The Pharma Data

JUNE 7, 2023

Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch. at the BioProcess International Theater.

Manufacturing 40

Manufacturing Development Protein Gene Therapy 40

XTalks

APRIL 11, 2024

Moreover, rather than producing antibodies, the cancer cells produce abnormal proteins that can cause complications. This could be seen as a positive for companies developing CAR T-cell therapies for autoimmune diseases and solid tumors. In addition, the companies are also gunning for a first-line setting approval.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

Drug Discovery World

MARCH 13, 2023

The cell and gene therapy (CGT) landscape has grown significantly in the past year. Between the 24 therapies already approved by the FDA 1 and a marked increase in clinical trials, widespread accessibility to precision medicine feels within reach. One example: Zynteglo, a newly approved gene therapy priced at a record-breaking $2.8M

Gene Therapy 52

Gene Therapy Gene Manufacturing Development 52

The Pharma Data

AUGUST 15, 2021

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.

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52