The Pharma Data

DECEMBER 14, 2020

AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. In parallel, AlgoTx firmed-up ATX01’s development pathway via a pre-IND consultation with the FDA and obtained an Orphan Drug Designation from the FDA to explore ATX01’s activity in erythromelalgia. Source link.

Clinical Development 52

Clinical Development Clinical Supply Pharmacokinetics Clinical Trials 52

Drug Target Review

SEPTEMBER 10, 2024

However, developing an accelerated IND application requires that good laboratory practice (GLP) toxicological data must be generated, collected, interpreted and integrated in the IND-enabling data package. Therefore, there would be almost no appetite for trying to justify a change in formulation between Tox and clinical supplies.

Drug Development 64

Drug Development Clinical Supply Production Protein Expression 64

LifeSciVC

AUGUST 21, 2024

I am fortunate to have a great Tech Ops team at Lifordi who is on top of managing all the moving parts across the globe for making tox and clinical supply for us. We will have to support an evolving clinical development plan and to keep manufacturing off the critical path.

Clinical Trials 62

Clinical Trials Trials Disease Treatment 62