Month: July 2020
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Biocon Biologics’ itolizumab gets DCGI nod for emergency use to treat covid-19
Biocon Biologics has received an emergency use authorisation (EUA) for its monoclonal antibody Itoliuzumab from the Drug Controller General of India (DCGI) to treat cytokine storms – one of the leading causes of death among patients with severe covid-19. As per the DCGI, the novel drug can be used only in a hospital set-up, and…
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COVID-19 GUIDANCE & PHARMACOVIGILANCE
Safety observer has shared the document that highlights impact on Safety Reporting procedures for both Clinical Trial and Post-Marketing Pharmacovigilance activities due to Covid-19. Most of the authorities have published guidance documents during this pandemic that have been related to the conduct of Clinical Trials, and intended to protect subject safety and data validity and…
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International regulators on phase 3 COVID-19 vaccine trials
Medicines regulatory authorities from around the world have published a report on Thursday highlighting the outcomes of the second workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The report describes the regulatory positions agreed by the meeting participants on two key topics: Data needed…
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Reporting, investigation and causality assessment of AEFI’s
Detection and reporting of AEFI Parents of immunized infants/children, health workers at immunization facilities and staff of accident and emergency rooms in hospitals are most likely to recognize or detect AEFIs when they first occur. Reportable AEFIs: Serious AEFIs Signals and events associated with a newly introduced vaccine AEFI’s caused because of immunisation errors Significant…
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Importance of pharmacovigilance during COVID-19
As the medical and scientific community work tirelessly to find suitable treatments for COVID-19, pharmacovigilance research is essential to understanding the safety and efficacy of treatment alternatives. To collect sufficient information about the efficacy and adverse drug reactions of treatments used against COVID-19, it’s crucial that all adverse events are recorded and reported as quickly…
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Six months of coronavirus
The scientists are still racing to solve the mysteries behind Coronavirus, from immunity to the role of genetics. In late December 2019, reports emerged of a mysterious pneumonia in Wuhan, China. Six months and more than ten million confirmed cases later, the COVID-19 pandemic has become the worst public-health crisis in a century. More than…
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WHO discontinues trial for hydroxychloroquine
WHO announced Saturday it will discontinue trials of hydroxychloroquine and the HIV drug lopinavir/ritonavir because trials are showing that the drugs don’t reduce mortality, at least not in those hospitalized. The International Steering Committee formulated the recommendation in light of the evidence for hydroxychloroquine vs standard-of-care and for lopinavir/ritonavir vs standard-of-care from the Solidarity trial…
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Lupin, Marksans Pharma, Aurobindo Pharma and Alembic Pharmaceuticals are recalling products in the US markets
Indian drug firms like Lupin, Marksans Pharma, Aurobindo Pharma and Alembic Pharmaceuticals are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Lupin and Marksans Pharma are recalling diabetes drug, Aurobindo and Alembic are recalling psychiatric medication in the US market. As per…
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Dapagliflozin gets DCGI approval for treatment of heart failure
AstraZeneca Pharma India has received the Marketing Authorization for Dapagliflozin (Forxiga), for the treatment of patients with heart failure with reduced ejection fraction (HFrEF). This is the first in class SGLT-2 inhibitor drug approved for the treatment of HFrEF. Reportedly, it is the first drug proven to significantly reduce the risk of cardiovascular death and…
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UMC – MED SAFETY APP: AN INTERNATIONAL MOBILE TOOL FOR DRUG SAFETY
Reporting of adverse events is a mainstay of pharmacovigilance, and an ongoing challenge for the field is how to ensure more reports of higher quality to provide more comprehensive information. A simple app is now being deployed by Uppsala Monitoring Centre (UMC), internationally to boost both the quantity and quality of reporting UMC along with…