The Drugs Controller General of India (DCGI) has granted emergency approvals to Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin vaccines for the prevention of Covid-19. COVISHIELD has been developed at the Serum Institute of India’s laboratory in Pune with a master seed from Oxford University and pharma giant AstraZeneca. According to DCGI VG […]
AstraZeneca has secured extended approval from the US Food and Drug Administration for using Tagrisso (osimertinib) as an adjuvant treatment of non-small cell lung cancer (NSCLC) in patients whose tumors have a certain type of genetic mutation. According to the FDA, nearly 20% of patients with non-small cell lung cancer will have epidermal growth factor […]
Continue reading …AstraZeneca acquisition of Alexion Pharmaceuticals : Pharma giant AstraZeneca has signed a $39 billion deal to acquire Alexion Pharmaceuticals, a US biopharma company engaged in developing therapies for rare disorders. As per the terms of the deal, Alexion Pharmaceuticals’ shareholders will be paid $60 in cash and 2.1243 American Depositary Shares (ADSs) of AstraZeneca, valuing […]
Continue reading …BRILINTA FDA approval : AstraZeneca has bagged approval for BRILINTA (ticagrelor) from the US Food and Drug Administration for its use in reducing the risk of stroke in patients having acute ischemic stroke or high-risk transient ischemic attack (TIA). The FDA approval was driven by the positive results from the THALES phase 3 clinical trial […]
Continue reading …AstraZeneca said that clinical trials for the AZD1222 Covid-19 vaccine candidate, have resumed in various parts of the world after regulators across the US, UK, Brazil, Japan, and South Africa confirmed that it was safe to continue them. The US Food and Drug Administration (FDA) has authorized the restart of AZD1222 clinical trials in the […]
Continue reading …AstraZeneca said that AZD7442, which is being developed for the prevention and treatment of Covid-19, will move into two phase 3 clinical trials. AZD7442 is a combination of a couple of monoclonal antibodies (mAbs) extracted from convalescent patients with SARS-CoV-2 infection. It will be assessed in more than 6,000 participants at sites in and outside […]
Continue reading …AstraZeneca has been granted breakthrough therapy designation (BTD) for Farxiga (dapagliflozin) from the US Food and Drug Administration (FDA) for the treatment of patients with chronic kidney disease (CKD), irrespective of type 2 diabetes (T2D). According to the US Centers for Disease Control and Prevention (CDC), chronic kidney disease is a serious, progressive condition defined […]
Continue reading …AstraZeneca said that it has finalized a deal with the European Commission (EC) for the delivery of up to 400 million doses of the AZD1222 Covid-19 vaccine candidate (formerly ChAdOx1 nCoV-19). The deal is said to consolidate on the existing agreement with Europe’s Inclusive Vaccines Alliance led by Germany, France, the Netherlands, and Italy. It […]
Continue reading …AstraZeneca has signed a deal potentially worth up to $6 billion with Daiichi Sankyo for the global development and commercialization for the latter’s DS-1062, a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC), which is being developed for the treatment of multiple tumor types. Daiichi Sankyo is developing the antibody drug conjugate for multiple tumors […]
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