In-depth analysis of the critical issues impacting the full spectrum of the pharmaceutical manufacturing value chain.
Reshoring manufacturing, including drug manufacturing, has gained policy momentum in the US and EU stemming in part from supply-chain vulnerabilities exposed during the COVID-19 pandemic. But will that momentum continue, and how would such policies...
Medicines for Europe, which represents generic-drug and biosimilar manufacturers, is calling on the EU to recognize value-added medicines as a separate group of medicines and with that recognition, to develop specific frameworks for their...
We all know that active pharmaceutical ingredient (API) end user supply chain security is a critical component to getting the finished dosage to market. Securing the supply chain means that discipline, diligence, expertise and compliance are...
In 2020, the FDA approved or tentatively approved 948 abbreviated new drug applications for generics, including 72 first generics, which was on par with recent years. The COVID-19 pandemic had an impact as more than 660 supplements and 50 original...
Small molecules continue to dominate new drug approvals, accounting for three-fourths of new molecular entities approved by the FDA in 2020, on par with recent years. What’s the impact for CDMOs/CMOs? The latest expansion activity announced in 2020...
CDMOs/CMOs are proceeding with expansions and advancing technology in parenteral drug development and manufacturing. DCAT Value Chain Insights rounds up the latest developments announced in 2020 and 2021 to date.
CDMOs/CMOs expand
Driven by...
What is driving growth in the CDMO/CMO market for parenteral drugs, and what is the outlook for 2021? An industry roundtable weighs in on key trends, including the impact of increased demand for COVID-19 projects.
An industry roundtable
To gain a...
In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.
The FDA cut back inspections in 2020 due to COVID-19 and reverted to remote inspections and alternative tools, but what has been the impact? The FDA conducted 52 domestic inspections from March to September 2020, compared to about 400 in prior...
Which biologics are slated for the strongest sales growth in 2021, and how do they compare with sales growth for small-molecule drugs? What biologics were approved as new molecular entities in 2020, and which drugs are slated for future blockbuster...
