVYZW5CPZIKDIZHDRXCJ6A/ ※全文の閲覧には購読（有料）が必要です。 世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip
2025-07-0303 minCiteline Podcasts
Citeline PodcastsChina Biopharma English-Language Podcast: Obesity Drugs Not All About Weight LossIn the first episode of this new China Biopharma English-language mini podcast, Shanghai-based senior reporter Xu Hu looks at the main directions in which obesity drug developers are moving, Chinese pharma firms’ position in the global race for muscle-preserving weight loss drugs and China's challenge in matching accessible drugs with well-guided weight loss. Related story links: https://insights.citeline.com/scrip/r-and-d/chinese-developers-showcase-potentially-differentiated-weight-loss-assets-at-ada-TGCGQMCVBFHS7LNTWM6YDPEC3I/; https://insights.citeline.com/in-vivo/global-vision/chinese-firms-build-obesity-clinical-pipeline-but-face-wider-hurdles-KX5GZJDC2NGKRDO6VUU7HROF4Y/
2025-07-0210 minCiteline Podcasts
Citeline PodcastsMaster Regulatory Hurdles and Accelerate Your Drug DevelopmentWith growing FDA bottlenecks and regulatory changes, this episode explores how biotechs are looking beyond borders by rethinking trials, embracing real-world data, and finding new global pathways to bring therapies to life. Small Biotechs, Big Decisions is a limited podcast series exploring the challenges and opportunities facing emerging biotech companies, hosted by Daniel Chancellor, VP of Thought Leadership at Norstella, and Claire Riches, VP of Clinical Solutions at Citeline, a leading provider of life sciences data and insights. View the video series and find out more information here: https://www.citeline.com/biotech
2025-06-3013 minCiteline Podcasts
Citeline PodcastsPost-BIO Podcast: Thoughts From The FrontlinesJoin Scrip editors Mandy Jackson and Mary Jo Laffler and Pink Sheet editor Sarah Karlin-Smith as they discuss the general mood at the recent BIO International Convention in Boston and around the current US economic and biopharma policy environment in general, along with other key topics at BIO including vaccines, deal and financing and the rise of China's innovation. https://insights.citeline.com/scrip/conferences/bio/post-bio-podcast-thoughts-from-the-frontlines-ID7TBPASUFG4HKFSH56TK44DUM/ https://insights.citeline.com/pink-sheet/conferences/bio/post-bio-podcast-thoughts-from-the-frontlines-VGDKPJ2QQRBV5B6TY36ROPKE4Q/ Time stamps (0:45) Economic and policy environment in the US (2:50) BIO leadership surprisingly open about the industry’s...
2025-06-2641 minCiteline Podcasts
Citeline PodcastsHow to Crush Competitive Threats and Stand Out in BiotechThe race for new therapies is more intense than ever. This episode uncovers how biotech and pharma use competitive intelligence, AI, and data to outsmart rivals and change the game. Small Biotechs, Big Decisions is a limited podcast series exploring the challenges and opportunities facing emerging biotech companies, hosted by Daniel Chancellor, VP of Thought Leadership at Norstella, and Claire Riches, VP of Clinical Solutions at Citeline, a leading provider of life sciences data and insights. View the video series and find out more information here: https://www.citeline.com/biotech
2025-06-2314 minCiteline Podcasts
Citeline PodcastsDrug Fix: The US and Ex-US Impact Of Most-Favored Nation Drug PricingPink Sheet Executive Editor Derrick Gingery, Senior Writer Francesca Bruce, Senior Editor Cathy Kelly and Editor-in-Chief Nielsen Hobbs consider European officials’ opinions of President Trump’s Most Favored Nation drug pricing proposal (:29), the uncertainty the plan has created and could create for the pharmaceutical industry (22:48), as well as its potential impact on the both sides of the Atlantic Ocean (27:42). More On These Topics From The Pink Sheet ‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/brainless-us-mfn-policy-could-drive-pharma-investment-to-europe-Z3FC7WBPKNF2LLG4YVZK3RBDUA/ US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access...
2025-06-1334 minCiteline Podcasts
Citeline PodcastsCiteline Japan Awards 2025 - Entry Deadline Approaching! (Bilingual English/Japanese)The 14 July entry deadline for the Citeline Japan Awards 2025 in Tokyo on 21 October is fast approaching! Join Ian Haydock and Lisa Takagi in this bilingual mini podcast as they outline the event and the various Award categories. (Japanese starts at 2:20.) More information on categories, entry criteria, table bookings and sponsorship opportunities here: English: https://www.citeline.com/en/awards/citelinejapanawards) Japanese: https://www.citeline.com/ja-jp/awards/citelinejapanawards)
2025-06-1204 minCiteline Podcasts
Citeline PodcastsStrategies to Secure Critical Biotech Funding Amid Market ChallengesBiotechs are racing to change the rules in this tough market. This episode reveals how AI, real-world data, and strategic partnerships are reshaping drug development. Is reinvention biotech’s last hope? Small Biotechs, Big Decisions is a limited podcast series exploring the challenges and opportunities facing emerging biotech companies, hosted by Daniel Chancellor, VP of Thought Leadership at Norstella, and Claire Riches, VP of Clinical Solutions at Citeline, a leading provider of life sciences data and insights. View the video series and find out more information here: https://www.citeline.com/biotech
2025-06-1115 minCiteline Podcasts
Citeline PodcastsHow to Survive Innovation Pressure in Today’s Biotech LandscapeSmall biotech companies are facing tough times, shrinking funding and uncertain futures. But beneath the surface, quiet forces of innovation and resilience are rising. This episode explores how biotechs ignite innovation despite economic headwinds, regulatory uncertainty, and fierce competition. Small Biotechs, Big Decisions is a limited podcast series exploring the challenges and opportunities facing emerging biotech companies, hosted by Daniel Chancellor, VP of Thought Leadership at Norstella, and Claire Riches, VP of Clinical Solutions at Citeline, a leading provider of life sciences data and insights. View the video series and find out more information here: https://www.citeline.com/biotech
2025-06-1109 minCiteline Podcasts
Citeline PodcastsDrug Fix: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget CutsPink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss why seemingly routine comments from Vinay Prasad, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, that he would stay away from daily review decisions were notable (:26), as well as the impact of proposed FDA budget cuts by the White House and the House of Representatives (17:16). More On These Topics From The Pink Sheet Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors: https://insights.citeline.com/pink-sheet/rare-diseases/prasad-says-involvement-in-us-fda-product-approvals-will-mirror-prior-cber-directors-KF4LJWX5U5...
2025-06-0628 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine RecommendationPink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the potential comments that US Food and Drug Administration Commissioner Martin Makary and other senior agency leaders could receive during their pharma CEO listening tour (:30), as well as the impact of Health and Human Services Secretary Robert F. Kennedy Jr.’s decision to change US Centers for Disease Control and Prevention policy and no longer recommend healthy children and pregnant women receive COVID-19 vaccines (15:47). More On These Topics From The Pink Sheet US FDA Makary’s Pharma CEO Tour Goes Against Tran...
2025-05-3035 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA’s Big Vaccine Policy WeekPink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the limited label that Novavax received for its new COVID-19 vaccine Nuvaxovid, the impact of the new COVID-19 vaccine development policy announced by the US Food and Drug Administration and additional upcoming indicators of the evolving policy. More On These Topics From The Pink Sheet Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened: https://insights.citeline.com/pink-sheet/vaccines/novavaxs-covid-19-vaccine-label-narrowed-after-political-officials-intervened-56OPC7DJ6NCXFLQYGE27SVTEH4/ Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy: https://insights.citeline.co...
2025-05-2350 minCiteline Podcasts
Citeline PodcastsDrug Fix: A New Director For US FDA’s Biologics Center, Guidance Production SlowdownsPink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider early excitement and concern about Vinay Prasad’s potential impact on product development as director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research (:20). They also consider the consequences of the FDA missing product-specific guidance publication deadlines (14:59) and its potential impact on the upcoming user fee reauthorization negotiations (20:00). More On These Topics From The Pink Sheet Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tougher-approval-standards-may-follow-vinay-prasads-appointment-to-lead-us-fdas-cber-WEULXI5EJRE43BWU752PG...
2025-05-0924 minCiteline Podcasts
Citeline PodcastsDrug Fix: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor in Chief Nielsen Hobbs consider the impact of FDA Commissioner Martin Makary directing one of his assistants to take over the review of Novavax’s COVID-19 vaccine (:40), as well as how states or courts could respond (19:19). They also discuss several announcements of missed user fee deadlines and whether FDA layoffs could have contributed (28:33). More On These Topics From The Pink Sheet Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review: https://insights.citeline.com/pink-sheet/vaccines/political-official-pushing-novavax-to-conduct-covid-19-vaccine-postmarket-rct-BZTIWKSTK5G77BUQGGD3G2...
2025-05-0240 minCiteline Podcasts
Citeline PodcastsDrug Fix: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ ApprovalPink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss the impact of the departures of several senior leaders in the US Food and Drug Administration’s facility inspection group, Office of Generic Drugs and Office of Prescription Drug Promotion (:26). They also consider Commissioner Martin Makary’s intent to combine the agency’s many adverse event databases (14:52), his idea for a new approval pathway based on a “plausible mechanism” (26:25) and the seemingly increasing influence of politics at the agency despite his declarations that the FDA is apolitical (36:16). More On These Topics From The Pink Sheet US F...
2025-04-2541 minCiteline Podcasts
Citeline Podcasts미국 관세 롤러코스터에 제약업계는 여전히 불안 (Korean-language podcast)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
2025-04-1103 minCiteline Podcasts
Citeline PodcastsDrug Fix: Understanding The US FDA Reduction-In-Force And Its Long-Term ImpactPink 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 Bi...
2025-04-0441 minCiteline Podcasts
Citeline PodcastsDrug Fix: Understanding The Impact Of The Latest HHS Layoffs On The US FDAIntroduction: 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 Un...
2025-03-2831 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA Productivity Complaints Emerge, Internal Return To Office HeadachesPink 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 Rais...
2025-03-2130 minCiteline Podcasts
Citeline PodcastsScrip's Five Must-Know Things - 17 March 2025Audio roundup of selected biopharma industry content from Scrip over the business week ended 14 March 2025. In this episode: Roche’s big new obesity deal; J&J opts out of next-gen Darzalex; Arvinas and Pfizer’s protein degrader misses Phase III endpoint; Kelun wins first TROP2 ADC approval in lung cancer; and big name brands poised to lose US exclusivity. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-QOIAKBVZ2FDQ7NL2SFMWK66HP4/ This episode was produced using AI text-to-voice and voice emulation software. Let me know your views: ian.haydock@citeline.com. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
2025-03-1715 minCiteline Podcasts
Citeline PodcastsDrug Fix: Buyouts, Departures and Other US FDA ChaosPink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the US Food and Drug Administration’s early retirement and buyout programs to further cut its workforce (:25), leadership departures in the Center for Biologics Evaluation and Research (9:13), the quick arrival and resignation of a new FDA chief counsel (12:35), and Commissioner nominee Martin Makary closing in on confirmation, as well as the impact of the staffing changes on the agency he likely will be running (22:45). More On These Topics From The Pink Sheet US FDA Reviewers, Inspectors Not Eligible For HHS Buyouts: https://insights.citeline.com/pi...
2025-03-1431 minCiteline Podcasts
Citeline Podcasts【3分で解説 世界のファーマ】第23回 トランプ関税 製薬への影響は (Japanese-language podcast)世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 今回取り上げた記事はこちら 「As Trumps Ups The Ante On Tariffs, Reactions Are Mixed（邦訳：止まらぬトランプ関税措置　業界の反応は複雑化）」 URL:　 https://insights.citeline.com/scrip/business/manufacturing/as-trumps-ups-the-ante-on-tariffs-reactions-are-mixed-7WMIGZ3O5JHF7AJSICVLRUE3GY/ ※全文の閲覧には購読（有料）が必要です。 世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip
2025-03-0703 minCiteline Podcasts
Citeline PodcastsDrug Fix: What We Learned From US FDA Commissioner Nominee Makary’s Confirmation Hearing?Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss the issues that dominated the Senate confirmation hearing for US Food and Drug Administration Commissioner nominee Martin Makary, including vaccines (1:03) and mifepristone (14:45), as well as several questions that were not asked (23:31). They also consider the potential impact of his answers on the agency. More On These Topics From The Pink Sheet Makary Plans To Review Mifepristone Data, Raising Concerns Of Abortion Pill Access Rollbacks: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/makary-plans-to-review-mifepristone-data-raising-concerns-of-abortion-pill-access-rollbacks-24NTRIXLKJD23OKNBB5Z7UAFL4/ Senators Scrutinize US FDA Commissioner...
2025-03-0733 minCiteline Podcasts
Citeline PodcastsDrug Fix: Laid Off US FDA Staff Called Back, Vaccine Adcomm Cancelled, Lilly’s Manufacturing PushPink 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 S...
2025-02-2832 minCiteline Podcasts
Citeline PodcastsDrug Fix: Understanding the US FDA Layoffs And Their Impact On IndustryPink 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 Impa...
2025-02-2127 minCiteline Podcasts
Citeline PodcastsDrug Fix: RFK’s First Actions, Pitch To Extend Current US FDA User Fee Agreement, More Trump ImpactsPink 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 commun...
2025-02-1432 minCiteline Podcasts
Citeline PodcastsDrug Fix: Kennedy’s Assurances To Gain HHS Nod, US FDA Coms Freeze Continues ThawingIntroduction: 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-F45HDCJQJ...
2025-02-0717 minCiteline Podcasts
Citeline PodcastsDrug Fix: President Trump’s Policies Begin Changing The US FDA, Kennedy’s Hill HearingsPink 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...
2025-01-3130 minCiteline Podcasts
Citeline PodcastsDrug Fix: Concerns and Questions As Trump Administration Takes Control Of US FDAPink 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 transi...
2025-01-2438 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA And Trump’s Reforms, CDER Director Parting Comments, 2024 Approval TrendsPink Sheet editors consider ex-FDA officials’ advice for the Trump Administration on implementing FDA reforms (:24), comments CDER Director Patrizia Cavazzoni made before her departure from the agency about wanting to release review documents for applications that received complete response letters (12:35), and diverging trends between CDER and CBER novel application approvals (21:53). More On These Topics From The Pink Sheet Trump’s US FDA Reforms Need Center Director, Staff Support To Succeed, Former Leaders Say: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/trumps-us-fda-reforms-need-center-director-staff-support-to-succeed-former-leaders-say-VCCGXSBJGZGXPHEYJFAHIHEI7A/ Exit Interview: US FDA’s Patrizia Cavazzoni Says CDER Staff In ‘Best Place Possible’: https://insights.citeline.com/pink-sheet...
2025-01-1737 minCiteline Podcasts
Citeline PodcastsDrug Fix: CDER Director Retires, US FDA Guidance ‘Blizzard,’ Rare Pediatric Disease Program Hangs OnPink Sheet editors discuss Center for Drug Evaluation and Research Director Patrizia Cavazzoni’s surprising retirement announcement (:32), the importance of the large bolus of guidance documents that the FDA released 6 January (12:42), and the FDA’s decision to continue reviewing and granting rare pediatric disease designations even though the program lapsed (18:48). More On These Topics From The Pink Sheet Digging Through The US FDA Guidance Blizzard: https://insights.citeline.com/pink-sheet/legislation/elections/digging-through-the-us-fda-guidance-blizzard-TR6LKKXLZ5C5ZG5HUYDJ6XJO3M/ Artificial Intelligence: US FDA Outlines 7 Steps To Establishing Model Credibility: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/artificial-intelligence-us-fda-outlines-7-steps-to-establishing-model-credibility-ZZTAXYUP3BDKPKLF6CVECQYO7M/ ...
2025-01-1025 minCiteline Podcasts
Citeline PodcastsDrug Fix: COVID-19 Vaccine EUAs In Danger, DOGE And US FDA, New 340B Rebate Pricing ModelsPink Sheet reporter and editors discuss potential threats to the COVID-19 vaccine pediatric indications under the Trump Administration (:24), the DOGE commission’s search for spending cuts and its impact on the FDA (12:52), as well as a new 340B rebate pricing model that some pharma companies are implementing to contain the program’s costs (22:52). More On These Topics From The Pink Sheet Pediatric COVID Shots, Still Under EUA, Would Be Vulnerable In Anti-Vax HHS: https://insights.citeline.com/pink-sheet/vaccines/pediatric-covid-shots-still-under-eua-would-be-vulnerable-in-anti-vax-hhs-UWJRLYQUCJEWTLC42IFR7X2XFY/ Can US FDA Dodge DOGE? Return To Office Mandate May Be Biggest Hit: https://insights.citeline.com/pink...
2024-12-0634 minCiteline Podcasts
Citeline PodcastsScrip's Five Must-Know Things - 25 November 2024Audio roundup of selected biopharma industry content from Scrip over the business week ended 22 November 2024. In this episode: Novo’s semaglutide looks good in NASH; J&J’s psoriasis drug hits multiple Phase III goals; NASH competition gets serious; China dominates APAC and increasingly global trials; and why has M&A decreased in 2024. https://insights.citeline.com/scrip/podcasts/quick-listen-scrips-five-must-know-things-YDQU2ROM3JAXDD72TMXMOYZGGE/ Link to APAC Clinical Trials White Paper: https://www.citeline.com/en/resources/exploring-the-asia-pacific-clinical-trials-landscape Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
2024-11-2216 minCiteline Podcasts
Citeline PodcastsDrug Fix: Trump’s Potential Impact On FDA User Fees, Dr. Oz’s Potential Impact On CMSPink Sheet reporter and editors discuss concerns that the incoming administration could try to influence the upcoming FDA user fee reauthorization (:30), as well as the changes Dr. Mehmet Oz, President-elect Donald Trump’s controversial selection of to run the US Centers for Medicare and Medicaid Services, could impose if confirmed (22:35). #pharma #business More On These Topics From The Pink Sheet Trump’s US FDA User Fee Cycle: ‘An Underappreciated Threat’: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/trumps-us-fda-user-fee-cycle-an-underappreciated-threat-GVVSHUIRXBDOHDLWQXHSLC2U4A/ Medicare Price Negotiation Under CMS Chief Oz May See Early 2025 Test: https://insights.citeline.com/pink-sheet/agency-leadership/medicare-price-negotiation-under-cms-chief-oz-may-see-early-2025-test-UOROAUBSE5CWJC65XK6Q5I37...
2024-11-2232 minCiteline Podcasts
Citeline PodcastsDrug Fix: Trump Picks Robert F. Kennedy Jr. To Lead HHS, How Could He Disrupt FDA?Pink Sheet reporter and editors, and guest Michael McCaughan of Prevision Policy, continue the discussion of Donald Trump’s potential impact on the FDA, including how Robert F. Kennedy Jr. could change the agency as head of HHS (:37), whether lasting changes are coming to the FDA (13:00), and Commissioner Robert Califf’s request that industry help preserve the agency status quo (18:18). More On These Topics From The Pink Sheet Speed Of Novel Approvals In Jeopardy As RFK Jr. Lands US HHS Secretary Nod: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/speed-of-novel-approvals-in-jeopardy-as-rfk-jr-lands-us-hhs-secretary-nod-PBKQI3K2XBHK5F53ZBHRD6VX2Q/ Three Ways Trump Could Disr...
2024-11-1528 minCiteline Podcasts
Citeline PodcastsConference Catch-Up: Navigating the Evolving CDMO LandscapeContract development and manufacturing organizations (CDMOs) are reshaping pharmaceutical production, playing a pivotal role in supply chain stability and driving innovation. In today’s fast-evolving environment, CDMOs help life sciences companies enhance speed, flexibility, and efficiency, which ultimately advances access to life-saving therapies. Norstella provides tailored insights, tools, and intelligence solutions to support this progress, empowering companies to make informed decisions and optimize their manufacturing partnerships. This year at CPHI Milan, our team observed key industry trends, including innovations to strengthen supply chains and enhance sustainable practices. At Citeline’s (a Norstella company) 11th Annual Global Generics & Biosimilars Awards, we also...
2024-11-1016 minCiteline Podcasts
Citeline PodcastsDrug Fix: How Will Trump’s Second Term Impact The US FDA?Pink Sheet reporter and editors discuss potential changes that the incoming Trump Administration could make on the FDA, as well as worries about political interference in decision-making, and policy and staffing changes. More On These Topics From The Pink Sheet US FDA’s Drug Approval Norms Could Be Upended In Second Trump Term: https://insights.citeline.com/pink-sheet/legislation/elections/us-fdas-drug-approval-norms-could-be-upended-in-second-trump-term-ICH6FUN4OBHRJPN4QFJ4OPLHNU/ Warp Speed For All And A Boost For Small Biotechs In Trump’s Second Term, Ex-Official Says: https://insights.citeline.com/pink-sheet/legislation/elections/warp-speed-for-all-and-a-boost-for-small-biotechs-in-trumps-second-term-ex-official-says-DA3BUPKEWVGVNDEPG6JMVLV7UI/ With Trump’s Return, Pharma Trades Disagreeable Knowns...
2024-11-0822 minCiteline Podcasts
Citeline Podcasts【3分で解説 世界のファーマ】第22回 AD治療、費用対効果に悩む英国 (Japanese-language podcast)世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 今回取り上げた記事はこちら 「Déjà Vu In England: Lilly’s Alzheimer’s Drug Kisunla Gets MHRA Yes, But NICE Says No（邦訳：アルツハイマー治療薬ケサンラ承認で議論再び、薬価負担に悩む英国）」 URL:　 https://insights.citeline.com/pink-sheet/geography/europe/united-kingdom/deja-vu-in-england-lillys-alzheimers-drug-kisunla-gets-mhra-yes-but-nice-says-no-OX4YRPW4AFAYXAQVANZSSHURP4/ ※全文の閲覧には購読（有料）が必要です。 世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip
2024-10-2903 minCiteline Podcasts
Citeline PodcastsDrug Fix: SubQ Drugs And Price Negotiations, GLP-1s In Court, US FDA Approach To Black Box AIPink Sheet reporter and editors discuss an emerging pharma strategy to avoid Medicare price negotiations (:25), legal wrangling related to compounding GLP-1 drugs for obesity and diabetes (14:20), and the varying opinions of FDA officials on the acceptability of artificial intelligence models that are not fully explainable (29:08) #pharma #business More On These Topics From The Pink Sheet Keytruda, Opdivo SubQ Conversions Cloud Near-Term Medicare Negotiation Savings Forecasts: https://insights.citeline.com/pink-sheet/keytruda-opdivo-subq-conversions-cloud-near-term-medicare-negotiation-savings-forecasts-BJNQCECWVNESHGCKNPJSKVIH4I/ GLP-1s: Compounders Get Temporary Reprieve But US FDA May Be Building Stronger Case: https://insights.citeline.com/pink-sheet/legalandip/litigation/glp-1s-compounders-get-temporary-reprieve-but-us-fda-may-be-building-stronger-case-2SJVLIMS5FDERNWA7UQV3IM7JM/ ...
2024-10-1835 minCiteline Podcasts
Citeline PodcastsDrug Fix: Inside Medicare Price Negotiations, New US FDA Vaccine PathwayIntroduction: Pink Sheet reporter and editors discuss experts’ experience helping drug sponsors negotiate prices with CMS (:33) and the FDA’s proposal for a new pathway to update vaccines before a pandemic is declared (12:02). More On These Topics From The Pink Sheet: Perspectives From The Front Lines: Navigating The First Round Of Medicare Price Negotiation: https://pink.citeline.com/PS155353/Perspectives-From-The-Front-Lines-Navigating-The-First-Round-Of-Medicare-Price-Negotiation US FDA Proposes New ‘Inter-Pandemic’ Pathway For Updating Flu Vaccines: https://pink.citeline.com/PS155345/US-FDA-Proposes-New-Inter-Pandemic-Pathway-For-Updating-Flu-Vaccines US FDA Advisors Urge Faster Movement, mRNA Consideration, In Updating Pandemic Flu Vaccines: https://pink.citeline.com/PS155358/US-FDA-Advisors-Urge-Faster-Movement-mRNA-Consideration-In-Updating-Pandemic-Flu-Vaccines
2024-10-1124 minCiteline Podcasts
Citeline PodcastsDrug Fix: Pfizer Pulls Sickle Cell Drug, ODAC Calls Back Approved Products, New AAM CEOPink Sheet reporters and editors discuss Pfizer’s abrupt decision to withdraw Oxbryta (:32), the US FDA’s Oncologic Drugs Advisory Committee bringing sponsors of approved products back to discuss labeling changes while competitors are pending (10:46), and the new CEO of a generic industry trade association (27:34). More On These Topics From The Pink Sheet Pfizer Withdraws Oxbryta, But Overall Market Impact May Be Limited: https://pink.citeline.com/PS155302/Pfizer-Withdraws-Oxbryta-But-Overall-Market-Impact-May-Be-Limited EMA Discusses Fatal Events That Prompted Pfizer To Pull Oxbryta From Global Markets: https://pink.citeline.com/PS155296/EMA-Discusses-Fatal-Events-That-Prompted-Pfizer-To-Pull-Oxbryta-From-Global-Markets New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Comp...
2024-09-2737 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA Worries About Celebs Endorsing Drugs, Post-Chevron Lawsuits EmergingIntroduction: Pink Sheet reporter and editor discuss the FDA’s latest advertising enforcement letter, which targeted a migraine treatment TV commercial featuring Serena Williams, and its impact on drug promotion (:36), as well as the now growing list of legal cases targeting agency decisions with Chevron deference overturned (13:32). More On These Topics From The Pink Sheet Celebs Bring Extra Scrutiny To Advertisements, US FDA Tells AbbVie: https://pink.citeline.com/PS155225/Celebs-Bring-Extra-Scrutiny-To-Advertisements-US-FDA-Tells-AbbVie Lilly Challenges US FDA Classification Of Obesity Drug Retatrutide, Citing Chevron Overturn: https://pink.citeline.com/PS155205/Lilly-Challenges-US-FDA-Classification-Of-Obesity-Drug-Retatrutide-Citing-Chevron-Overturn Life After Chevron: US Supreme Court Ruling Cited In FDA Exclusivity De...
2024-09-1324 minCiteline Podcasts
Citeline PodcastsDrug Fix: Pediatric Rare Disease PRV Deadline Approaches, Potential Makena Compounding BanPink Sheet reporter and editors discuss the potential fallout if the US FDA’s rare pediatric disease priority review voucher program is allowed to sunset on 1 October (:30), as well as an upcoming agency advisory committee meeting on potentially banning compounding of the now withdrawn pre-term birth prevention drug Makena (18:39). More On These Topics From The Pink Sheet US FDA’s Rare Pediatric Voucher Program Faces Tight Deadline For Reauthorization: https://pink.citeline.com/PS155196/US-FDAs-Rare-Pediatric-Voucher-Program-Faces-Tight-Deadline-For-Reauthorization Ipsen Outpaces Market With Lucrative Priority Review Voucher Deal: https://pink.citeline.com/PS155197/Ipsen-Outpaces-Market-With-Lucrative-Priority-Review-Voucher-Deal
2024-09-0634 minCiteline Podcasts
Citeline PodcastsDrug Fix: New US FDA Developments In AI RegulationPink Sheet reporter and editors discuss new developments in the FDA’s plans to regulate artificial intelligence and drugs associated with it, including a new AI Council within CDER, as well as some of the unanswered questions about AI in drug development. More On These Topics From The Pink Sheet Artificial Intelligence: CDER’s New Council Takes Charge Of Oversight, Coordination: https://pink.citeline.com/PS155173/Artificial-Intelligence-CDERs-New-Council-Takes-Charge-Of-Oversight-Coordination AI In Drug Development: Regulatory Clarity Needed On Inspections, Human Role: https://pink.citeline.com/PS155156/AI-In-Drug-Development-Regulatory-Clarity-Needed-On-Inspections-Human-Role
2024-08-3016 minCiteline Podcasts
Citeline PodcastsDrug Fix: What We Learned From The First Batch Of Medicare Negotiated Drug PricesPink Sheet reporter and editors discuss the take-aways from the landmark first Medicare negotiated drug prices and what additional information remains outstanding. More On These Topics From The Pink Sheet Medicare Negotiation Announcement: Discounts From List Price Up To 79%, But Net Savings Unclear: https://pink.citeline.com/PS155128/Medicare-Negotiation-Announcement-Discounts-From-List-Price-Up-To-79-But-Net-Savings-Unclear Medicare Unveils Negotiated Prices, But Near-Term Opportunity To Learn From Process Is Limited: https://pink.citeline.com/PS155129/Medicare-Unveils-Negotiated-Prices-But-NearTerm-Opportunity-To-Learn-From-Process-Is-Limited Round 1 Of US Drug Price Negotiations Suggests Medicare Can Beat Original Part D System: https://pink.citeline.com/PS155130/Round-1-Of-US-Drug-Price-Negotiations-Suggests-Medicare-Can-Beat-Original-Part-D-System The Next 340B Battle: Discount Duplication With Medicare Negotiated Prices...
2024-08-1635 minCiteline Podcasts
Citeline PodcastsDrug Fix: Clinical Trial Diversity, Off-Label Standard Of Care Issues, In-Person US FDA AdcommsPink Sheet reporter and editors discuss former Surgeon General Jerome Adams’ views on how the FDA can better ensure clinical trial diversity (:27), questions about approving a new drug that would be used with a standard of care regimen that is off-label (15:00), and the agency beginning to schedule fully in-person advisory committee meetings (24:03). More On These Topics From The Pink Sheet ‘You Shall Not Pass:' Former Surgeon General On Why US Government Should Push Trial Diversity: https://pink.citeline.com/PS155063/You-Shall-Not-Pass-Former-Surgeon-General-On-Why-US-Government-Should-Push-Trial-Diversity Gaps Found In Most Pharma Trial Diversity Policies: https://pink.citeline.com/PS155086/Gaps-Found-In-Most-Pharma-Trial-Diversity-Policies Zevra’s Arimoclomol Use With S...
2024-08-0933 minCiteline Podcasts
Citeline PodcastsDrug Fix: August User Fee Goals, Oncology Trial Design Issues, EMA Review ChangesPink Sheet reporter and editors discuss the US FDA drug approval decisions that could arrive in August (:34), a trial design issue that could ensnare BMS’ Opdivo along with AstraZeneca’s Imfinzi (10:11), and the EMA potentially asking all sponsors to provide raw clinical data as part of application reviews (33:14). More On These Topics From The Pink Sheet Dozen Novel Agents Dream Of August US FDA Approval: https://pink.citeline.com/PS155070/Dozen-Novel-Agents-Dream-Of-August-US-FDA-Approval BMS’s Opdivo May Be Next Casualty Of US FDA’s Perioperative Trial Redesign Push: https://pink.citeline.com/PS155056/BMSs-Opdivo-May-Be-Next-Casualty-Of-US-FDAs-Perioperative-Trial-Redesign-Push EU Pilot On Raw Data Analysis Shows Benefits For Stre...
2024-08-0238 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA Device Director Retires, PBM Execs On Capitol Hill, Voucher Program Renewal PushEditors from the Pink Sheet and Medtech Insight discuss the retirement of Jeff Shuren (:35), PBM executives again appearing unscathed after another Capitol Hill appearance (10:12), and the growing push to ensure the FDA’s rare pediatric disease priority review voucher program is renewed (20:41). More On These Topics From The Pink Sheet Shuren Steps Down As US FDA Device Center Director: https://pink.citeline.com/PS155031/Shuren-Steps-Down-As-US-FDA-Device-Center-Director PBM Execs Stay On Message Amid Growing US Congressional Frustration At Hearing: https://pink.citeline.com/PS155030/PBM-Execs-Stay-On-Message-Amid-Growing-US-Congressional-Frustration-At-Hearing FDA Leadership Changes Tune On Pediatric Priority Review Voucher Benefit: https://pink.citeline.com/PS155019/FDA-Leadership-Changes-Tune-On-Pediatric-Priority-Review-Voucher-Benefit
2024-07-2627 minCiteline Podcasts
Citeline PodcastsDrug Fix Special: Why The US Approves Most New Drugs Before The EUPink Sheet reporter and editors discuss the impact of a US and EU drug approvals analysis that found the US FDA still clears many novel products first, including most new cell and gene therapies and cancer treatments. More On This Topics From The Pink Sheet Pharma Looks To America First: US FDA Holds Overwhelming Lead Over EMA In Novel Approvals: https://pink.citeline.com/PS154948/Pharma-Looks-To-America-First-US-FDA-Holds-Overwhelming-Lead-Over-EMA-In-Novel-Approvals Getting To Global Is A Hurdle For Cell And Gene Therapies: https://pink.citeline.com/PS154953/Getting-To-Global-Is-A-Hurdle-For-Cell-And-Gene-Therapies New Oncologics Overwhelmingly Approved In US Before EU: https://pink.citeline.com/PS154952/New-Oncologics-Overwhelmingly-Approved-In-US-Before-EU Approval Geography: Novel...
2024-07-1930 minCiteline Podcasts
Citeline Podcasts【3分で解説 世界のファーマ】第19回 FDA「密な面談」を企業に呼び掛け (Japanese-language podcast)世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 今回取り上げた記事はこちら 「US FDA’s Cell-Gene Therapy Office Head Wants Sponsors To Seek Out Meetings（ 邦題意訳：米国FDAの細胞遺伝子治療室長「もっと面談を」企業に求める理由は）」   （英語版） https://pink.citeline.com/PS154749/US-FDAs-Cell-Gene-Therapy-Office-Head-Wants-Sponsors-To-Seek-Out-Meetings ※全文の閲覧には購読（有料）が必要です。   世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip
2024-07-0903 minCiteline Podcasts
Citeline PodcastsDrug Fix: What’s In And Out Of US FDA’s Diversity Action Plan Guidance, AI Guidance Also ComingPink Sheet reporter and editors discuss what the FDA included in its long-awaited guidance on clinical trial diversity action plans, along with what was left out (:35), as well as an upcoming guidance on the use of artificial intelligence in regulatory decision-making (27:30). More On These Topics From The Pink Sheet Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says: https://pink.citeline.com/PS154894/Diversity-Action-Plans-Should-Be-Brief-And-Waiver-Requests-Filed-Early-US-FDA-Says Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need To Overenroll Key Groups: https://pink.citeline.com/PS154895/Diversity-Enrichment-US-FDA-Guidance-Suggests-Sponsors-May-Need-To-Overenroll-Key-Groups US FDA Guidance On Artificial Intelligence For Regulatory Decision-Making Expected This Year...
2024-06-2835 minCiteline Podcasts
Citeline PodcastsCiteline Japan Awards 2024 - Enter Now! (Bilingual English/Japanese)As the 15 July entry deadline for the 3rd edition of the annual Citeline Japan Awards approaches, join us in this bilingual English/Japanese podcast to learn more about the categories and event itself. (Japanese starts at 2' 25".) English event site: https://www.citeline.com/en/awards/citelinejapanawards Japanese event site: https://www.citeline.com/ja-jp/awards/citelinejapanawards
2024-05-2805 minCiteline Podcasts
Citeline PodcastsDrug Fix: Novel Clinical Trial Reg Problems, NIH Drug ‘Access Plans’, Good Ole Days Of WoodcockPink Sheet editors discuss the US FDA’s consideration of regulatory changes to promote innovative clinical trial designs (:32), an NIH proposal to require patent licensees create plans to ensure access to the commercialized product (7:29), and lawmakers longing for the days when Janet Woodcock ran the FDA’s Center for Drug Evaluation and Research (15:35). More On These Topics From The Pink Sheet ‘Antiquated’ Regulations Slowing Adoption of Innovative Clinical Trial Approaches: https://pink.citeline.com/PS154730/Antiquated-Regulations-Slowing-Adoption-of-Innovative-Clinical-Trial-Approaches US FDA Looking To Modernize Clinical Trial Regulations To Spur ‘Evolution’ In Research: https://pink.citeline.com/PS154721/US-FDA-Looking-To-Modernize-Clinical-Trial-Regulations-To-Spur-Evolution-In-Research NIH Drug Patent Licensees Would Develop ‘Acc...
2024-05-2423 minCiteline Podcasts
Citeline Podcasts【3分で解説 世界のファーマ】第18回 GLP-1を超える肥満治療薬のカギとは？(Japanese-language podcast)世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 今回取り上げた記事はこちら 「Hibernating Squirrels And Exercise In A Pill: The Next Wave of Cardiometabolic Therapies（ 邦題意訳：GLP-1を超える心代謝系治療薬のヒントは、冬眠するリスか、地道な運動か）」 （日本語版） https://www.citeline.com/ja-jp/resources/hibernating-squirrels-and-exercise-in-a-pill ※全文の閲覧には情報の登録（無料）が必要です。 （英語版） https://scrip.citeline.com/SC150222/Hibernating-Squirrels-And-Exercise-In-A-Pill-The-Next-Wave-of-Cardiometabolic-Therapies 世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip
2024-05-2303 minCiteline Podcasts
Citeline PodcastsDrug Fix: BIOSECURE Act Advances, Trial Diversity Sticks, Platform Principles Without DesignationPink Sheet editors and reporter consider the implications of the BIOSECURE Act as it advances through a House committee (:30), whether industry would improve clinical trial diversity with tougher enforcement of the regulation (22:26), as some have suggested, and the FDA’s use of platform technology ideas for gene therapies not participating in the program (33:07). More On These Topics From The Pink Sheet As Biosecure Bill Mores Forward, Clock Ticking For Industry To Move Away From Chinese CDMOs: https://pink.citeline.com/PS154707/As-Biosecure-Bill-Mores-Forward-Clock-Ticking-For-Industry-To-Move-Away-From-Chinese-CDMOs BIOSECURE Act Update Offers Biotech Companies Eight Years to Divest Contracts With Firms Of ‘Concern’: https://pink.citeline.com/PS...
2024-05-1738 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA Adcomm Reform, A Boost For Clinical Trial Modeling, AI For Drug ReviewPink Sheet reporter and editors discuss what an upcoming listening session means for the FDA’s advisory committee reform effort (:32), the agency’s efforts to help the clinical trial modeling and simulation industry (16:22), and the UK’s MHRA plan to use artificial intelligence to assist in drug application reviews (21:05). More On These Topics From The Pink Sheet US FDA Adcomm Reform: Does Listening Session Suggest No Major Near-Term Changes?: https://pink.citeline.com/PS150167/US-FDA-Adcomm-Reform-Does-Listening-Session-Suggest-No-Major-Near-Term-Changes US FDA Wants Advice About Advisory Committees: Try Having Some?: https://pink.citeline.com/PS154644/US-FDA-Wants-Advice-About-Advisory-Committees-Try-Having-Some US FDA Developing Model Master File System To Grow Modeli...
2024-05-0331 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA Biosimilar Strategy, Gene Therapy Accelerated Approvals, FDA v. Partisan PoliticsPink Sheet reporter and editors discuss the impact of FDA biosimilar promotion guidance on the future of the interchangeability designation (:34), upcoming guidance on accelerated approval for gene therapies (14:15), and partisan attacks on the agency from Capitol Hill (27:13). More On These Topics From The Pink Sheet Rx Advertising: Interchangeability Doesn’t Mean Clinical Superiority To Other Biosimilars, FDA Says: https://pink.citeline.com/PS150143/Rx-Advertising-Interchangeability-Doesnt-Mean-Clinical-Superiority-To-Other-Biosimilars-FDA-Says US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios: https://pink.citeline.com/PS150140/US-FDA-Gene-Therapy-Accelerated-Approval-Guidance-Will-Describe-Buckets-Of-Use-Scenarios Partisan Politics Returns To US FDA Congressional Oversight: https://pink.citeline.com/PS150114/Partisan-Politics-Returns-To-US-FDA-Congressional-Oversight
2024-04-2634 minCiteline Podcasts
Citeline PodcastsCiteline - Cerba Research Podcast V2Citeline - Cerba Research Podcast V2 by Citeline
2024-04-2319 minCiteline Podcasts
Citeline PodcastsDrug Fix: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine DevelopmentPink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi (:28), Janet Woodcock’s new post-FDA role (12:28), and ongoing preparations for new pneumococcal vaccines that will reach the market soon (17:28). #business #pharma More On These Topics From The Pink Sheet Medicare Spending Forecast For Leqembi Reflects CMS Angst About Alzheimer’s Drug Costs: https://pink.citeline.com/PS150095/Medicare-Spending-Forecast-For-Leqembi-Reflects-CMS-Angst-About-Alzheimers-Drug-Costs Woodcock Takes On Rare Disease Challenges In Retirement, Keeps FDA, Industry At Arm’s Length: https://pink.citeline.com/PS150111/Woodcock-Takes-On-Rare-Disease-Challenges-In-Retirement-Keeps-FDA-Industry-At-Arms-Length Change Is Constant For Pneumococcal Vaccines: US CDC Prepares For Merck’s V116: https://pink.citeline.com/PS150029/Change-Is...
2024-04-1930 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA Adcomm Open Public Hearings, Clinical Trial Diversity Plans, Stealth’s ElamipretidePink Sheet reporter and editors discuss Richard Pazdur’s call for more diverse opinions in FDA advisory committee meeting open public hearings (:36), agency questions about the stakeholders sponsors consult to execute clinical trial diversity plans (20:52), and Stealth BioTherapeutics’ application for the Barth Syndrome candidate elamipretide getting reviewed (32:23). More On These Topics From The Pink Sheet Adcomm Open Public Hearings Have Become Too Sponsor-Driven – US FDA's Pazdur: https://pink.citeline.com/PS150077/Adcomm-Open-Public-Hearings-Have-Become-Too-SponsorDriven--US-FDAs-Pazdur Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations: https://pink.citeline.com/PS150081/Clinical-Trial-Diversity-Requires-Sponsors-Work-With-An-Assortment-Of-Patient-Advocates-Community-Organizations Stealth’s Elamipretide Gets US FDA Review, But Same Que...
2024-04-1238 minCiteline Podcasts
Citeline PodcastsDrug Fix: Relyvrio And Public Promises, Allergy Biomarker Adcomms, PMDA In The USAPink Sheet reporters and editor discuss the implications of Amylyx following through on its pledge to remove Relyvrio from the market after its trial failed (:32), an FDA idea to bring potential biomarkers for promising allergy and asthma treatments to advisory committees (9:08), and Japan’s PMDA opening an office in Washington D.C. (16:19). More On These Topics From The Pink Sheet Amylyx’s Relyvrio Withdrawal May Trigger More Public Pledges Based On Confirmatory Trial Data: https://pink.citeline.com/PS150060/Amylyxs-Relyvrio-Withdrawal-May-Trigger-More-Public-Pledges-Based-On-Confirmatory-Trial-Data US FDA Envisions Advisory Committees For Allergy, Asthma Biomarkers With ‘Real Impact’: https://pink.citeline.com/PS149915/US-FDA-Envisions-Advisory-Committees-For-Allergy-Asthma-Biomarkers-With-Real-Impact Breaking Barriers: Japan's...
2024-04-0521 minCiteline Podcasts
Citeline PodcastsDrug Fix: Mifepristone And Misinformation At SCOTUS, Understanding US FDA’s ODACPink Sheet reporters and editor discuss the upcoming US Supreme Court arguments on mifepristone access (:34), the SCOTUS reaction to the fight against misinformation (18:28), and the FDA’s Oncologic Drugs Advisory Committee going against three negative product reviews (31:23). More On These Topics From The Pink Sheet Mifepristone Supporters Highlight Voter Trust In FDA Decisions Ahead Of Supreme Court Arguments: https://pink.citeline.com/PS149998/Mifepristone-Supporters-Highlight-Voter-Trust-In-FDA-Decisions-Ahead-Of-Supreme-Court-Arguments US FDA’s Anti-Misinformation Campaigns Look Safer After Supreme Court Oral Arguments: https://pink.citeline.com/PS149985/US-FDAs-Anti-Misinformation-Campaigns-Look-Safer-After-Supreme-Court-Oral-Arguments The Dog That Didn’t Bark: ODAC Gives Nod To Three Products Despite Negative FDA Reviews: https://pink.citeli...
2024-03-2243 minCiteline Podcasts
Citeline Podcasts【3分で解説 世界のファーマ】第17回 LSDで不安症を治療 第III相開始へ (Japanese-language podcast)Summary: 今回取り上げた記事はこちら 「MindMed Ready To Take LSD Therapy Into Phase III For Anxiety（MindMed、LSD療法を不安症治療の第III相治験へ）」 https://www.citeline.com/ja-jp/resources/mindmed-ready-to-take-lsd-therapy-into-phase-iii-for-anxiety ※全文の閲覧には情報の登録（無料）が必要です。 世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 (英語版) https://scrip.citeline.com/SC149912/MindMed-Ready-To-Take-LSD-Therapy-Into-Phase-III-For-Anxiety ※全文の閲覧には購読（有料）が必要です。 世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip
2024-03-1303 minCiteline Podcasts
Citeline PodcastsDrug Fix: Vanda Appeals US FDA Jet Lag Denial In Court, Mark Cuban Battles PBMs, Austere FDA BudgetPink Sheet reporters and editor discuss Vanda’s decision to sue the FDA over the rejection of the Hetlioz jet lag indication (:30), Mark Cuban’s comments at a White House event that the federal government and others should stop doing business with the big three PBMs (11:50), and the cut in non-user fee dollars in the FY 2024 FDA appropriations bill (24:49). More On These Topics From The Pink Sheet Vanda Appeals FDA’s Denial Of Hetlioz Jet Lag Application As It Is Hit With CRL For Insomnia: https://pink.citeline.com/PS149914/Vanda-Appeals-FDAs-Denial-Of-Hetlioz-Jet-Lag-Application-As-It-Is-Hit-With-CRL-For-Insomnia Mark Cuban: Pharma’s Secret Weapon In The Fight Against...
2024-03-0834 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA And Psychedelic Drugs, Aduhelm Clinical Trial Data, Adcomm CandidatesPink Sheet reporters and editors discuss the FDA’s approach to psychedelic drugs (:25), whether postmarket clinical trial data from the Alzheimer’s drug Aduhelm will be published (16:32), and the FDA offering more time to find candidates for its new Genetic Metabolic Diseases Advisory Committee (27:19). More On These Topics From The Pink Sheet Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance: https://pink.citeline.com/PS149813/Lykos-MDMA-NDA-Leads-Upcoming-Tests-Of-US-FDAs-Psychedelics-Draft-Guidance For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards: https://pink.citeline.com/PS149812/For-Psychedelics-US-FDA-Is-Open-To-Creative-Thinking-But-Firm-On-Approval-Standards A Visual Trip Through The Psychedelic Pipeline: https://pink.citeline...
2024-02-2332 minCiteline Podcasts
Citeline PodcastsDrug Fix: Price Negotiation Suit Tossed, Drug Shortage Probe, FDA-Approved MarijuanaPink Sheet reporters and editors discuss the dismissal of PhRMA’s suit challenging the Medicare price negotiation provisions (:30), the US FTC and HHS investigation of drug shortages (12:01), and the potential for FDA-approved marijuana products (23:47). More On These Topics From The Pink Sheet PhRMA’s Lawsuit Against Medicare Trips Over ‘Administrative Remedy’ Standard; Will Others? https://pink.citeline.com/PS149791/PhRMAs-Lawsuit-Against-Medicare-Trips-Over-Administrative-Remedy-Standard-Will-Others FTC, HHS Probe GPO Contracting Practices As Source Of Generic Drug Shortages: https://pink.citeline.com/PS149790/FTC-HHS-Probe-GPO-Contracting-Practices-As-Source-Of-Generic-Drug-Shortages Prescription Marijuana? FDA Rescheduling Memo Sets Stage To Test Whether There’s A Viable Market: https://pink.citeline.com/PS149781/Prescription-Marijuana-FDA-Rescheduling-Memo-Sets-Stage-To-Test-Whether-Theres-A-Viable-Market
2024-02-1637 minCiteline Podcasts
Citeline PodcastsDrug Fix: State Of The Generic Industry, US FDA Under Second Trump Term, Inspections And ShortagesPink Sheet reporter and editors discuss the issues and concerns raised during a major generic industry conference (:42), former FDA Commissioner Scott Gottlieb’s views on what a second Trump term as president would mean for the agency (13:54), and congressional hearings on FDA foreign manufacturing facility inspections and drug shortages (23:51). More On These Topics From The Pink Sheet ‘We Did Too Good Of A Job’ On Lowering Prices: Sandoz’s Haruvi Discusses Generic Sustainability: https://pink.citeline.com/PS149745/We-Did-Too-Good-Of-A-Job-On-Lowering-Prices-Sandozs-Haruvi-Discusses-Generic-Sustainability Blue Shield Of California’s Pharmacy Benefit Overhaul Could Still See Boost From Transparency Legislation: https://pink.citeline.com/PS149751/Blue-Shield-Of-Californias-Pharmacy-Benefit-Overhaul-Could-Still-See-Boost-From-Transparency-Legislation Gottlieb...
2024-02-0936 minCiteline Podcasts
Citeline Podcasts혁신 육성 전략에 기반한 한국의 제약바이오 강국 야망 (Korean-language podcast)박민수 보건복지부 2차관은 Citeline의 Pink Sheet과의 인터뷰에서 정부의 혁신적 R&D 우선순위와 이같은 목표 달성을 위한 과제, 바이오산업 투자심리 악화에 대한 대응책, 신약 개발 지원을 위한 규제 변화 등 다양한 이슈에 대해 이야기했습니다. https://pink.citeline.com/PS149348/Koreas-Powerhouse-Ambitions-Build-On-Innovation-Fostering-Policies
2024-02-0703 minCiteline Podcasts
Citeline PodcastsDrug Fix: Janet Woodcock And The US FDA’s G.O.A.T., Puberty Blockers Meeting, CAR-T SafetyPink Sheet reporters and editor discuss FDA Principal Deputy Commissioner Janet Woodcock’s place in the pantheon of FDA leaders (:27), an agency meeting with stakeholders on puberty blockers (23:55), and a new boxed warning for CAR-T therapies (35:42). More On These Topics From The Pink Sheet Immortalizing Janet Woodcock: https://pink.citeline.com/PS149666/Immortalizing-Janet-Woodcock On Puberty Blockers, FDA Is In ‘Listen Only’ Mode – For Now: https://pink.citeline.com/PS149679/On-Puberty-Blockers-FDA-Is-In-Listen-Only-Mode--For-Now CAR-Ts Getting Boxed Warning On Secondary Malignancies Despite Sponsor Causation Questions: https://pink.citeline.com/PS149673/CAR-Ts-Getting-Boxed-Warning-On-Secondary-Malignancies-Despite-Sponsor-Causation-Questions Kite’s Tecartus Boxed Warning Will More Closely Resemble Other CAR-Ts After FDA Changes Co...
2024-01-2645 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA Adcomm Schedule, CMS And Drug Importation, Missed User Fee GoalsPink Sheet reporters and editors discuss the nearly wide open 2024 FDA advisory committee calendar, CMS’s impact on Florida’s drug importation plan, and the FDA’s many missed user fee goals in 2023. More On These Topics From The Pink Sheet The Sudden Stop In US FDA Advisory Committees: https://pink.citeline.com/PS149641/The-Sudden-Stop-In-US-FDA-Advisory-Committees Drug Importation And Medicaid: Trump Era Guidance Likely Disincentivizes Use: https://pink.citeline.com/PS149635/Drug-Importation-And-Medicaid-Trump-Era-Guidance- Likely-Disincentivizes-Use US FDA’s Missed User Fee Goals Spiked In 2023 – And Not Just Because Of COVID-19: https://pink.citeline.com/PS149629/US-FDAs-Missed-User-Fee-Goals-Spiked-In-2023--And-Not-Just-Because-Of-COVID-19
2024-01-1943 minCiteline Podcasts
Citeline Podcasts【3分で解説 世界のファーマ】第16回 JPモルガンで見えた2024年の製薬業界 (Japanese-language podcast)（日本語版）今回取り上げた記事はこちら 「J.P. Morgan 2024: Optimism With An Undercurrent Of Tension（J.P.モルガン2024年：緊張をはらんだ楽観論）」 https://www.citeline.com/ja-jp/resources/jp-morgan-2024-optimism-with-an-undercurrent-of-tension ※全文の閲覧には情報の登録（無料）が必要です。 世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 （英語版） https://scrip.citeline.com/SC149614/JP-Morgan-2024-Optimism-With-An-Undercurrent-Of-Tension ※全文の閲覧には購読（有料）が必要です。 世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip
2024-01-1903 minCiteline Podcasts
Citeline PodcastsDrug Fix: Project Orbis For Gene Therapy, US FDA Leaders’ 2024 Predictions, FDA and AIPink Sheet reporter and editors discuss a new pilot project allowing collaborative reviews of gene therapies by multiple regulators (:42), predictions for the upcoming year by current and former US FDA leaders (11:12), and the FDA commissioner’s take on artificial intelligence (21:23). More On These Topics From The Pink Sheet Don’t Call It Project Orbis: CoGenT Global Will Pilot Collaborative Review Of Gene Therapies: https://pink.citeline.com/PS149607/Dont-Call-It-Project-Orbis-CoGenT-Global-Will-Pilot-Collaborative-Review-Of-Gene-Therapies EMA To Become Observer Of FDA’s Project Orbis Early This Year: https://pink.citeline.com/PS149579/EMA-To-Become-Observer-Of-FDAs-Project-Orbis-Early-This-Year New Year’s Predictions From FDA Leadership Past And Present: GLP-1s, Mental Health...
2024-01-1229 minCiteline Podcasts
Citeline PodcastsCardio Conversations: AVS Cracks Calcium With Novel Pressure Wave BalloonIn this edition of Cardio Conversations, Medtech Insight editor Reed Miller talked to Robert Chisena, the co-founder and CTO of AVS. He talked about the company's novel interventional technology for calcified peripheral arterial disease and how the company came together during the pandemic. Further Reading https://medtech.citeline.com/MT148128/Shockwave-Begins-First-All-Female-Study-Of-Coronary-Interventions https://medtech.citeline.com/MT147704/Reimbursement-For-Shockwaves-IVL-Device-May-Pose-Quandary-For-CMS https://medtech.citeline.com/MT147623/Abbott-Buys-CSI-To-Add-Peripheral-And-Coronary-Atherectomy-Technologies https://medtech.citeline.com/MT147548/Shockwave-Buys-Neovasc-Hoping-Reducer-Angina-Device-Complements-Coronary-Lithotripsy https://medtech.citeline.com/MT143510/FDA-Approves-Shockwave-Coronary-Intravascular-Lithotripsy-System Further Listening The full recording of this podcast, as well as all of our other Citeline podcasts, are available on Apple Podcasts, Google Podcasts, SoundCloud...
2024-01-0527 minCiteline Podcasts
Citeline PodcastsDrug Fix: Looking Back And Looking Ahead: Key US and EU LegislationPink Sheet reporter and editors discuss key US and EU legislation that impacted 2023 and how it also could affect 2024, including EU legislative reform (:56), US Medicare drug price negotiations (14:43), and the US Food and Drug Administration user fee reauthorization (30:57). More On These Topics From The Pink Sheet European Commission Explains Impact Of EU Pharma Review On SMEs & Non-Profit Entities: https://pink.citeline.com/PS149505/European-Commission-Explains-Impact-Of-EU-Pharma-Review-On-SMEs--NonProfit-Entities Biopharma’s Prospects Under A Second Trump Term: They Can’t Get Much Worse: https://pink.citeline.com/PS149562/Biopharmas-Prospects-Under-A-Second-Trump-Term-They-Cant-Get-Much-Worse The following special topic pages include links to all of our coverage: EU Legislative Reform: https://pink...
2024-01-0536 minCiteline Podcasts
Citeline Podcasts【3分で解説 世界のファーマ】第15回 治験に被験者の「多様性」を 米国の課題 (Japanese-language podcast)世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。  今回取り上げた記事はこちら  「Clinical Trial Diversity Plans: Early Oncology Experience Shows More Work Needed, US FDA Says（邦題意訳：FDA、被験者の多様性を義務化へ　がん治験では課題も）」  https://pink.citeline.com/PS149444/Clinical-Trial-Diversity-Plans-Early-Oncology-Experience-Shows-More-Work-Needed-US-FDA-Says 世界の薬事規制ニュースPink Sheet（ピンクシート）とは？ https://www.citeline.com/ja-jp/products-services/regulatory-and-compliance/pink-sheet
2023-12-2203 minCiteline Podcasts
Citeline PodcastsDrug Fix: Taking A Look Back, And Forward, With US FDA’s Project OrbisPink Sheet reporters and editors in the US and Europe consider the growth and impact of Project Orbis after a year in which two major regulators joined the program, but several countries did not keep up with the US approval pace. More On These Topics From The Pink Sheet Project Orbis 2023: FDA Approves Six New Cancer Drugs, But Partner Nations Lag Behind: https://pink.citeline.com/PS149452/Project-Orbis-2023-FDA-Approves-Six-New-Cancer-Drugs-But-Partner-Nations-Lag-Behind Project Orbis: More Cancer Drugs Available In Scotland Than England: https://pink.citeline.com/PS149063/Project-Orbis-More-Cancer-Drugs-Available-In-Scotland-Than-England EMA Will Observe Project Orbis In Effort To Increase Collaboration: https://pink.citeline.com/PS148458...
2023-12-1523 minCiteline Podcasts
Citeline PodcastsDrug Fix: CAR-T Malignancy Reports, Background Music In DTC Ads, New No. 2 At US FDAPink Sheet reporter and editors discuss the FDA acknowledging reports of malignancies in patients who received CAR-T cell immunotherapies (:35), the agency’s policy for using background music in direct-to-consumer advertising (7:27), and the FDA’s new incoming principal deputy commissioner (13:44). More On These Topics From The Pink Sheet CAR-T Malignancy Reports Could Temper Excitement For Use Beyond Oncology: https://pink.citeline.com/PS149420/CAR-T-Malignancy-Reports-Could-Temper-Excitement-For-Use-Beyond-Oncology Background Music During Risk Segment Of Rx Drug Ads: FDA Explains Its Policy: https://pink.citeline.com/PS149411/Background-Music-During-Risk-Segment-Of-Rx-Drug-Ads-FDA-Explains-Its-Policy US FDA Chief Scientist Bumpus Will Become Principal Deputy Commissioner: https://pink.citeline.com/PS149428/US-FDA-Chief-Scientist-Bumpus-Will-Become-Principal-Deputy-Commissioner
2023-12-0120 minCiteline Podcasts
Citeline PodcastsDigital Health Roundup: Black Friday Hits – Digital Twins, Biowearables, Robotics, CardiologyIn this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with Abbott’s head of Lingo Biowearables and top executives at Twin Health. Reed Miller provides an update on J&J MedTech’s launch of the Ottava soft-tissue robotic surgery system and Barnaby Pickering talks about his recent interview with Leo Grady, former CEO of Paige AI, to talk about his new start-up Jona. Medtech Insight articles addressing topics discussed in this episode: Can Digital Twin Technology Help Beat Chronic Disease? Twin Health Is Getting Users Hooked, And Off Their Meds https://medtech.citeline.com/MT148407/Can-Digi...
2023-11-2113 minCiteline Podcasts
Citeline PodcastsDrug Fix: Janet Woodcock retiring, Accelerated Approval Reform, US FDA Meeting Recording PolicyPink Sheet reporters and editors discuss US FDA Principal Deputy Commissioner Janet Woodcock’s legacy as her retirement approaches (:42), the stance of the FDA’s oncology division on confirming benefit after an accelerated approval (16:59), and why formal meetings between the agency and sponsors cannot be recorded (36:51). More On These Topics From The Pink Sheet With Woodcock’s Retirement, US FDA Loses A Renaissance Woman: https://pink.citeline.com/PS149368/With-Woodcocks-Retirement-US-FDA-Loses-A-Renaissance-Woman Confirmatory Trial Plan For Acrotech’s Folotyn, Beleodaq Needs Rethinking, FDA Panel Says: https://pink.citeline.com/PS149361/Confirmatory-Trial-Plan-For-Acrotechs-Folotyn-Beleodaq-Needs-Rethinking-FDA-Panel-Says FDA Panel To Consider Strategies For Timely Completion Of Accelerated Approval Confirma...
2023-11-1743 minCiteline Podcasts
Citeline PodcastsDrug Fix: FTC Orange Book Patent Challenges, Ad/Promo Due Diligence, US FDA Adcomm Decision AppealPink Sheet reporter and editors discuss the FTC’s challenges of Orange Book patents (:35), DTC promotion practices as part of acquisition due diligence (12:39), and how Intarcia’s advisory committee decision appeal could play out (19:06). More On These Topics From The Pink Sheet In Swift Challenge To Orange Book Patent Listings, Federal Trade Commission Fills FDA Ministerial Gap: https://pink.citeline.com/PS149316/In-Swift-Challenge-To-Orange-Book-Patent-Listings-Federal-Trade-Commission-Fills-FDA-Ministerial-Gap Rx Ad/Promo Practices Should Be Part Of Acquisition Due Diligence, DoJ Official Says: https://pink.citeline.com/PS149309/Rx-AdPromo-Practices-Should-Be-Part-Of-Acquisition-Due-Diligence-DoJ-Official-Says Intarcia Appeals Advisory Committee On Diabetes Drug-Device Combo, Claiming ‘Misrepresentation’: https://pink.citeline.com/PS149311/Intarcia-Appeals-Advisory-Committee-On-Diabetes-DrugDevice-Combo-Claiming-Misrepresentation
2023-11-1027 minCiteline Podcasts
Citeline PodcastsDrug Fix: CMS Listens On Price Negotiations, Elevidys Top-Line Trial Data, Gene Therapy Reg ChangesPink Sheet reporters and editor discuss take-aways from the first Medicare price negotiation program public listening sessions (:35), next steps after Sarepta reported questionable top-line data for its Duchenne muscular dystrophy gene therapy Elevidys (14:45), and indications the FDA may adjust its regulatory approach to gene editing products (26:27). More On These Topics From The Pink Sheet Could Government Negotiated Prices Curtail Access? PBMs And Potential Perverse Incentives Dominate First Medicare Listening Session: https://pink.citeline.com/PS149097/Could-Government-Negotiated-Prices-Curtail-Access-PBMs-And-Potential-Perverse-Incentives-Dominate-First-Medicare-Listening-Session Elevidys And The EMBARK Trial: Is Another Advisory Committee Meeting Coming? https://pink.citeline.com/PS149282/Elevidys-And-The-EMBARK-Trial-Is-Another-Advisory-Committee-Meeting-Coming US FDA’s Confidence In Gene Editing Sa...
2023-11-0340 minCiteline Podcasts
Citeline Podcasts【3分で解説 世界のファーマ】第14回 承認２カ月後に新薬発売へ、スイスの新制度 (Japanese-language podcast)世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 今回取り上げた記事はこちら 「Swiss To Introduce Parallel HTA & Regulatory Submissions, More Transparent Decisions（邦題意訳：新たな制度を導入のスイス、医薬品審査の透明性確保へ）」 https://pink.citeline.com/PS149096/Swiss-To-Introduce-Parallel-HTA--Regulatory-Submissions-More-Transparent-Decisions 世界の薬事規制ニュースPink Sheet（ピンクシート）とは？ https://www.citeline.com/ja-jp/products-services/regulatory-and-compliance/pink-sheet
2023-11-0203 minCiteline Podcasts
Citeline PodcastsDrug Fix: Off-Label Coms Guidance, Price Negotiations And Prescribing, Bertagnolli’s NIH BidPink Sheet reporters and editors discuss new off-label use communications guidance (:35), how price negotiations could impact prescribing (9:49), and Monica Bertagnolli’s nomination for NIH director advancing (17:18). More On These Topics From The Pink Sheet Off-Label Guidance Creates ‘Safe Harbor’ For Dissemination of Certain Info To HCPs: https://pink.citeline.com/PS149058/Off-Label-Guidance-Creates-Safe-Harbor-For-Dissemination-of-Certain-Info-To-HCPs Underwater: Medicare Negotiated Prices For Part B Cancer Drugs Could Change Prescribing: https://pink.citeline.com/PS149065/Underwater-Medicare-Negotiated-Prices-For-Part-B-Cancer-Drugs-Could-Change-Prescribing Bertagnolli NIH Nomination Advances, But Sanders Will Remain Thorn In Side Of Biden’s Health Agenda: https://pink.citeline.com/PS149072/Bertagnolli-NIH-Nomination-Advances-But-Sanders-Will-Remain-Thorn-In-Side-Of-Bidens-Health-Agenda
2023-10-2724 minCiteline Podcasts
Citeline PodcastsAI In Behavioral Health ClinicsIn this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with behavioral health experts on implementing AI solutions to help ease the administrative burden on clinicians as well as recent coverage from the LSX Congress USA and HLTH conferences. Reed Miller discusses findings of EY’s annual pulse of the medtech industry report and Hannah Daniel discusses FDA guidance on regulating AI/ML. Medtech Insight articles addressing topics discussed in this episode: https://medtech.citeline.com/MT148350/EY-Report-Offers-Advice-For-Medtech-To-Regain-Its-Pre-COVID-Mojo https://medtech.citeline.com/MT148349/Generative-AI-Providing-Behavioral-Health-Solutions-But-Not-Therapy--Yet https://medtech.citeline.com/MT148349/Generative-AI-Providing-Behavioral-Health-Solutions-But-Not-Therapy--Yet
2023-10-2514 minCiteline Podcasts
Citeline PodcastsDrug Fix: BrainStorm Withdraws NurOwn, NIH Nominee On Drug Pricing, Gene Therapy Long-Term Follow-UpPink Sheet reporters and editor discuss BrainStorm’s next steps after withdrawing the NurOwn BLA (:38), NIH director nominee Monica Bertagnolli’s thoughts on drug affordability (8:13), and the US FDA’s effort to ensure long-term follow-up of gene therapy patients (19:41). More On These Topics From The Pink Sheet BrainStorm Eyes New Phase III Trial For NurOwn In Mild ALS Following BLA Withdrawal: https://pink.citeline.com/PS149035/BrainStorm-Eyes-New-Phase-III-Trial-For-NurOwn-In-Mild-ALS-Following-BLA-Withdrawal NIH Nominee Says Americans Deserve ‘Return On Investment’ Via Affordable Meds, But Offers No Implementation Plan: https://pink.citeline.com/PS149040/NIH-Nominee-Says-Americans-Deserve-Return-On-Investment-Via-Affordable-Meds-But-Offers-No-Implementation-Plan Obesity Funding, AI and Clinical Trial Diversity: Where The NIH Director Nominee St...
2023-10-2031 minCiteline Podcasts
Citeline PodcastsDrug Fix: US FDA Suffers From Shutdown Threat, Alnylam’s CR Letter, ARPA-H Wants FDA IncentivesPink Sheet reporters and editor discuss the problems that emerged for the US FDA from just the threat of a government shutdown (:38), take-aways on the FDA advisory committee process based on the complete response letter issued for Alnylam’s Onpattro (10:25), and incentives that the FDA could offer for ARPA-H projects that reach the application stage (20:16). More On These Topics From The Pink Sheet Shutdown Threat Forced US FDA To Cancel Some Travel: https://pink.citeline.com/PS149003/Shutdown-Threat-Forced-US-FDA-To-Cancel-Some-Travel Alnylam’s Complete Response Is Classic Example Of FDA-Advisory Committee Disagreement: https://pink.citeline.com/PS149000/Alnylams-Complete-Response-Is-Classic-Example-Of-FDA-Advisory-Committee-Disagreement US FDA Rejects Onpattro Label Expa...
2023-10-1330 minCiteline Podcasts
Citeline PodcastsDrug Fix: Adcomm Rejects NurOwn For ALS, FDA In Shutdown Mode, Limited Price Negotiation SavingsPink Sheet reporters and editors consider the fallout from Brainstorm Cell Therapeutics Inc.’s negative US FDA advisory committee decision on its ALS drug (:43), the impact of a government shutdown on the agency (10:00), and a study showing only a limited possibility for significant savings in the first round of Medicare price negotiations (22:58). More On These Topics From The Pink Sheet BrainStorm’s NurOwn Gets Many, Many Thumbs Down From US FDA Panel: https://pink.citeline.com/PS148915/BrainStorms-NurOwn-Gets-Many-Many-Thumbs-Down-From-US-FDA-Panel Preparing For A Shutdown: US FDA To Retain 81% Of Workforce, Thanks Mostly To User Fees: https://pink.citeline.com/PS148923/Preparing-For-A-Shutdown-US-FDA-To-Retain-81-Of-Workforce-Thanks-Mostly-To-User-Fees Repu...
2023-09-2932 minCiteline Podcasts
Citeline PodcastsDrug Fix: Regeneron’s COVID Monoclonal Deal, New FDA Advisor, Project Optimus In Cancer CombosPink Sheet reporter and editors discuss the somewhat novel pricing language in Regeneron’s deal with the US government to develop a COVID-19 monoclonal antibody (:34), US FDA Commissioner Robert Califf hiring a new senior advisor (12:10), and optimizing dosing in cancer combination therapies (21:21). More On These Topics From The Pink Sheet Price Caps In Regeneron’s COVID Monoclonal Deal With HHS: Not A Precedent, But Enough For Bernie: https://pink.citeline.com/PS148843/Price-Caps-In-Regenerons-COVID-Monoclonal-Deal-With-HHS-Not-A-Precedent-But-Enough-For-Bernie Califf Hires New US FDA Senior Advisor, But Duties Seem Vague: https://pink.citeline.com/PS148848/Califf-Hires-New-US-FDA-Senior-Advisor-But-Duties-Seem-Vague Project Optimus Is Coming To Cancer Combination Therapy Development: https://pink...
2023-09-1530 minCiteline Podcasts
Citeline PodcastsDrug Fix: FTC Ends Amgen-Horizon Case, New Ultra-Rare Cancer Partnership, Generic Applications LagPink Sheet reporter and editors discuss the US Federal Trade Commission ending its attempt to block the Amgen acquisition of Horizon Therapeutics (:28), a proposed public-private partnership to develop ultra-rare cancer drugs (9:54), and a slow-down in ANDA submissions to the US Food and Drug Administration (22:02). More On These Topics From The Pink Sheet FTC’s Test Case Opposing Amgen-Horizon Deal Ends With No-Bundling Agreement: https://pink.citeline.com/PS148804/FTCs-Test-Case-Opposing-Amgen-Horizon-Deal-Ends-With-No-Bundling-Agreement Ultra-Rare Tumors: Public-Private Partnership Eyed To Boost Drug Development: https://pink.citeline.com/PS148813/Ultra-Rare-Tumors-Public-Private-Partnership-Eyed-To-Boost-Drug-Development ANDA Submissions Lagging As FY 2023 Nears Its End: https://pink.citeline.com/PS148818/ANDA-Submissions-Lagging-As-FY-2023-Nears-Its-End
2023-09-0827 min