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So far Steen Bjerre has created 213 blog entries.

Attune Advances Medication for Treatment of HAE


Attune Pharmaceuticals, Inc. announces the completion of a $23 million Series B financing with the proceeds to be used to advance a pipeline including the ongoing clinical development of ATN-249, a novel orally-administered plasma kallikrein inhibitor for the treatment of HAE. Andrew McDonald, Ph.D., CEO of Attune, said, “This financing brings together a syndicate of [...]

Serving an important role in the management of HAE


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


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


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


“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


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


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


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


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


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 [...]