News

Evonik and Stanford University have signed a research collaboration to develop and market a new drug delivery platform for mRNA and gene therapy.

Yposkesi is building its second commercial facility for cell and gene therapy manufacturing at its campus on Corbeil-Essonnes, France.

Optima has teamed up with the Robert-Bosch-Krankenhaus and Heidelberg University to develop a unit for decentralized, automated production of CAR-T cell therapies.

Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.

The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.

The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.

As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.

Brinter has successfully closed a €1.2 million (US $1.5 million) seed funding round, which was led by the early-stage venture capitalist Innovestor.

Researchers from the Chalmers University of Technology and AstraZeneca have developed a new method of detecting and testing lipid nanoparticles.

Immodulon has received an indication of allowability from the European Patent Office for the claims in its patent application relating to its lead drug candidate.

FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.

The vaccine is now authorized for ages 12 and older in European Union member states and the UK.

The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.

VIVEbiotech has opened its new lentiviral vector manufacturing facilities in Spain, expanding capacity for lentiviral vectors for use in cell and gene therapies.

AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.

FDA has granted fast track designation to a GLP-1/glucagon dual agonist in development by Boehringer Ingelheim and Zealand Pharma for the treatment of NASH.

FDA has granted Janssen breakthrough therapy designation for teclistamab, an investigational bispecific antibody under development for treating relapsed or refractory multiple myeloma.

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.

The acquisition of Advanz Pharma by Nordic Capital has now completed, in a deal worth $846 million.

Hovione has re-joined iBET to increase its R&D programs in novel and high potential pharmaceutical technologies and to combine expertise for industrial innovation in new therapeutic fields.

Through the acquisition, Aceto can now offer its customers support throughout the drug development process and access to North American manufacturing for APIs and advanced intermediates.

The added capabilities include clinical-scale sachet and blister packaging for clinical trial pharmaceuticals and a relationship with a European Union Qualified Person for its CTS offerings.

GoSilico’s software for digital twins of downstream biopharmaceutical processes will be integrated into Cytiva.

Currently, PNI offers a Genetic Medicine Toolkit, including its GenVoy LNP delivery platform and NanoAssemblr microfluidic-based nanoparticle manufacturing platform, for the development of genetic medicines.

Through the acquisition, Avantor will have access to RIM’s Changzhou, China, facility, making it Avantor’s first single-use production plant in the AMEA region.

The companies are expanding their collaboration to extend the drug substance manufacturing of Moderna’s COVID-19 vaccine with the addition of a new manufacturing line at Lonza’s Geleen, Netherlands, site.

PPD has opened its new multipurpose clinical research laboratory in Suzhou, China, which offers bioanalytical, biomarker, and vaccine sciences services for China and the global market.