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The government has issued an advisory tightening regulation of stem cell therapy, allowing standard clinical use only for approved indications. Stem cell treatment for autism remains limited to approved clinical trials, with unauthorised use, promotion or advertising attracting professional misconduct and disciplinary action
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The Union Health Ministry has eased pharmaceutical regulations, allowing companies to start drug development and low-risk clinical studies via online intimation to CDSCO, cutting approval timelines, reducing regulatory burden, and boosting research and innovation in the Indian pharma sector
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Preparations for human clinical trials of first-age reversal gene therapy are ongoing.
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The interim results on 353 patients showed that the drug has been successful in reducing viral load effectively with RT-PCR negativity.
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Hyderabad-based pharma company has approached the Drug Controller General of India to seek Emergency Use Authorization for the investigational drug in India
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Several research activities are being carried out to study Variants of Concern and assess their suitability for follow-up booster doses, the company said here on Tuesday.
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The plea filed through advocate Prashant Bhushan sought direction to the government to make public the segregated data of the clinical trials for the vaccines.
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India has become the 60th country to approve Sputnik V, RDIF, Russia's sovereign wealth fund, said in a statement.
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Making the announcement on Friday, The Whiteboard said that this acquisition increases its breadth of courses.
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The Nation's first indigenously developed DNA vaccine candidate against COVID-19, ZyCoV-D, by M/s Zydus Cadila has been approved by Drugs Controller General of India (DCGI), for the conduct of the Phase III clinical trials
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The trials, which will commence in December, will be conducted on 250 patients across 20-25 centres in India.
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Zydus Cadila has announced that the phase-I clinical trial of its vaccine candidate ZyCoV-D was over and it has commenced phase-II clinical trials from August.
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According to the RDIF -- Russia's sovereign wealth fund, the vaccine's interim clinical trial results show 95 per cent efficacy on the 42nd day after the first dose.
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To ensure participant safety, trials start with small groups and examine whether a new method causes any harm or unsatisfactory side effects.
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Vaccine showed 90% efficacy in one dosing regimen when the vaccine was given as a half dose, followed by a full dose at least a month later, and another dosing regimen showed 62% efficacy when given as two full doses
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Regulatory approval was being sought for the vaccine to progress to Phase 3 clinical trials before the end of the year.
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SII and ICMR are conducting phase II/III clinical trial of the vaccine at 15 different centres across the country.
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Collaboration will allow Dr Reddy’s to identify and use some of the Biotechnology Industry Research Assistance Council’s clinical trial centres
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The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3)
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The virus is still spreading rapidly worldwide, with over one million deaths and 37 million infections.