News

Swiss Agency to Begin Review Process for Lanadelumab to Treat Hereditary Angioedema

A marketing authorization application for Lanadelumab, Shire‘s investigational therapy for hereditary angioedema (HAE), was recently cleared by the Swiss Agency for Therapeutic Products (Swissmedic), the company announced. Supported by data from four clinical trials, acceptance of the marketing authorization application signals that the formal review process of the…

NIH Agency Pioneers Collaborative Research into Rare Diseases

A little-known government entity within the National Institutes of Health (NIH) is helping to lead U.S. efforts to speed up the development of therapies for some 7,000 rare diseases. The Office of Rare Diseases Research (ORDR), headquartered in Bethesda, Maryland, was established in 1993 within the NIH Office of the…

EMA Quickens Review of Lanadelumab for Hereditary Angioedema

The European Medicines Agency (EMA) will begin an accelerated review of Shire’s lanadelumab, a treatment candidate to prevent hereditary angioedema (HAE) swelling attacks, the company announced. This follows the EMA’s acceptance of Shire’s marketing authorization application (MAA) for the potential therapy, which reduces the number of days…