Bjerre

About Steen Bjerre

This author has not yet filled in any details.
So far Steen Bjerre has created 199 blog entries.

“Global Perspectives” #3/2018 out now

2018-09-26T18:05:08+00:00

Dear HAE friends, We have just released the third 2018 issue of the HAEi magazine ’Global Perspectives’. Once more we give you a comprehensive insight into a great number of HAE related things going on around the globe. Among the topics in the magazine you will find an article on the additions to our Regional [...]

Firazyr approved for HAE attacks in Japan

2018-09-21T08:47:05+00:00

The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted manufacturing and marketing authorization for Firazyr for the acute treatment of HAE attacks in adult patients. “As a long-term partner to the HAE community, we continually strive to bring treatments to those living with HAE around the world,” said Andreas Busch, Ph.D., Executive [...]

Health Canada authorizes TAKHZYRO

2018-09-20T13:40:57+00:00

Shire plc and Shire Pharma Canada ULC (Shire Canada) announces that following priority review, Health Canada has authorized TAKHZYRO (lanadelumab injection) for routine prevention of attacks of HAE in adolescents and adults (12 years of age and older). "The burden HAE patients and their families face every day can’t be ignored,” said Jacquie Badiou, President, HAE Canada. “Our [...]

Additional clinical trial data for prophylaxis of HAE requested

2018-09-26T17:37:26+00:00

Pharming Group N.V. has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the supplemental Biologics License Application (sBLA) for Ruconest [C1 Esterase Inhibitor (recombinant)] to expand the current indication to include prophylaxis in patients with HAE. In November 2017, following feedback from FDA on two completed trials of [...]

KalVista Reports First Quarter Results

2018-09-14T17:11:20+00:00

From the KalVista Pharmaceuticals, Inc. financial results for the fiscal first quarter ended July 31, 2018: “Our recent financings provide significant additional capital for late-stage development of KVD900, our oral plasma kallikrein inhibitor for potential treatment of on-demand acute attacks in patients with HAE,” said Andrew Crockett, CEO. Additionally, we remain committed to our work [...]

BioCryst reports positive results in trial

2018-09-06T16:48:55+00:00

BioCryst Pharmaceuticals, Inc. announces the initial results from the ZENITH-1 trial showing that a single 750 mg oral dose of BCX7353 was well tolerated and superior to placebo (p<0.05) against the majority of efficacy endpoints evaluated in HAE patients suffering an acute attack. BCX7353 is a novel oral plasma kallikrein inhibitor being developed for both [...]

Shire acquires plasma collection company

2018-09-06T16:34:41+00:00

Shire plc has acquired sanaplasma AG, a source plasma collection company headquartered in Switzerland. The acquisition is expected to increase Shire’s access to plasma in the longer term and add to its European plasma collection network, complementing existing core capabilities in plasma supply and manufacturing. Plasma is essential to the manufacture of immunoglobulin therapies that help [...]

Orphan Drug Designation for Novel Gene Therapy Candidate

2018-08-26T18:00:19+00:00

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ADVM-053, a preclinical gene therapy candidate being investigated as a potential single‑administration treatment which has the potential to provide sustained levels of the C1 esterase inhibitor (“C1EI”) protein. “We are pleased to receive the Orphan Drug Designation for ADVM-053 from the [...]

US FDA approves TAKHZYRO

2018-08-25T15:01:55+00:00

Following priority review, the U.S. Food and Drug Administration (FDA) has approved TAKHZYRO (lanadelumab-flyo) injection, for prophylaxis to prevent attacks of HAE in patients 12 years of age and older. “TAKHZYRO provides the HAE community with a new option for the prevention of HAE attacks,” said Anthony J. Castaldo, President, U.S. HAEA. “We are grateful [...]

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 [...]