Effective translation of breakthrough discoveries into innovative products in the clinic
requires proactive mitigation or elimination of several drug development challenges. These …

The global market of pharmaceutical biologics has expanded significantly during the last few
decades. Currently, pharmaceutical biologic products constitute an indispensable part of the …

Background Prices of anti-cancer drugs are skyrocking. We aimed to assess the clinical
benefit of new drugs for treating advanced solid tumors at the time of their approval by the …

Since the approval of the first molecularly targeted tyrosine kinase inhibitor (TKI), imatinib, in
2001, TKIs have heralded a new era in the treatment of many cancers. Among their …

Enzyme therapeutics have received increasing attention due to their high biological
specificity, outstanding catalytic efficiency, and impressive therapeutic outcomes. Protecting …

Objective This study aims to compare the efficacy and safety of different poly (ADP-ribose)
polymerase (PARP) inhibitors in patients with ovarian cancer through a network meta …

The biotechnology segment of the overall biopharma industry has existed for only about 40–
45 years, as a driver of new product development. This driving force was initiated with the …

During the developability assessment of therapeutic monoclonal antibody (mAb) candidates,
utilization of robust high-throughput predictive assays enables rapid selection of top …

The discovery and development of new medicines classically involves a linear process of
basic biomedical research to uncover potential targets for drug action, followed by applied …

A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual
property and abbreviated approval pathways | Nature Biotechnology Skip to main content …