Clinical Development Licensing Packaging 
Camargo
AUGUST 11, 2021
The FDA oversees all drug approvals in the US via New Drug Applications (NDAs), with approvals for biologic products being approved via Biologics License Applications (BLAs). Meeting Package Due. To address a stalled product development plan or an important safety issue. Meeting Type. Meeting Purpose. Meeting Timing 1.
The Pharma Data
NOVEMBER 18, 2021
Gilead has been encouraged by early clinical data generated for each of the three programs. By concluding in early to all three programs now, Gilead and Arcus are suitable to accelerate the clinical development and advancement of these clinical- stage motes and grease the disquisition of treatment combinations across the portfolios.
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The Pharma Data
DECEMBER 8, 2020
Now poised to advance a robust therapeutics pipeline to clinical development, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. Already having been in clinical studies at Roche, all four candidates have strong clinical and preclinical safety packages.
The Pharma Data
JANUARY 13, 2021
.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare.
The Pharma Data
OCTOBER 30, 2020
These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue (..)
The Pharma Data
OCTOBER 14, 2020
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. 1 Noyce RS, et al. 2018) PLoS One. 13(1):e0188453. About Tonix Pharmaceuticals Holding Corp.
The Pharma Data
DECEMBER 17, 2020
Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” “The investigational cocktail is now available to indicated high-risk U.S.
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