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  • With the announcement of COVAXIN by Bharat Biotech and ZyCov-D Vaccine by Zydus Cadila the proverbial silver line in the dark clouds of COVID19 appears at the horizon. Now the nod given by the Drug Controller General of India CDSCO (The Central Drugs Standard Control Organisation) for the conduct of the human trial for the vaccines, marks the beginning of the end.

  • 6 July 2020
    International regulators provide guiding principles for COVID-19 clinical trials

    EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory Authorities (ICMRA). Medicines regulators from around the world have jointly developed this statement to step up global collaboration to facilitate and expedite the development and evaluation of therapeutics, diagnostics and vaccines against COVID-19.

  • 6 July 2020
    FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer

    U.S. Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving chemotherapy.

  • ICMR has partnered with Bharat Biotech lnternational Limited (BBIL) to fast-track clinical trials of the indigenous COVID-19 vaccine (BBV152 COVID Vaccine) and its clinical trials were approved by DCGI by end of June.

     

  • Sun Pharma and includes its subsidiaries and/or associate companies) announced that one of its wholly-owned subsidiaries has received approval from the Ministry of Health, Labour and Welfare (MHLW), Japan for ILUMYA (tildrakizumab) for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies. Japan has approximately 430,000 people currently suffering from psoriasis.

  • Drug Controller General of India (DCGI) has given approval for human clinical trials of COVAXIN, the first potential COVID-19 Vaccine developed in India. The potential vaccine has been developed by Hyderabad-based Bharat Biotech, in association with Indian Council for Medical Research (ICMR). Human Trials for Phase I and Phase II are scheduled to start across the country from next month.

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