Tag Archives: EMA

Sales of Carvykti Continue to Grow; FDA and EMA Advisory Committees Will Review Carvykti Applications for Early MM; JNJ Considers Entering in Autoimmune Diseases; JNJ’s Q4 2023 Earnings Call Summary

On Tuesday, January 23, JNJ held its Q4 and FY2023 earnings call (press release / presentation) highlighting Carvykti’s (BCMA CAR-T) revenue growth. On the same day, Legend disclosed (SEC filing) that advisory committees of the FDA and the EMA will meet to discuss the applications for using Carvykti in ≥2L MM.

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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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Abecma’s Regulatory Applications for R/R MM Accepted in the US, Europe, and Japan

Abecma’s Regulatory Applications for R/R MM Accepted in the US, Europe, and Japan

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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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Breyanzi Absent from December’s CHMP Agenda

On Monday, December 12, the CHMP agenda for December was released. Of note, Breyanzi’s (BMS’s CD19 CAR-T) Type II Variation for 2L LBCL transplant-intended patients was absent from the agenda, and no other cell therapy-related updates were observed. On Friday, December 16, when the CHMP highlights are released, the Celltelligence team will provide updated timelines for Breyanzi’s potential EU approval.

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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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Breyanzi Absent from November’s CHMP Highlights

On Friday, November 11, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, Breyanzi’s (BMS’s CD19 CAR-T) Type II Variation for 2L LBCL transplant-intended patients was absent from November’s CHMP meeting. Below, Celltelligence provides updated EU timelines for Breyanzi.

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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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The EC Grants Carvykti (BCMA CAR-T) Conditional Marketing Authorization for ≥4L R/R MM

On Thursday, May 26, JNJ announced (press release) that the European Commission (EC) granted Conditional Marketing Authorization for Carvykti (cilta-cel; BCMA CAR-T) in ≥4L r/r MM. Of note, Carvykti’s EC approval was based on results from the Ph1b/2 CARTITUDE-1 trial. The Celltelligence team will be conducting a full thoughts-on analysis in the coming days.

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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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Will Abecma Receive a Positive CHMP Opinion by June 24? Breyanzi’s EU Regulatory Delay Continues; CAT Agenda June 2021

On Wednesday, June 16, the Committee for Advanced Therapies’s (CAT) agenda (June 16 – 18) was released. Of note, Abecma (BMS’s BCMA CAR-T) has been listed as ‘for opinion’ in June’s CAT agenda, while BMS has requested a clock-stop extension for Breyanzi (BMS; CD19 CAR-T). Below, Celltelligence provides updated likely EU approval timelines for Abecma and Breyanzi.

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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