Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications
Following the review of around 20 candidate vaccines by the external advisory group, MVC's vaccine was selected as one of two to be included in the global trial
Filing marks first protein-based vaccine submitted to MHRA for authorization
Support from DFC will help produce one billion vaccine doses by the end of 2022
Strengthens supply chain continuity with first manufacturing facility outside of the U.S.
The company is continuing with the evaluation of canakinumab in lung cancer, and is applying findings to the overall lung cancer development plan
It’s the company’s fourth manufacturing site worldwide. Others are located in the US, UK and China
This strategic collaboration will enable continued innovation in cancer care
Incidences of Non-alcoholic Fatty Liver Disease (NAFLD) have been rising exponentially worldwide and are associated with co-morbidities including obesity, diabetes, hypertension and metabolic disorders
Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
It has exercised intellectual property options from IP Group regarding research results generated by the UK Cystic Fibrosis Gene Therapy Consortium, and from Oxford Biomedica regarding their lentiviral vector technology
The first patient dosed with VX-880 demonstrated restoration of insulin production and achieved C-peptide of 560 pmol/L in response to Mixed Meal Tolerance Test (MMTT) at Day 90 visit
The trial met the primary endpoint of overall survival with a single priming dose of tremelimumab plus Imfinzi every four weeks vs. sorafenib
U.S. FDA to decide whether to authorize a booster dose in the coming days
Ipsen obtains an exclusive license to develop, manufacture and commercialize a pre-clinical stage METTL3-inhibitor programme
U.S. FDA has accepted the investigational new drug application for phase 1 clinical trial in non-Hodgkin’s lymphoma
Standalone use of Sputnik Light also provides much higher efficacy against severe disease and hospitalizations
New safety data show a consistent benefit-risk profile across all Ocrevus clinical trials
This expansion will support the global operations network and help meet global demand for mammalian development services that support Lonza’s manufacturing sites
This new lyophilizer is equipped with systems to best protect high value Active Pharmaceutical Ingredients (APIs) and doubles the lyophilization capacity at the site
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