Single booster dose at 6 months of NVX-CoV2373 increased wild-type neutralizing antibodies more than 4-fold versus primary vaccination series
Nexviazyme specifically targets the M6P receptor, the key pathway for enzyme replacement therapy, to effectively clear glycogen build-up in muscle cells
Deal for 100 million doses with additional 100 million through 2023
The TWYMEEG approval is supported by numerous preclinical and clinical studies, including the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) program managed jointly by both the companies
Allecra Therapeutics would now either directly or through out license file for NDA of this molecule.
The facility is expected to be completed in 2024
Molnupiravir is an investigational oral antiviral drug currently being studied in a Phase 3 trial for the treatment of non-hospitalized patients with confirmed COVID-19
The vaccine was 85 percent effective in preventing severe disease across all regions.
Bharat Biotech expects to share further details of the trial results as additional data become available.
The company will review FDA's response and decide on appropriate next steps soon.
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