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Yearly Archives: 2020

What is Pharmacovigilance?

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As per WHO: “Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or...

FDA Ok’s for Filing of New Drug Application for Sol-Gel Technologies Epsolay®

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Sep. 10, 2020: "Sol-Gel Technologies, a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment...

FDA Warns Website Operators Illegally Selling Opioids to Consumers

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September 10, 2020: "The U.S. Food and Drug Administration has issued warning letters to 17 website operators for illegally selling unapproved and misbranded opioids...

AstraZeneca to list US ADR equity and all US debt securities on Nasdaq

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September 10, 2020: "AstraZeneca announced that it will be transferring the listing of its American Depositary Receipts (ADRs) and its US-listed debt securities from...

Pfizer and Biontech share positive early data on lead mRNA Vaccine candidate bnt162b2 against COVID-19

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Pfizer and BioNTech SE shared additional Phase 1 safety and immunogenicity data from their ongoing U.S. study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which...

FDA OKs expanded use of Glaxo’s Trelegy Ellipta in asthma

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Sep. 10, 2020: "The FDA has approved a new indication for GlaxoSmithKline and Innoviva's Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of...

Innovate UK backs ATDBio & University of Oxford research in single-cell sequencing

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September 09, 2020: "ATDBio, a leader in complex oligonucleotide synthesis, and a research team at the Botnar Research Centre, University of Oxford, have been awarded...

FDA Ok’s Onureg® for Adults in First Remission with Acute Myeloid Leukemia

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September 09, 2020: "Bristol Myers Squibb announced that the U.S.FDA has approved Onureg® (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with...

AstraZeneca pauses Covid-19 vaccine trials over suspected adverse event

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September 09, 2020: "AstraZeneca has put on hold all global clinical trials of its Covid-19 vaccine candidate over a suspected adverse event in a...

Inhaled ensifentrine will be assessed in hospitalised patients with COVID-19

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Sept. 08, 2020:Verona Pharma, a clinical-stage biopharmaceutical company focused on respiratory diseases, announces the initiation of a pilot study to investigate the efficacy and...

Coronavirus (COVID-19) Update: Daily Roundup Sep 04, 2020

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September 04, 2020: "The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: The FDA issued...

Russia reports positive early data on Covid-19 vaccine Sputnik V

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September 07, 2020: "The Russian Direct Investment Fund (RDIF) and the Gamaleya National Research Center of Epidemiology and Microbiology have reported positive early results...
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