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Drug firm AstraZeneca India on Friday said it has received approval from the domestic drug regulator to market a drug to treat biliary tract cancer (BTC) in the country. The company has received approval from the Central Drugs Standard Control Organisation (CDSCO) for Durvalumab, the drug firm said in a statement. BTC is a group of rare and aggressive gastrointestinal (GI) cancers that form in the cells of the bile ducts (cholangiocarcinoma), gallbladder or ampulla of Vater (where the bile duct and pancreatic duct connect to the small intestine). Apart from ampullary cancer, early-stage BTC often presents without clear symptoms and most new cases of BTC are therefore diagnosed at an advanced stage, when treatment options are limited, and the prognosis is poor. More than 30,000 new cases of BTC are seen in India every year with 90 per cent of them diagnosed in the advanced stage. "The approval underpins our commitment to transform patient outcomes by harnessing the power of science
AstraZeneca Pharma India on Wednesday said Gagandeep Singh Bedi has resigned from the post of managing director. The drug firm said it has approved the appointment of Sanjeev Panchal as its managing director for a period of three years with effect from January 1, 2023. Panchal had joined AstraZeneca Pharma in February 2003 as Brand Associate and progressed through several positions in India, Indonesia, Asia Pacific and the international region, based in Singapore and the United Kingdom (UK), it said.
Drug firm AstraZeneca India on Tuesday said it has received approval from the country's drug regulator to market anti-diabetes medication Dapagliflozin. The company said it has received approval from the Central Drugs Standard Control Organization (CDCSCO) for the drug indicated for diabetes patients with chronic kidney disease (CKD). Dapagliflozin is the first and only anti-diabetic drug approved to significantly reduce the risk of sustained eGFR (estimated Glomerular Filtration Rate), cardiovascular deaths and hospitalisations due to heart failure in adults with progressive chronic kidney disease, the drug firm said. The approval is applicable for both diabetic and non-diabetic CKD patients, it added. CKD is one of the leading causes of hospitalisation globally and in India, representing a significant clinical and economic burden. "The timely approval of Dapagliflozin from the CDCSCO committee with the additional indication is a huge boost for nephrologists across the country .
AstraZeneca's intranasally-administered vaccine against COVID-19 did not perform as expected in a small study published on Tuesday, suggesting there are likely to be challenges in making nasal sprays a reliable option. The findings from a Phase 1 clinical trial, published in the journal eBioMedicine, show mucosal antibody responses were generated in a minority of participants. Systemic immune responses, which involves many other immune cells, to intranasal vaccination were also weaker compared with intramuscular vaccination, the researchers said. The study was performed in collaboration with the University of Oxford and used the same vaccine based on the ChAdOx1 adenovirus vector, as is already licensed for use by injection. The ChAdOx1 vector used in the vaccine is a weakened version of a common cold virus (adenovirus) that has been genetically modified so it is impossible for it to replicate in humans. The latest study is thought to be the first to have published data from ...
Drug firm AstraZeneca India on Friday said it has received an approval from the Drugs Controller General of India to market its drug for the treatment of breast cancer. The Drugs Controller General of India (DCGI) has approved Lynparza (Olaparib) as a monotherapy for the treatment of adult patients with early breast cancer, who have previously been treated with neoadjuvant or adjuvant chemotherapy. The approval was based on results from the OlympiA Phase III trial, which suggested that Olaparib demonstrated a statistically significant and clinically meaningful improvement, with an overall survival benefit, AstraZeneca India said in a statement. With the DCGI's nod, Lynparza is now approved in the US, EU, Japan, India and several other countries for the treatment of early-stage breast cancer, it added. Currently, Lynparza is the first and only approved medicine targeting BRCA (Breast Cancer gene) mutations in early-stage breast cancer. "The regulatory approval of Lynparza...reinfor