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,…
Generics and the EU: The Push for Value-Added Medicines
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…
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…
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 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.…
Industry Roundtable: Parenteral Drug Manufacturing
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…
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…
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…
What may be in store for the pharma industry in 2021? What trends will continue and what will emerge? From telemedicine to new models in drug development, to supply-chain adjustments,…
President Biden Issues Executive Order on US-Based Manufacturing
President Joe Biden issued a “Made in America” executive order this week (January 25, 2021) for federal procurement of goods, materials, and products. It includes establishing a Made in America…
