About Steen Bjerre

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So far Steen Bjerre has created 175 blog entries.

Adalvo announces successful DCP closure for Icatibant

2021-10-09T16:09:03+02:00October 9, 2021|HAEi News|

Adalvo is pleased to announce the successful closure on the DCP procedure for our Icatibant development, a complex injectable peptide product, forming part of our high-value product portfolio offering to our partners. Icatibant is an equivalent and more affordable version of Firazyr that will now be made more accessible to patients world-wide. The product is [...]

Plasma can help those with life-threatening diseases

2021-10-09T16:00:47+02:00October 9, 2021|HAEi News|

Plasma helps your body fight diseases, and it deserves greater recognition. Ask people who have certain rare and chronic complex diseases – they will tell you that therapies made from donated plasma help them manage conditions such as immunodeficiency disorders, hemophilia, and HAE. Plasma is a core substance within our blood and carries important cells, [...]

Intellia authorized to initiate Phase 1/2 clinical trial of NTLA-2002

2021-10-06T18:28:29+02:00October 6, 2021|HAEi News|

Intellia Therapeutics, Inc.'s Clinical Trial Application (CTA) has been authorized by the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) to initiate a Phase 1/2 study evaluating NTLA-2002 for the treatment of adults with HAE. NTLA-2002 is a systemically administered single-dose CRISPR/Cas9-based therapeutic candidate designed to inactivate the target gene Kallikrein B1 (KLKB1) to [...]

New treatment option supplied in prefilled syringes

2021-09-30T08:24:31+02:00September 30, 2021|HAEi News|

Cycle Pharmaceuticals launces Sajazir (icatibant) Injection, a new treatment option for patients affected by HAE approved by the US Food and Drug Administration (FDA). Sajazir is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of HAE in adults 18 years of age and older. Sajazir is supplied in a prefilled syringe delivering 30 [...]

Preclinical data demonstrates utility of RNA Actuating Platform

2021-09-30T07:59:41+02:00September 30, 2021|HAEi News|

CAMP4 Therapeutics presents preclinical data demonstrating the utility of its RNA Actuating Platform (RAP) and the therapeutic potential of oligonucleotide-mediated gene upregulation targeting a new class of RNA known as regulatory RNAs (“regRNAs”). The data describe this novel treatment approach for two genetically defined diseases, one being HAE. “These data demonstrate that by using oligonucleotides [...]

UK National Institute for Health and Care Excellence recommends Orladeyo

2021-09-16T12:17:52+02:00September 16, 2021|HAEi News|

The United Kingdom National Institute for Health and Care Excellence (NICE) recommends Orladeyo (berotralstat) for preventing recurrent attacks of HAE in eligible patients 12 years and older if they have at least two attacks per month. With this recommendation, HAE patients in England, Wales and Northern Ireland will have access to the first oral, once-daily [...]

FDA lifts clinical hold for Phase 2 Trial of KVD824

2021-09-14T14:02:17+02:00September 14, 2021|HAEi News|

The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on KalVista Pharmaceuticals, Inc.'s  Phase 2 clinical trial of KVD824 for oral prophylactic treatment of HAE. “The execution of Komplete, our Phase 2 clinical trial for KVD824 as a potential oral prophylactic therapy for HAE, is expected to accelerate now that we can [...]

Results from clinical trials for COVID-19 treatment with Ruconest

2021-09-14T08:30:48+02:00September 14, 2021|HAEi News|

Pharming Group N.V. announces the topline results from two randomized, open label, controlled, pilot clinical trials of patients hospitalized with COVID-19 treated with Ruconest (recombinant human C1 inhibitor) for the prevention of severe SARS-CoV-2 infection. The primary endpoint in both studies was disease severity on the 7-point WHO ordinal scale on Day 7. In the [...]

Launch of dedicated support platform for rare disease patients

2021-09-14T08:18:13+02:00September 10, 2021|HAEi News|

Cycle Pharmaceuticals has launched Cycle Vita, a support platform for rare disease patients. The platform provides a vast range of high-quality support programs to both healthcare providers and rare disease patients across the United States, who have been prescribed a Cycle treatment. “Cycle Vita is the ultimate expression of the heart of Cycle. At Cycle, we [...]

Important advancement for HAE patients in the United Arab Emirates

2021-09-09T13:25:47+02:00September 9, 2021|HAEi News|

The Ministry of Health and Prevention in the United Arab Emirates has granted marketing authorization for oral, once-daily Orladeyo (berotralstat) for the prevention of recurrent attacks in patients with HAE 12 years and older. To support commercialization efforts in the United Arab Emirates, BioCryst Pharmaceuticals, Inc. has entered into a supply and distribution agreement with NewBridge [...]

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