Shire’s Adynovi has been approved for use in Europe for on-demand and prophylactic use in patients 12 years and older with the rare bleeding disorder haemophilia A.
An experimental drug being developed by Shire to treat cytomegalovirus (CMV) infection has been given a boost in the US with a ‘Breakthrough Therapy Designation’.
Irish biotechnology firm Shire has received 510(k) marketing clearance for its myPKFiT for ADVATE [Antihemophilic Factor (Recombinant)] software from the US Food and Drug Administration (FDA).
Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in serving patients with rare diseases, announced today that the European Commission (EC) has approved a label extension granting a new indication for FIRAZYR® (icatibant injection), broadening its use to adolescents and children aged 2 years and older, with hereditary angioedema (HAE) caused by C1-esterase-inhibitor (C1-INH) deficiency. FIRAZYR has been approved in the European Union (EU) since 2008 for symptomatic treatment of acute attacks of HAE in adults with C1-INH deficiency.
Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, announced the U.S. Food and Drug Administration (FDA) awarded Orphan Drug Designation(ODD) to Shire`s gene therapy candidate SHP654 (also designated as BAX 888), an investigational factor VIII (FVIII) gene therapy for the treatment of hemophilia A. The regulatory agency also granted Shire investigational new drug (IND) status for SHP654.
The FDA has granted Fast Track designation to Shire's SHP607 for the prevention of chronic lung disease in extremely premature infants.
European regulators have validated the marketing authorisation application for Shire’s experimental von Willebrand Disease therapy Veyvondi.
Alterations in human DNA range from minor single nucleotide variations to substantial alterations involving the deletion or duplication of extensive DNA segments, known as copy number variations (CNVs). While CNVs contribute significantly to human genetic diversity and are often harmless, they can also lead to various neurodevelopmental disorders like Angelman syndrome, DiGeorge syndrome, and Williams-Beuren syndrome. Children suspected of having genetic conditions due to these significant DNA deletions or duplications typically undergo a lengthy diagnostic process that begins with microarray testing and may advance to more comprehensive genome-wide sequencing tests, such as exome or genome sequencing. Detecting CNVs in sequencing data and interpreting them can be challenging for clinical teams, which is why microarrays are commonly employed. Scientists have now created a single approach to identify these structural alterations using data from genome-wide exome sequencing assays. The findings of the study by researchers from the Wellcome Sanger Institute (Cambridgeshire, UK) ...
Melioidosis, a neglected tropical disease, is believed to affect around 165,000 individuals globally each year, with approximately 89,000 succumbing to it. This illness is caused by the bacterium Burkholderia pseudomallei, which thrives in the soil and water of tropical and subtropical areas, gaining entry into humans through skin cuts, consumption, or inhalation. Diagnosing melioidosis poses challenges due to its varying symptoms ranging from localized infections and pneumonia to severe septicemia or prolonged chronic conditions. The disease’s tendency to predominantly affect isolated rural communities contributes to its significant underreporting. Diagnosis traditionally depends on culturing bacterial specimens, a process extending over three to four days. Meanwhile, a large percentage of patients with melioidosis succumb to the disease, often within the initial 24 to 48 hours of hospital admission, while waiting for a diagnosis. Although no vaccine exists for melioidosis, it can be effectively managed with specific intravenous antibiotics if identified promptly. However, ...
Different factors, such as illness duration and virus variant, impacted patients cognitive abilities Imperial College London (ICL) researchers have revealed that people who have recovered from COVID-19 could have small but long-lasting impacts on the performance of cognitive and memory tasks. Published in the New England Journal of Medicine, the REACT Long COVID study enrolled over 140,000 participants, including long COVID patients, who undertook at least one cognitive task. COVID-19 is an infectious disease caused by the SARS-CoV-2 virus. For some patients, the condition can lead to long COVID, where symptoms can last up to 12 weeks. Using an innovative online cognitive assessment via the Cognitron platform, researchers detected subtle changes in different areas of brain function, including memory, reasoning, executive function, attention and impulsivity. The study revealed small deficits that were still detectable after a year or more following infection, including in people who had a short duration of ...
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