The Pharma Data

SEPTEMBER 15, 2020

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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Clinical Supply Clinical Trials Doctors Clinical Development 52

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.

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PPD

SEPTEMBER 6, 2023

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).

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The Pharma Data

JANUARY 10, 2021

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. More information at www.morphosys.com or www.morphosys-us.com.

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Clinical Trials Clinical Development Clinical Supply Trials 52

Drug Target Review

SEPTEMBER 10, 2024

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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The Pharma Data

AUGUST 15, 2021

VTX-801 is a novel investigational gene therapy to be evaluated in a Phase 1/2 clinical trial to determine the safety, tolerability, and pharmacological activity of a single intravenous infusion in adult patients with Wilson Disease. Pfizer is collaborating with Vivet on the clinical supply of VTX-801 for the Phase 1/2 clinical trial.

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Disease FDA Treatment Clinical Trials 52

The Premier Consulting Blog

OCTOBER 26, 2022

The process will be transferred from the development lab to a pilot or small-scale manufacturing facility and, if the program is successful, to a facility for commercial manufacturing. The tool used to transfer the information to the receiving party is called the manufacturing process description (MPD).

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