A decade later, another MIT retreat explores factors behind slow adoption of technologies touted in the first – and how the barriers could be overcome to deliver higher-quality, more shortage-proof generic drugs.
The vision goes like this: drug manufacturers will build more resilient supply chains and prevent drug shortages by restoring US-based manufacturing, and they will do it by adopting advanced technologies that enable them to achieve higher quality while competing on price against India and China despite higher wages and greater environmental and worker protections in the US.
In support of this vision, the US Food and Drug Administration has worked to facilitate the use of continuous and...
The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.
Private Company Edition: June’s eight $100m-plus venture capital rounds already outpace the seven each raised in March, April and May, including €255m ($274.2m) for ITM and $200m for Upstream, but while there were five $25m or less VC financings during the past week, mid-sized deals were lacking.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
