Highlights•Drug repositioning and similar terms have been a trending topic since
2004.•From a legal or regulatory perspective stimulation of drug repositioning requires …

Purpose Recent years have seen a change in the way that clinical trials are being
conducted. There has been a rise of designs more flexible than traditional adaptive and …

The concept of adaptive licensing (AL) has met with considerable interest. Yet some remain
skeptical about its feasibility. Others argue that the focus and name of AL should be …

Modern neuropsychopharmacology commenced in the 1950s with the serendipitous
discovery of first-generation antipsychotics and antidepressants which were therapeutically …

Abstract The World Health Organization (WHO) guidelines on evaluation of similar
biotherapeutic products (SBPs; also called biosimilars) were adopted by the WHO Expert …

The urgency to develop vaccines against Covid-19 is putting pressure on the long and
expensive development timelines that are normally required for development of lifesaving …

Decentralized clinical trials (DCTs) can be a valuable addition to the clinical trial landscape.
However, the practice of DCTs is dependent on a regulatory system designed for …

Evidence‐based medicine requires strong scientific evidence upon which to base treatment.
In rare diseases, study populations are often small, and thus this evidence is difficult to …

The current development paradigm for biosimilars required by regulators in highly regulated
jurisdictions is derived from the development of novel drugs and is unnecessarily …

Conditional marketing authorization (CMA) in the European Union (EU) is an early access
pathway for medicines that show promising therapeutic effects, but for which comprehensive …