The Swiss Agency for Therapeutic Products (Swissmedic) Validates Shire’s Marketing Authorization Application (MAA) for Investigational Hereditary Angioedema (HAE) Treatment Lanadelumab

Lanadelumab, the first investigational monoclonal antibody in HAE, is being evaluated for the prevention of angioedema attacks in patients 12 years and older Swissmedic validation shows continued regulatory progress for lanadelumab HAE is a rare, genetic disorder that causes debilitating,

FDA approves VONVENDI® [von Willebrand factor (recombinant)] for perioperative management of bleeding in adult patients with von Willebrand disease[1]

Expanded use for VONVENDI – the first and only purified recombinant von Willebrand factor – builds on previously approved on-demand treatment indication1  VONVENDI now offers an individualized approach to bleed control in appropriate patients undergoing surgery1 von Willebrand disease is

Shire Reports Regulatory Milestones for Investigational Hereditary Angioedema (HAE) Treatment Lanadelumab

The European Medicines Agency (EMA) validates Shire’s Marketing Authorization Application for investigational Hereditary Angioedema (HAE) treatment lanadelumab. Validation signals EMA has sufficient data to begin review (under accelerated assessment) Health Canada has accepted Shire’s New Drug Submission (NDS) for lanadelumab under

District Court Issues Ruling Finding Adderall XR® Patents Infringed

Cambridge, Mass., USA – March 23, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG) announces that its subsidiary, Shire Development LLC, welcomes yesterday’s favorable ruling against Abhai LLC in connection with their Abbreviated New Drug Application (ANDA) for a generic version