Remove Clinical Supply Remove Clinical Trials Remove Manufacturing Remove Protein
article thumbnail

Catalent Expands OneBio® Suite for Integrated Development, Manufacturing and Supply Across Biologic Modalities

The Pharma Data

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.

article thumbnail

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. Concerns of Early Deaths The expanded approvals come after the FDA had flagged reports of early deaths in clinical trials evaluating the therapies in earlier treatment line settings.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Overcoming inefficiencies to improve access to cell and gene therapy 

Drug Discovery World

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. This approach meant that when the supply chain temporarily shifted due to the global crisis, companies could not get the resources they needed when they needed them.

article thumbnail

Molecular Partners Announces Collaboration With Novartis to Develop Two DARPin(R) Therapies Designed for Potential Use Against COVID-19

The Pharma Data

MP0420 and MP0423 are potential medicines with a unique approach for both the prevention and treatment of COVID-19, with the possibility to manufacture at scale, easy administration and with the potential to bypass cold storage. Novartis is making multiple contributions to the global efforts to combat the COVID-19 pandemic.

article thumbnail

Molecular Partners Doses First Cohort in Phase 1 Trial of COVID-19 DARPin(R) Therapeutic Candidate MP0420

The Pharma Data

MP0420 is designed to bind the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells. MP0420 is subject to an option and license agreement with Novartis AG to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program.

Trials 40
article thumbnail

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

The Pharma Data

VTX-801 is a novel investigational gene therapy to be evaluated in a Phase 1/2 clinical trial to determine the safety, tolerability, and pharmacological activity of a single intravenous infusion in adult patients with Wilson Disease. Pfizer is collaborating with Vivet on the clinical supply of VTX-801 for the Phase 1/2 clinical trial.