Outsourcing

Articles

In replacing the retiring Paul Hegwood, Ricci Whitlow will oversee global clinical trial operations.

Whitlow to Lead Catalent’s Clinical Supply Services Business

Drug development contract services company PPD announces initial public offering. 

PPD Launches IPO

Catalent’s FlexDirect service offers sponsors multiple delivery options from a single inventory.

Catalent Launches Direct-to-Patient Clinical Supply Services

The trial will test experimental stem-cell treatments against biologic therapies for severe forms of relapsing multiple sclerosis.

NIH Launches Clinical Trial that Compares Stem Cell Transplantation to Biologic Therapies for MS Treatment

Catalent’s planning service is designed to assist in evaluating needs for launching and maintaining clinical trials. 

Catalent Announces Clinical Trial Planning Service

Label management specialist, Prisym ID, announced that its clinical trial solution, PRISYM 360, has been chosen by CME to be part of a just in time clinical trials handling system for the Medicines Manufacturing Innovation Centre project.

Prisym ID’s Clinical Trial Solution Chosen for Medicines Manufacturing Innovation Centre Project

Sangamo Therapeutics has revealed that the United Kingdom’s Medicines Healthcare Products Regulatory Agency (MHRA) has authorized the first in-human clinical trial evaluating a chimeric antigen receptor regulatory T cell (CAR-Treg) therapy.

Sangamo Gains MHRA Authorization for Clinical Trial of CAR-Treg Therapy

The company will produce the anti-HER3 antibody drug HMBD-001for use within a clinical partnership between Cancer Research UK and Hummingbird Bioscience to test the agent in a Phase I trial.

BioInvent Enters into Production Agreement Expected to Generate $30 million

The new location was established to ensure uninterrupted support for clients’ trials in both the United Kingdom and Europe if the UK leaves the European Union on Oct. 31, 2019, especially in the event of a no-deal Brexit.

Yourway Opens New Slovakia Location to Secure Client Trials in Case of No-Deal Brexit

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.

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