Merck and Ridgeback’s Molnupiravir, an Oral COVID-19 Antiviral Medicine, receives first authorization in the world with trade name of Lagevrio (molnupiravir), by MHRA. Lagevrio is not intended to be used as a substitute for vaccination against COVID-19 but for the treatment of Mild-to-Moderate COVID-19 in adults with a positive SARS-CoV-2 …
EMA had released its first safety update on a COVID-19 vaccine — Comirnaty. It concludes that safety data collected on Comirnaty use in vaccination campaigns is consistent with the known safety profile of the vaccine, and no new side effects were identified. Summary points: The latest safety data for this vaccine are …
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 …
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 …
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 …
COVAXINTM, India’s indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility. Covaxin is an inactivated vaccine. That …
No medicine, not even vaccine are 100% safe. There is a certain risk associated with them. Drug safety cannot be considered as an absolute, it can only be assessed relative to drugs benefits. Safety and risk are always individual depending on with whom, when and conditions the drug interacts. At …
