MHRA has authorized use of Oxford/AstraZeneca vaccine, goal to “give as many people in at-risk groups their first dose” but recommending a 2nd up to 3 months later. Safety information from the trials: The most frequently reported adverse reactions were injection site tenderness (>60%); injection site pain, headache, fatigue (>50%); …
The FDA has toughened its risk evaluation and mitigation and strategy (REMS) requirements for transmucosal immediate-release fentanyl (TIRF) products, seeking to reduce inappropriate prescribing of the powerful opioids. REMS are post-market programs that the agency requires as part of its approval of certain drugs to help ensure that the benefits …
FDA released breifing document on Moderna covid19 vaccine. Below are the highlights on safety from the document: Efficacy of the vaccine to prevent COVID-19 occurring at least 14 days after dose 2 was 94.5%, (95% CI 86.5%; 97.8%) in participants without prior evidence of SARS-CoV-2 infection. VE was >93% in …
The European Pharmacopoeia Commission has adopted a new general chapter for the analysis of N-nitrosamine impurities in active substances. The chapter is considered an analytical toolbox that relies on three procedures using GC-MS, LC-MS/MS and GC-MS/MS. A varied set of procedures using different instruments were used to cover the diverse needs …
Favipiravir, an antiviral drug, is being used for COVID-19 treatment. It inhibits viral replication by arresting RNA polymerase. Although most of the preclinical safety and efficacy data for favipiravir are derived from the studies that have proven its antiviral activity against Ebola and influenza viruses, it has also shown efficacy against …
Medicines and Healthcare products Regulatory Agency (MHRA) issued warning to women using modafinil during pregnancy as increased risk of birth defects is identified with the drug. Modafinil is a prescription-only medicine that is licensed only for the treatment of narcolepsy, a chronic disorder associated with sudden sleep that can cause …
Phase 3 trial in Peru for 2 Sinopharm inactivated virus vaccines suspended to investigate possible Guillain-Barre in a participant (which is a serious neurological event known to be a rare vaccine effect). Guillain-Barre syndrome is a rare and non-contagious disorder which affects the movement of the arms and legs. The …
FDA has released breifing document on Pfizer and BioNTech Covid 19 vaccine emergency use authorization. Safety data key points from the document are: Efficacy overall (that’s the 95% you keep hearing about) and stratified by age group. Looks similar whether > or < 55 years of age. 126 serious events …
Today University of Oxford and AstraZeneca researchers present a pooled analysis of Phase 3 trials of a vaccine against SARS-CoV-2 across two different dose regimens, resulting in an average efficacy of 70.4%. The new study published in the Lancet is the first peer-reviewed publication of phase 3 data from studies …
Pharmacovigilance is proactive detection, assessment, understanding and prevention of any drug related problems and it is a complex science characterised by many processes and outputs. The quality and precision of safety data processing is crucial for ensuring correct analysis and undertaking corrective actions in timely manner, which directly impact safety …
