steenbjere

About Steen Bjerre

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So far Steen Bjerre has created 145 blog entries.

Rapid Improvement in Attacks Treated With Oral Treatment

2021-06-06T09:57:36+02:00June 6, 2021|HAEi News|

At the 12th C1-Inhibitor Deficiency & Angioedema Workshop, KalVista Pharmaceuticals, Inc. presents clinical data supporting KVD900 as an oral on-demand treatment for HAE. “Our goal is to provide the best outcome for HAE patients experiencing an attack, and that means offering them the ability to treat early in the attack progression to shorten attack duration,” says Andrew [...]

Pharvaris Presents Data for Oral HAE Medication 

2021-06-04T11:53:10+02:00June 4, 2021|HAEi News|

At the 12th C1 Inhibitor Deficiency and Angioedema Workshop (held virtually 3-6 June 2021), Anne Lesage, Ph.D., Chief Early Development Officer at Pharvaris, presents bradykinin challenge data supporting the pharmacokinetic and pharmacodynamic profile of PHA121 (PHA-022121) for the treatment of HAE. “Findings presented here from pre-clinical and clinical studies, particularly from in vivo bradykinin challenge studies, [...]

Reimbursement of Ruconest in Spain

2021-06-04T09:03:00+02:00June 4, 2021|HAEi News|

Pharming Group N.V. has reached an agreement with the Spanish Ministry of Health to grant reimbursement for Ruconest (conestat alfa) in Spain. Ruconest is the first and only plasma-free recombinant human C1 esterase inhibitor (rhC1INH) protein replacement therapy approved for the treatment of acute HAE attacks in adults and children aged 2 years and over. Clinical [...]

Oral, once-daily Orladeyo now available in Germany

2021-06-03T15:35:40+02:00June 3, 2021|HAEi News|

Oral, once-daily Orladeyo (berotralstat) from BioCryst Pharmaceuticals, Inc. was approved by the European Medicines Agency (EMA) on 30 April 2021 for the prevention of recurrent HAE attacks in patients 12 years and older - and now the product is available for patients with a prescription in Germany. “We have an experienced team in place in Germany [...]

Pharvaris on track with new HAE medications

2021-05-26T16:22:11+02:00May 26, 2021|HAEi News|

At the presentation of the Pharvaris financial results for the first quarter ended 31 March 2021, co-founder and CEO Berndt Modig said: “We continue to execute on a development strategy which we believe provides value to shareholders and patients, as demonstrated by the continued enrollment of our Phase 2 on-demand study of PHVS416, from which [...]

Glenmark gets final go from FDA for Icatibant injection

2021-05-24T15:17:38+02:00May 24, 2021|HAEi News|

Glenmark Pharmaceuticals Limited has received final approval by the United States Food & Drug Administration (U.S. FDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, the generic version of Firazyr Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, of Shire Human Genetic Therapies, Inc. This marks Glenmark’s first synthetic decapeptide injectable [...]

Optime Care celebrates hae day :-)

2021-05-17T17:46:27+02:00May 17, 2021|HAEi News|

The pharmacy, distribution and patient management organization Optime Care is pleased to recognize hae day :-) and celebrate the 10th anniversary of an awareness campaign that unites the HAE community. “Access to innovative therapies that can improve quality of life is critical for people with rare diseases like HAE,” says Donovan Quill, President and CEO, Optime [...]

UK MHRA Approves First Oral, Once-daily Therapy

2021-05-13T00:04:53+02:00May 13, 2021|HAEi News|

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for oral, once-daily Orladeyo (berotralstat) for the routine prevention of recurrent HAE attacks in HAE patients 12 years and older. “HAE UK welcomes the decision as HAE is an unpredictable and life-threatening condition which causes significant emotional and economic burdens on people [...]

HAEGARDA is now available in all of Canada

2021-05-11T21:00:18+02:00May 11, 2021|HAEi News|

HAEGARDA (C1 Esterase Inhibitor Subcutaneous [Human]) from CSL Behring - a subcutaneous C1 esterase inhibitor (C1-INH) therapy indicated for routine prevention of HAE attacks in adolescent and adult patients - is now available in all of Canada. “As a physician that treats this disease, I’m pleased to have HAEGARDA available for patients across Canada. HAEGARDA represents another [...]