Page 5 - Astrazeneca

AstraZeneca Pharma India Q1 PAT jumps over two-fold to Rs 53.86 cr

AstraZeneca Pharma India Ltd on Monday reported over two-fold rise in profit after tax at Rs 53.86 crore for the first quarter ended June 30, 2023. The company had posted a profit after tax of Rs 20.15 crore in the same quarter last fiscal, AstraZeneca Pharma India said in a regulatory filing. Revenue from operations during the quarter under review stood at Rs 295.46 crore, as against Rs 232.33 crore in the year-ago period, it added. Total expenses were higher at Rs 232.17 crore, as against Rs 209.14 crore, the company said.

AstraZeneca Pharma India gets GCGI approval to import heart failure drug

AstraZeneca Pharma India on Monday said it has received approval from the Drugs Controller General of India to import heart failure treatment drug Dapagliflozin tablets. The company has received permission from the DCGI to import pharmaceutical formulations of a new drug for sale, the drug firm said in a regulatory filing. Dapagliflozin tablets are indicated for the treatment of heart failure in adults, it added. The receipt of this permission paves the way for the launch of the product in India for the specified indication, subject to the receipt of related statutory approvals and licenses, it said. Shares of the company on Monday ended 0.86 per cent down at Rs 3,769.40 apiece on the BSE.

AstraZeneca's cancer drug shows more potential over chemotherapy: Study

The results potentially validate Astra's decision to pay as much as $6 billion for the right to develop the medicine with Daiichi Sankyo Co. and its bet to revive growth a decade ago

Stocks to watch: Adani Enterprises, Tata Motors, NHPC, AstraZeneca, SJVN

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AstraZeneca receives CDSCO's approval for cancer drug Tremelimumab

AstraZeneca Pharma India on Thursday said it has received approval from the Central Drugs Standard Control Organisation (CDSCO) for its cancer drug Tremelimumab Concentrate to be administered intravenously. The approval for Tremelimumab in combination with Durvalumab is based on results from Phase III HIMALAYA clinical trial and is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC), the drug firm said. The trial was conducted in 181 centres across 16 countries, including in the US, Canada, Europe, South America and Asia including India, it added. The approval paves the way for the launch of Tremelimumab solution of 20 mg/ml (25 mg/1.25 ml and 300 mg/15 ml presentations in single-dose vials in India for the specified indication, AstraZeneca Pharma said. "This approval is in line with our ambition of transforming patient outcomes and not leaving any patient behind. We have a breadth of scientific platforms to attack cancer while exploring the po

AstraZeneca Pharma India gets DCGI's nod for cancer-treating drug

AstraZeneca Pharma India Ltd on Wednesday said it has received an approval from the Drug Controller General of India (DCGI) for the cancer drug trastuzumab deruxtecan for treatment of metastatic breast cancer. The company said it has been granted approval to import and market trastuzumab deruxtecan used in the treatment of select "HER-2 positive" breast cancer. "The India approval is based on a global, head-to-head, randomised, open label, registrational Phase III trial DESTINY Breast 03. Globally, trastuzumab deruxtecan is approved in more than 40 countries, including the US, for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer," AstraZeneca Pharma India said in a statement. HER2 is a form of growth-promoting protein expressed on the surface of multiple tumours, including breast, gastric, lung and colorectal cancers, and is one of the biomarkers expressed in breast cancer tumours, it added. "India's approval of trastuzumab deruxtecan mark

Astrazeneca India to set up five centres for severe asthma management

AstraZeneca India on Tuesday said it will set up five centres across Delhi, Ahmedabad, Goa and Cochin to provide a systematic approach to standardised management of patients with severe asthma. The Centers of Excellence (COEs) would concentrate on specialty and clinical assessment, diagnosis, patient counselling, biologics initiation, and data management related to severe asthma, the drug firm said in a statement. "In India, severe asthma is largely managed by oral glucocorticoids that have side effects such as osteoporosis, hypertension, ulcers, weight gain, etc., despite availability of newer treatment options such as biologicals that have shown to improve outcomes in patients," AstraZeneca India Vice President - Medical Affairs & Regulatory Anil Kukreja said. The company's goal is to establish more such centres of excellence throughout the country and tackle complications by continually monitoring patients, educating healthcare professionals and improving respiratory health for

US FDA panel backs restricted use of AstraZeneca's prostate cancer drug

Lynparza is already approved by the FDA to treat a type of breast cancer, ovarian cancer, as well as a different form of prostate cancer

AstraZeneca shot raised heart-related death risk in young women: Report

AstraZeneca's Covid vaccine (manufactured and administered in India as Covishield) raised the risk of heart problem, and death by 3.5 times in young women in the first three months following

AstraZeneca gets CDSCO nod for drug to treat biliary tract cancer

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's MD resigns; appoints Sanjeev Panchal for 3 years

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.

Fosun's sale of Gland Pharma to become India's biggest pharma deal: Report

With the acquisition, Gland pharma may also get access to global companies like AstraZeneca, Sanofi, Mylan, and Organon

Woman slips into coma after AstraZeneca vaccine dose against Covid-19

Diagnosed with rare, serious condition

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AstraZeneca India gets regulator's approval to market anti-diabetes drug

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 nasal Covid vaccine not as effective as expected: Study

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 ...

Fight against Covid-19: Here is a list of vaccines approved in India

Besides Bharat Biotech's nasal vaccine, India has 13 vaccines to fight against Covid-19. Two have been approved for manufacturing, while 11 have been approved for emergency use

AstraZeneca India gets DCGI approval to market drug treating breast cancer

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

Canada to throw out 13.6 million doses of AstraZeneca Covid vaccine

Canada is going to throw out about 13.6 million doses of the Oxford-AstraZeneca COVID-19 vaccine because it couldn't find any takers for it either at home or abroad

Covid vaccines prevented 20 million deaths in first year of rollout: Study

While more than 7 million deaths were likely averted in countries covered by Covax, the WHO-backed distribution program, the research nonetheless highlights the devastation caused by uneven access