Development

FDA has cleared an IND from Poseida Therapeutics, allowing continued development of the company’s allogeneic CAR-T cell therapy candidate for treating multiple solid tumors.

Warp speed is amazoning pharma practices and protocols.

Although mRNA and viral vector vaccines have been top of mind for COVID-19 treatments, other technologies and treatments are emerging—along with new variants.

Modeling techniques can improve process control and monitoring in biopharmaceutical production.

Qualified algorithms enable validation of machine learning models that can be used for process optimization.

New and emerging biotherapeutic molecules drive the need for innovative solutions to meet cold-chain requirements.

Multispecific analysis is complex but can be achieved using appropriate strategies.

Amgen and Syngene International have extended their research collaboration to 2026.

Genezen has opened its new process development and analytical lab for viral vector production.

GlaxoSmithKline, together with the University of Oxford, has launched the Oxford-GSK Institute under a new collaboration that aims to study complex diseases to accelerate the success of drug discovery and drug development efforts.

The authors review some of the monoclonal antibody candidates that reached Phase III clinical trials but were discontinued at later stages.

Lonza has signed a five-year services agreement to provide for the development and manufacturing of biologics and small molecules for portfolio companies owned by Bioqube Ventures.

Sanofi’s acquisition of Origimm Biotechnology will add to its pipeline of vaccine candidates for treating acne.

Recordati’s blockbuster acquisition of EUSA Pharma gives them access to a portfolio of four drugs that treat rare cancers.

This collaboration aims to better understand Alzheimer’s and Parkinson’s disease and increase drug discovery and development success rates.

High price tags threaten to block patient access to potentially life-saving cures and treatments.

Fujifilm’s center adds local support in Suzhou, China for cell culture media optimization.

EMA has fully validated the marketing authorization application for Atara Biotherapeutics’ off-the-shelf allogeneic T-cell therapy, tab-cel (tabelecleucel), with an approval decision expected in 2022.

Chinook Therapeutics has formed a 50/50 joint venture with investors to develop kidney disease therapies in China.

Autologous tumor cells engineered for immune system stimulation can target unique metabolic, genomic, and phenotypic characteristics of cancer cells.

Glycosylation monitoring has been heavily dependent on manual processes, but the automation of sample preparation streamlines the overall workflow.

COVID-19 is refocusing calls for new tools and urgent therapeutic responses.

BeiGene has acquired property in Hopewell, NJ to build a new manufacturing site and clinical R&D center for advanced new medicines.

Samsung Biologics, GreenLight Biosciences, and Environmental Impact Acquisition Corp. have partnered to advance GreenLight’s mRNA COVID-19 vaccine candidate.

The companies are testing their existing vaccines against the new variant of concern and are pursuing variant-specific versions.