Citeline Podcasts

Audio roundup of selected biopharma industry content from Scrip over the business week ended 26 April 2024. In this episode: 2023’s top selling drugs and the COVID cliff; falling sales force Roche to reassess priorities; Phase III immunology win for Sanofi; BMS’s strong pipeline: and which companies could be acquired next.

https://scrip.citeline.com/SC150182/Quick-Listen-Scrips-Five-MustKnow-Things

2024 Global Generics & Biosimilars Awards by Citeline

Learn how molecular technology is enhancing patient safety for CAR-T clinical trials.

US FDA recently initiated class safety labeling changes after evaluating the safety of CAR-T cancer treatment therapies. What does this mean for developers in the CAR-T landscape? Listen to your free podcast to find out.

Listen in on the conversation as experts from Cerba discuss facilitating patient safety measures in CAR-T therapies by accurately identifying the integration of viral vectors, utilizing flow cytometry, and more.

Listen now as experts discuss answers to:

· What patient monitoring is required by the FDA?

· What molecular technology does Cerba use and how does it meet FDA requirements?

· What is the importance of cytometry assays in monitoring CAR-T cells?

· What are the opportunities for combining flow cytometry with genomic solutions?

· What key innovations are poised to improve patient monitoring in clinical trials?

Pink 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

Pulmonologist Bing Xue, MD, reviews the latest GOLD guidelines and discusses relevant topics regarding COPD treatment.

Join Scrip's China-based editors Brian Yang and Dexter Yan in this Chinese/English podcast as they look at data presented to AACR by Chinese pharma firms and recent acquisitions of China-based companies. UK-based writer Andrew McConaghie also joins to provide his perspectives, including on the proposed US BIOSECURE Act.

https://scrip.citeline.com/SC150164/China-Biotech-Podcast-AACR-BIOSECURE-European-Perspectives

Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.

Citeline - Cerba Research Podcast V2 by Citeline

Scrip's Joseph Haas, Kevin Grogan and Edwin Elmhirst talk about the biopharma M&A environment and which companies might look particularly appealing to potential acquirers.

In this episode of the In Vivo podcast, Eric Finzi, CEO of Healis Therapeutics, discusses how his company is targeting major depression, post-traumatic stress disorder and other mental illnesses using facial botox injections.