Remove Clinical Supply Remove Treatment Remove Trials
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Neuroendocrine carcinoma drug granted orphan status

Drug Discovery World

PT217 was granted ODD for the treatment of SCLC by the FDA in 2022 and granted Fast Track designation by the agency in 2024 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor.

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Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility to Support Clinical Supply Demand for Cell and Gene Therapy Development

The Pharma Data

The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinical supply, and follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in specialized, ultra-low temperature storage capabilities. With sites in the U.S.,

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How direct-to-patient clinical trial models can accelerate speed-to-market

The Pharma Data

Analyzing the benefits and challenges of implementing direct-to-patient services in the clinical supply chain to help meet patient requirements, improve supply chain efficiency and accelerate speed to market. The benefits of developing a patient-centric clinical supply chain. Add bookmark.

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How to plan for uncertainty while maximizing the efficiency of your clinical sup…

The Pharma Data

Supply chain uncertainty is a challenge every clinical supply chain manager wrestles with – stemming from increasing product demand and quality, the growing complexity of clinical trial designs and a lack of visibility in the supply chain. Accelerating your clinical trial supply through digitalization.

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A Biotech Midsummer’s Madness

LifeSciVC

Clinical Trials Are your clinical trials on track? Companies fortunate enough to have reached the clinical stage are asking this question. What has the impact of summer been on recruiting efforts and the ability to manage clinical trial participants? Or maybe you are nearing the clinic.

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AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

The Pharma Data

The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021. About AlgoTherapeutix AlgoTx was founded in 2018 by Stéphane Thiroloix and Olivier Bohuon to develop topical treatments for complex pain and was incubated by Paris Biotech Santé.

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Catalent Expands OneBio® Suite for Integrated Development, Manufacturing and Supply Across Biologic Modalities

The Pharma Data

Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch. At the BIO International Convention, Carey Connolly, Ph.D.,