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.

Manufacturing 40

Manufacturing Development Protein Gene Therapy 40

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. Planning—without hoarding resources—is everything.

Gene Therapy 52

Gene Therapy Gene Manufacturing Development 52

XTalks

APRIL 11, 2024

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

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

The Pharma Data

AUGUST 15, 2021

Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. The FDA’s Fast Track program is designed to facilitate the development, and expedite the review of, novel potential therapies that are designed to treat serious conditions and fill unmet medical need. NYSE: PFE) today announced the U.S.

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52