Pharmaceuticals, Biotechnology and Life Sciences
Shire got the good news from the European Commission (EC) for Marketing Authorisation for Takhzyro injection, for prevention of recurrent…
European Medicines Agency (EMA) has validated Shire’s marketing authorization application (MAA) for its lanadelumab, which was also accepted by Health…
Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted an accelerated assessment for…
Shire, Microsoft and EURORDIS-Rare Diseases Europe want to handle together with the diagnostic challenge for patients living with a rare…
AB Biosciences will grant Shire an exclusive worldwide license to develop and commercialize AB Biosciences’ pan receptor interacting molecule (PRIM)…
The European Commission (EC) has given Shire’s ADYNOVI a green light as an extended half-life recombinant factor VIII (rFVIII) treatment…
The U.S. Food and Drug Administration (FDA) has granted 510(k) marketing clearance to Shire’s myPKFiT for ADVATE, a free web-based…
Shire’s partner in Japan, Shionogi & Co has received the approval of the Japanese Ministry of Health, Labor and Welfare to manufacture and market Intuniv, a new, once-daily non-stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD), a common psychiatric disorder in children and adolescents.
Shire said on Thursday that the European Commission (EC) has approved a label extension granting three new indications for CINRYZE® (C1 inhibitor [human]), broadening its use to children with Hereditary angiodema (HAE), a rare, genetic disorder that results in recurring attacks of edema (swelling). The body sites most commonly affected are mainly the extremities and abdomen.
Argenx and Shire have extended their strategic partnership from 2014 to advance the discovery and development of novel human therapeutic antibodies for diverse rare and unmet diseases for a further year until May 30, 2018.