858-449-1310 contact@somatek.com

Biologics

Who’s afraid of IgM?

Immunoglobulin M (IgM) is the second most common antibody in humans surpassed only by immunoglobulin G (IgG). The IgM molecule is a pentamer - whereas IgG is a dimer - and with a molecular weight of appr. 900,000 D IgM has more than 5 times the molecular weight of...

read more

Monoclonals for migraine

Exciting news regarding a new indication for monoclonal antibodies. FDA has approved Aimovig, a product of the Amgen and Novartis Neuroscience Collaboration, for the prevention of frequent, debilitating migraines.  Aimovig is a human immunoglobulin G2 monoclonal...

read more

A novel recombinant protein for treatment of stroke

Stroke is the fifth leading cause of death in the United States and the number one cause of adult disability. Acute ischemic strokes occur when a clot blocks blood flow to the brain. To date, the FDA has approved only one drug treatment, called tissue plasminogen...

read more

FDA’s Top Ten Drug GMP Citations

At the FDA/Xavier University PharmaLink conference at Xavier University in Cincinnati, Ohio, in March 2017, FDA's Robert Tollefsen and Dell Moller presented the top ten drug GMP inspection citations for FY 2016. As summarized by Elanco's Brent Conatser these citations...

read more

FDA approves 19 biological licenses in 2017

This year FDA moved to approve 19 new biological licenses including biologics for the treatment of blood cancers and hemophilia. Notably, 2017 saw the approval of a new type of immunotherapy using genetically engineered, patient-derived T-cells, so-called CAR-T cells....

read more