BioCentury | Nov 6, 2020
Regulation

Pressure builds for Celgene payout as BMS faces possible liso-cel delay

...approval of another CAR T, idecabtagene vicleucel (ide-cel...
...on the CMC module. BMS also gained ide-cel...
BioCentury | Nov 5, 2020
Product Development

Data Byte: BCMA stands out at ASH 2020

...ide-cel). JNJ and Legend have guided for a 2H20 BLA submission for cilta-cel.bluebird also shared updated ide-cel...
BioCentury | Oct 2, 2020
Regulation

After COVID-related delays, first approval may come in Europe for bluebird’s Lenti-D

...and BMS received a refuse-to-file letter for ide-cel...
BioCentury | Sep 23, 2020
Deals

Sept. 22 Quick Takes: Celgene CVR still in play; plus Dr. Reddy’s in Sputnik deal, $30M for Siolta, Amgen-Lilly, BioNTech-Novartis, Genentech-Scenic

...Staff Priority Review for bluebird-BMS program could fulfill CVR goalFDA’s review timeline for idecabtagene vicleucel (ide-cel...
...shareholders to receive a payout worth up to $6.8 billion, FDA would need to approve ide-cel...
BioCentury | Jul 25, 2020
Regulation

FDA makes Gilead’s Tecartus, for mantle cell lymphoma, third U.S.-approved CAR T

...by regulators include lisocabtagene maraleucel liso-cel from Bristol Myers Squibb Co. (NYSE:BMY) and idecabtagene vicleucel ide-cel...
BioCentury | Jul 10, 2020
Regulation

Ocular toxicity assessment stands between multiple myeloma patients and the first BCMA approval

...others are in the clinic (see “Ide-cel’s Challengers in the BCMA Pipeline” ). Idecabtagene vicleucel (ide-cel...
BioCentury | Jul 3, 2020
Deals

July 2 Quick Takes: Novartis to ante up $678M in settlement; plus Zai, Neoleukin, Base Genomics, Sarepta-Hansa, Dr. Reddy-Fujifilm

Novartis to pay $678M in kickbacks settlement Novartis AG (NYSE:NVS; SIX:NOVN) will pay $678 million and, under a corporate integrity agreement, conduct its speaker programs virtually for the next five years after the pharma reached...
BioCentury | Jun 26, 2020
Regulation

Data Bytes: CHMP’s June opinions

A recommendation by EMA’s CHMP suggests remdesivir from Gilead Sciences Inc. (NASDAQ:GILD) could soon gain a speedy conditional approval to treat COVID-19. The committee announced the decision this week along with a basket of other...
BioCentury | Jun 2, 2020
Tools & Techniques

Spark’s approach to the problem of redosing AAV gene therapies

Spark aims to solve one of the big problems plaguing gene therapy -- immune responses against viral vectors -- by adapting a strategy Hansa has been developing for transplant rejection. Past infections with adenoviruses or...
BioCentury | May 23, 2020
Product Development

Hot topics at ASCO 2020

...turn of events, a decision by FDA to push back the review of idecabtagene vicleucel (ide-cel...
...the field as the conference approaches. On May 13, FDA issued a refusal-to-file letter for ide-cel...
...partners will present updated data at ASCO from the pivotal Phase II KarMMA study of ide-cel...
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