About Steen Bjerre

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So far Steen Bjerre has created 98 blog entries.

Japan Approves Berinert for Short-Term Prophylaxis

As of 24 March 2017, Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an extended use of Berinert from CSL Behring, a C1-esterase inhibitor (C1-INH) concentrate, for pre-procedure prevention (short-term prophylaxis) of acute episodes of HAE . Berinert is now indicated for the treatment of acute episodes and for pre-procedure prevention (short-term prophylaxis) of acute [...]

Pivotal Phase III Data for CSL Behring’s Subcutaneous C1-Esterase Inhibitor

New England Journal of Medicine (NEJM) has published results from the COMPACT study, a pivotal Phase III study evaluating the safety and efficacy of CSL830 (a novel, investigational, self-administered, subcutaneous C1-Esterase Inhibitor [C1-INH] Human replacement therapy) from CSL Behring. The study met its primary efficacy endpoint, significantly reducing the time-normalized number of HAE attacks. In [...]

Cooperation and networking among health care professionals worldwide

From 7 to 9 March 2017, CSL Behring in Bern, Switzerland hosted the First Intercontinental Immunoglobulin and Hereditary Angioedema Academy. The conference included presentations from 13 international immunodeficiency and HAE specialists, as well as a plant tour at CSL Behring AG. During the meeting, the approximately 90 immunologists from all over the world enjoyed a [...]

Cinryze first HAE treatment approved for routine prevention in paediatrics

The European Commission has approved a label extension granting three new indications for Cinryze (C1 inhibitor [human]) from Shire plc, broadening its use to children with HAE. Cinryze is now indicated for routine prevention of angioedema attacks in children (ages 6 years and above) with severe and recurrent attacks of HAE who are intolerant to [...]

Financial report 2016 from Pharming Group

Pharming Group N.V. has presented its (unaudited) financial report for the full year ended 31 December 2016. Sijmen de Vries, CEO and Chairman of the Board of Management, comments: 2016 was a major year for Pharming. During the year we achieved a number of positive milestones that culminated in December in the game-changing re-acquisition of [...]

KalVista appoints Senior Vice President of Medical

KalVista Pharmaceuticals, Inc. has appointed Andreas Maetzel, M.D., M.Sc., Ph.D, to the role of Senior Vice President, Medical. “Andreas Maetzel brings a wealth of experience in HAE and over 25 years of leadership in the pharmaceutical industry, including clinical development, medical and regulatory affairs,” said Andrew Crockett, CEO of KalVista. “I am confident that he [...]

Attune Pharmaceuticals announces pre-clinical data

Attune Pharmaceuticals, a biotechnology company focused on the discovery and development of novel oral small molecule therapeutics for the treatment of rare diseases, has announced the first preclinical data results for ATN-249, a novel orally administered plasma kallikrein inhibitor for the treatment of HAE. The data was presented in a late-breaking poster presentation at the 2017 [...]

Positive interim results from APeX-1 trial

BioCryst Pharmaceuticals, Inc. has announced results from an interim analysis of its Phase 2 APeX-1 trial in HAE. APeX-1 is a dose ranging trial designed to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered once daily (QD) BCX7353 for 28 days, as a preventative treatment to reduce the frequency of attacks in HAE patients. [...]

Phase 1b results for investigational treatment published

The New England Journal of Medicine has just published the results from the Phase 1b study of lanadelumab (SHP643; formerly DX-2930) from Shire plc. Lanadelumab is a subcutaneously administered, human monoclonal antibody that specifically binds and inhibits plasma kallikrein, and it is being investigated for the prevention of angioedema attacks in patients with HAE. "In this [...]

European Commission amends Marketing Authorisation for Ruconest

Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP), the European Commission has adopted the Commission Implementing Decision to amend the marketing authorisation for Ruconest to include self administration using the Ruconest Administration Kit. This decision allows for self-administration of Ruconest for acute HAE attacks by adolescents and adults with a new [...]