Remove 2021 Remove FDA Approval Remove Immune Response
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A Visual Guide to Gene Delivery

Codon

Casgevy , the first FDA-approved CRISPR-based therapy, is also an ex vivo gene therapy; it aims to cure sickle cell disease by editing a patient’s blood-producing stem cells so they generate functional fetal hemoglobin, then returning these corrected cells to the bloodstream. This changed with the discovery of AAVs.

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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

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The information contained in this release is as of May 7, 2021. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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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. Clover intends to initiate a separate pivotal clinical trial of the S-Trimer vaccine candidate in combination with Dynavax’s advanced CpG 1018 adjuvant plus alum in the first half of 2021.

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

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PFIZER AND BIONTECH ANNOUNCE SUBMISSION OF INITIAL DATA TO U.S. FDA TO SUPPORT BOOSTER DOSE OF COVID-19 VACCINE

The Pharma Data

Pfizer and BioNTech plan to seek licensure of the third dose via a supplemental Biologics License Application (BLA) in individuals 16 years of age and older, pending FDA approval of the primary BLA submitted in May 2021. today announced that they have submitted Phase 1 data to the U.S. In the U.S.,

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

The Pharma Data

Depending on the overall COVID-19 attack rate, interim data in the UK trial, which is also event-driven, are expected as soon as early first quarter 2021. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.?Novavax?is

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Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

Interim data in this event-driven trial are expected as soon as early first quarter 2021, although the timing depends on the overall COVID-19 rate in the region. availability of efficacy data depends on the illness rate in South Africa and may be available as soon as the first quarter 2021. European Union and other countries.