Drug Discovery World

FEBRUARY 14, 2024

While a typical chemisty, manufacturing and controls (CMC) timeline from DNA to Investigational New Drug (IND) application in 2015 would have been approximately 24 months, by 2023 the same pathway was expected to take only 10 months. Thadani NN, Gurev S, Notin P, et al. DDW Volume 25 – Issue 1, Winter 2023/2024 References Tripathi T.

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Protein Vaccination Vaccine Manufacturing 59

pharmaphorum

JUNE 9, 2022

We will use the tremendous experience of our senior team to build what really matters to be successful in innovative pharmaceutical drug discovery and drug development in an agile and highly collaborative way, with external partners.”. Herpers, P. Gjerdrum, P. About Micreos Pharmaceuticals. Eichenseher, B. Badoux, J. Lindahl, A.

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Bacteria Development In-Vitro Drugs 104

The Pharma Data

MAY 7, 2021

Review will support a formal Marketing Authorisation Application. The rolling review will continue until enough evidence is available to support a formal marketing authorisation application. An Emergency Use Authorization (EUA) application for sotrovimab has been submitted to the US Food and Drug Administration (FDA).

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Antibody Trials Vaccination Vaccine 52

The Pharma Data

MARCH 26, 2021

today announced the submission of an application to the U.S. Results of the interim analysis, based on data from 583 patients enrolled in the trial, demonstrated an 85% (p=0.002) reduction in hospitalisation or death in those receiving VIR-7831 compared to placebo, the primary endpoint of the trial.

Antibody 52

Antibody Trials Vaccination Vaccine 52