Bjerre

About Steen Bjerre

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So far Steen Bjerre has created 224 blog entries.

Serving an important role in the management of HAE

2019-02-22T11:33:56+00:00January 23, 2019|HAEi News|

Following the presentation of two abstracts at the Western Society of Allergy, Asthma and Immunology (WSAAI) in Maui, Hawaii, USA, the Pharming Group N.V. COO Bruno Giannetti (MD, PhD) said: “This real-world evidence demonstrates that Ruconest continues to serve an important role in the management of HAE despite the availability of other therapeutic options.” The presentations are: [...]

Positive Phase 1 Results for Oral Plasma Kallikrein Inhibitor

2019-02-18T09:47:12+00:00January 22, 2019|HAEi News|

Attune Pharmaceuticals announces the positive results from the first in human studies evaluating ATN-249, a novel orally administered plasma kallikrein inhibitor for the treatment of HAE. The data were presented by Ira Kalfus, M.D., chief medical officer of Attune, as a poster presentation at the Western Society of Allergy, Asthma and Immunology (WSAAI) 2019 Annual [...]

Takeda Completes Acquisition of Shire

2019-02-18T09:47:20+00:00January 10, 2019|HAEi News|

Takeda Pharmaceutical Company Limited has completed its acquisition of Shire plc, becoming a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan. Takeda now has an attractive, expanded geographic footprint and leading position in Japan and the U.S., bringing its highly-innovative medicines to approximately 80 countries/regions with dedicated employees worldwide. Takeda’s R&D efforts are focused on [...]

KalVista Development Update and 2019 Clinical Plans

2019-02-18T09:47:24+00:00January 6, 2019|HAEi News|

“In December we filed with regulatory authorities to begin our Phase 2 study of KVD900 as a potential oral acute treatment for HAE. This enlarged study is expected to provide data in late 2019. We continue to be excited by the potential for KVD900 to provide a safe, oral on-demand option for HAE patients to [...]

“Global Perspectives” #4/2018 out now

2019-05-15T11:02:43+00:00December 21, 2018|HAEi News|

Dear HAE friends, With this fourth and final issue of the HAEi magazine Global Perspectives, we send you our sincerest best wishes for a festive holiday season and a healthy 2019. In this issue of our magazine you will, among many other items, find information on: HAEi South Eastern Europe Workshop 2018 HAEi Central Eastern Europe Conference and Workshop [...]

Enlarged Phase 2 Trial on Track

2019-02-18T09:47:31+00:00December 14, 2018|HAEi News|

KalVista Pharmaceuticals, Inc. has provided an operational update and released financial results for the fiscal second quarter ended October 31, 2018. CEO Andrew Crockett says: “We are still on track with our robust Phase 2 study for KVD900 as a potential acute therapy for patients with HAE. Our intention is to have an aggressive development plan [...]

Favorable conclusion from study of acute HAE therapies

2018-12-07T09:51:06+00:00December 7, 2018|HAEi News|

A new study examines and compares re-dosing rates inter alia for human C1 esterase inhibitor in recombinant form (Ruconest®) and plasma-derived forms (Berinert®, Cinryze®) to icatibant (Firazyr®) in seven individual patients at risk of HAE attacks. A total of 69 attacks were recorded.  The study was led by Professor Dr Marcus Magerl of the Department [...]

European approval for subcutaneous HAE medication

2018-11-30T10:13:09+00:00November 30, 2018|HAEi News|

The European Commission (EC) has granted Shire plc Marketing Authorisation for TAKHZYRO™ (as Lanadelumab) subcutaneous injection for routine prevention of recurrent attacks of HAE in patients aged 12 years and older. TAKHZYRO is a first-of-its-kind fully human monoclonal antibody (mAb) that inhibits the activity of plasma kallikrein, an enzyme which is uncontrolled in people with [...]

Complete Results of Study Evaluating Preventive Treatment

2019-05-07T12:56:14+00:00November 27, 2018|HAEi News, Uncategorized|

The Journal of the American Medical Association (JAMA) publishes the complete results from the Phase 3 HELP Study™, a randomised, placebo-controlled trial evaluating the efficacy and safety of subcutaneously administered Lanadelumab versus placebo over 26 weeks in 125 patients 12 years of age or older with HAE. The HELP Study™ is the largest randomised controlled [...]