Atara's Ebvallo and pipeline candidate put on clinical hold in US after partner's failed plant inspection
After receiving a complete response letter last week, the other shoe has dropped for Atara Biotherapeutics and its pipeline of T-cell immunotherapies. | Atara announced that the FDA has placed a clinical hold on the company’s investigational new drug applications for the Europe-approved Ebvallo and the allogeneic CD19-targeted CAR-T candidate ATA3219.
Atara Biotherapeutics reports clinical hold placed on Ebvallo programs, ATA3219
Atara Biotherapeutics (ATRA) announced that the FDA has placed a clinical hold on Atara’s active investigational new drug, or IND,
Atara Biotherapeutics Shares Plunge 38% Following FDA Response to EBVALLO Application
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FDA Places Clinical Hold On Atara Biotherapeutics' Two Cell Therapy Programs
On Tuesday, the U.S. Food and Drug Administration (FDA) placed a clinical hold on Atara Biotherapeutics, Inc.’s (NASDAQ:ATRA) active Investigational New Drug (IND) applications. These INDs include the EBVALLO (tabelecleucel) program for patients two years of age and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD),
Atara extends losses after FDA clinical hold
Shares of Atara Biotherapeutics (NASDAQ:ATRA) continued to trade lower in the premarket on Tuesday after the U.S. Food and Drug Administration (FDA) slapped the cell therapy developer with a clinical hold,
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Atara’s T cell programmes hit with clinical hold after third-party site woes
The FDA placed a clinical hold on two Atara assets, following an inspection at a third-party site that also led to a CRL for ...
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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 ...
Atara Biotherapeutics: Another Dip Buying Opportunity Following CRL For CMC Issues
Atara Biotherapeutics has just announced a CRL by FDA for EBVALLO. Click here to read more about ATRA stock and why it is ...
BioSpace2d
FDA Presses Pause on Atara’s Programs, Play on Amylyx’s ALS Assets
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a ...
Atara Biotherapeutics Provides Update on Clinical Programs Related to EBVALLO™ (tabelecleucel) and ATA3219
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr ...
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ATRA Stock Down After FDA Issues CRL for Rare Blood Cancer Candidate
Shares of Atara Biotherapeutics ATRA plunged 40.5% on Thursday after the FDA issued a complete response letter (CRL) against ...
BioSpace8d
Manufacturing Issues Result in FDA Rejection of Atara’s Cell Therapy
Atara Therapeutics’ Ebvallo, already marketed in Europe for a transplant-related blood cancer, will not hit the U.S. market ...
Atara announces Ebvallo CRL did not find clinical efficacy deficiencies
Atara Biotherapeutics (ATRA) announced it received a complete response letter from the FDA for the Ebvallo biologics license application as ...