Drug Approval | September 01, 2022
Biological E. announces CDSCO recommendation of its infant’s vaccine
Subject Expert Committee(SEC) of Central Drugs Standard Control Organization (CDSCO)
Subject Expert Committee(SEC) of Central Drugs Standard Control Organization (CDSCO)
National Institute of Biologicals should undertake the testing of more biologicals and also extend its testing expertise in helping other countries
The move comes a few weeks after receiving the EUA for children between the ages of 5 and 12
Primarily set up to address the Covid-19 emergency, the WHO technology transfer hub has the potential to expand manufacturing capacity for other products as well, including treatments, and target other priorities such as malaria, HIV and cancer
In a Nature Communications Medicine publication, the Verita proprietary platform detected 96 per cent of stage 1 pancreatic cancers and three-quarters of stage 1 ovarian cancers using isolated exosomes and AI-enabled protein marker analysis
To date, 30 crore vaccines have been produced as part of the commitment made to the Government of India
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Shilpa Biologicals has tie-ups with Zydus to supply ZyCoV-D vaccine drug substance and Dr Reddy’s to make Sputnik V from its facility in Dharwad
The Subject Expert Committee has recommended grant of permission to conduct Phase 3 trials under certain conditions
Support from DFC will help produce one billion vaccine doses by the end of 2022
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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