Following 30 years of research and development, the first malaria vaccine was recommended by the World Health Organization (WHO) for widespread use in children living in countries with moderate to high P. falciparum malaria transmission. The vaccine, known as RTS,S/AS01, is marketed as Mosquirix and manufactured by GlaxoSmithKline (GSK). It is not only the first …
Attacking KRAS Proteins to Kill Cancer
Recent advancements have led to the development of new cancer therapies that target mutations in KRAS proteins, which were once considered untreatable. In 2021, the FDA approved the first KRAS-targeted cancer therapy, sotorasib (LumakrasTM). And while researchers in academia and the pharmaceutical industry continue working to develop ways to improve their approach, recent research may …
New Anti-Amyloid Drug Offers Cognitive Benefit for Patients with AD
A recent Phase III clinical trial found that lecanemab reduces cognitive decline in patients with early Alzheimer’s disease (AD). The findings indicate that participants who received the new drug candidate, a monoclonal antibody, showed a statistically significant 27% reduction in cognitive decline. A press release detailed the preliminary results. While some researchers maintain skepticism, awaiting …
FDA Sanctions First Interchangeable Biosimilar Sans Switching Study
In August 2022, the Food and Drug Administration (FDA) approved Cimerli™ (ranibizumab-eqrn) as a biosimilar for Lucentis® (ranibizumab). In a time when high prescription costs can mean unaffordable out-of-pocket costs for patients, the potential implications are far-reaching. Cimerli became the 37th of 38 (as of this writing) biosimilar drugs approved by the agency and the …
Hangry Is Officially a Thing. So, What Should We Do About It?
In 2018 the word “hangry,” the portmanteau of hungry and angry, was finally added to the Oxford English Dictionary. We say finally because the concept had been around for a while. Katherine Connor Martin, Head of Product for Oxford Languages, said its first appearance in print was in a psychoanalytic journal in 1956. It is …
War in Ukraine Impacts Clinical Research Industry
Russia’s invasion of Ukraine is causing what the Financial Times called a “many-sided economic shock,” sending global prices sky-high for goods ranging from fuel to fertilizer. While the consumer-facing economic impact is undeniable, the war in Ukraine is also taking a toll on a less visible sector: the clinical research industry. Per the U.S. Food …
Using Video Games for Early Detection of Parkinson’s Disease
Parkinson’s Disease (PD) is diagnosed based on classical motor symptoms, including bradykinesia (slowed movement and loss of spontaneous movement), muscular rigidity, resting tremors and postural instability. In the prodromal phase (an early phase of PD), however, the signs and symptoms shown by patients are often not severe enough for a definitive diagnosis. If physicians can …
Working with Families in Pediatric Clinical Drug Trials
When designing pediatric clinical drug trials, it’s important to work with the entire family to ensure the experience is convenient, comfortable, and rewarding. If certain factors are overlooked, families may drop out of a trial, making it difficult to complete a statistically relevant trial. From the recruiting process to the running of the trial, there …
Guidance for Scheduling Clinical Trials in Children
Children are not little adults, but due to a lack of pediatric clinical trials, children are often prescribed drugs that have only been approved for use in adults. Fortunately, more pediatric clinical trials are being conducted to study and approve more drugs for use in children. In some ways, clinical trials in children are identical to …
New Horizons for Patient Studies at QPS-NL
In the pharmaceutical and biotechnology industry more small and even virtual companies are established thereby changing the traditional way of working in early drug development. In the last decade there evolved a trend to obtain Proof of Concept (PoC) as fast as possible directly in patients instead of healthy subjects or as part of an …
