Atara hit with cell therapy clinical hold after FDA inspection
2 days ago · Atara linked the hold to a recent FDA inspection of a third-party manufacturing facility for Ebvallo, which resulted in a U.S. rejection of the allogeneic cell therapy.
Atara Biotherapeutics Provides Update on Clinical Programs …
2 days ago · U.S. FDA issues clinical hold on EBVALLO™ (tabelecleucel) and ATA3219 studies linked to EBVALLO Complete Response Letter (CRL). THOUSAND OAKS, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and ...
Atara Biotherapeutics Provides Update on Clinical Programs …
2 days ago · THOUSAND OAKS, Calif., January 21, 2025--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to ...
Atara Biotherapeutics reports clinical hold placed on Ebvallo …
3 days ago · Atara Biotherapeutics announced that the FDA has placed a clinical hold on Atara’s active investigational new drug, or IND, applications. These INDs include the Ebvallo program as monotherapy ...
Atara Biotherapeutics’ Ebvallo™ (tabelecleucel) Receives …
Dec 19, 2022 · EBV+ PTLD is a rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when a patient’s T-cell immune response is compromised by immunosuppression. It can impact patients who have undergone solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT).
FDA Places Clinical Hold On Atara Biotherapeutics' Two Cell …
3 days ago · 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 Provides Regulatory and Business Update …
Jan 16, 2025 · Atara remains focused on preserving future EBVALLO financial value for the benefit of all stockholders. Atara has entered into a non-binding term sheet with Redmile Group to provide up to $15 million in funding, which Atara believes is sufficient to fund the ongoing activities required to achieve BLA approval
Atara Biotherapeutics Provides Regulatory and Business Update on EBVALLO
Jan 16, 2025 · Preservation of Future EBVALLO Milestone and Royalty Income Value to Shareholders: Atara remains eligible to receive a $60 million milestone payment from Pierre Fabre upon FDA approval of the ...
Atara Biotherapeutics Provides Update on Clinical ... - Morningstar
3 days ago · Atara Biotherapeutics Provides Update on Clinical Programs Related to EBVALLO™ (tabelecleucel) and ATA3219 U.S. FDA issues clinical hold on EBVALLO ™ (tabelecleucel) and ATA3219 studies linked ...
Atara, Pierre Fabre hit a hurdle with Ebvallo in the US courtesy of ...
Jan 16, 2025 · 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 la
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