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So far Steen Bjerre has created 113 blog entries.

KalVista appoints Senior Vice President of Medical


KalVista Pharmaceuticals, Inc. has appointed Andreas Maetzel, M.D., M.Sc., Ph.D, to the role of Senior Vice President, Medical. “Andreas Maetzel brings a wealth of experience in HAE and over 25 years of leadership in the pharmaceutical industry, including clinical development, medical and regulatory affairs,” said Andrew Crockett, CEO of KalVista. “I am confident that he [...]

Attune Pharmaceuticals announces pre-clinical data


Attune Pharmaceuticals, a biotechnology company focused on the discovery and development of novel oral small molecule therapeutics for the treatment of rare diseases, has announced the first preclinical data results for ATN-249, a novel orally administered plasma kallikrein inhibitor for the treatment of HAE. The data was presented in a late-breaking poster presentation at the 2017 [...]

Positive interim results from APeX-1 trial


BioCryst Pharmaceuticals, Inc. has announced results from an interim analysis of its Phase 2 APeX-1 trial in HAE. APeX-1 is a dose ranging trial designed to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered once daily (QD) BCX7353 for 28 days, as a preventative treatment to reduce the frequency of attacks in HAE patients. [...]

Phase 1b results for investigational treatment published


The New England Journal of Medicine has just published the results from the Phase 1b study of lanadelumab (SHP643; formerly DX-2930) from Shire plc. Lanadelumab is a subcutaneously administered, human monoclonal antibody that specifically binds and inhibits plasma kallikrein, and it is being investigated for the prevention of angioedema attacks in patients with HAE. "In this [...]

European Commission amends Marketing Authorisation for Ruconest


Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP), the European Commission has adopted the Commission Implementing Decision to amend the marketing authorisation for Ruconest to include self administration using the Ruconest Administration Kit. This decision allows for self-administration of Ruconest for acute HAE attacks by adolescents and adults with a new [...]

KalVista Closes Merger with Carbylan


KalVista Pharmaceuticals, Inc. has announced the closing of the previously announced merger with Carbylan Therapeutics, Inc. As a result of the completion of this transaction, Carbylan changed its name to KalVista Pharmaceuticals, Inc. KalVista is now funded with more than 38 million USD to support its portfolio of drug development programs, initially focused on oral plasma [...]

A Randomized Trial of Subcutaneous C1-INH for HAE Attack Prevention


Current options for prophylaxis of acute HAE attacks are very limited. The international, prospective, double-blind, crossover, phase III COMPACT trial evaluated a volume-reduced, subcutaneous C1-inhibitor preparation, CSL830, for the prevention of HAE attacks. After obtaining written consent, patients with type I/II HAE were randomized to one of four treatment sequences, each involving two 16-week treatment [...]

Results of phase II study for prophylaxis of HAE attacks


The results of a “Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human C1 Inhibitor for Prophylaxis of Hereditary Angioedema Attacks” has been presented by Marco Cicardi, Professor of Internal Medicine University of Milan, Hospital L. Sacco Milan and co-prinicipal investigator for the study. The presentation was held during the American College of Allergy, Asthma and Immunology 2016 [...]

Pharming announces progress on financing


Pharming Group N.V. has made significant progress with financing towards completion of the transaction with subsidiaries of Valeant Pharmaceuticals International, Inc. signed on 8 August 2016 for Pharming to acquire the commercialization rights to its own product Ruconest in North America. The company has signed a term sheet with a syndicate of debt providers. The documentation [...]

CHMP adopts positive opinion to include self-administration for Ruconest


The Committee for Medicinal Products for Human Use (CHMP), an advisory committee of the European Medicine Agency (EMA), has adopted a positive opinion recommending an extension to the terms of the marketing authorisation for Ruconest to the European Commission. This recommendation will allow self-administration of Ruconest for acute HAE attacks by adolescents and adults with [...]