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BioPharmaceutical Advisory Committees

Recent And Upcoming FDA Advisory Committee Meetings

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Executive Summary

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

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QUOTED. 9 December 2019. Linda Ricci.

A draft guidance document by the US FDA that tackles medical device cybersecurity will likely be issued in the next several months, says Linda Ricci, a health scientist for the agency’s Office of Device Evaluation. Check out her comments on cybersecurity here.

J&J Quickly Advances BCMA-Targeting CAR-T As JNJ-4528 Shows 100% Response

Phase Ib data at ASH look competitive with new pivotal trial results for Bristol/bluebird’s leading BCMA CAR-T bb2121. The Phase II portion of the CARTITUDE-1 study for JNJ-4528 is fully enrolled.

Chiesi Files India Legal Action Against Cipla Over Respiratory Therapy Patent

The Italian firm has initiated legal proceedings in India against Cipla, alleging infringement of a patent for an inhalation therapy.
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