Citeline Podcasts

In the third episode of Off-Patent, On Record, Generics Bulletin’s senior reporter Urtė Fultinavičiūtė is joined by Sandoz’s head of IP Julia Pike to analyze the European intellectual property system, how it compares to the US, and the financial decisions behind litigation for off-patent companies.

For any podcast feedback or queries, you can now reach us at [email protected].

In this Strategic Intent episode, In Vivo speaks with Ken Getz, executive director of the Tufts CSDD and research professor at the Tufts University School of Medicine, and Pamela Tanaerts, CMO and CSO at Medable, to discuss promising data from an AI Clinical Monitoring Agent.

The Global Self-Care Federation has updated its analysis of the health, social and economic value of self-care, using data from 155 countries.

Savings to health systems are up 21% to around $144bn a year, and for the first time the report looks in detail at self-care’s role in prevention.

GSCF director general Greg Perry and Ben Carrick, co-chair of the federation’s policy committee, join HBW Insight on the Over the Counter podcast to talk through the findings.

Carrick, who also works in global public and government affairs at Kenvue, worked on both editions of the study.

We discuss what has changed since 2022, why a single OTC pack in North America is worth around $362 in welfare gains, who should pay for self-care in poorer countries, and what GSCF wants governments, regulators and pharmacists to do next.

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/

What if you could design a diagnostic and a therapeutic directly from a pathogen's genetic code, faster than the disease can spread? Jared Bauer, co-founder and CEO of Seek Labs, joins Proof of Concept to explain how his company's AI engine maps conserved targets across 145+ pathogens to build programmable CRISPR therapeutics and rapid, lab-free diagnostics.

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

Six Chinese Drugs On Course For Blockbuster Status As Five-Year Plan Sets The Bar https://insights.citeline.com/scrip/focus-on-asia/china/six-chinese-drugs-on-course-for-blockbuster-status-as-five-year-plan-sets-the-bar-KEBII2JIZNC7RIE2KMLCA2O4D4/

China Eyes Central Role On Global Biopharma Stage https://insights.citeline.com/pink-sheet/geography/asia/china/china-eyes-central-role-on-global-biopharma-stage-NWR3FDT5ZJBB3A53YZEGGJW7RI/

※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

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).

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/