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AstraZeneca Pharma on Tuesday said it has received approval from the national drug regulator to market a cancer treatment drug in the country. The company has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import, market, and distribute Trastuzumab Deruxtecan for an additional indication in India, the drug firm said in a statement. With this approval, Trastuzumab Deruxtecan is now indicated for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumours, who have received prior systemic therapy and have no satisfactory alternative treatment options, it added. This marks the first and only antibody drug conjugate in India with a tumour-agnostic indication, representing a significant advancement in precision oncology, the company said. "This milestone reflects our unwavering commitment to patient-centricity, scientific excellence, and equitable access to breakthrough therapies. By bringing Trastuzumab Deruxtecan to ..
Global bio-pharmaceutical company AstraZeneca has established its state-of-the-art Global Hub in Bengaluru investing Rs 166 crore to focus on development of AI-powered healthcare solutions, a top official said on Thursday. This marks the second major investment by AstraZeneca in July 2024 after it announced expansion of its Global Innovation and Technology Centre in Chennai with an outlay of Rs 250 crore. The new facility in Bengaluru is designed to accommodate nearly 1,300 employees including 400 new jobs. It will support the company's capabilities in AI-powered innovation across Research and Development, global business services, Information Technology and digital health operations, among others. The Global Hub in Bengaluru is dedicated to Research and Development, Global Business Services, Information Technology while the Global Innovation and Technology Centre in Chennai serves as a strategic hub for IT, Global Business Services. Following the expansion of the facility, the ...
AstraZeneca Pharma India Ltd on Tuesday said it has surrendered the marketing authorisation of prostate cancer treatment drug Olaparib (Lynparza) 100mg and 150mg in India citing commercial reasons. The company had received marketing authorisation for Olaparib film-coated tablets 100mg and 150mg (Lynparza) on November 17, 2023, AstraZeneca Pharma India said in a regulatory filing. It has now surrendered the marketing authorisation of the indication of Olaparib (Lynparza) 100mg and 150mg, the filing added. "...since the date of receipt of marketing authorisation for the said indications i.e. November 17, 2023, till date, we have never marketed the said indication in India," the company said, adding, "the discontinuation decision is only on the basis of commercial reasons and is not due to efficacy or safety reasons." The drug is indicated in combination with Abiraterone and Prednisone or Prednisolone for the treatment of adult patients with metastatic castration-resistant prostate ..