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Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. VTX-801 is a novel investigational gene therapy to be evaluated in a Phase 1/2 clinical trial to determine the safety, tolerability, and pharmacological activity of a single intravenous infusion in adult patients with Wilson Disease.
Regulatory Excellence - Licenses for Schedule I through IV drug substances. Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA.
Food and Drug Administration (FDA) granted accelerated approval of the company’s proprietary product Monjuvi (R) (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma. In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc.,
Food and Drug Administration (“FDA”) approval. Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases. PharmaDrug Inc.
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