News

CureVac’s first-generation COVID-19 vaccine candidate, CvnCoV, did not meet efficacy targets in a second interim analysis.

The US government will invest $3 billion from the American Rescue Plan into a COVID-19 antiviral development strategy.

GlaxoSmithKline and iTeos Therapeutics enter into a development and commercialization collaboration worth up to $2.08 billion for a new therapeutic anti-cancer mAb candidate.

Recent analysis has shown that two doses of COVID-19 vaccines are highly effective against hospitalization as a result of infection with the Delta variant of COVID-19.

BIA has published a report presenting the findings of a survey on the public attitudes toward equal access to medicines for those living with rare diseases.

Horiba has joined a consortium aimed at accelerating the development of process analytical technologies for cell and gene therapy manufacturing

Sanofi’s new Pennsylvania facility expands production of Fluzone High-Dose Quadrivalent flu vaccine.

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.

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.

The CGT Catapult has formed a consortium aimed at advancing the technology development and lowering costs of cell and gene therapy manufacturing.

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.