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DCGI approves trials for Biocon, Quark new eye drug

The Dollar Business Bureau India’s leading Biopharmaceutical firm Biocon Ltd on Thursday said that the Drug Controller General of India (DCGI) has given approval to it and its partner Israel-based Quark Pharmaceuticals Inc to go on with the clinical trials on human subjects for their new drug candidate, 'QPI-1007', which is aimed to treat ocular neuroprotection.  Both the companies also informed the randomisation of first patient in the country in the Phase II/III global study of the latest drug candidate, Biocon said in a statement.  Randomisation is referred to as providing subjects to treatment groups to check selection and accidental bias.  “Biocon and Quark Pharmaceuticals have got the approval from DCGI to go on with the study, the first ever ...

Biocon Introduces therapy for Hepatitis-C in India

The Dollar Business Bureau The 12-week treatment course will cost about $94,000 in the US, about Rs.63 lakh in India   Biocon Ltd. on Thursday announced that it has introduced an advanced novel therapy CIMIVIR-L for the treatment of Hepatitis C in India. “The Drug Controller General of India (DGCI) recently approved the sale of Sofosbuvir - Ledipasvir combination, which is being manufactured in India under a license from Gilead,” Biocon Ltd. said in an announcement. A combination of Ledipasvir 90 mg and Sofosbuvir 400 mg, CIMIVIR-L, is once-a-day oral therapy useful for people infected with the Hepatitis – C Virus (HCV). The therapy is indicted for Hepatitis – C Genotype 1 patients who account for about 25% of the total estimated ...

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