Advarra

AUGUST 8, 2023

As of June 2023, 416 Phase III studies are listed, representing a growing pipeline of gene therapy products preparing to undergo consideration for FDA approval. Risks and Regulatory Requirements Most clinical researchers are familiar with the regulatory requirements pertaining to the FDA phases of review as well as with IRB review.

Gene Therapy 52

Gene Therapy Gene Research Genetics 52

The Pharma Data

NOVEMBER 9, 2020

NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 30, 2020

NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. We caution investors not to place considerable reliance on forward-looking statements contained in this press release. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History. Source: Novavax, Inc. . Posted: November 2020.

Clinical Development 52

Clinical Development Vaccination Vaccine Development 52

pharmaphorum

NOVEMBER 2, 2021

Clinical interest in bsAbs gained momentum following the promising data and market success of blinatumomab (BLINCYTO®, Amgen), a fragment-based bispecific T cell engager (BiTE), which first received FDA approval in 2014 and EMA approval in 2015.

Antibody 52

Antibody Immune Response Production Engineer 52

XTalks

AUGUST 17, 2020

In 2017, the US FDA approved a CAR-T cell treatment for young adults and children with B-cell ALL. A growing area in the immunotherapy space is the development of biological modulators, which are genetically engineered proteins that target specific components of the immune system. Image from Cue Biopharma.

Protein 98

Protein Engineer Immune Response In-Vivo 98