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Biotechnology major Biocon on Wednesday said it has initiated a clinical study in collaboration with Equillium Inc to evaluate efficacy of Itolizumab in patients with Ulcerative Colitis. This is a phase two randomised, double-blind, parallel-group, placebo and active-controlled (adalimumab), two treatment period study to evaluate the safety and efficacy of Itolizumab for the induction of remission in biologics naive patients with moderate to severely active Ulcerative Colitis (UC), Biocon said in a statement. Having obtained approval from the Drugs Controller General of India (DCGI), the study will cover several tertiary hospitals specialised in handling UC cases, it added. The first patient who intended to participate in the study was screened on December 1, 2022, the company said. "The commencement of the Phase two clinical study, that will determine its efficacy for the treatment of Ulcerative Colitis, is an important step forward in our efforts to bring its benefit to patients
FSSAI has come out with draft regulations for genetically modified food, proposing mandatory prior approval from the regulator to manufacture, sell and import food or ingredients produced from genetically-modified organisms. The proposed Food Safety and Standards (Genetically Modified Foods) Regulations, 2022 will apply to Genetically Modified Organisms (GMOs) intended for food use, as per the Food Safety and Standards Authority of India (FSSAI). The regulations, once implemented, will also be applicable to food ingredients produced from GMOs that contain modified DNA as well as for food ingredients produced from GMOs that do not contain modified DNA but includes ingredients/additives/processing aids derived from GMOs. GMO means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology. "No person shall manufacture, pack, store, sell, market or otherwise distribute or import any food or food ingredient produced from
Biotechnology major Biocon on Wednesday reported a 71 per cent increase in consolidated net profit at Rs 144 crore for the June quarter on the back of robust growth across business verticals. The company had posted a net profit of Rs 84 crore in the April-June quarter of the previous fiscal. Total revenue rose to Rs 2,217 crore in the first quarter as compared with Rs 1,808 crore in the year-ago period, Biocon said in a regulatory filing. Biocon Executive Chairperson Kiran Mazumdar-Shaw said revenues grew as a result of robust growth in both biosimilar and generics verticals. "Our financial performance this quarter includes the impact of annual increments in personnel costs as well as increased input and freight costs, pursuant to pandemic and geopolitical disruptions of global supply chains," she added. All the company businesses are poised for the next phase of sustainable growth which has been challenged during the two years of the Covid pandemic, Mazumdar-Shaw said.