Regulatory Hurdles Stall Bharat Biotech's Phase III Tuberculosis Vaccine Trials

Regulatory Hurdles Stall Bharat Biotech’s Phase III Tuberculosis Vaccine Trials

Regulatory Oversight Delays Vaccine Progress The Central Drugs Standard Control Organization (CDSCO) has requested additional data from Bharat Biotech regarding its proposed phase III clinical trial for MTBVAC, a leading tuberculosis vaccine candidate. The decision, announced this week in New Delhi, temporarily halts the progression of the trial in India, citing specific gaps in the…

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Regulatory Hurdles Stall Bharat Biotech's Phase III Tuberculosis Vaccine Trials

Regulatory Hurdles Stall Bharat Biotech’s Phase III Tuberculosis Vaccine Trials

Regulatory Oversight Delays Vaccine Progress The Central Drugs Standard Control Organization (CDSCO) has halted the immediate approval of Bharat Biotech’s phase III clinical trials for MTBVAC, citing critical gaps in the proposed study design. The decision, issued this week in New Delhi, forces the Hyderabad-based vaccine manufacturer to address specific safety and efficacy protocols before…

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