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
New safety data show a consistent benefit-risk profile across all Ocrevus clinical trials
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The two doses of Covaxin are likely to be administered to children with a gap of 28 days
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
It recommends using the vaccine to prevent the spread of the disease
The aim is to first produce Covid-19 vaccines and then add more vaccines in the years to come
The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)
The 462,000 square foot state-of-the-art building targeting LEED Zero certification and is designed to be the most sustainable commercial lab building in Cambridge
Fastminar is a 40-feet structure made with approximately 80,000 toothbrushes and is located at Terna Dental College in Navi Mumbai
The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology
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