Three COVID-19 vaccines by Pfizer/BioNTech, Moderna, and J&J have been authorized for emergency use in the US. What are the supply targets for 2021 and beyond, and what manufacturing networks…
FDA Addresses Supply Constraints Due to COVID-19; Plus, Packaging Suppliers Expand
The FDA has released a new guidance outlining a risk-based approach to facilitate changes to container-closure-system components, such as glass vials and stoppers, used in COVID-19 vaccines and therapeutics. The…
President Biden Calls for Review of US Drug Supply Chain
Supply-chain vulnerabilities exposed during the COVID-19 pandemic as well as those existing pre-pandemic were behind an executive order signed by President Joe Biden late last month (February 2021) to require…
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…
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…
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…
