Industry Radar

The European Commission’s Pharmaceutical Strategy for Europe calls for a structured dialogue to identify vulnerabilities in the pharma supply chain and provide policy options to strengthen medicines supply in the…

In 2020, the FDA approved 53 new molecular entities (NMEs), the second highest level of NMEs approved in a given year in the past decade and over the 48 approvals…

The COVID-19 pandemic has obliged a re-evaluation of manufacturing networks and supply lines. An upcoming DCAT webinar, Pharma’s Manufacturing and Supply Lines: New Ways for Risk Mitigation Post COVID-19, provides thought…

The CDMO industry enters 2021 in the strongest position it has ever been in. The industry has reaped substantial benefits from government responses to the COVID-19 pandemic, especially those measures…

Having received emergency use authorization from the FDA for their COVID-19 vaccine, Pfizer and BioNTech reached a significant milestone in an unprecedented effort to develop a safe and effective vaccine…

What were the key moves made by CDMOs/CMOs in 2020? Expansion activity was robust in biologic drug-substance and drug-product manufacturing, in part due to COVID-19-related projects, but other manufacturing segments…

Following the adoption of the European Commission’s Pharmaceutical Strategy for Europe late last month, EU policy makers are moving forward with ways to address vulnerabilities in the global drug supply…

COVID-19 was the most important development impacting biomanufacturing in 2020. What have been, and what will be, the adjustments required of biopharma companies, CMOs, and suppliers to fortify production capacity…

Viatris is the new company formed from the combination of Upjohn, Pfizer’s off-patent branded and generic established medicines business, and Mylan. The companies had announced the deal in July 2019,…

The FDA has issued a list of 223 essential medicines as part of an executive order that directs the FDA and other agencies to develop strategies for acquiring the products…