HC allows Biocon, Mylan to sell their drug for three cancers
PTI The Delhi High Court today allowed drug companies Biocon and Mylan to sell their version of Trastuzumab for two kinds of breast cancer and metastatic gastric cancer in view of the approval granted to it by the Drugs Controller General of India (DCGI). "In view of the fact that appropriate authority has approved the package insert and the drug for all three indications (diseases), we feel there should be no restriction imposed at this stage with regard to second and third indication also," a bench of justices Badar Durrez Ahmed and Sanjeev Sachdeva said. "Consequently, till further orders, Biocon and Mylan are permitted to sell Trastuzumab under their respective brand names for all three indications (metastatic breast cancer, ...
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 ...
Karnataka approves Rs.2,211 crore investment proposals
The Dollar Business Bureau The government of Karnataka has approved three projects, including Biocon and PepsiCo India, thus committing to a total investment of Rs.2,211 crore. An official release said that Biocon has proposed an investment of Rs.1,060 crore for the manufacturing of monoclonal, injectable and anti-bodies vaccines, in the Anekal Taluk. The project is expected to employ 750 people. In the same way, PepsiCo India is investing Rs.590 crore and has proposed to set up beverage and snack unit at Nanjangud taluk in Mysuru district. This project is expected to employ 900 people. The 44th state level clearance meeting that was chaired by Siddaramaiah, Chief Minister of Karnataka, also approved the expansion project of Manyata Promoters Pvt.Ltd. The additional investment for this project ...
Biocon receives approval for generic Crestor in Europe
The first generic formulations approval in the regulated markets marks an important milestone in Biocons small molecules strategy of forward integration from APIs to finished dosages The Dollar Business Bureau Biocon plans to collaborate with regional partners to provide access to the affordable generic and help patients and governments bring down their healthcare spends Bengaluru-based bio-pharmaceuticals company Biocon Ltd. on Monday announced that it has received European approvals for its Rosuvastatin Calcium 5 mg, 10 mg, 20 mg and 40 mg tablets, a generic version of Crestor tablets, indicated for hyperlipidemia or mixed dyslipidemia. The approval for Rosuvastatin Calcium, through decentralised procedure will open the doors for Biocon to over 15 European countries and will enable the company to address $1.2 billion opportunity, ...
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 ...