Tag Archives: Novartis

UPDATED: Novartis on Track to File Kymriah in R/R FL and 2L DLBCL in 2021; Meet the Management Investor Call Summary

New content: The Celltelligence team has included and updated its CAR-T indications table for estimated approvals and submissions (see below for download) and made a small clarification that BELINDA trial results for Kymriah are expected at ASH 2021.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Kymriah’s First Asian Commercial Manufacturing Facility is Approved; Novartis Increases Manufacturing Footprint to Five Global Centers

On Friday, October 30, Novartis announced (press release) that they have received marketing authorization from Japan’s MHLW (Ministry of Health, Labor and Welfare) for the FBRI (Foundation for Biomedical Research and Innovation) to commercially manufacture Kymriah. Below, Celltelligence provides thoughts on the impact of Novartis’s Japanese manufacturing site and anticipated approvals in other locations.

About The Author

The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Novartis Ph1b PORTIA Results Presented at Virtual AACR II

On Monday, June 23, Novartis presented (Ulrich Jaeger et al, June 2020) updated clinical data from the Kymriah + pembrolizumab (pembro, a PD-1 inhibitor) Ph1 PORTIA study in ≥3L R/R DLBCL. Below, Celltelligence provides thoughts on the significance of this data, and particularly how it compares to recent CAR-T + checkpoint inhibitor data from Gilead (Yescarta), BMS (Liso-cel), and Autolus (AUTO3).

About The Author

The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Novartis Discusses Their Activated Rapid Manufacturing Program and Kymriah in the Community Setting

On Monday, June 15, Novartis held an investor call (presentation), highlighting advances to their activated rapid manufacturing (ARM) platform for cell therapy, and their assessment of the community setting for CD19 CAR-T therapies. Below, Celltelligence provides thoughts on the significance of the ARM platform compared to other rapid manufacturing methods, and the potential impact Kymriah could have outside Centers of Excellence (COE).

About The Author

The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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