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

Novel Automated Process May Speed Up Development of New Medicines

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

CGT Catapult Forms Consortium to Accelerate Manufacturing Technology Development

 Washington Editor, jillwechsler7@gmail.com.

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

New Alzheimer’s Drug Heightens Debate Over FDA Accelerated Approval Process

The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.

FDA Publishes Guidance Documents to Enhance Supply Chain Security

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

FDA Grants Accelerated Approval for Biogen’s Alzheimer’s Drug

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

Biden Budget “Wish List” Maps FDA and Health Care Priorities

As COVID-19 continues to spread, industry leaders are banding together to stop the disease in its tracks. 

Industry Consortiums Work to Tackle COVID-19

Moderna has initiated a rolling submission process with FDA for a biologics license application for its mRNA COVID-19 vaccine for individuals 18 years of age and older.

Moderna Initiates Rolling Submission of Biologics License Application for its COVID-19 Vaccine

FDA has issued an emergency use authorization for sotrovimab, an investigational monoclonal antibody therapy, for the treatment of mild-to-moderate COVID-19. 

FDA Issues EUA for mAb Therapy for the Treatment of COVID-19

In the face of a growing clamor for greater worldwide access to COVID-19 vaccines, biopharma companies are promising to expand distribution of free and low-cost preventives to curb the pandemic globally. 

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