What is NME/NCE?

What is NME/NCE?

The therapeutically beneficial molecule or ion in a drug is its active moiety. A New Molecular Entity or NME is a drug that has an active moiety that has not been previously approved by the FDA. However, an NME differs from an NCE or New Chemical Entity which has no active moiety that has ever been FDA-approved before. As we can see, the difference is this: an NCE must not have a single approved active moiety, while an NME has at least one previously unapproved active moiety. An NCE stamp from the FDA gives the sponsor five years of marketing exclusivity, and the FDA does not accept any ANDA or 505(b)(2) for that drug during those five years.

What is a monoclonal antibody?

A monoclonal antibody or mAb is an antibody produced in the laboratory from a single ancestral plasma cell

What Is Non-Hodgkin Lymphoma?

Non-Hodgkin lymphoma (also known as non-Hodgkin’s lymphoma or NHL) is a cancer of the lymphocytes, a type of white blood cells and an important part of the immune system.

What is INI1 and SMARCA4?

INI1 and SMARCA4 are subunits of SWI/SNF, a chromatin modifying protein complex, which opposes the activity of PRC2, the complex within which EZH2 resides.