Drug Discovery World

MARCH 19, 2024

The company plans to submit an Investigational New Drug (IND) application to the FDA for AT-108 by 2026, expand and reinforce its research and development team, and fuel new reprogramming modalities and delivery platforms to strengthen the pipeline. We believe this breakthrough strategy will give rise to the next generation of cell therapies.

Immune Response 130

Immune Response Packaging Therapies FDA 130

Agency IQ

AUGUST 2, 2024

While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026. September 30, 2024 PDUFA Novel Approaches to Development of Cell and Gene Therapy Convene a public meeting to solicit input on methods and approaches (e.g.,

FDA 40

FDA Science Regulations Biosimilars 40

The Pharma Data

JANUARY 6, 2021

End-to-End Single-Site Solution from Drug Substances to Fill-Finish & Packaging. In addition to drug substance manufacture, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services. Packaging line?. TOKYO , Jan. 8 x 20,000L bioreactors for mammalian cells.

Packaging 52

Packaging Small Molecule Production FDA Approval 52

Agency IQ

JUNE 9, 2023

Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. High-priced cell and gene therapies are being increasingly developed for rare diseases.

Marketing 40

Marketing Biosimilars Regulations Drugs 40