Gene therapy—is it really a sound investment prospect?

More grounds for optimism on stopping the poison jabs

Hedley Rees

Dec 10, 2023

∙ Paid

What are the grounds for optimism on stopping the gene therapy jabs?

First, there is this recent post:

Kymriah GMP issues in NJ led to FDA letter for Novartis—Is gene therapy on its last legs?

Hedley Rees

December 8, 2023

Kymriah GMP issues in NJ led to FDA letter for Novartis—Is gene therapy on its last legs?

Kymriah GMP issues in NJ led to FDA letter for Novartis This is potentially a watershed event: The US FDA has highlighted GMP deficiencies in the production of CAR-T therapy Kymriah at Novartis’ Morris Plains plant. In November and December last year, the United States Food and Drug Administration (FDA) inspected the Morris Plains, New Jersey facility, resulting in it issuing a Form 483 [inspection report] with an undisclosed number of observations to Novartis. This is an extract:

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The US FDA is hot on the heels of Novartis’ Kymriah and it’s shoddy manufacturing practices at their Morris Plains facility. Kymriah is a treatment for rare blood cancers known as CAR-T therapy. The active substance is based on Lentiviral Vector Technology and is manufactured by Oxford Biomedica.

Oxford Biomedica also manufactures the AstraZeneca active substance adenovirus vector. Side effects are similar to the Kymriah gene therapy.

Then there is this vote of confidence below,

INSIDE PHARMA

Gene therapy—is it really a sound investment prospect?

More grounds for optimism on stopping the poison jabs

What are the grounds for optimism on stopping the gene therapy jabs?

Kymriah GMP issues in NJ led to FDA letter for Novartis—Is gene therapy on its last legs?

This post is for paid subscribers