Pharmaceutical Technology Editors

The partners have established PathoQuest, Inc., a US subsidiary, and will construct an NGS-based testing lab at Charles River’s Wayne, PA, site.

When administered together in clinical trials, casirivimab and imdevimab were shown to lessen COVID-19 hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.

An independent data safety monitoring board found that clinical trial data demonstrated that the vaccine candidate met its primary endpoint and demonstrated protection from COVID-19.

Following an EUA application from Pfizer and NioNTech, FDA outlines the process for committee and agency review.

Under the terms of the agreement, Pfizer will provide $70 million toward in-licensing and co-development.

Researchers concluded that the nasal spray should catch and coat the virus inside the nose, preventing it from spreading throughout the body, and it is then removed by nose-blowing or swallowing.

The first of its kind, Lycagel is made up of pea starch technology.

Watson-Marlow Limited Ireland has revealed plans for a new ISO 14644-1 Class 7 cleanroom to be added to the company’s existing site in Cork, Ireland.

A second global Phase III clinical trial investigating the safety and efficacy of a two-dose regimen of JNJ-78436735 has been initiated by Johnson & Johnson.

CordenPharma has announced the expansion of its non-GMP SPPS manufacturing capacity at its Centre of Excellence for Peptide Process Development and non-GMP manufacturing in Frankfurt, Germany.

Bone Therapeutics has reported the completion of Catalent’s acquisition of Skeletal Cell Therapy Support SA (SCTS)—Bone Therapeutics’ cell therapy manufacturing subsidiary.

Eisai has announced an expansion of its manufacturing operations at its Hatfield production plant in the United Kingdom to meet global demand.

Interim results of AZD1222 trial have demonstrated lower reactogenicity in older adults, and strong immune responses across all adult age groups.

Almac Sciences has been granted an award by the COVID-19 Therapeutics Accelerator for the development of an efficient and scalable production process for remdesivir.

Moderna has reported that EMA's CHMP has started a rolling review of mRNA-1273—Moderna’s COVID-19 vaccine candidate.

The agency’s safety monitoring plan outlines how information that emerges after the authorization of COVID-19 vaccines will be collected and reviewed.

EDQM announced three new Official Control Authority Batch Release guidelines that describe the tests to be performed by Official Medicines Control Laboratories in the European Union OCABR Network.

The announcement comes after the company saw growth and performance in Asia and decided to continue the expansion of biopharmaceutical manufacturing in the region.

The expansion will feature added capabilities for formulation development via the upgrade of drug product development laboratories and the addition of Gerteis roller compaction equipment for dry granulation processing.

Stephen Hahn promises disclosure of supporting scientific data used to issue EUAs.

The agency recommended treatments for a variety of cancers as well as treatments for glaucoma and influenza.

The guidance was published in connection with a safety monitoring plan for COVID-19 vaccines.

The agency marked the annual European Antibiotic Awareness Day with the launch of a social media campaign highlighting the prudent use of antibiotics.

The expansion will be designed to meet the growing demand for small molecule drug substance development and manufacturing.

The event will be rescheduled for Oct. 19–21, 2021 at the Javits Center in New York City.

Moderna CEO Stéphane Bancel says the company will submit EUA data for its vaccine candidate, mRNA-1273, which has shown efficacy of 94.5% in the first analysis of Phase III clinical test results.

The new facility, which is expected to be operational by mid-2026, will utilize cell-based technology to produce influenza vaccines for influenza pandemics and seasonal vaccination programs, both in Australia and globally.

The companies will work together on research activities through to the selection of a preclinical candidate, after which Roche will handle further development and global commercialization.

The 110,000 ft2 site, which is set to be operational by the second half of 2021, will feature new technology including 2000-L scale bioreactors and additional fill-finish capabilities.

Apeiron Biologics has selected Domainex to advance the development of inhibitors for the E3 ubiquitin ligase Cbl-b.