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So far Steen Bjerre has created 129 blog entries.

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 [...]

Pharming and HAEi partners with Inceptua for Global Access Program


Pharming Group N.V in association with HAEi announce the appointment of Inceptua Medicines Access as their new distribution partner for the “HAEi Global Access Program” (HAEi GAP) enabling patients in all countries where Pharming’s product RUCONEST is not commercially available to gain access to the drug through an ethical and regulatory compliant mechanism.  It is [...]

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 [...]