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.
The US Food and Drug Administration (FDA) has announced new measures to promote medical device innovation and provide patients with fast access to beneficial technologies.
When it comes to high blood pressure, a lack of exercise and a poor diet are often the primary suspects. A new study, however, finds that our skin may play a significant role in the development of the condition.
Biogen (NASDAQ: BIIB) announced that it has increased the profit potential on aducanumab, its Phase 3 investigational treatment for early Alzheimer’s disease, by reducing the potential royalty payment on potential commercial sales of aducanumab to Neurimmune Holding AG. In exchange for a 15 percent reduction in the previously negotiated royalty rates, Biogen agreed to make a one-time $150 million payment to Neurimmune Holding AG.
Patient participation in clinical trials for cancer patients has been in decline. Researchers determine the barriers prohibiting participation.
A drug that targets the appetite control system in the brain could bring about significant weight loss in people with clinical obesity, according to new research.
New research suggests that people with rheumatoid arthritis are more likely to develop chronic obstructive pulmonary disease (COPD), which is a group of lung diseases that damage the airways and cause problems with breathing.
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 NIH has amended its definition of clinical trials to include brain studies, introducing new regulations considered unnecessary by many researchers.
Researchers at the University of Illinois at Urbana-Champaign have developed technology that enables a smartphone to perform lab-grade medical diagnostic tests that typically require large, expensive instruments. Costing only $550, the spectral transmission-reflectance-intensity (TRI)-Analyzer from Bioengineering and Electrical & Computer Engineering Professor Brian Cunningham’s lab attaches to a smartphone and analyzes patient blood, urine, or saliva samples as reliably as clinic-based instruments that cost thousands of dollars.
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