News

Some patients taking Brilinta (ticagrelor) for a condition called acute coronary syndrome might develop hypersensitivity to the medication that manifests as angioedema and sudden breathing problems, a new case report shows. The circumstances of a 69-year-old African man who developed angioedema shortly after receiving Brilinta was reported in the journal Case…

In recognition of Rare Disease Day 2018, Bionews Services — which publishes this website — will attend and report on three relevant conferences in the U.S. dealing with policies and programs of importance to patients and their families. The three are among 50 events in 32 states…

The U.S. Food and Drug Administration (FDA) will review Shire’s application requesting that Cinryze (C1 esterase inhibitor [human]) be approved for the prevention of hereditary angioedema attacks in children 6  years and older. The supplemental biologics license application (sBLA) received priority review, meaning the process will be shortened from the standard 12 months…

  The application requesting that lanadelumab be reviewed with priority as a new treatment for the prevention of angioedema attacks has been accepted by Health Canada, the medicine’s manufacturer, Shire, announced. The New Drug Submission (NDS) is requesting the lanadelumab’s approval for patients older than 12 years, who live with hereditary angioedema (HAE). In…

The recently announced merger of BioCryst Pharmaceuticals and Idera Pharmaceuticals will strengthen the two companies’ focus on developing and commercializing treatments to serve patients with rare diseases, including angioedema, the companies said. The name of the new company has not yet been announced. Among BioCryst’s ongoing development programs is BCX7353, a…

The biopharmaceutical company Shire is expected to soon submit a biologics license application to the U.S. Food and Drug Administration (FDA) seeking marketing approval of its investigational monoclonal antibody lanadelumab as therapy for patients with hereditary angioedema. The application is supported by positive results from the company’s Phase 3 HELP…