In-Vitro In-Vivo Regulation 
Pharmaceutical Technology
APRIL 25, 2023
sCFH is an engineered and improved version of complement factor H (CFH) that can fit into adeno-associated virus (AAV) vectors with solid expression and applications confirmed in cultured human cells in vitro, in addition to various preclinical animal models in vivo. The firm will also receive single-digit royalties on net sales.
pharmaphorum
AUGUST 10, 2020
The filing with the FDA follows approval by several regulators across the world, including in the European Union and Japan. Originally intended as a treatment for Ebola virus, Veklury is a nucleotide analogue with broad-spectrum antiviral activity both in vitro and in vivo in animal models against several emerging viruses.
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The Pharma Data
JANUARY 12, 2021
Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. Previously, he held roles as CMO at Trimeris Inc.
XTalks
SEPTEMBER 20, 2024
Such challenges highlight a significant unmet need and call for further advancements in the field. Vittoria Biotherapeutics is a clinical-stage cell therapy company that incorporates the latest advancements in cell therapy and gene editing with a unique approach that potentially overcomes some of the issues with this therapeutic modality.
Delveinsight
JANUARY 18, 2021
For instance, GTX-102 , an antisense therapy silencing the gene expression by binding to the RNA molecule behind the regulation of its expression, has also secured USFDA Fast Track Designation. Angelman syndrome (AS) is a complex genetic rare disorder that affects the nervous system. GeneTx and Ultragenyx are co-developing the therapy.
FDA Law Blog
OCTOBER 11, 2022
Moreover, the draft guidance is the first time FDA tried to explicitly describe its position on such a key phrase (“confirmatory evidence”) that was made a part of the plain language of the statutory standard for drug approval in 1997, a 22-year interval of near public silence.
XTalks
OCTOBER 1, 2020
Leaving academia for industry is a route that academic scientists and professors did not traditionally pursue in the past due to perceived differences in skillsets, experiences and even associated stigmas. However, this has since changed, and now, transitioning between academia and industry has become more commonplace. Key Moments.
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