Strong Growth in Biopharmaceutical Approvals
Applied Clinical Trials
Biotechnology is delivering substantially higher numbers of new product approvals. During the period 2000 to 2009, 65 biopharmaceutical products received US marketing approval, nearly double the number of products approved during the 1990 to 1999 period and five times the 1980 to 1989 level.
Biotechnology is delivering substantially higher numbers of new product approvals. During the period 2000 to 2009, 65 biopharmaceutical products received US marketing approval, nearly double the number of products approved during the 1990 to 1999 period and five times the 1980 to 1989 level.
Biopharmaceutical approvals represented one-third of all new therapeutics approved by the FDA between 2000 and 2009. This is up from 7% and 14% of all new therapeutics approved by the FDA between 1980 to 1989 and 1990 to 1999 respectively. Recombinant proteins comprise the majority of new biopharmaceutical approvals at 57% of the total. Monoclonal antibody product approvals now account for 28% of all new biopharmaceutical approvals, up from only 8% of new product approvals between 1980 and 1989. Half of new biopharmaceuticals approved by the FDA during the 2000s received a priority-review rating.
—Tufts Center for the Study of Drug Development, http://csdd.tufts.edu.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
STEP UP Trial Shows Semaglutide 7.2 mg Achieves Superior Weight Loss vs. 2.4 mg, Placebo
January 17th 2025Semaglutide 7.2 mg significantly outperformed semaglutide 2.4 mg and placebo with a 20.7% average reduction in weight and a comparable safety and tolerability profile, further establishing its efficacy in obesity treatment.
