News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Two Americans stricken with the Ebola virus in Liberia were flown back to the US following treatment with an unapproved treatment manufactured from tobacco plants in Kentucky. Manufacturing of the treatment is expected to ramp up as the patients improve.
With the EMA’s CHMP (Committee for Medicinal Products for Human use) recommending approval for a new insulin biosimilar early last month, some in the industry are expecting an increasingly competitive field moving forward.
The US Food and Drug Administration (FDA) has issued guidance on biologics exclusivity, stipulating the evidence drugmakers must provide to ensure a 12-year exclusivity period.