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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.
