Solidarity is an international clinical trial to help find an effective treatment for COVID-19, launched by the World Health Organization and partners. The Solidarity Trial will compare four treatment options against standard of care, to assess their relative effectiveness against COVID-19. By enrolling patients in multiple countries, the Solidarity Trial aims to …
Glenmark will conduct a phase 3 trial in India, testing the efficacy of antivirals favipiravir and umifenovir for the treatment of COVID-19. The trial will examine if early administration of the drug combination will enhance efficacy in 158 hospitalized patients with moderate COVID-19, who will be randomized to receive either …
The FDA has approved Takeda Pharmaceuticals’ Alunbrig (brigatinib) for adults with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC). The approval was based on the results of a phase 3 trial in which Alunbrig reduced the risk of disease progression or death twofold compared to crizotinib. The trial …
Tramadol and hyperacusis Tramadol and hyperacusis was identified as a potential signal in a screening of VigiBase, the WHO global database of individual case safety reports, focusing on patient reports. As of June 2019, there were 20 reports for the combination. Overall, they support an association between tramadol and hyperacusis …
A signal is defined by WHO as reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually more than a single report is required to generate a signal, depending upon the seriousness of the event and the …
As per regulatory guidelines, clinical research is important in order to develop new therapies and diagnostic procedures as well as to understand how diseases begin and progress. Due to multiple process involved in drug discovery and development it takes an average of 12 years for an experimental drug to travel …
Multi-Item Gamma Poisson Shrinker (MGPS) is based on the metaphor of the “market basket problem”, in which a database of “transactions” (adverse event reports) is mined for the occurrence of interesting (unexpectedly frequent) itemsets (e.g., simple drug-event pairings or more complex combinations of drugs and events representing interactions and/or syndromes). …
Like drug pharmacovigilance, vaccine pharmacovigilance aims to detect adverse events early to trigger accurate risk assessment and appropriate response (risk-management) to the problem. This ensures the minimization of negative effects to individuals. Another goal of vaccine pharmacovigilance is to lessen the potential negative impact on immunization programmes. Vaccines, like other …
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 …
The BCPNN (Bayesian Confidence Propagation Neural Network) is now routinely used in signal detection to search single drug – single ADR combinations. BCPNN not just aids in the early detection of adverse drug reactions (ADRs) but in addition further evaluation of such signals. BCPNN can also be used for detecting …
