Bjerre

About Steen Bjerre

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So far Steen Bjerre has created 180 blog entries.

European Regulatory Designations for HAE Treatment

2018-05-25T15:37:42+00:00

The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on BioCryst Pharmaceuticals, Inc.'s application for orphan designation of BCX7353 for the treatment of HAE. In addition, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a Promising Innovative Medicine (PIM) designation to BCX7353. The positive [...]

Pharming supports haeday :-)

2018-05-18T15:57:33+00:00

On May 16th HAE patient organizations from around the world, led by HAEi (The international HAE patient organisation), come together to support the global awareness day for Hereditary Angioedema; a rare life-threatening condition. “haeday:)” aims to raise global awareness to ensure each and every patient receives faster diagnosis and the care they need to lead a [...]

Agreement for production of recombinant C1 Esterase Inhibitor

2018-05-08T16:17:04+00:00

CEVEC Pharmaceuticals GmbH and CSL Limited have signed an exclusive licensing agreement for the development, manufacture, and commercialization of recombinant C1 Esterase Inhibitor (C1-INH) proteins for HAE and other potential indications using CEVEC’s proprietary CAP®Go technology.  Under the terms of the agreement, CEVEC grants an exclusive license for the development, manufacture and commercialization of CAP®Go-derived C1-INH [...]

First Quarter 2018 Financial Results from BioCryst

2018-05-08T15:58:47+00:00

“We are off to a strong start in 2018 as we continue to make progress advancing all our HAE development programs and remain on track to read out top-line data from APeX-2 in the first half of next year,” says Jon P. Stonehouse, the BioCryst Pharmaceuticals, Inc. President and CEO, at the announcement of the [...]

HAEi Jakobsweg Walk 2018 – information for all pilgrims

2018-05-15T15:33:33+00:00

Buen Camino, HAE pilgrims! Thank you for signing up for the HAEi Jakobsweg Walk 2018 — we look very much forward to walking with you and the many other HAE pilgrims. On this page, you will find answers to all the questions related to the event that we can possibly answer. If it is not [...]

Swissmedic Validates Marketing Authorization Application for Lanadelumab

2018-04-18T10:15:38+00:00

The Swiss Agency for Therapeutic Products (Swissmedic) has validated the marketing authorization application (MAA) for Lanadelumab (SHP643). The validation of the MAA confirms that the Lanadelumab MAA submission is complete and that the formal review process will begin. Lanadelumab is an investigational treatment being evaluated for the prevention of angioedema attacks in patients 12 years [...]

Join the community for HAEi youngsters

2018-04-17T15:33:43+00:00

As you may recall the HAE Global Conference 2016 in Madrid, Spain contained a full track for HAE youngsters – and in August 2017 HAEi arranged the first ever HAEi Youngsters’ Summer Camp, which took place in Frankfurt, Germany. Based on connections first made or strengthened during these two events a group of energetic HAEi [...]

The HAEi Global Access Program helps changing lives of HAE patients

2018-04-17T15:33:19+00:00

Since announcing the appointment of Inceptua Medicines Access as the new HAEi Global Access Program (GAP) distribution partner last year, HAEi has been responding to a number of inquiries from those in countries where RUCONEST® is not commercially available. “HAEi is committed to helping the global HAE patient community obtain access to life-saving modern therapies, [...]

HAEi Connect – online membership database free for all member organizations

2018-04-17T15:32:54+00:00

HAEi is proud to present a new initiative for the member organizations: HAEi Connect – a cloud-based member database for national organizations to manage their members. “In our close collaboration with the national member organizations, we have learned that management of members is handled in many different ways – ranging from simple Word files and [...]