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Why Advanced Manufacturing Technologies Haven’t Prevented Drug Shortages – And How They Could

 
• By Bowman Cox

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 answer is money
the missing ingredient • Source: Shutterstock

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 other advanced manufacturing technologies by promoting the benefits and clearing...

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EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

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.