About Steen Bjerre

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So far Steen Bjerre has created 126 blog entries.

Recommendations for Prophylaxis and Treatment of HAE Attacks


The Food and Drug Administration (FDA) has recently received reports from patients, physicians, and specialty pharmacies that they have been unable to obtain C1-Esterase Inhibitor (Human) Cinryze. Healthcare providers and patients may wish to consider alternate treatment options, including: For Prophylaxis: Haegarda was recently licensed for prophylaxis of HAE attacks. Haegarda is administered subcutaneously, twice [...]

Diplomat acquires Focus Rx


Diplomat Pharmacy, Inc. has completed its acquisition of Focus Rx Pharmacy Services Inc., a customer-focused healthcare partner that provides home infusion and specialty prescription management services. This acquisition bolsters Diplomat’s offering of extensive solutions to meet growing demand for infusion therapies. Diplomat’s specialty infusion services are built on the combined experience of experts in a [...]

Portfolio of Oral Plasma Kallikrein Inhibitors Continues to Advance


  From the KalVista Pharmaceuticals, Inc. operational and financial results for the fiscal first quarter ended July 31, 2017: “We continue to make progress with our portfolio of oral plasma kallikrein inhibitors in pursuit of our goal of a best-in-class oral therapy for HAE,” said CEO Andrew Crockett. “We are completing the first-in-human trial of [...]

Significant reduction of attack rate


Shire plc announces positive topline Phase 3 results for the Sahara study, a global, multi-center, randomized, double-blind, placebo-controlled, partial crossover trial that evaluated the efficacy and safety of subcutaneously administered C1 esterase inhibitor [human] Liquid for Injection, also referred to as SHP616 Liquid, versus placebo over two 14-week treatment periods in patients 12 years of [...]

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 [...]