Category: News
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Update on Covid-19 vaccine
More than four months into the coronavirus pandemic, how close are the U.S. and the world to a safe and effective vaccine? Scientists say they see steady progress and are expressing cautious optimism that a vaccine could be ready by spring. As of early July, roughly 160 vaccine projects were underway worldwide, according to the…
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Preliminary report of an mRNA Vaccine against SARS-CoV-2
The Phase 1 of the Moderna, SARSCoV2 vaccine results published by NEJM and they are very encouraging for immune response and safety in 45 healthy people, 2 shots, increasing doses. The study is funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461). This phase 1, dose-escalation, open-label trial including…
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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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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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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…
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EMA make recommendations drawing on lessons learnt from presence of nitrosamines in medicines
The European medicines regulatory network has issued recommendations on impurities in medicines following the conclusion of an exercise to draw on lessons learnt from the presence of nitrosamines in a class of blood pressure medicines known as sartans. Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. However, there…
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Falsified and contaminated Defibrotide identified in Western Pacific, Europe and Eastern Mediterranean
WHO has released an alert relates to falsified DEFIBROTIDE 200MG VIALS OF 2.5ML (80MG/ML) CONCENTRATE FOR SOLUTION FOR INFUSION which is sold under the brand name Defitelio, identified in Australia, Latvia and Saudi Arabia. DEFIBROTIDE is used to treat hepatic veno-occlusive disease, in which the blood vessels in the liver become damaged and obstructed by…