Pink Sheet Podcasts

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Norstella

The award-winning Pink Sheet editorial team dispenses "Drug Fix" every Friday for regulatory affairs professionals, drug developers, and anyone serious about staying ahead in biopharma. From US FDA review performance to inspection crackdowns to agency leadership shake-ups, we help you understand the regulatory shifts that move markets. Explore the full archive of Pink Sheet's deeper reporting here at https://insights.citeline.com/pink-sheet/. For any podcast feedback or queries, you can now reach us at podcasts@norstella.com.

  1. 1d ago

    Drug Fix: Could Other Products Use Peptide Order For Access, Industry Opposes CRL Release

    Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Senior Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs consider the impact of the Health and Human Services Department’s temporary order allowing compounding of unapproved peptides on the drug industry (1:58), including whether stakeholder could use the precedent to gain access to other products (4:05). They also analyze HHS’ dismissal of US Food and Drug Administration safety concerns (11:28). In addition, the group discusses the Pharmaceutical Research and Manufacturers of America’s opposition to releasing complete response letters and the future of legislative efforts to codify the practice (19:52). More On These Topics From The Pink Sheet HHS Peptide Policy Brushes Off US FDA Safety Concerns As Hypothetical: https://insights.citeline.com/pink-sheet/compliance/manufacturing/hhs-allows-compounding-of-six-unapproved-peptides-UEKWZWETHFG4XJXTVA4VUNE3PU/ Peptides Compounding Would ‘Undermine’ US FDA Drug Approval Process, Ex-Agency Official Argues: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/peptides-compounding-would-undermine-us-fda-drug-approval-process-ex-agency-official-argues-7RZQLE3HJ5B4FMB3AUREB5LUZU/ US FDA’s Complete Response Letter Postings A Gift To Chinese Competitors, PhRMA Says: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/us-fdas-complete-response-letter-postings-a-gift-to-chinese-competitors-phrma-says-IJ2VETAAGND5NH6CXWADH3R6TU/

    Drug Fix: Could Other Products Use Peptide Order For Access, Industry Opposes CRL Release

  2. Oct 16

    Drug Fix: What Drove US FDA Generics Chief To Step Down And New Rare Disease Framework

    Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the reasons Iilun Murphy, director of the US Food and Drug Administration’s Office of Generic Drugs, decided to step down (:53) and whether the move should concern senior agency officials (2:51). They also consider the FDA’s plan to create a fit-for-purpose rare disease approval framework (12:19), how it will connect with the agency’s litany of programs for the products (14:52) and the potential difficulties of systematizing regulatory flexibility (18:22).   More On These Topics From The Pink Sheet US FDA Generic Drugs Office Director Steps Down Amid ‘Political Pressure,’ Admin Burden: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/us-fda-generic-drugs-office-director-steps-down-amid-political-pressure-admin-burden-RSIU23LDWZETDO5XYPAAPCIKVM/ US FDA’s Rare Disease Framework Envisions Systematic Regulatory Flexibility: https://insights.citeline.com/pink-sheet/rare-diseases/us-fdas-rare-disease-framework-envisions-systematic-regulatory-flexibility-CKPMVFWBEVF3DNERAJBZZ23EYA/ US FDA Eyes Adaptive Rare Disease Framework To Replace Piecemeal Flexibilities: https://insights.citeline.com/pink-sheet/rare-diseases/us-fda-eyes-adaptive-rare-disease-framework-to-replace-piecemeal-flexibilities-JU2IHKV76ZHYXDZQBW23BE3FRI/

    Drug Fix: What Drove US FDA Generics Chief To Step Down And New Rare Disease Framework

  3. Oct 9

    Drug Fix: US FDA’s Peptide Drama, More Transparency, Ibogaine Clinical Trial Plans

    Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Senior Reporter Maaisha Osman discuss the drama unfolding at the US Food and Drug Administration related to a Health and Human Services Department plan to temporarily allow some compounding of unapproved peptides (:52). They also consider the impact of the FDA’s intent to acknowledge individual NDA and BLA filings (13:00) and whether the policy will have to endure legal challenges (26:48), as well as the potential clinical trial requirements for the psychedelic ibogaine and their potential impact on product development (28:27). More On These Topics From The Pink Sheet US FDA Staff Push Back Against Trump Administration Interim Peptide Dispensing Order: https://insights.citeline.com/pink-sheet/product-reviews/approvals/us-fda-staff-push-back-against-trump-administration-interim-peptide-dispensing-order-KE3EBXDBNBDKBJBSOBF772HUAY/ Transparency Growing: US FDA Plans Reg Allowing NDA, BLA Filing Disclosure: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/transparency-growing-us-fda-plans-reg-allowing-nda-bla-filing-disclosure-5OR6R4R54VFWRBCUKXJOSVMXZQ/ US FDA Signals Cardiac Safety Monitoring Will Be Ibogaine’s Regulatory Hurdle: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/us-fda-signals-cardiac-safety-monitoring-will-be-ibogaines-regulatory-hurdle-LGD2YI6EW5GPLBWHUDM3FMUIT4/

    Drug Fix: US FDA’s Peptide Drama, More Transparency, Ibogaine Clinical Trial Plans

  4. Oct 2

    Drug Fix: CMS Finalizes GLOBE Model And US FDA Adcomm, Personnel Changes

    Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Senior Writer Cathy Kelly discuss the limited impact the US Centers for Medicare and Medicaid Services’ Global Benchmark for Efficient Drug Pricing (GLOBE) model after it was finalized with only a handful of participants (:58), as well as several other questions still being asked about it (10:24). They also consider the impact of the Food and Drug Administration eliminating voting privileges for some advisory committee consumer representatives (15:15), the Health and Human Services Department eliminating some of the FDA’s legal oversight (24:13), and the FDA reopening its search for a cell and gene therapy office director (27:28). More On These Topics From The Pink Sheet Shrinking GLOBE: Medicare Part B Model Seems Increasingly Unlikely To Advance: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/shrinking-globe-medicare-part-b-model-seems-increasingly-unlikely-to-advance-2MFLVAIRWRG7JDEZQP2AQ7VZMY/ Possible GLOBE Participants Down To Four ... And Counting: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/possible-globe-participants-down-to-four-and-counting-4UYTIWXLRNAMXEIR7JNTRCNR3Q/ US FDA Wants Advisory Committee Members, But Not Voting Consumer Reps: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-wants-advisory-committee-members-but-not-voting-consumer-reps-5V4SKVJFB5FJLG2GPKKZJXZVLY/ Reorg Cuts US FDA Chief Counsel Oversight Position At HHS: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/reorg-cuts-us-fda-chief-counsel-oversight-position-at-hhs-5VPOXSOOLRCCVPGWEI2XECL6UE/ US FDA Continues Search For Cell, Gene Therapy Office Director, Lowers Education Requirement: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/us-fda-continues-search-for-cell-gene-therapy-office-director-lowers-education-requirement-IXJCWUATZBHKZLOTNFSCJBOHYE/

    Drug Fix: CMS Finalizes GLOBE Model And US FDA Adcomm, Personnel Changes

  5. Sep 25

    Drug Fix: Lessons From US FDA Commissioner Nominee Heidi Overton’s Confirmation Hearing

    Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs dissect US Food and Drug Administration commissioner nominee Heidi Overton’s answers during her Senate confirmation hearing and dominant themes (:58), rate the potential for her confirmation (13:14), as well as consider her responses to particular controversial issues like mifepristone safety (16:06) and more practical issues like advisory committee meetings (21:23). They also look at the remaining hurdles for Overton’s bid to take control of the agency (24:40). More On These Topics From The Pink Sheet Overton Calls MMR Vaccine ‘Not Lethal,’ Defends Trump’s Claim As Outreach To Vaccine Skeptics: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/overton-calls-mmr-vaccine-not-lethal-defends-trumps-claim-as-outreach-to-vaccine-skeptics-TO3WNT3NUZGJ5IDRRUBDHF5CIA/ US FDA Commissioner Nominee Overton Says Adcomms ‘Critical,’ Hedges On Mifepristone Safety: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioner-nominee-overton-says-panels-are-critical-hedges-on-mifepristone-safety-RGSODPP5IRHLDA7A26TGOZ7LRI/ Former FDA Commissioners’ Backing May Help Overton Amid Stakeholder Opposition: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/former-fda-commissioners-backing-may-help-overton-amid-stakeholder-opposition-66MIFWT47ZDKDLYEFSBHMUEOEE/

    Drug Fix: Lessons From US FDA Commissioner Nominee Heidi Overton’s Confirmation Hearing

  6. Sep 11

    Drug Fix: Increasing US FDA Leadership Stability And Where All The Adcomms Have Gone

    Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Editor-in-Chief Nielsen Hobbs and Prevision Policy Founding Member Mike McCaughan consider the impact of Michael Davis and Karim Mikhail’s promotions to permanent directors of the US Food and Drug Administration’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, respectively (1:05), as well as the impact a new commissioner could have on the positions (3:20). They also discuss the FDA’s limited advisory committee schedule and the potential reasons recent senior leadership changes have not spurred more meetings (18:22). More On These Topics From The Pink Sheet US FDA Names Permanent CDER, CBER Directors, Creates AI Deputy Commissioner Post: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-davis-mikhail-gain-permanent-cder-cber-director-positions-47N2SXKPHRB6BCBFLJGUF3Y2NA/ US FDA Advisory Committee Meetings Remain Rare Despite Leadership Changes: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-advisory-committee-meetings-remain-rare-despite-leadership-changes-LD3DFLJYQFDVFCERZXRBVECY3M/

    Drug Fix: Increasing US FDA Leadership Stability And Where All The Adcomms Have Gone

  7. Sep 4

    Drug Fix: US FDA Commissioner Nominee Heidi Overton’s Resume And COVID-19 Vaccine Trial Changes

    Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Senior Reporter Maaisha Osman, and Editor-in-Chief Nielsen Hobbs discuss Heidi Overton’s financial and educational background as she begins navigating the path to US Food and Drug Administration commissioner confirmation (1:01), as well as an FDA incentive program that she would not be able to use to recruit additional staff should she get the job (23:05). They also consider the reasons for recent changes to the COVID-19 vaccine postmarketing trials (26:59). More On These Topics From The Pink Sheet US FDA Nominee Overton Left Hopkins Residency, Pushed ‘Conservative’ Science, Has Few Pharma Ties: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-nominee-overton-left-hopkins-residency-pushed-conservative-science-has-few-pharma-ties-KTW56Z3D7RGCBMR5FDLEPK7Y6U/ US FDA Scraps Program That Paid Bonuses For Completing Speedy Drug Reviews: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-scraps-program-that-paid-bonuses-for-completing-speedy-drug-reviews-JF5MQA73GJHDZADHXQSTB6JA2A/ US FDA Spikes COVID-19 Vaccine Postmarketing Trials Due To ‘Feasibility Challenges’: https://insights.citeline.com/pink-sheet/vaccines/us-fda-spikes-covid-19-vaccine-postmarketing-trials-due-to-feasibility-challenges-PS54RXHTEBAZDEEMDQY6264BLA/

    Drug Fix: US FDA Commissioner Nominee Heidi Overton’s Resume And COVID-19 Vaccine Trial Changes

  8. Aug 28

    Drug Fix: MFN Finds Mid-Size Companies And More Vaccine Policy Moves

    Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the potential differences between Most Favored Nation drug pricing agreements for small and mid-size companies and the largest pharmas (1:03), as well as the impact of potential vaccine policy changes on the US public health apparatus (15:10). More On These Topics From The Pink Sheet MFN Deal Impact Unclear As White House Ready To Announce Agreements With Mid-Size Pharmas: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/mfn-deal-impact-unclear-as-white-house-ready-to-announce-agreements-with-mid-size-pharmas-ECRFYU4TOVBSPG63U26CWI5FIM/ HHS Builds A Legal Firewall Around Its Next Vaccine Moves With RFI On Federal Categories: https://insights.citeline.com/pink-sheet/vaccines/hhs-builds-a-legal-firewall-around-its-next-vaccine-moves-with-rfi-on-federal-categories-5HILL2G52BE3PI5BJTJ4UZ76RI/

    Drug Fix: MFN Finds Mid-Size Companies And More Vaccine Policy Moves
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The award-winning Pink Sheet editorial team dispenses "Drug Fix" every Friday for regulatory affairs professionals, drug developers, and anyone serious about staying ahead in biopharma. From US FDA review performance to inspection crackdowns to agency leadership shake-ups, we help you understand the regulatory shifts that move markets. Explore the full archive of Pink Sheet's deeper reporting here at https://insights.citeline.com/pink-sheet/. For any podcast feedback or queries, you can now reach us at podcasts@norstella.com.

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