Keep yourself updated with HAEi news and events
HAEi News Archive
On the way towards a once-daily oral HAE therapy
In its financial results for the full year ended 31 December 2018 the BioCryst Pharmaceuticals, Inc. President and CEO Jon Stonehouse said: [...]
Potentially ideal profile for oral on-demand treatment of HAE
In conjunction with the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting 2019 in San Francisco, CA. KalVista Pharmaceuticals, [...]
Results Confirm Rapid Onset of Action, Sustained Activity and Robust Dose Response
BioCryst Pharmaceuticals, Inc. reports additional topline data from the Phase 2 ZENITH-1 trial, including new data from the 250 mg [...]
Attune Advances Medication for Treatment of HAE
Attune Pharmaceuticals, Inc. announces the completion of a $23 million Series B financing with the proceeds to be used to [...]
Serving an important role in the management of HAE
Following the presentation of two abstracts at the Western Society of Allergy, Asthma and Immunology (WSAAI) in Maui, Hawaii, USA, the [...]
Positive Phase 1 Results for Oral Plasma Kallikrein Inhibitor
Attune Pharmaceuticals announces the positive results from the first in human studies evaluating ATN-249, a novel orally administered plasma kallikrein [...]
Takeda Completes Acquisition of Shire
Takeda Pharmaceutical Company Limited has completed its acquisition of Shire plc, becoming a global, values-based, R&D-driven biopharmaceutical leader headquartered in [...]
KalVista Development Update and 2019 Clinical Plans
“In December we filed with regulatory authorities to begin our Phase 2 study of KVD900 as a potential oral acute [...]
“Global Perspectives” #4/2018 out now
Dear HAE friends, With this fourth and final issue of the HAEi magazine Global Perspectives, we send you our sincerest best wishes [...]
Enlarged Phase 2 Trial on Track
KalVista Pharmaceuticals, Inc. has provided an operational update and released financial results for the fiscal second quarter ended October 31, [...]
European approval for subcutaneous HAE medication
The European Commission (EC) has granted Shire plc Marketing Authorisation for TAKHZYRO™ (as Lanadelumab) subcutaneous injection for routine prevention of [...]
Complete Results of Study Evaluating Preventive Treatment
The Journal of the American Medical Association (JAMA) publishes the complete results from the Phase 3 HELP Study™, a randomised, [...]
Oral formulation rapidly absorbed
BioCryst Pharmaceuticals, Inc. presents data showing that an oral formulation of BCX7353 was rapidly absorbed and exhibited a long half-life, two important characteristics [...]
Significant, clinically meaningful reduction of HAE attacks
Shire plc has announced additional data from the Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study, evaluating the efficacy and safety of [...]
More aggressive development plan for HAE candidate
“Thanks to our recent equity financing and the exciting Phase 1 data from our HAE candidate KVD900, we are pleased [...]
CHMP Recommends EU Marketing Authorisation of Lanadelumab
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the [...]
“Global Perspectives” #3/2018 out now
Dear HAE friends, We have just released the third 2018 issue of the HAEi magazine ’Global Perspectives’. Once more we [...]
Health Canada authorizes TAKHZYRO
Shire plc and Shire Pharma Canada ULC (Shire Canada) announces that following priority review, Health Canada has authorized TAKHZYRO (lanadelumab [...]
Additional clinical trial data for prophylaxis of HAE requested
Pharming Group N.V. has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the [...]
KalVista Reports First Quarter Results
From the KalVista Pharmaceuticals, Inc. financial results for the fiscal first quarter ended July 31, 2018: “Our recent financings provide [...]
BioCryst reports positive results in trial
BioCryst Pharmaceuticals, Inc. announces the initial results from the ZENITH-1 trial showing that a single 750 mg oral dose of [...]
Shire acquires plasma collection company
Shire plc has acquired sanaplasma AG, a source plasma collection company headquartered in Switzerland. The acquisition is expected to increase Shire’s [...]
Orphan Drug Designation for Novel Gene Therapy Candidate
The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ADVM-053, a preclinical gene therapy candidate [...]
US FDA approves TAKHZYRO
Following priority review, the U.S. Food and Drug Administration (FDA) has approved TAKHZYRO (lanadelumab-flyo) injection, for prophylaxis to prevent attacks [...]
U.S. FDA Grants Fast Track Designation for BioCryst’s BCX7353
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for BioCryst Pharmaceuticals, Inc.'s BCX7353 for the prevention [...]
Clinical Progress Across Gene Therapy Pipeline
Adverum Biotechnologies, Inc. updates its next-generation ADVM-053 targeting HAE. “We are excited to be able to share positive progress in [...]
Pharming’s Financial Results for first half of 2018
On the presentation of the Pharming Group N.V. financial report for the six months ended 30 June 2018 CEO Sijmen de Vries [...]
APeX-1 Clinical Trial Results for BCX7353
Results from the Phase 2, APeX-1 clinical trial of BCX7353 for the prevention of attacks in patients with HAE are [...]
The HAEi Magazine ‘Global Perspectives’ out now
It is July – and it is time for the second 2018 issue of the HAEi magazine ’Global Perspectives’. This [...]
FDA Approval for Label Expansion of Cinryze
The U.S. Food and Drug Administration (FDA) has approved a label expansion for Cinryze® (C1 esterase inhibitor [human]), making it [...]
Record-breaking HAE Global Walk 2018
In 2016 HAEi introduced the HAE Global Walk in order to raise awareness around the world. The third edition of [...]
Additional Analyses of APeX-1 Clinical Trial of BCX7353
BioCryst Pharmaceuticals, Inc. presented additional analyses of the APeX-1 trial of BCX7353 for the prevention of attacks in patients with [...]
Official video from the 2018 HAE Global Conference
17-20 May 2018 more than 730 delegates from 57 countries met in Vienna, Austria for the 4th HAE Global Conference. [...]
European Regulatory Designations for HAE Treatment
The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on BioCryst Pharmaceuticals, Inc.'s [...]
Pharming supports haeday :-)
On May 16th HAE patient organizations from around the world, led by HAEi (The international HAE patient organisation), come together to [...]
Agreement for production of recombinant C1 Esterase Inhibitor
CEVEC Pharmaceuticals GmbH and CSL Limited have signed an exclusive licensing agreement for the development, manufacture, and commercialization of recombinant C1 [...]
HAEi Jakobsweg Walk 2018 – information for all pilgrims
Buen Camino, HAE pilgrims! Thank you for signing up for the HAEi Jakobsweg Walk 2018 — we look very much [...]
Swissmedic Validates Marketing Authorization Application for Lanadelumab
The Swiss Agency for Therapeutic Products (Swissmedic) has validated the marketing authorization application (MAA) for Lanadelumab (SHP643). The validation of [...]
Join the community for HAEi youngsters
As you may recall the HAE Global Conference 2016 in Madrid, Spain contained a full track for HAE youngsters – [...]
The HAEi Global Access Program helps changing lives of HAE patients
Since announcing the appointment of Inceptua Medicines Access as the new HAEi Global Access Program (GAP) distribution partner last year, [...]
HAEi Connect – online membership database free for all member organizations
HAEi is proud to present a new initiative for the member organizations: HAEi Connect – a cloud-based member database for [...]
Get your website hosted at haei.org
A growing number of national HAE organizations have their own websites with their own individual hosting solution. However, some of [...]
HAEi Jakobsweg Walk 2018
After the successful HAEi/AEDAF Camino Walk on the Camino de Santiago in northwestern Spain in May 2016 and May 2017, [...]
2017 revision and update of the international WAO/EAACI guideline for the management of HAE
An international expert panel has reviewed the existing evidence and developed 20 recommendations that were discussed, finalized and consented during [...]
Two decades with AEDAF in Spain
Asociación Española de Angioedema Familiar por Deficiencia del Inhibidor de C1 – or in short AEDAF – held its 20th [...]
Potentially 28,000 HAE patients in China
By Fiona Wardman, HAEi Executive Committee member and President of HAE Australasia China has a population of approximately 1.4 billion, [...]
Thousands will help raise HAE awareness step by step
On and around hae day :-) 2018 a group of HAE patients, relatives, caregivers, doctors, nurses, people from HAE organizations, [...]
Regulatory Milestones for Investigational HAE Treatment Lanadelumab
The European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for Lanadelumab (SHP643) from Shire plc - and [...]
HAEi magazine #1/2018 out now
April is approaching fast, and so is the 2018 HAE Global Conference in Vienna, Austria. Therefore we publish the first [...]
KalVista Reports Fiscal Third Quarter Results
KalVista Pharmaceuticals, Inc. reports operational and financial results for the fiscal third quarter ended 31 January 2018. “We are pleased to have [...]
CSL Behring Receives Patient Impact Award
Imagine not knowing when you might experience unpredictable, severe and painful swelling without warning in different parts of your body, [...]
BioCryst Announces Initiation of Phase 3 APeX-2 Trial
BioCryst Pharmaceuticals, Inc. announces the dosing of the first patient into APeX-2, a Phase 3 clinical trial evaluating two dosage [...]
CSL’s CEO on Industry to Improve Patients’ Access to Medicines
In a keynote address on patients’ access to medicines at the eyeforpharma Barcelona summit, CSL Behring CEO and Managing Director [...]
Pharming’s Preliminary Financial Results for 2017
At the presentation of the Pharming Group N.V. preliminary (unaudited) financial report for the full year ended 31 December 2017 [...]
Adverum Reports Fourth Quarter 2017 Financial Results
From the Adverum Biotechnologies, Inc. financial results for the fourth quarter ended 31 December 2017 and corporate update: “We enter [...]
Sobi launches enhanced corporate sustainability initiative
Swedish Orphan Biovitrum AB (Sobi) announces the launch of an enhanced corporate sustainability programme with a strong connection to the [...]
BioCryst reports full year financial results
At the announcement of the BioCryst Pharmaceuticals, Inc. financial results for 2017 President & CEO Jon P. Stonehouse said: “Our team [...]
First patient dosed in APeX-S trial
BioCryst Pharmaceuticals, Inc. has dosed the first patient in APeX-S, a long-term safety trial evaluating two dosage strengths of BCX7353 [...]
EMA grants accelerated assessment for Lanadelumab
The European Medicines Agency (EMA) has granted an accelerated assessment for Lanadelumab (SHP643), an investigational treatment being evaluated for the [...]
FDA accepts BLA for Lanadelumab
The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted priority review for Lanadelumab [...]
Shire recognizes Rare Disease Day 2018
Shire plc announces its continuing global education and awareness efforts on Rare Disease Day 2018, to deliver on its commitment [...]
Accelerating time to diagnosis for children with rare diseases
Shire plc, Microsoft and EURORDIS-Rare Diseases Europe has formed a strategic alliance to address the diagnostic challenge for patients living [...]
FDA Accepts sBLA for Cinryze for Pediatric HAE Use
The U.S. Food and Drug Administration (FDA) has accepted the Cinryze (C1 esterase inhibitor [human]) supplemental Biologics License Application (sBLA) [...]
Cinryze Manufacturing Process Transfer Approved
The U.S. Food and Drug Administration (FDA) has granted approval for the technology transfer of Cinryze drug product manufacturing process [...]
BioCryst and Idera announces merger
BioCryst Pharmaceuticals, Inc. and Idera Pharmaceuticals, Inc. have signed a definitive merger agreement to form a new enterprise focused on the [...]
FDA Acceptance for Review of sBLA for Ruconest
The U.S. Food and Drug Administration (FDA) has accepted for review Pharming Group N.V.'s supplemental Biologics License Application (sBLA) for [...]
Verseon presents HAE program
Verseon has presented preclinical results in its HAE program at the 2018 Biotech Showcase in San Francisco, USA. The data show [...]
KalVista Commences Clinical Trial
KalVista Pharmaceuticals, Inc. will be initiating a Phase 1 trial for KVD 900, the second candidate in the oral HAE [...]
Adverum accelerates development of pipeline of gene therapies
Adverum Biotechnologies, Inc., a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases, reviews recent [...]
HAEi Connect is ready to help the global member organizations
Over the last months, HAEi has been working hard on completing HAEi Connect – a member database, communication management tool, [...]
HAE Scandinavia Conference 2017
The second weekend in November 2017 the beautiful conference venue Bergendal – right at the rim of Edsviken bay in [...]
First HAE doctors and patients meeting in South Africa
The first doctor and patient HAE meeting was held in Cape Town at the Groote Schuur Hospital on the 25 [...]
HAEi Central and Eastern Europe Workshop 2017
7-8 October 2017 the combined 4th HAE National Conference and the 2nd HAEi Central and Eastern Europe Workshop took place [...]
HAEi South Eastern Europe Workshop 2017
HAE Macedonia and the Regional Patient Advocate for South Eastern Europe Natasa Angjeleska hosted the second regional meeting for HAE [...]
December magazine out now
More and more HAE related activities are going on around the world. In the December 2017 issue of the HAEi [...]
KalVista Reports Second Quarter Results
KalVista Pharmaceuticals, Inc. today reported operational and financial results for the fiscal second quarter ended October 31, 2017. The initial [...]
The dawn of a new era of HAE management
Symposium 19th June 2017 - as part of the European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting in [...]
Supplemental Biologics License Application to FDA
Pharming Group N.V. has submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
September magazine out now
More and more HAE related activities are going on around the world. In fact, we think it is safe to [...]
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 [...]
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 [...]
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 [...]
Portfolio of Oral Plasma Kallikrein Inhibitors Continues to Advance
From the KalVista Pharmaceuticals, Inc. operational and financial results for the fiscal first quarter ended July 31, 2017: “We [...]
Significant reduction of attack rate
Shire plc announces positive topline Phase 3 results for the Sahara study, a global, multi-center, randomized, double-blind, placebo-controlled, partial crossover [...]
Conclusion of FDA End-of-Phase 2 interactions on Ruconest
Pharming Group N.V. has concluded its End-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA). As part of [...]
Positive Results from APeX-1 Phase 2 Trial
BioCryst Pharmaceuticals, Inc. has announced final results from its Phase 2 APeX-1 clinical trial in HAE. APeX-1 was a 3-part [...]
Berinert Approved by Health Canada
Heath Canada - responsible for helping Canadians maintain and improve their health - has approved Berinert (C1 Esterase Inhibitor, Human) [...]
Adverum Reports Second Quarter Financial Results
Adverum Biotechnologies, Inc. has reported financial results for the second quarter ended 30 June 2017 and provided a corporate update. [...]
BioCryst Reports Second Quarter Financial Results
BioCryst Pharmaceuticals, Inc. has announced financial results for the second quarter ended 30 June 2017. Jon P. Stonehouse, President & [...]
BioCryst Announces Initiation of ZENITH-1
BioCryst Pharmaceuticals, Inc. has announced the dosing of the first subject into ZENITH-1, a clinical trial studying up to three [...]
KalVista Pharmaceuticals Provides Operational Update
KalVista Pharmaceuticals, Inc. provides an operational update and released financial results for the fiscal fourth quarter and full year ended [...]
Pharming Reports on Financial Results for the First Half of 2017
Pharming Group N.V. presents its (unaudited) financial report for the six months ended 30 June 2017. CEO Sijmen de Vries [...]
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