Tag Archives: JNJ

JNJ / Legend Granted EU Accelerated Assessment for Cilta-cel; Can Cilta-cel’s MAA Submission Occur Before March 8, 2021?

On Monday, February 1, JNJ and Legend announced (press release) that the EMA granted cilta-cel (BCMA CAR-T) accelerated assessment for r/r MM. Management confirmed that they intend to file cilta-cel’s MAA during H1 2021. In case you missed it from January 25, Celltelligence revisits the likelihood of JNJ submitting an MAA by March 8, 2021 and cilta-cel’s potential regulatory timeline compared to ide-cel’s (BMS / bluebird).

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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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Could Kymriah Have Become the CAR-T Market Leader in Q4 2020? PORTIA Deprioritized; No Updates on Cilta-cel’s Regulatory Submissions; Novartis and JNJ Q4 2020 Earnings Call Summaries

On Tuesday, January 26, Novartis (press release / presentation) and JNJ (press release / presentation) held their Q4 2020 earnings calls. Novartis highlighted Kymriah’s FY 2020 WW growth of 68% YoY, while JNJ confirmed the rolling submission of cilta-cel’s BLA in December 2020. Below, Celltelligence provides insights on how Kymriah could become the CAR-T market leader, Novartis’s reprioritization of the Ph1b PORTIA trial (Kymriah + pembrolizumab), and the possibility of an August US approval for cilta-cel.

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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JPM 2021 Day 1: BMS, bluebird bio, Novartis, and JNJ

On the first day of JPM 2021, Celltelligence covered presentations by BMS, bluebird bio, Novartis, and JNJ. Below, Celltelligence provides a topline summary of key takeaways from each company followed by more in-depth coverage below.

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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