Tag Archives: Manufacturing

Gilead Announces EMA Approval for End-to-End Yescarta CAR-T Manufacturing at Amsterdam Facility

On Friday, June 12, Gilead announced (press release) that the European Medicine Agency (EMA) has approved the company’s Amsterdam facility for end-to-end manufacturing of Yescarta. Below, FENIX highlights the potential impact on Yescarta’s EU turn-around-time (TAT), and the effect this may have on Kymriah sales.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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New Ph1 Trial for Novartis’s BCMA CAR-T PHE885 Using a New Manufacturing Method

A new Novartis-sponsored Ph1 trial has been detected for the BCMA CAR-T, PHE885, in ≥3L relapsed and refractory multiple myeloma (RRMM). Of note, the trial uses a new CAR-T manufacturing method. Below, FENIX provides insights on this new trial and how a potentially improved manufacturing process could enhance Novartis’s position compared to the BCMA CAR-T leaders, BMS and Janssen.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.