About Steen Bjerre

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So far Steen Bjerre has created 137 blog entries.

KalVista Reports Second Quarter Results


KalVista Pharmaceuticals, Inc. today reported operational and financial results for the fiscal second quarter ended October 31, 2017. The initial focus is on inhibitors of plasma kallikrein, which is an important component of the body’s inflammatory response and which, in excess, can lead to increased vascular permeability, edema and inflammation. KalVista has developed a proprietary [...]

The dawn of a new era of HAE management


Symposium 19th June 2017 - as part of the European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting in Helsinki, Finland. This symposium provided an overview of past, current, and future therapies and routes of administration for patients with HAE. Prof Cicardi opened the symposium by welcoming attendees and introducing the main topics of [...]

Supplemental Biologics License Application to FDA


Pharming Group N.V. has submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Ruconest [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with HAE. The submission includes data from two completed trials of Ruconest for the prophylaxis of [...]

FDA application for new drug in 2018


Amber Salzman, Ph.D., President and CEO of Adverum Biotechnologies Inc., in the company's financial results for the third quarter of 2017: “We continue to make progress advancing our gene therapy programs to reach our goal of transforming Adverum into a clinical-stage company by the end of this year. Looking ahead, we plan to file an [...]

98 percent median reduction in HAE attacks


CSL Behring presents data indicating that, at the approved dose of 60 IU/kg, HAEGARDA®reduced the median number of HAE attacks per month by 98 percent in subjects who had frequent attacks, from a 16-week placebo period to a 16-week treatment period. Additionally, the breakthrough attack rate – extrapolated to one year – was reduced from [...]

Cinryze production has resumed


Shire plc announces unaudited results for the three months ended September 30, 2017. Flemming Ornskov, M.D., M.P.H., Shire CEO, commented: “We delivered strong growth this quarter despite a Cinryze supply shortage. We experienced a product shortage of Cinryze during the quarter due to a manufacturing interruption at a third-party manufacturer. The issue has been addressed and production [...]

On the right track


Pharming Group N.V. presents its (unaudited) financial report for the first nine months and the third quarter ended 30 September 2017. Operational highlights during the third quarter On September 11, following the conclusion of the End-of-Phase 2 interactions with the US Food and Drug Administration (FDA), Pharming announced that it will submit a supplemental Biologics [...]

European Approval for Label Extension of Firazyr


The European Commission (EC) has approved a label extension granting a new indication for Firazyr (icatibant injection), broadening its use to adolescents and children aged 2 years and older, with HAE caused by C1-esterase-inhibitor (C1-INH) deficiency. Firazyr has been approved in the European Union (EU) since 2008 for symptomatic treatment of acute attacks of HAE in [...]

Positive data from paediatric clinical trial with Ruconest


Pharming Group N.V. announces positive data from a clinical trial with the use of Ruconest [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for the treatment of HAE attacks in children. The open-label, single arm, Phase II clinical trial was designed in agreement with the European Medicines Agency (EMA) as part of a Paediatric Investigation Plan (PIP) [...]

Verseon developing oral treatment for HAE


Verseon Corporation has announced the launch of a drug program developing oral treatments for HAE. In their interim report, the Company presents data from a well-established HAE disease model which demonstrate the efficacy of their plasma kallikrein inhibitors in reducing swelling. An oral therapeutic would be a life-changing development for HAE patients who currently rely on [...]