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AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

The Pharma Data

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.

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PharmaDrug Enters Definitive Agreement for Acquisition of Sairiyo Therapeutics Inc. Who Recently Received Orphan Drug Designation from FDA for Esophageal Cancer

The Pharma Data

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval.

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How to Optimize Drug Development by Combining FSO and FSP Models

PPD

In 2018, market utilization of FSO models was at 72%, with usage of FSP models lagging at 28%. Awarded by specific function, in which a CRO could provide single or multiple services, such as site monitoring, data management, post-approval monitoring or clinical supply services, across numerous protocols.