steenbjere

About Steen Bjerre

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So far Steen Bjerre has created 90 blog entries.

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

2020-06-06T16:15:47+01:00June 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+01:00June 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+01:00June 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+01:00June 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+01:00May 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 [...]

BioCryst stands in solidarity with HAE community

2020-05-15T13:39:34+01:00May 15, 2020|HAEi News|

BioCryst Pharmaceuticals, Inc. stands in solidarity with the HAE community by participating in the annual HAE Global Walk. Since actual community walks cannot currently be organized, BioCryst employees around the world are joining virtually with others supporting hae day :-) by logging their steps and photographing their activities to raise awareness of HAE. “hae day [...]

Pharming’s financial results for first quarter 2020

2020-05-14T21:08:38+01:00May 14, 2020|HAEi News|

At the presentation of Pharming Group N.V.’s financial report for the first quarter of the year ended 31 March 2020 CEO Sijmen de Vries says: “We received EMA and FDA approval of our new production facility for Ruconest, which will double our production capacity once fully operational later this year. In addition, approval from the [...]

Intellia expects IND for HAE medication in H2 of 2021

2020-05-07T16:33:38+01:00May 7, 2020|HAEi News|

At the presentation of the financial results for the first quarter ended 31 March 2020, Intellia Therapeutics, Inc. President and CEO John Leonard, M.D. says: “Our mission is to develop curative, CRISPR/Cas9-based treatments for severe diseases. I am grateful to our team for remaining steadfast in our commitment to patients and putting us in the position [...]

BioCryst Reports Upcoming Key Milestones

2020-05-06T13:21:22+01:00May 6, 2020|HAEi News|

“This is a transformational year for BioCryst Pharmaceuticals, Inc. as we prepare to launch berotralstat in multiple territories to bring our oral, once-daily prophylactic medicine to HAE patients, and begin generating significant revenue,” says Jon Stonehouse, President and CEO at the announcement of BioCryst's financial results for the first quarter ended 31 March 2020. Program Updates [...]