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SII pauses trials of COVID-19 vaccine candidate Covishield in India
expresspharma
September 23, 2020
The company took this step after the DCGI issued a show cause notice to the company for not informing it about AstraZeneca pausing the clinical trials of the vaccine candidate in other countries.
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DCGI issues notice to Serum Institute over AstraZeneca-Oxford COVID-19 vaccine trial suspension
expresspharma
September 18, 2020
If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocol, said SII in response to show cause notice.
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Serum Institute receives DCGI approval to resume trials of Oxford COVID-19 vaccine
expresspharma
September 17, 2020
The DCGI has, however, put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study.
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PNB Vesper gets DCGI nod to test proprietary drug PNB 001 in COVID-19 patients
expresspharma
September 14, 2020
A study will be conducted on 40 moderately-ill COVID-19 patients at BMJ Medical College, Pune who are on oxygen support.
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Bharat Biotech gets DCGI nod for PHASE II trials of COVAXIN
expresspharma
September 07, 2020
The subject expert committee (SEC) has recommended that the trial will be conducted on 380 participants.
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Abbott gets DCGI approval for Ivabradine
expresspharma
September 03, 2020
Abbott has received approval from the Drugs Controller General of India (DCGI) for its Ivabradine, once-a-day formulation.
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Intas gets DCGI nod for clinical trials of hyperimmune globulin for COVID-19 treatment
expresspharma
August 27, 2020
It can be an important therapeutic option that can potentially help combat the disease until a vaccine is available, states the company.
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Stempeutics’ allogeneic cell therapy gets DCGI approval, Cipla to market and distribute Stempeucel
expresspharma
August 21, 2020
Indicated for the treatment of CLI due to Buerger’s Disease and Atherosclerotic Peripheral Arterial Disease, it is the first allogeneic cell therapy product to be approved for commercial use in India.
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Brinton Pharma gets DCGI nod for Faviton 400 mg
expresspharma
August 21, 2020
Brinton Pharmaceuticals has received approval from Drugs Controller General of India (DCGI) for the launch of Favipiravir 400mg under the brand name Faviton.
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AstraZeneca gets DCGI nod to import and market Olaparib film coated tablets
expresspharma
August 20, 2020
It is additionally indicated as a monotherapy to treat adults with metastatic castration-resistant prostate cancer and homologous recombination repair gene mutations。