steenbjere

About Steen Bjerre

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So far Steen Bjerre has created 74 blog entries.

KalVista has two oral candidates in clinical trials

2020-07-01T17:41:20+02:00July 1, 2020|HAEi News|

At the presentation of the financial results for the fiscal year ended 30 April 2020 CEO Andrew Crockett of KalVista Pharmaceuticals, Inc. says: “We have two oral candidates in clinical trials that have the potential to provide HAE patients with a complete set of options to treat their disease. We are pleased with our progress [...]

Global Perspectives #2 2020 is ready for you

2020-07-01T13:53:59+02:00June 29, 2020|HAEi News|

The second 2020 issue of the HAE International magazine Global Perspectives is out now. This time you will, among many other items, find articles on these topics: News from the HAE International Regional Patient Advocates The 2020 HAE Global Conference goes Virtual Great HAE Global Walk Despite Pandemic News from Member Organizations Around the Globe Emergency Card now in 34 [...]

Berotralstat Expanded Access Program for US HAE Patients

2020-06-09T22:31:50+02:00June 9, 2020|HAEi News|

BioCryst Pharmaceuticals, Inc. has established an expanded access program (EAP) with oral, once-daily berotralstat, an investigational drug, for patients with HAE in the United States. Through this program, physicians may be able to request berotralstat for HAE patients who do not have access to the product through a clinical trial. According to the U.S. Food [...]

Results for Garadacimab as Preventive HAE Treatment

2020-06-08T16:16:56+02:00June 8, 2020|HAEi News|

CSL Behring has announced results of a Phase 2 clinical trial for garadacimab (previously known as CSL312), an investigational novel Factor XIIa-inhibitory monoclonal antibody (FXIIa mAb) in development as a preventive treatment in HAE. The data, presented at the European Academy of Allergy and Clinical Immunology (EAACI) Digital Congress 2020, showed that the study met [...]

New Data Extension Evaluate Long-Term Safety and Efficacy of Takhzyro

2020-06-06T16:15:47+02:00June 6, 2020|HAEi News|

Findings from two new interim analyses of data from the Phase 3 HELP Study Open-label Extension (OLE) suggest that Takhzyro (lanadelumab) is well-tolerated and can prevent HAE attacks over an extended treatment period, with a sustained and consistent reduction in monthly attack rate across a range of different patient subgroups. The data are being presented [...]

Robust and Durable Reductions in HAE Attacks with Berotralstat

2020-06-06T09:53:58+02:00June 6, 2020|HAEi News|

New data from the APeX-2 and APeX-S clinical trials show that HAE patients taking oral, once-daily berotralstat experienced sustained decreases in their attack frequency and improvements in quality of life (QoL) scores over 48 weeks. Berotralstat was also safe and generally well-tolerated over 48 weeks in both APeX-2 and APeX-S. The data were presented by [...]

Patients Report Breakthrough Attacks on Injectable/Infused Prophylactics

2020-06-06T09:49:20+02:00June 6, 2020|HAEi News|

BioCryst Pharmaceuticals, Inc. presents findings from two patient surveys conducted to gain insights into patients’ current HAE treatment expectations, experience and satisfaction. Patient-reported attack history shows patients treated with current injectable or infused prophylactic medications (Takhzyro, Haegarda, Cinryze) continue to experience breakthrough attacks with a mean ranging from 0.9 to 1.8 attacks over the three [...]

Great HAE Global Walk despite pandemic

2020-06-04T10:46:46+02:00June 4, 2020|HAEi News|

As HAE friends around the globe will know the annual hae day :-) aims to raise awareness worldwide – and as part of the efforts to raise awareness HAE International organizes the HAE Global Walk. This was also going to be the case in 2020, and we had pretty high expectations regarding setting another record. [...]

Positive CHMP Opinion for Pre-filled Syringe Presentation of Takhzyro

2020-05-29T17:51:34+02:00May 29, 2020|HAEi News|

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on a Type II Variation regulatory application and recommended the approval of a pre-filled syringe presentation of Takhzyro (lanadelumab) from Takeda Pharmaceutical Company Limited.  Takhzyro is a subcutaneous injectable prescription medication approved in Europe for routine prevention of [...]