FDA Formally Accepts PharmaCyte Biotech’s Drug Master File for Company’s Pancreatic Cancer Therapy

Nachrichtenquelle: Business Wire (engl.)
05.08.2020, 15:00  |  423   |   |   

PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, announced today that the Drug Master File (DMF) that its partner, Austrianova, filed with the U.S. Food and Drug Administration (FDA) has been accepted without any questions or suggested changes.

The FDA’s Center for Biologics Evaluation and Research (CBER) successfully processed PharmaCyte’s DMF, which provides all confidential and detailed information covering the production of the CypCaps final product that was produced by Austrianova and will be used in PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “CBER’s acceptance and processing of our Drug Master File without any questions or comments is a credit to the painstaking work and dedication by Austrianova and our consultants to ensuring that the entire process is properly conducted and completed before any further documents are submitted to the FDA.

“We now look forward to presenting the FDA with our Investigational New Drug Application very soon for our planned clinical trial in locally advanced, inoperable pancreatic cancer.”

A DMF is submitted to the FDA to provide detailed information about facilities, processes and materials used in the manufacturing, processing and packaging of human drugs. It is a prerequisite to securing approval and commercialization and ensures confidentiality of proprietary information related to the Active Pharmaceutical Ingredient (API). The information contained in a DMF is used to support, among other things, an IND.

The DMF requirements are complex and specific, encompassing every detail involved with the manufacture of the API – from raw materials to analytical methods, process development and optimization. The scrutiny goes all the way back to the starting materials used in the API.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: https://www.PharmaCyte.com/Cancer

About PharmaCyte Biotech

PharmaCyte Biotech, Inc. (PharmaCyte) is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed.

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