Biotech | 22 October 2021
WuXi ATU opens manufacturing facility in Shanghai to enhance its CTDMO services
It’s the company’s fourth manufacturing site worldwide. Others are located in the US, UK and China
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
VIPER AI solutions support care teams by automating the identification of potentially eligible patients at the time of diagnosis and easily matching them to relevant trials
AZD7442 reduced risk of developing severe Covid-19 or death in Tackle Phase III outpatient treatment trial
The rolling submission to the U.S. FDA will begin in the fourth quarter of this year
Gantenerumab is an investigational antibody in Phase III development for early Alzheimer's disease (AD) and a comprehensive data set with an expected readout in mid-2022
Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the U.S. Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE)
Alnylam is the latest partner in the Medicines Manufacturing Innovation Centre’s third Grand Challenge project, which aims to revolutionise the manufacturing process for oligonucleotide therapies
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