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.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Oveporexton Shows Superior Efficacy in Phase II Narcolepsy Type 1 Trial Without Hepatotoxicity
May 16th 2025In the TAK-861-2001 Phase IIb study, oveporexton significantly improved wakefulness, daytime sleepiness, and cataplexy frequency in patients with narcolepsy type 1, outperforming current therapies and avoiding liver toxicity seen with earlier OX2R agonists, according to results published in The New England Journal of Medicine.
