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[Webinar] How biotech companies can improve clinical supply planning and distrib…

The Pharma Data

Find out solutions to mitigate the impact from clinical supply chain risk and discover how to improve dynamic drug supply forecasting strategies. Join this webinar to learn how supply forecasting and interactive response technology can help biotech companies improve supply planning and distribution while reducing cost and risk.

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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. Source link.

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

The Pharma Data

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development.

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A Biotech Midsummer’s Madness

LifeSciVC

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.

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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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Rapid delivery of toxicological material

Drug Target Review

Drug developer companies across the pharma industry report notable reductions in drug development timelines where 10 to 12 months, from lead monoclonal antibody (mAb) identification to IND application, is the new norm and in which earlier Tox material generation has been a critical component for shortening IND timelines.

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How to Optimize Drug Development by Combining FSO and FSP Models

PPD

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. Most often done using the vendor’s systems and standard operating procedures (SOP).