Atara, Pierre Fabre hit a hurdle with Ebvallo in the US courtesy of manufacturing plant's shortfalls
As partners Atara Biotherapeutics and Pierre Fabre Laboratories work to grow the reach of their novel T-cell immunotherapy Ebvallo, a manufacturing-related hitch has tripped up their ambition to ...
These INDs include the EBVALLO TM (tabelecleucel ... and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of ...
Atara on Tuesday announced that the FDA has placed a clinical hold on the company’s investigational new drug applications for the Europe-approved Ebvallo in Epstein-Barr virus positive post ...
FDA places a clinical hold on Atara's EBVALLO and ATA3219 programs due to GMP compliance issues at a third-party facility. Atara to pause new participant enrollment; CAR-T programs may suspend in ...
Atara Biotherapeutics' cell therapy Ebvallo should be approved to treat Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD), according to the EMA's human medicines ...
Atara Biotherapeutics (ATRA) announced it received a complete response letter from the FDA for the Ebvallo biologics license application as monotherapy treatment for adult and pediatric patients ...
The revision follows concerns related to the delayed approval of Atara's Ebvallo and the possibility that the company may discontinue its CAR-T development in the first quarter of 2025.
Atara Biotherapeutics (NASDAQ:ATRA) has announced plans to cut around 50% of its workforce, just a little over a week after it said the FDA had declined to approve its immunotherapy Ebvallo.
Atara remains eligible to receive a $60M milestone payment from Pierre Fabre upon FDA approval of the Ebvallo BLA, as well as significant double-digit tiered royalties as a percentage of net sales ...
These INDs include the EBVALLO TM (tabelecleucel) program as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant ...
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