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J&J’s Carvykti and BMS’ Abecma Win FDA Approvals for Earlier Use in Multiple Myeloma

XTalks

Moreover, rather than producing antibodies, the cancer cells produce abnormal proteins that can cause complications. J&J and Legend have been working to increase their manufacturing capacity as the second-line approval is expected to significantly expand the number of patients who will be eligible for Carvykti. “We

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Overcoming inefficiencies to improve access to cell and gene therapy 

Drug Discovery World

While there is no silver bullet for increasing the availability of CGTs, improving manufacturing processes that enable their development at scale can help reduce the cost of these treatments and get them to those who need them most. Planning—without hoarding resources—is everything.

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VTX-801 RECEIVES U.S. FDA FAST TRACK DESIGNATION FOR THE TREATMENT OF WILSON DISEASE

The Pharma Data

Food and Drug Administration (FDA) has granted Fast Track designation to VTX-801, Vivet’s clinical-stage gene therapy for the treatment of Wilson Disease – a rare, genetic disorder that reduces the ability of the liver and other tissues to regulate copper levels, causing severe hepatic damage, neurological symptoms, and potentially death.