The U.S. government has secured 100 million doses of Moderna’s vaccine candidate mRNA-1273 as part of the goal of securing early access to safe and effective COVID-19 vaccines for the American people. The award of up to $1.525 billion is for the manufacturing and delivery of 100 million doses of mRNA-1273 including incentive payments for timely delivery of the product. […]

Biogen and Eisai today announced that the FDA has accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally. The application has been […]

Biogen and Denali Therapeutics have signed a binding agreement to co-develop and co-commercialize Denali’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for Parkinson’s disease. Biogen will also receive rights to opt into two programs and a right of first negotiation for two additional programs, in each case for neurodegenerative diseases leveraging Denali’s Transport […]

Cambridge-based Seres Therapeutics has reported positive topline results from its Phase 3 study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI). “Based on our prior discussions with the FDA, we believe this trial should provide the efficacy basis for submitting an application for product approval. We look forward to meeting with the […]

Sanofi and GSK have entered into a collaborative effort with the U.S. government to accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine. The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK’s established pandemic adjuvant […]

Gene editing company CRISPR Therapeutics is building a new cell therapy manufacturing facility in Framingham, Massachusetts for clinical and commercial production of the company’s investigational cell therapy product candidates. “We look forward to building a state-of-the-art manufacturing facility, which will accelerate our programs and allow us to scale for commercial supply. We are thankful for […]