Pink 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 Co ..read more

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 ..read more

2024 Global Generics & Biosimilars Awards by Citeline ..read more

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 b ..read more

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 Guidan ..read more

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

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 ..read more

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 ..read more

Citeline - Cerba Research Podcast V2 by Citeline ..read more

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 ..read more