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U.S. FDA Grants Orphan Drug Designation to Riliprubart for Treating Antibody-Mediated Rejection in Solid Organ Transplant Recipients

The Pharma Data

This designation represents a significant regulatory milestone for Sanofi and further underscores the company’s expanding efforts to address rare and serious immune-mediated disorders. This form of rejection can occur early or late after transplantation and is notoriously difficult to treat.

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2025 Merkin Prize in Biomedical Technology awarded to pioneers of CAR T-cell therapy

Broad Institute

He showed that these synthetic CAR T cells could launch an immune response when they encountered the corresponding tumor protein, called CD19. In the early 2000s, both teams began preparing for clinical trials. That ability to stick around, which is critical for attacking cancer over time, was another turning point.

Therapies 119
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A Visual Guide to Genome Editors

Codon

The treatment, now known as Casgevy, became the first CRISPR-based therapy to gain FDA approval, in 2023. The core of the CRISPR immune response is a guide RNA (gRNA) that binds to a CRISPR-associated (Cas) protein. Dozens more clinical trials, based upon similar gene-editing technologies, are now underway.

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The Long Road to End Tuberculosis

Codon

Fortunately, some novel preventatives and therapies are in the works, including a vaccine equipped with adjuvants that efficiently prime the immune system and newer antibiotics against which the bacteria have yet to evolve resistance. A phase 3 clinical trial for M72/AS01E, funded by the Gates Foundation, began this year.

Vaccine 114
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Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet

The Pharma Data

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

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Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma Data

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

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Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA

The Pharma Data

“While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History. and globally.”.

Vaccine 52