INSIDE PHARMA

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INSIDE PHARMA
Gene therapy—why is UK going full pelt into a minefield?

Gene therapy—why is UK going full pelt into a minefield?

Find out here, and it's not good news

Hedley Rees's avatar
Hedley Rees
Aug 10, 2022
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INSIDE PHARMA
INSIDE PHARMA
Gene therapy—why is UK going full pelt into a minefield?
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Why do I keep banging on about gene therapy?

COVID-19 has been manna from heaven for companies developing gene therapy-based products. What lots don't know is they had been languishing in the doldrums for a very long time prior to the SARS-CoV-2 (alleged) outbreak.

Proving they were safe and effective was holding everything up, and still is, if we refer to the Cell and Gene Therapy Catapult UK Clinical Trials Report, which includes the Cell and Gene Therapy Catapult ATMP Clinical Trials Database 2021.

The database is 29 pages of clinical trials in various stages of progress. Start dates range from 2004 to 2021. Trust me, the problems are horrendous, and that’s what has been holding things up.

What are these problems?

I did a post on this in March, and re-post it here.

INSIDE PHARMA
GENE THERAPY AND ITS SUPPLY CHAINS ARE NOT WELL UNDERSTOOD
WHAT ARE THE ISSUES? On Aug. 30, 2017, the Food and Drug Administration (FDA) approved the first gene therapy product to launch in the U.S. Novartis’ drug—brand name Kymriah—is now out of the clinic and available to patients. Eye-watering price aside, it has been hailed as a landmark event in the history of the U.S. pharma industry…
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3 years ago · 3 likes · Hedley Rees

It recounts one of the first gene therapy products to be approved, Novartis’ Kymriah.

Here you can see the package insert from the FDA website.

This is the warning on there:

“WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL T…

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