Remove Clinical Supply Remove Therapies Remove Treatment
article thumbnail

Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility to Support Clinical Supply Demand for Cell and Gene Therapy Development

The Pharma Data

State-of-the-art cryogenic freezers alongside material transfer equipment have been installed that are designed to retain the integrity of investigational advanced therapy products by minimizing their time-out-of-environment. With sites in the U.S.,

article thumbnail

Neuroendocrine carcinoma drug granted orphan status

Drug Discovery World

PT217 was granted ODD for the treatment of SCLC by the FDA in 2022 and granted Fast Track designation by the agency in 2024 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor.

Insiders

Sign Up for our Newsletter

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

Trending Sources

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.

article thumbnail

A Biotech Midsummer’s Madness

LifeSciVC

And importantly, breaks from treatment or treatment protocols can literally make or break trials. There is no room for a missed dose, a scheduled follow-up visit or opportunities to bring new clinical sites on board. can have a significant impact on manufacturing timelines and drug supply chains.

article thumbnail

Overcoming inefficiencies to improve access to cell and gene therapy 

Drug Discovery World

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. Additionally, the complexity of these drugs remains vastly under appreciated.

Therapies 130
article thumbnail

MorphoSys To Present At the 39th Annual J.P. Morgan Healthcare Conference

The Pharma Data

About MorphoSys MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases. The presentation as well as a replay of the webcast will also be available on MorphoSys’ website.

article thumbnail

A supply chain to match the changing face of science 

Drug Discovery World

Ten years ago, cell and gene therapy (CGT) was really finding its feet as success stories such as that of Emily Whitehead began to hit the news. Even ten years ago, the supply chain process for drugs like those used to treat Emily was incredibly complex for several key reasons. Next steps .

Science 130