About Steen Bjerre

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So far Steen Bjerre has created 152 blog entries.

Conclusion of FDA End-of-Phase 2 interactions on Ruconest


Pharming Group N.V. has concluded its End-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA). As part of these interactions, Pharming provided the FDA with the results of two completed Phase 2 trials of Ruconest for the prophylaxis of HAE attacks; a randomized, double-blind, placebo-controlled trial and an open-label study. The two studies [...]

Positive Results from APeX-1 Phase 2 Trial


BioCryst Pharmaceuticals, Inc. has announced final results from its Phase 2 APeX-1 clinical trial in HAE. APeX-1 was a 3-part dose ranging trial designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of orally administered once-daily (QD) BCX7353 for 28 days, as a preventative treatment to reduce the frequency of attacks in HAE [...]

Berinert Approved by Health Canada


Heath Canada - responsible for helping Canadians maintain and improve their health - has approved Berinert (C1 Esterase Inhibitor, Human) from CSL Behring for pediatric HAE. “HAE is an unpredictable and life threatening disease with few treatment options approved for children,” said Paul Keith, M.D., Associate Professor, Division of Clinical Immunology and Allergy, Department of [...]

Adverum Reports Second Quarter Financial Results


Adverum Biotechnologies, Inc. has reported financial results for the second quarter ended 30 June 2017 and provided a corporate update. “We are making important progress with our development and regulatory initiatives to transform Adverum into a clinical-stage company by the end of this year,” said Amber Salzman, Ph.D., president and CEO of Adverum Biotechnologies.  “Since [...]

BioCryst Reports Second Quarter Financial Results


BioCryst Pharmaceuticals, Inc. has announced financial results for the second quarter ended 30 June 2017. Jon P. Stonehouse, President & CEO, comments: "We are excited by the positive results previously reported in Parts 1 and 2 of the APeX-1 clinical trial that indicate we have an active oral drug, and look forward to completing the [...]

BioCryst Announces Initiation of ZENITH-1


BioCryst Pharmaceuticals, Inc. has announced the dosing of the first subject into ZENITH-1, a clinical trial studying up to three dosage strengths of a liquid formulation of BCX7353 given as a single oral dose for the acute treatment of angioedema attacks in patients with HAE. "We are excited to launch the ZENITH-1 exploratory Phase 2 [...]

KalVista Pharmaceuticals Provides Operational Update


KalVista Pharmaceuticals, Inc. provides an operational update and released financial results for the fiscal fourth quarter and full year ended 30 April 2017. From CEO Andrew Crockett's remarks: "KalVista has been making substantial advances with our portfolio of oral small molecule plasma kallikrein inhibitors for treatment of HAE. The first HAE program in the portfolio, KVD818, [...]

Pharming Reports on Financial Results for the First Half of 2017


Pharming Group N.V. presents its (unaudited) financial report for the six months ended 30 June 2017. CEO Sijmen de Vries comments: "Our strategic decision to reacquire the commercial rights to sell RUCONEST in North America has significantly increased revenue and profit generation for the first half of the year compared to the first half of [...]

The Lancet publicizes RUCONEST® prophylactic data


The weekly peer-reviewed general medical journal The Lancet has published data from a Phase II, double-blind, placebo-controlled, randomized clinical trial (NCT02247739) evaluating the efficacy and safety of RUCONEST (C1 esterase inhibitor [recombinant]) for the prevention of HAE attacks. As previously reported, in a study with 32 patients RUCONEST® 50 IU/kg (max 4200 IU) demonstrated a [...]

FDA Orphan-Drug Exclusivity for HAEGARDA


The U.S. Food and Drug Administration (FDA) has granted CSL Behring seven years of orphan-drug exclusivity for HAEGARDA (C1 Esterase Inhibitor Subcutaneous [Human]), the first and only subcutaneous treatment option for prevention of HAE attacks. HAEGARDA was approved by the FDA on 22 June 2017 for routine prophylaxis to prevent HAE attacks in adolescent and [...]