Bjerre

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So far Steen Bjerre has created 190 blog entries.

U.S. FDA Grants Fast Track Designation for BioCryst’s BCX7353

2018-08-07T07:30:25+00:00

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for BioCryst Pharmaceuticals, Inc.'s BCX7353 for the prevention of angioedema attacks in patients with HAE. Fast Track Designation provides opportunities for frequent interactions with the FDA during development of a product candidate and provides the opportunity for priority review if supported by clinical [...]

Clinical Progress Across Gene Therapy Pipeline

2018-08-03T09:45:08+00:00

Adverum Biotechnologies, Inc. updates its next-generation ADVM-053 targeting HAE. “We are excited to be able to share positive progress in our lead gene therapy program and to share our continued commitment to improving the quality of life for patients with unmet medical needs,” said Leone Patterson, interim president and CEO of Adverum Biotechnologies. “We are [...]

Pharming’s Financial Results for first half of 2018

2018-07-27T11:38:20+00:00

On the presentation of the Pharming Group N.V. financial report for the six months ended 30 June 2018 CEO Sijmen de Vries said: “We are delighted with the further progress we have made expanding the reach of Ruconest, allowing more patients to access the clinical benefits of our product. We have continued net profitability in the second [...]

APeX-1 Clinical Trial Results for BCX7353

2018-07-26T16:24:09+00:00

Results from the Phase 2, APeX-1 clinical trial of BCX7353 for the prevention of attacks in patients with HAE are published online in the July 26th issue of The New England Journal of Medicine. The APeX-1 trial was a double blind, randomized, parallel group, placebo-controlled Phase 2 dose ranging trial comparing the safety and efficacy [...]

The HAEi Magazine ‘Global Perspectives’ out now

2018-07-11T20:15:16+00:00

It is July – and it is time for the second 2018 issue of the HAEi magazine ’Global Perspectives’. This time the magazine is truly covering the world as we focus on the record-breaking 2018 HAE Global Conference that took place in Vienna, Austria 17-20 May. Indeed, the fourth HAE global Conference set new records [...]

Agreement with PMDA on Clinical Trial and Regulatory Requirements

2018-06-25T22:29:36+00:00

BioCryst Pharmaceuticals, Inc. has reached agreement on the design of a Phase 3 trial and regulatory requirements for marketing authorization of BCX7353 for HAE with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. The Phase 3 trial design agreed upon for Japan, APeX-J, is a randomized, placebo-controlled double-blind trial of 24 weeks duration with [...]

FDA Approval for Label Expansion of Cinryze

2018-06-21T08:39:03+00:00

The U.S. Food and Drug Administration (FDA) has approved a label expansion for Cinryze® (C1 esterase inhibitor [human]), making it available to help prevent angioedema attacks in children aged 6 years and older with HAE. Cinryze has been approved in the U.S. since October 2008 for routine prophylaxis against attacks in adolescents and adults living [...]

Record-breaking HAE Global Walk 2018

2018-06-04T09:43:51+00:00

In 2016 HAEi introduced the HAE Global Walk in order to raise awareness around the world. The third edition of the HAE Global Walk took place from 1 April to 31 May 2018 and broke each and every record as 54,609,008 steps were taken by 4,262 people from 37 countries. That is 42,007 km or [...]

Additional Analyses of APeX-1 Clinical Trial of BCX7353

2018-05-30T16:42:11+00:00

BioCryst Pharmaceuticals, Inc. presented additional analyses of the APeX-1 trial of BCX7353 for the prevention of attacks in patients with HAE at the annual congress of the European Academy of Allergy and Clinical Immunology (EAACI) 26-30 May 2018 in Munich, Germany. “These additional analyses of our Phase 2 APeX-1 trial of once-daily oral BCX7353 provide [...]