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So far Steen Bjerre has created 210 blog entries.

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 [...]

Oral formulation rapidly absorbed


BioCryst Pharmaceuticals, Inc. presents data showing that an oral formulation of BCX7353 was rapidly absorbed and exhibited a long half-life, two important characteristics of desired new acute treatments for HAE attacks. In the trial, the pharmacokinetic (PK) and kallikrein inhibition profiles of BCX7353 were evaluated for 24 hours post-dose in six subjects with HAE Type I or II [...]

Significant, clinically meaningful reduction of HAE attacks


Shire plc has announced additional data from the Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study, evaluating the efficacy and safety of subcutaneously administered Lanadelumab in HAE. Data shows that patients treated with Lanadelumab 300 mg every two weeks experienced significantly fewer HAE attacks, were less likely to have moderate or severe attacks or use rescue medication [...]

More aggressive development plan for HAE candidate


“Thanks to our recent equity financing and the exciting Phase 1 data from our HAE candidate KVD900, we are pleased to announce that we are building on these successes with a more aggressive development plan for KVD900, to potentially accelerate our time to market,” says Andrew Crockett, CEO of KalVista Pharmaceuticals, Inc. “Our first step [...]