Clinical Trial Materials

The companies have entered into a manufacturing agreement to supply leronlimab, an investigational new drug currently being used in clinical trial protocols for COVID-19.

NIH trial shows remdesivir accelerates recovery; Gilead study shows similar efficacy for 5- and 10-day dosing.

A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.

FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.

The guidance details considerations FDA has set in place to assure the safety of participants while maintaining compliance with good clinical practices and minimizing risks to trial integrity.

Understanding of scale-up parameters and use of process analytical technology are important to meet demand for larger batch sizes.

The acquisition will bring four new GMP-compliant facilities to the PCI network in the United States, Germany, and Canada.

The fully integrated, pre-qualified, pre-installed aseptic filling facility can be shipped globally for drug development and the manufacturing of personalized medicines and clinical trial supplies.

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

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

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.

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.

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.

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.

The Phase III clinical studies for the drug candidate, elenbecestat, were discontinued based on a recommendation by a data safety monitoring board.

The companies have entered into a manufacturing agreement for the production of Phase III clinical trial material.

Personalized medicine and direct-to-patient trial models have made the difficult even more challenging.

Tech transfer is key to succession advancing biopharmaceutical pipeline products from research to preclinical.

The contract research organization has increased its US-based early phase clinical capacity and doubled its specialty lab space.

The new center will integrate biologics drug discovery, development, clinical manufacturing, and commercial manufacturing.

The expanded Frederick, MD, site will help meet global demand for diagnostic instruments and cell and gene therapies for clinical trials.

The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.

PCI Pharma Services and CSP Technologies will partner on protective packaging solutions for clinical trials and stability testing.

ICS distribution center will serve manufacturers of specialty medications, biosimilars, and cell and gene therapies.

The pharmaceutical, clinical, and bioanalytical contract solutions provider has implemented advanced techniques for the collection and use of peripheral blood mononuclear cells (PBMCs) for early-phase clinical trials at its Clinical Pharmacology Unit in Antwerp, Belgium.

Increasingly complex trial protocols have added to IMP manufacturing challenges.

Experts from the Partnership for Research on Ebola VACcination report on progress and uncertainties regarding a safe and effective Ebola vaccine.

The National Institute of Allergy and Infectious Diseases began a first-in-human trial of an experimental live, attenuated Zika virus vaccine.

Researchers at the National Cancer Institute have developed a new approach to immunotherapy that led to the complete regression of breast cancer in a patient who was unresponsive to all other treatments.

Demand for direct-to-patient services is exploding. Michael Sweeney, senior director of patient-centric logistics at World Courier, discusses issues that the new model presents.