About Steen Bjerre

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So far Steen Bjerre has created 207 blog entries.

APeX-1 Clinical Trial Results for BCX7353


Results from the Phase 2, APeX-1 clinical trial of BCX7353 for the prevention of attacks in patients with HAE are published online in the July 26th issue of The New England Journal of Medicine. The APeX-1 trial was a double blind, randomized, parallel group, placebo-controlled Phase 2 dose ranging trial comparing the safety and efficacy [...]

The HAEi Magazine ‘Global Perspectives’ out now


It is July – and it is time for the second 2018 issue of the HAEi magazine ’Global Perspectives’. This time the magazine is truly covering the world as we focus on the record-breaking 2018 HAE Global Conference that took place in Vienna, Austria 17-20 May. Indeed, the fourth HAE global Conference set new records [...]

Agreement with PMDA on Clinical Trial and Regulatory Requirements


BioCryst Pharmaceuticals, Inc. has reached agreement on the design of a Phase 3 trial and regulatory requirements for marketing authorization of BCX7353 for HAE with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. The Phase 3 trial design agreed upon for Japan, APeX-J, is a randomized, placebo-controlled double-blind trial of 24 weeks duration with [...]

FDA Approval for Label Expansion of Cinryze


The U.S. Food and Drug Administration (FDA) has approved a label expansion for Cinryze® (C1 esterase inhibitor [human]), making it available to help prevent angioedema attacks in children aged 6 years and older with HAE. Cinryze has been approved in the U.S. since October 2008 for routine prophylaxis against attacks in adolescents and adults living [...]

Record-breaking HAE Global Walk 2018


In 2016 HAEi introduced the HAE Global Walk in order to raise awareness around the world. The third edition of the HAE Global Walk took place from 1 April to 31 May 2018 and broke each and every record as 54,609,008 steps were taken by 4,262 people from 37 countries. That is 42,007 km or [...]

Additional Analyses of APeX-1 Clinical Trial of BCX7353


BioCryst Pharmaceuticals, Inc. presented additional analyses of the APeX-1 trial of BCX7353 for the prevention of attacks in patients with HAE at the annual congress of the European Academy of Allergy and Clinical Immunology (EAACI) 26-30 May 2018 in Munich, Germany. “These additional analyses of our Phase 2 APeX-1 trial of once-daily oral BCX7353 provide [...]

European Regulatory Designations for HAE Treatment


The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on BioCryst Pharmaceuticals, Inc.'s application for orphan designation of BCX7353 for the treatment of HAE. In addition, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a Promising Innovative Medicine (PIM) designation to BCX7353. The positive [...]

“Youngsters’ Voice” May 2018


Welcome to Youngsters’ Voice – the magazine created by the HAEi Youngsters community to keep you up to date with all its activities. Get the magazine here.

Pharming supports haeday :-)


On May 16th HAE patient organizations from around the world, led by HAEi (The international HAE patient organisation), come together to support the global awareness day for Hereditary Angioedema; a rare life-threatening condition. “haeday:)” aims to raise global awareness to ensure each and every patient receives faster diagnosis and the care they need to lead a [...]