BioPharm International Editors

FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19.

The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy.

Wacker will support production of CureVac’s COVID-19 mRNA-based vaccine candidate at its biotech site in Amsterdam, with production scheduled to start in the first half of 2021.

Dolomite Microfluidics and MilliporeSigma have begun a collaboration to release off-the-shelf microfluidic device kits for the fabrication of PLGA particles.

The new powerful, precise, and compact instrument can be retrofitted for point-of-care clinical testing at urgent care facilities, hospitals, or physicians’ offices.

The expansion of the companies’ partnership will integrate lead optimization efforts to advance cancer immune therapy drug discovery.

The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies.

The companies have entered into an agreement for the technology transfer and clinical manufacturing of Mustang’s MB-107 lentiviral gene therapy program for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, in Europe.

The expansion will include a new 25,000-ft2 warehouse, a filling line for flexible plastic containers, a high-speed automated syringe fill line with the ability to fill up to 600 units per minute, and a high-speed automated visual inspection line.

The acquisition gives Merck a new Phase III COVID-19 therapeutic candidate, CD24Fc, a fusion protein that targets the innate immune system, in its pipeline.

The new super plant, being built in Incheon, South Korea, will have a total biopharmaceutical manufacturing capacity of 256,000 L.

The companies have formed a long-term manufacturing agreement to accelerate the global supply for Lilly’s COVID-19 antibody therapeutics.

The agreement follows a recent announcement that Sartorius plans to invest $100 million in Songdo, South Korea’s bio cluster.

The agreement will allow Roche to use CEVEC’s proprietary ELEVECTA technology, which is designed to enable fully scalable, high-performance AAV vector production in suspension bioprocesses.

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.

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.

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.

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.

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.

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

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

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.

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

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