GPhA commends IGBA for persuading WHO evaluation of BQ impact

The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council has released a statement from its President and CEO, Chip Davis, commending the International Generic and Biosimilar Medicines Association (IGBA) for persuading the World Health Organization (WHO) to carry out an evaluation of the global impact for the voluntary biologic qualifier (BQ) proposal for the quality, safety and access to biologic products. Read More »

Amgen submits sBLA to FDA for BLINCYTO

Amgen announced earlier this week that it has submitted to the U.S. Food and Drug Administration (FDA) a supplemental Biologics License Application (sBLA) for BLINCYTO (blinatumomab) that will include new information to support the treatment of pediatric and adolescent patients who have been diagnosed with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Read More »