About Steen Bjerre

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So far Steen Bjerre has created 134 blog entries.

FDA application for new drug in 2018


Amber Salzman, Ph.D., President and CEO of Adverum Biotechnologies Inc., in the company's financial results for the third quarter of 2017: “We continue to make progress advancing our gene therapy programs to reach our goal of transforming Adverum into a clinical-stage company by the end of this year. Looking ahead, we plan to file an [...]

98 percent median reduction in HAE attacks


CSL Behring presents data indicating that, at the approved dose of 60 IU/kg, HAEGARDA®reduced the median number of HAE attacks per month by 98 percent in subjects who had frequent attacks, from a 16-week placebo period to a 16-week treatment period. Additionally, the breakthrough attack rate – extrapolated to one year – was reduced from [...]

Cinryze production has resumed


Shire plc announces unaudited results for the three months ended September 30, 2017. Flemming Ornskov, M.D., M.P.H., Shire CEO, commented: “We delivered strong growth this quarter despite a Cinryze supply shortage. We experienced a product shortage of Cinryze during the quarter due to a manufacturing interruption at a third-party manufacturer. The issue has been addressed and production [...]

On the right track


Pharming Group N.V. presents its (unaudited) financial report for the first nine months and the third quarter ended 30 September 2017. Operational highlights during the third quarter On September 11, following the conclusion of the End-of-Phase 2 interactions with the US Food and Drug Administration (FDA), Pharming announced that it will submit a supplemental Biologics [...]

European Approval for Label Extension of Firazyr


The European Commission (EC) has approved a label extension granting a new indication for Firazyr (icatibant injection), broadening its use to adolescents and children aged 2 years and older, with HAE caused by C1-esterase-inhibitor (C1-INH) deficiency. Firazyr has been approved in the European Union (EU) since 2008 for symptomatic treatment of acute attacks of HAE in [...]

Positive data from paediatric clinical trial with Ruconest


Pharming Group N.V. announces positive data from a clinical trial with the use of Ruconest [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for the treatment of HAE attacks in children. The open-label, single arm, Phase II clinical trial was designed in agreement with the European Medicines Agency (EMA) as part of a Paediatric Investigation Plan (PIP) [...]

Verseon developing oral treatment for HAE


Verseon Corporation has announced the launch of a drug program developing oral treatments for HAE. In their interim report, the Company presents data from a well-established HAE disease model which demonstrate the efficacy of their plasma kallikrein inhibitors in reducing swelling. An oral therapeutic would be a life-changing development for HAE patients who currently rely on [...]

Pharming and HAEi partners with Inceptua for Global Access Program


Pharming Group N.V in association with HAEi announce the appointment of Inceptua Medicines Access as their new distribution partner for the “HAEi Global Access Program” (HAEi GAP) enabling patients in all countries where Pharming’s product RUCONEST is not commercially available to gain access to the drug through an ethical and regulatory compliant mechanism.  It is [...]

Recommendations for Prophylaxis and Treatment of HAE Attacks


The Food and Drug Administration (FDA) has recently received reports from patients, physicians, and specialty pharmacies that they have been unable to obtain C1-Esterase Inhibitor (Human) Cinryze. Healthcare providers and patients may wish to consider alternate treatment options, including: For Prophylaxis: Haegarda was recently licensed for prophylaxis of HAE attacks. Haegarda is administered subcutaneously, twice [...]

Diplomat acquires Focus Rx


Diplomat Pharmacy, Inc. has completed its acquisition of Focus Rx Pharmacy Services Inc., a customer-focused healthcare partner that provides home infusion and specialty prescription management services. This acquisition bolsters Diplomat’s offering of extensive solutions to meet growing demand for infusion therapies. Diplomat’s specialty infusion services are built on the combined experience of experts in a [...]