Citeline Podcasts

Pink 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

In 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

Over The Counter 24 Oct 2023: An Approach To MoCRA With Good Face Project’s Iva Teixeira by Citeline

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Daiichi’s huge ADC deal with Merck; mixed data for Rybrevant at ESMO; Pfizer girds for cost cuts; myeloma helps J&J’s Q3; and five key points for cell and gene Meeting on the Mesa.

https://scrip.citeline.com/SC149230/Quick-Listen-Scrips-Five-MustKnow-Things

Pink 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 Stands: https://pink.citeline.com/PS149046/Obesity-Funding-AI-and-Clinical-Trial-Diversity-Where-The-NIH-Director-Nominee-Stands

US FDA Struggling With Long-Term Follow-Up Requirements For Gene Therapies: https://pink.citeline.com/PS149041/US-FDA-Struggling-With-Long-Term-Follow-Up-Requirements-For-Gene-Therapies

n this special podcast, Medtech Insight managing editor Elizabeth Orr talks to consultant Steve Silverman about the FDA’s current position on real-world evidence and real-world data, as well as how manufacturers can best put the evidence types to use.

Q&A with Dr. Marc Sandberg: A Specialist in Endocrinology, Diabetes & Metabolism by Citeline

Listen as executives from Centrient Pharmaceuticals share insider perspectives on innovations in sustainable, efficient, clean manufacturing practices.

Q&A with Sleep Medicine Specialist Nathaniel Watson, MD by Citeline

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: BMS buys Mirati; slow Q3 for biopharma M&A; Roche on its neuroscience strategy; Alexion talks about AstraZeneca integration; and Gilead on trial diversity.

https://scrip.citeline.com/SC149190/Quick-Listen-Scrips-Five-MustKnow-Things