Shire

pharmaphorum media | March 23, 2017

The US regulator has given a Fast Track designation to a Shire pipeline drug for a life-threatening blood clotting disease, hereditary thrombotic thrombocytopenic purpura....

Pharma times | June 22, 2017

The drug, which was first submitted in the country back in 2006, has the same active ingredient as the firm's Adderall XR (mixed amphetamine salts), but is designed to provide symptom control for adults with ADHD for up to 16 hours as opposed to the 12 to 14 hours currently offered by alternative treatments....

FDA | September 13, 2017

The FDA has granted Fast Track designation to Shire's SHP607 for the prevention of chronic lung disease in extremely premature infants. SHP607, currently in phase 2 clinical development, is a recombinant human version of the naturally occurring protein complex of insulin-like growth factor 1 (IGF-1) and its most abundant binding protein, IGF binding protein-3 (IGFBP-3). IGF-1 plays an important role in the development of the fetus in the uterus....

Shire | October 27, 2017

European regulators have approved a label extension for Shire’s Firazyr, broadening its use include adolescents and children aged two years and older with a particular type of HAE....