FDA Efforts to Bring Patients into Treatment Decisions Focus of NORD Webinar

The U.S. Food and Drug Administration (FDA), a vast government bureaucracy, employs about 17,500 people and had a budget of $5.7 billion in 2019. Yet even with its enormous resources, the FDA these days relies more and more on patients to…

The gleaming new Dutch headquarters of the European Medicines Agency (EMA), fronting Domenico Scarlattilaan in Amsterdam’s suburban Zuidas business district, finally opened for business last month — just over two years after the European Union decided to relocate the EMA to the Netherlands in the wake of Brexit.

People in Poland with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV) are treated according to existing guidelines, and the most common treatment-associated adverse event is infection, according to a nationwide study. The study, “Treatment and its side effects in ANCA-associated vasculitides – Study based on POLVAS registry…

An elderly woman was diagnosed with the granulomatosis with polyangiiti (GPA) subtype of ANCA-associated vasculitis (AAV) after being misdiagnosed with pneumonia, illustrating the challenges in diagnosing this condition, according to a case report.  All types of AAV should be in the differential diagnosis for all…

Muscle weakness may be an under-recognized symptom of antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis (AAV) with diagnosis likely requiring a biopsy of the muscle itself, a case report has found. The report, titled “Severe proximal muscle weakness with normal CK as a presenting feature of ANCA-associated vasculitis,”…

A family history of cardiovascular disease and higher vasculitis disease activity are risk factors for fatal and non-fatal cardiac disease in patients with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, a study suggests.  The study, “Predictors of fatal and non-fatal…

Kidney transplantation is safe and effective for treating children with ANCA-associated vasculitis (AAV) who develop serious kidney problems as a result of their disease, a long-term study in Japan suggests. The transplant successfully prevented the return of AAV-related kidney damage in seven children over a median of seven years,…

ChemoCentryx has secured a credit facility of up to $100 million from Hercules Capital to support the upcoming costs of its new drug application (NDA) for avacopan, its investigational treatment for ANCA-associated vasculitis (AAV), and the therapy’s commercial launch, if approved. The $100 million credit will be divided into…

People with anti‑neutrophil cytoplasmic antibody (ANCA)‑associated vasculitis (AAV) who have high levels of cellular microparticles in their blood may be at higher risk for venous thromboembolism (VTE), a life-threatening blood-clotting condition, a recent study suggests. A 10% increase…

The presence of the bacterium Staphylococcus aureus was not associated with a higher relapse rate of ANCA-associated vasculitis (AAV), a recent study suggests. These results challenge the idea that use of certain antibiotics may prevent AAV relapses, the researchers said. Titled “No evident association of nasal…