Blog | BioInformant

Qrons Appoints Veteran U.S. Based Biotech Executive Dr. John N. Bonfiglio to Lead IND and Capital Markets Related Activities

June 27, 2019 By Cade Hildreth, Founder & President Leave a Comment

New York, NY, June 27, 2019 — Qrons Inc. (OTC: QRON), an emerging biotechnology company developing advanced stem cell-synthetic hydrogel-based solutions for the treatment of traumatic brain injuries (“TBIs”), including concussions and penetrating injuries, announced today the appointment of John N. Bonfiglio, PhD, MBA as its Chief Operating Officer. Qrons Inc. (OTC: QRON)

Dr. Bonfiglio’s primary responsibility will be to oversee all investigational new drug (“IND”) activities in the United States in coordination with Qrons’ Israeli-based scientific team. [Read more…]

Mesoblast’s Mesenchymal Precursor Cell (MPC) Therapy Receives Orphan Drug Designation

June 24, 2019 By Cade Hildreth, Founder & President Leave a Comment

Mesoblast (ASX:MSB; Nasdaq: MESO) announced that the U.S. FDA granted the company’s product candidate, Revascor, Orphan Drug Designation for prevention of gastrointestinal bleeding in patients with left ventricular assist devices.

Revascor, Mesenchymal Precursor Cells

Revascor is Mesoblast’s investigational cell therapy composed of 150 million allogeneic mesenchymal precursor cells (MPCs). [Read more…]

Rhemastem, Leveraging Stem Cells from Solid Tumors in the Race to Cure Colorectal Cancer

June 24, 2019 By Cade Hildreth, Founder & President Leave a Comment

Headquartered in Monza, Italy, RhemaStem is a unique biotech company that specializes in developing innovative and effective drugs for colorectal cancer and other solid cancers. The company’s mission is to cure colorectal cancer and other solid cancers using its expertise in the area of cancer and normal stem cells. I had the distinct honour of interviewing Dr. Zeni of RhemaStem.

In this interview, we explore the founding of Rhemstem, its unique technology platform, intellectual property (IP), future directions, and more. Enjoy! [Read more…]

ElevateBio to Operate at a Hybrid CDMO and Investment Holding Group

June 17, 2019 By Cade Hildreth, Founder & President Leave a Comment

ElevateBio, a newcomer to the cell and gene therapy sector, is taking a different approach than the competition. Founded only months ago in early 2019, the company plans to aggregate a portfolio of cell and gene therapy companies that will develop, manufacture and commercialize life-transforming medicines.

It has launched with an unusual business model, which is to be a hybrid CDMO for cell and gene therapy companies, as well as an investment holding company. It will accomplish this feat by offering “R&D and cGMP manufacturing facilities to be shared across several portfolio companies, each with a different disease focus.”

Key to ElevateBio’s plan is the construction of an R&D and cGMP manufacturing facility in Cambridge, MA, that it calls BaseCamp. The complex will act as a centralized research and manufacturing group to support a portfolio of promising cell and gene therapy companies, each which will have a different disease focus.

[Read more…]

Breaking: FDA Announces Program to Help Manufacturers of HCT/Ps Understand Regulatory Pathways for Specific Products

June 16, 2019 By Cade Hildreth, Founder & President Leave a Comment

The U.S. Food and Drug Administration is announcing a temporary program called the Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP), which will operate as part of FDA’s Tissue Reference Group.

The program will assist manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), including those stakeholders that market HCT/Ps to healthcare professionals and/or patients, obtain a rapid, preliminary, informal, non-binding assessment from the FDA regarding how specific HCT/Ps are regulated.

The agency intends to respond to inquiries that contain sufficient detail for evaluation within three days of receipt, as resources permit. The program will be available until December 31, 2019.

View full FDA announcement:

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-announces-temporary-streamlined-program-help-manufacturers-human-cell-tissue-and

Source: U.S. FDA