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So far Steen Bjerre has created 141 blog entries.

FDA Acceptance for Review of sBLA for Ruconest


The U.S. Food and Drug Administration (FDA) has accepted for review Pharming Group N.V.'s supplemental Biologics License Application (sBLA) for Ruconest [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with HAE. The FDA has indicated that the sBLA is sufficiently complete to permit a substantive [...]

Verseon presents HAE program


Verseon has presented preclinical results in its HAE program at the 2018 Biotech Showcase in San Francisco, USA. The data show that Verseon’s plasma kallikrein inhibitors are well-suited as oral treatments for this rare genetic disease. To treat HAE, Verseon is developing oral small-molecule inhibitors of plasma kallikrein, a serine protease central to the HAE pathway. [...]

KalVista Commences Clinical Trial


KalVista Pharmaceuticals, Inc. will be initiating a Phase 1 trial for KVD 900, the second candidate in the oral HAE portfolio. The trial commenced in December 2017, in line with KalVista’s previously stated 2017 objectives. Says Andrew Crockett, CEO of KalVista: “2018 will be an exciting year for our HAE portfolio, with our second oral [...]

Adverum accelerates development of pipeline of gene therapies


Adverum Biotechnologies, Inc., a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases, reviews recent progress and provides an outlook for 2018: “In 2017, our newly-assembled team achieved our stated goal of transforming Adverum into a clinical-stage company,” said Amber Salzman, Ph.D., president and CEO of Adverum Biotechnologies. “We are [...]

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 [...]