Local blood substitute biotech company faces challenges

Biopure (which happens to be located just a couple of blocks from our office here in East Cambridge), is running up against some opposition as it tries to get its blood substitute approved for human use in the US, according to the Boston Globe. The company was supposed to have a closed-door meeting today with the FDA, but it was cancelled. Public Citizen sued the FDA last week to have the meeting open to the public. The FDA said in a statement yesterday: “We will work toward a future meeting where information can be shared with the public.”

The road to an FDA-approved blood substitute is littered with setbacks and failures (see this Nature Biotech article). Public advocates have been keeping a close eye on companies like Biopure and their experimental products. One of the concerns with Biopure’s product is that the company wanted to test it in trauma patients without their consent, according to the Globe article.

This year, the company started selling its blood substitute in South Africa and applied for regulatory approval in the UK.

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