Remove FDA Approval Remove Immune Response Remove RNA
article thumbnail

A research team searches for every gene that helps tumors evade immunotherapy

Broad Institute

As a first step, Manguso set his sights on treatments called PD-1 checkpoint inhibitors, which at the time had shown tremendous promise in clinical trials and would receive their first FDA approval in 2014. The findings suggest a complex, context-dependent relationship between IFNγ signaling and the anti-tumor immune response.

Research 137
article thumbnail

Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates

The Pharma Data

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. We are encouraged by the high level of neutralizing antibodies in combination with the strong Th1 response which we believe could play an important role in controlling infection.

Vaccine 52
article thumbnail

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. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

article thumbnail

Months of Work Hang in the Balance as Moderna’s COVID-19 Vaccine Awaits AdComm Vote

The Pharma Data

To this point, Moderna has only submitted two months of follow-up safety data, and the FDA typically requires six months for a full approval. intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA.

Vaccine 52
article thumbnail

Monthly News Roundup – December 2020

The Pharma Data

The messenger RNA (mRNA) vaccines encode a form of the spike (S) protein of SARS-CoV-2 virus. The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus. FDA Approves First-In-Class Topical Klisyri to Treat Actinic Keratosis .

article thumbnail

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

The Pharma Data

In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information. The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material.

Vaccine 52
article thumbnail

The Long Road to End Tuberculosis

Codon

If present before vaccination, memory immune cells primed to destroy the environmental relatives might cross-react with and neutralize the BCG strain before it has a chance to set up an immune response against itself and M. Food and Drug Administration (FDA)-approved drug library, some of which inhibit E.

Vaccine 83