News from the EMA: Pediatric regulation

Regulators in the European Union (EU) have taken several initiatives in the past four years to increase the efficiency of pediatric regulatory processes and boost the development of medicines for children. These achievements are highlighted in the closing report of the EMA and European Commission (EC) action plan on pediatrics.

FDA News: Overview of biosimilars

Check out the FDA’s biosimilars resource! Designed for both healthcare professionals and patients, these pages provide valuable information on the safety and efficacy of biosimilars. With more treatment options and increased access to life-saving medications, biosimilars have the potential to lower healthcare costs through competition. Learn more about biosimilars’ use in treating a range of illnesses, including psoriasis, Crohn’s disease, arthritis, diabetes, and cancer.

Long COVID: 3 years in

March 11 marked 3 years since WHO declared COVID-19 to be a pandemic. Did you know that at least 65 million people are estimated to struggle with long COVID, a debilitating post-infection multisystem condition that can last for months or years? This condition can impact people of all ages and often affects those with mild acute illness. The consequences are extensive, including harm to people’s health, wellbeing, and livelihoods. With one in ten people with long COVID stopping work, there are extensive economic losses. It’s important to understand and address this new medical challenge. Check out this article to learn more about long COVID and the progress made to tackle this condition.

One Health action for health security and equity

The importance of integrated One Health approaches to reduce the likelihood and impacts of emerging infectious disease outbreaks has been widely accepted. However, implementing One Health requires transdisciplinary approaches, with a systemic focus on the health of animals, humans, and ecosystems worldwide, and potential solutions that are equitable, inclusive, and sustainable.

Access to treatment for multiple sclerosis

Access to treatments for neurological disorders is egregiously insufficient, particularly in low-income and middle-income countries (LMICs). The inclusion of therapeutic agents on the WHO Model List of Essential Medicines (referred to as the essential medicines list [EML]) is an initial step to potentially increase their availability worldwide, as the list serves as a guide for the development of national and institutional EMLs.

Drug safety news regarding pseudoephedrine

EMA’s safety committee (PRAC) has started a review of medicines containing pseudoephedrine following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), conditions affecting blood vessels in the brain. Pseudoephedrine is taken by mouth and is used alone or in combination with other medicines to treat nasal congestion (a blocked nose) resulting from a cold, flu or allergy.

Choosing the Right Path toward Polio Eradication

The Global Polio Eradication Initiative (GPEI), launched 34 years ago, aimed to eradicate poliomyelitis by 2000. The chosen strategy was to stop circulation of wild polioviruses, following the successful example of smallpox eradication. The task, however, turned out to be much more challenging than eradicating smallpox had been, since there are hundreds of asymptomatic poliovirus infections for each paralytic case that occurs, which substantially complicates critical surveillance. Aside from challenges inherent in vaccine delivery in some countries, another reason for the failure to eradicate polio were outbreaks caused by circulating vaccine-derived poliovirus (cVDPV) strains that emerged from viruses used in Oral Polio Vaccine (OPV). Thus, to actually eradicate poliovirus, the use of OPV must also be stopped.