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FDA Grants Fast Track Review To Johnson & Johnson's Nipocalimab For Autoimmune Disorder That Affects Tears, Saliva
18 Mar 2025 16:37 GMT
The U.S. Food and Drug Administration granted on Tuesday Fast Track designation to Johnson & Johnson’s JNJ investigational nipocalimab for moderate-to-severe Sjögren’s disease (SjD).
Last year, FDA granted Breakthrough Therapy designation (BTD) for the …
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Johnson & Johnson halts late-stage E.coli vaccine trial after poor results
13 Feb 2025 17:33 GMT
Pharmaceutical giants Johnson & Johnson and Sanofi have stopped a late-stage clinical trial for their experimental E.coli vaccine after results failed to demonstrate sufficient efficacy.
The companies announced on Thursday that while the vaccine showed …
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J&J stops Phase III trial of Sanofi’s E. Coli vaccine citing ‘disappointing’ results
14 Feb 2025 12:55 GMT
Johnson and Johnson (J&J) has … vaccine for extraintestinal pathogenic Escherichia coli (E. Coli) after results were found … from the US market.
E. Coli typically manifests as food … bacteriophages to treat uropathogenic E. Coli infections to the South …
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E. Coli Vaccine Candidate Fails to Demonstrate Efficacy in Phase 3 Trial
14 Feb 2025 20:47 GMT
… sufficiently effective at preventing E. coli disease (IED) compared … event caused by E. coli, and E. coli-related pyelonephritis and … on extraintestinal pathogenic E. coli vaccine phase 3 clinical … /johnson-johnson-statement-on-phase-3-e-mbrace-study …
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Sanofi announces update on extraintestinal pathogenic E. coli vaccine phase 3 clinical study
14 Feb 2025 06:37 GMT
A scheduled review of the E.mbrace phase 3 study (clinical trial identifier: NCT04899336) conducted by an independent data monitoring committee (IDMC) determined that Sanofi and Johnson & Johnson’s vaccine candidate for extraintestinal pathogenic E. …
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Investigational E coli Vaccine Does Not ‘Demonstrate Sufficient Efficacy’ in Phase 3 Study
13 Feb 2025 21:07 GMT
An independent data monitoring committee (IDMC) determined that the Sanofi and Johnson & Johnson’s vaccine candidate for extraintestinal pathogenic E coli was not sufficiently effective at preventing invasive E coli disease (IED) compared to placebo. …
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Sanofi to take $250M charge on study failure for E. coli vaccine
13 Feb 2025 18:08 GMT
Dive Brief:
Sanofi and Johnson & Johnson are ending a Phase 3 study of an experimental E. coli vaccine after it failed to show a significant benefit over placebo in a review by an independent monitoring board.
J&J began the study in 2021 and …
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E. coli Vaccine Candidate Flops For Adults With Urinary Tract Infections
13 Feb 2025 17:22 GMT
(Vax-Before-Travel)According to disappointing news released today, the world must wait for an approved vaccine that prevents invasive E. coli disease (IED).
Sanofi announced today that a scheduled review of the E.mbrace phase 3 clinical study conducted by …
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Sanofi, J&J abandon trial of E coli vaccine after poor data
13 Feb 2025 15:48 GMT
Johnson & Johnson and Sanofi's vaccine for preventing invasive disease caused by the problem pathogen Escherichia coli looks all but defunct after the two partners halted a phase 3 trial.
In a statement issued this morning, the partners confirmed …
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Sanofi Hit With $250M Impairment After Scrapping J&J-Partnered E. Coli Vaccine
13 Feb 2025 15:14 GMT
Sanofi and Johnson & Johnson on Thursday terminated the Phase III E.mbrace study of their investigational vaccine for invasive E. coli disease due to disappointing data.
As a result of the termination, Sanofi will record a $250 million impairment …