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. This financing also follows a strong pre-clinical package providing PoC for AT-108.

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Immune Response Packaging Therapies FDA 130

Agency IQ

AUGUST 2, 2024

Happy 40 th Birthday, generic drugs: September 24 will mark the 40 th anniversary of the 1984 signing of the Hatch-Waxman Act, which created a formal pathway for the approval of generic drugs. We expect the FDA to mark the occasion, especially since drug pricing continues to be such a potent issue in the Presidential election.

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. This new facility will offer large-scale cell culture manufacturing of bulk drug substance with 8 x 20,000L bioreactors (physical volume), with the potential to expand and add a further 24 x 20,000L bioreactors based on market demand.

Packaging 52

Packaging Small Molecule Production FDA Approval 52

Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? 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.

Marketing 40

Marketing Biosimilars Regulations Drugs 40