Bjerre

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So far Steen Bjerre has created 90 blog entries.

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 [...]

Pharming Announces Positive Results from Trial with Ruconest

Pharming Group N.V. has announced positive results from a Phase 2 clinical study of Ruconest (recombinant C1 esterase inhibitor, 50 IU/kg) for prophylaxis in patients with HAE. In the study, Ruconest showed a clinically relevant and statistically significant reduction in attack frequency for both the twice-weekly and once-weekly treatment regimens as compared with placebo. 32 HAE patients [...]

Pharming amends Ruconest Distribution Agreement with Sobi

Pharming Group NV and Swedish Orphan Biovitrum AB (Sobi) has signed an amendment of their Ruconest distribution agreement from 2009. In addition to Austria, Germany and Netherlands, Pharming will market Ruconest directly into an additional 21 countries, effective 1 October 2016. These countries include Algeria, Andorra, Bahrain, Belgium, France, Ireland, Jordan, Kuwait, Lebanon, Luxembourg, Morocco, Oman, Portugal, [...]

Carbylan and KalVista Enter into Share Purchase Agreement

Carbylan Therapeutics, Inc. and KalVista Pharmaceuticals Ltd. have entered into a definitive share purchase agreement pursuant to which the shareholders of KalVista will become the majority owners of Carbylan. David Renzi, President and CEO of Carbylan stated: "We are optimistic that KalVista’s pipeline and strong leadership team, together with the combined company’s cash resources, will enable [...]

12,000,000+ steps for HAE

Before hae day :-) 2016 quite a number of people told HAEi that they would really have liked to take part in the Camino Walk but were for one reason or the other unable to go. Therefore the organization set up a website for a Global HAE Walk and encouraged everyone interested to participate. All they [...]

80 people walked the Camino for HAE

From 15 to 17 May 2016 almost 80 people – the majority of them suffering from HAE – walked part of the legendary Camino de Santiago in northern Spain together. Over three days they took close to 4,000,000 steps for HAE awareness. These brave souls - coming from Canada, USA, Mexico, Venezuela, Brazil, Argentina, Sweden, Denmark, [...]

KalVista to Support Global HAE Conference

KalVista Pharmaceuticals supports the third HAE Global Conference in Madrid, Spain, from 19-22 May 2016. Andrew Crockett, KalVista’s CEO, said: "KalVista is delighted to support the HAE Global Conference, which aligns with our mission to provide oral treatments for HAE patients. We believe that an oral plasma kallikrein inhibitor provides a more convenient way to [...]