Bjerre

About Steen Bjerre

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So far Steen Bjerre has created 106 blog entries.

Results of phase II study for prophylaxis of HAE attacks

The results of a “Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human C1 Inhibitor for Prophylaxis of Hereditary Angioedema Attacks” has been presented by Marco Cicardi, Professor of Internal Medicine University of Milan, Hospital L. Sacco Milan and co-prinicipal investigator for the study. The presentation was held during the American College of Allergy, Asthma and Immunology 2016 [...]

Pharming announces progress on financing

Pharming Group N.V. has made significant progress with financing towards completion of the transaction with subsidiaries of Valeant Pharmaceuticals International, Inc. signed on 8 August 2016 for Pharming to acquire the commercialization rights to its own product Ruconest in North America. The company has signed a term sheet with a syndicate of debt providers. The documentation [...]

CHMP adopts positive opinion to include self-administration for Ruconest

The Committee for Medicinal Products for Human Use (CHMP), an advisory committee of the European Medicine Agency (EMA), has adopted a positive opinion recommending an extension to the terms of the marketing authorisation for Ruconest to the European Commission. This recommendation will allow self-administration of Ruconest for acute HAE attacks by adolescents and adults with [...]

Financial report from Pharming

Pharming Group N.V. presents its financial report for the nine months ended 30 September 2016. From CEO Sijmen de Vries' comments: After a relatively modest start to sales of Ruconest® (recombinant C1 esterase inhibitor, 50 IU/kg) in 2016, revenue growth during the third quarter has significantly increased. Sales efforts in the US drove this growth. We [...]

FDA Accepts Application for Subcutaneous Prophylactic Therapy

The U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for CSL Behring's low-volume subcutaneous (SC) C1-Esterase Inhibitor (C1-INH) Human replacement therapy, CSL830, as prophylaxis to prevent HAE attacks. “The review of this application is another step towards providing advanced prophylactic treatment options to people living with HAE,” said [...]

KalVista Initiates Phase 1 Clinical Trial for HAE Treatment

KalVista Pharmaceuticals announces the dosing of the first subject in a first-in-human clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of orally delivered KVD818 in healthy volunteers. A KalVista discovery, KVD818 is a novel, potent, and selective inhibitor of plasma kallikrein in development for the prevention of attacks of edema in patients with HAE. [...]

BioCryst Initiates APeX-1 Clinical Trial of BCX7353 for HAE

BioCryst Pharmaceuticals, Inc. has dosed the first subject in the APeX-1 clinical trial of BCX7353 for the oral treatment of HAE. "We are very pleased that the adaptively-designed APeX-1 trial is now under way, and look forward to reporting Part 1 results around the end of 2016," said William P Sheridan, SVP & Chief Medical Officer at [...]

Pharming acquire all North American commercialization rights to Ruconest

Pharming Group N.V. has entered into a definitive agreement to acquire all North American commercialization rights to its own product Ruconest (recombinant human C1 esterase inhibitor), including all rights in the US, Mexico and Canada, from Valeant Pharmaceuticals International, Inc. Ruconest is an orphan drug designated therapy developed by Pharming, already approved for the treatment of [...]

BioCryst continues to make progress

Announcing the BioCryst Pharmaceuticals financial results for the second quarter of 2016 Jon P. Stonehouse, President & CEO, said: "We continue to make progress, and have initiated subject screening to start the APeX-1 trial evaluating our once daily oral kallikrein inhibitor BCX7353 to prevent HAE attacks.  Our goal remains to report out initial data by year end [...]

U.S. FDA Approves Berinert as the First and Only Pediatric Treatment

The U.S. Food and Drug Administration (FDA) has approved the use of Berinert [C1 Esterase Inhibitor (Human)], the CSL Behring therapy for treating HAE attacks, for use in pediatric patients. This expands the use of Berinert into all age groups, making it the first and only approved HAE treatment available to patients under 12 years of age. A child has [...]