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May 18, 2021
The US Supreme Court has denied a petition by Sandoz, a Novartis company, to review a July 2020 ruling concerning its biosimilar Erelzi (etanercept-szzs), blocking the company from launching the product.
May 12, 2021
NIH reported that an investigational gene therapy developed by researchers from the University of California, Los Angeles and Great Ormond Street Hospital in London can restore the immune systems of infants and children who have severe combined immunodeficiency due to adenosine deaminase deficiency.
May 10, 2021
Pfizer and BioNTech have initiated a rolling submission of a biologics license application to FDA for the approval of their COVID-19 vaccine in individuals 16 years of age and older.
May 07, 2021
Projects led by collaborating researchers from both Sanofi and Stanford Medicine will focus on autoimmune diseases and inflammatory conditions.
Eli Lilly and Company has partnered with leading diabetes tech firms to offer app compatibility with insulin smart pens to streamline diabetes management with automated data collection.
The European Commission has approved an additional indication for Roche’s Tecentriq (atezolizumab) as a first-line monotherapy treatment for metastatic non-small cell lung cancer.
Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences.
Janssen has submitted a marketing authorization application to EMA seeking approval of its investigational BCMA-directed CAR-T cell therapy.
May 05, 2021
Cellares has raised $82 million to accelerate the development of its Cell Shuttle, a factory-in-a-box that allows for the automation of the process of creating highly individualized cell therapies.