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India approves Serum Institute’s Covishield and Bharat Biotech’s Covaxin vaccines

India approves Serum Institute’s Covishield and Bharat Biotech’s Covaxin vaccines

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 gets FDA approval for Tagrisso for type of NSCLC

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 […]

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AstraZeneca to acquire US biopharma company Alexion Pharmaceuticals for $39bn

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 […]

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AstraZeneca gets BRILINTA FDA approval for reducing risk of stroke in acute ischemic stroke or high-risk transient ischemic attack

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 […]

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AstraZeneca resumes AZD1222 Covid-19 vaccine trials after brief pause

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 […]

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AstraZeneca to advance AZD7442 into phase 3 Covid-19 trials

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 […]

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AstraZeneca gets FDA breakthrough status for Farxiga in CKD

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 […]

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AstraZeneca acquires oral PCSK9 inhibitors from Dogma Therapeutics

Pharma giant AstraZeneca has signed a deal to acquire a preclinical oral PCSK9 inhibitor asset from Dogma Therapeutics, a portfolio company of Viva Biotech. The financial terms of the deal were not disclosed. AstraZeneca intends to take the PCSK9 inhibitor program into clinical trials in 2021 for dyslipidemia and also familial hypercholesterolemia. People having dyslipidemia, […]

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AstraZeneca finalizes AZD1222 Covid-19 vaccine candidate deal with EC

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 […]

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AstraZeneca strikes $6bn worth deal for Daiichi Sankyo’s DS-1062

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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