Bjerre

About Steen Bjerre

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So far Steen Bjerre has created 175 blog entries.

Regulatory Milestones for Investigational HAE Treatment Lanadelumab

2018-03-30T12:55:22+00:00

The European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for Lanadelumab (SHP643) from Shire plc - and Health Canada has completed screening and accepted the New Drug Submission (NDS) under Priority Review for this investigational compound. Lanadelumab is an investigational treatment being evaluated for the prevention of angioedema attacks in patients 12 [...]

HAEi magazine #1/2018 out now

2018-03-29T11:45:10+00:00

April is approaching fast, and so is the 2018 HAE Global Conference in Vienna, Austria. Therefore we publish the first issue of the HAEi magazine ”Global Perspectives” where you, among many other topics, will find articles on: News from the HAEi Regional Patient Advocates Potentially 28,000 HAE Patients in China Two Decades With AEDAF in Spain [...]

KalVista Reports Fiscal Third Quarter Results

2018-03-16T14:51:36+00:00

KalVista Pharmaceuticals, Inc. reports operational and financial results for the fiscal third quarter ended 31 January 2018. “We are pleased to have the second candidate from our oral HAE portfolio in a Phase 1 trial as we continue to pursue a best-in-class therapy,” said Andrew Crockett, CEO of KalVista. KalVista has announced the initiation of a Phase 1 [...]

CSL Behring Receives Patient Impact Award

2018-03-16T14:37:02+00:00

Imagine not knowing when you might experience unpredictable, severe and painful swelling without warning in different parts of your body, including the abdomen, face, and larynx. This is what it’s like for patients with HAE who often go undiagnosed well into their adult years, ”imprisoned” by their rare disorder. Life Sciences Pennsylvania presented its 2018 [...]

BioCryst Announces Initiation of Phase 3 APeX-2 Trial

2018-03-16T14:31:58+00:00

BioCryst Pharmaceuticals, Inc. announces the dosing of the first patient into APeX-2, a Phase 3 clinical trial evaluating two dosage strengths of BCX7353 administered orally once-daily (QD)  as a preventive treatment to reduce the frequency of attacks in patients with HAE. “The ability to safely prevent attacks of angioedema with an oral medicine has been [...]

CSL’s CEO on Industry to Improve Patients’ Access to Medicines

2018-03-15T16:00:51+00:00

In a keynote address on patients’ access to medicines at the eyeforpharma Barcelona summit, CSL Behring CEO and Managing Director Paul Perreault told fellow biotech industry leaders that access to life-saving medicines remains a global challenge that cannot be ignored. “Our role in ensuring patients have access to these medicines is an imperative, not an [...]

Pharming’s Preliminary Financial Results for 2017

2018-03-07T12:04:55+00:00

At the presentation of the Pharming Group N.V. preliminary (unaudited) financial report for the full year ended 31 December 2017 CEO Sijmen de Vries said: "The remarkable growth reported in 2017 was a direct result of our strategic decisions to reacquire the commercial rights to Ruconest in North America and implement direct marketing in the major [...]

Adverum Reports Fourth Quarter 2017 Financial Results

2018-03-07T11:49:48+00:00

From the Adverum Biotechnologies, Inc. financial results for the fourth quarter ended 31 December 2017 and corporate update: “We enter 2018 with significant momentum following a year of critical execution to transform Adverum into a clinical-stage company,” said Amber Salzman, Ph.D., President and CEO. “We plan to submit an Investigational New Drug Application with the [...]

Sobi launches enhanced corporate sustainability initiative

2018-02-28T16:14:48+00:00

Swedish Orphan Biovitrum AB (Sobi) announces the launch of an enhanced corporate sustainability programme with a strong connection to the company’s strategy of providing sustainable access to treatments for rare diseases. As part of the new sustainability strategy, Sobi has identified several focus areas that are important for both the stakeholder communities and Sobi’s business. [...]