More DCAT Value Chain Insights

In-depth analysis of the critical issues impacting the full spectrum of the pharmaceutical manufacturing value chain.

Small molecules continue to dominate approvals of new molecular entities (NMEs), accounting for approximately three-quarters of NME approvals over the past several years. What have been the small molecules approved as new molecular entities thus...

The pandemic challenged the global supply chain instantly. Geopolitical tensions and the call for localizations and self-reliance are further adding to the complexity of today’s API souring. In this article we look on supply chain security in a...

The FDA announced in July (July 2020) that it planned to resume “prioritized” domestic inspections and later issued a Q&A document to further explain how it is now handling inspections of both domestic and foreign manufacturing facilities in...

Which pharma/biopharma companies are drawing the attention of investors and the pharmaceutical majors? What companies are pursuing novel approaches in drug development, and what products are gaining attention? DCAT Value Chain Insights looks at the...

What has been the impact of the COVID-19 pandemic on clinical trials and thus supplying materials for these trials? DCAT Value Chain Insights takes an inside look and tracks the latest developments. COVID-19 and clinical trials One of the...

President Donald Trump issued an executive order late last week (August 6, 2020) to increase US-based production and federal procurement of essential medicines, medical countermeasures, and critical inputs. What does the executive order authorize,...

Reflecting the fallout from the COVID-19 pandemic, real GDP in the US decreased at an annual rate of 32.9% in the second quarter, and GDP in the eurozone shrank by 12.1%, both historical lows. How has the pharma industry fared facing such strong...

The FDA is considering a pilot program for the toxicological and quality evaluation of novel excipients. Excipients now are not separately reviewed by the FDA, and some say a separate review mechanism would support development of new excipients and...

Reforming drug pricing in the US has emerged again with the signing of executive orders by President Trump late last week. What do the executive orders require, and what is the impact on the pharmaceutical industry? Drug-pricing reform...