Wisconsin-based Waisman Biomanufacturing will produce the vaccine under development by Heat Biologics for the virus that causes COVID-19.
The NDA submission is intended to support the approval of Tivozanib as a treatment for adult renal cell carcinoma in the United States.
Tecentriq (atezolizumab) has been approved by the FDA as a first-line treatment for adult PD-L1-high metastatic non-small cell lung cancer.
Patient enrollment in the phase 1/2 trial of NVX-CoV2373 has already started with preliminary phase 1 trial data expected in July of 2020.
Dupixent (dupilumab), developed by Regeneron and Sanofi, has shown “significant efficacy” for Eosinophilic Esophagitis in a phase 3 trial.
Potential NantKWest COVID-19 therapy BM-AlloMSC will be tested in a phase 1b clinical trial with cell product from Be The Match BioTherapies.
The European Commission approved subcutaneous Entyvio as a maintenance therapy for adults with Ulcerative Colitis or Crohn’s Disease.
Oncolytics Biotech has announced a publication demonstrating positive data for Pelareorep, FOLFIRI, and bevacizumab in colorectal cancer.
Navidea Biopharmaceuticals’ phase 2B NAV3-31 clinical trial is evaluating Tc99m Tilmanocept Planar Imaging in rheumatoid arthritis patients.
The phase 3 CheckMate 9LA trial by Bristol Myers Squibb evaluated the efficacy of Opdivo and Yervoy for treating non-small cell lung cancer.