The European regulator has warned of the risk of myocarditis, pericarditis and anaphylaxis with Novavax’s COVID-19 vaccine, Nuvaxovid, while Switzerland has updated its guidance on the use of COVID-19 medicines against virus variants. Iconovo has received funding to develop its ICOone nasal inhaler for use in pandemics in resource-poor settings.
The European Medicines Agency’s pharmacovigilance committee, the PRAC, has issued a series of safety updates and recommendations for changes to the product information for a number of COVID-19 vaccines.
On 3 August, the PRAC said it had concluded that pericarditis and myocarditis can occur following vaccination with Novavax, Inc.’s protein-based vaccine Nuvaxovid, “based on a small number of...
Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.
The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.
Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.
The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
