NEWS
BioCryst submits marketing authorization application in the UK
BioCryst Pharmaceuticals, Inc. has submitted a marketing authorization application (MAA) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) seeking approval of Orladeyo (berotralstat) for the prevention of recurrent HAE attacks in HAE patients [...]
First patient dosed in on-demand Phase 2 study
Pharvaris announces dosing of the first patient in RAPIDe-1, an on-demand Phase 2 study evaluating the efficacy, safety, and pharmacokinetics of PHVS416 in patients with HAE due to C1-Inhibitor Deficiency type 1 and 2. “The [...]
Intellia on track to submit application for clinical studies
Intellia Therapeutics, Inc. reports operational highlights and financial results for the fourth quarter and year ended 31 December 2020. “Intellia’s achievements in 2020 reflect important progress on both our full-spectrum strategy and our mission to [...]
BioCryst Receives Positive CHMP Opinion for Orladeyo
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Orladeyo (berotralstat) for routine prevention of recurrent attacks of HAE in adult and adolescent patients aged [...]
BioCryst expects EU review of Orladeyo very soon
“With two approvals for Orladeyo, our launch in the U.S., and the addition of more than 425 million USD through our May and December financings, 2020 was a transformational year,” Jon Stonehouse, President and CEO [...]
Expanded reimbursement for Firazyr in South Korea
From March 2021 the Ministry of Health and Welfare in South Korea will grant expanded reimbursement for the acute HAE treatment Firazyr. The ministry will expand the insurance benefits for Firazyr to two doses per [...]
Single-dose treatment demonstrates effective bradykinin inhibition
At the 2021 American Academy of Allergy Asthma & Immunology (AAAAI) Virtual Annual Meeting Pharvaris presents clinical data supporting the pharmacokinetic and pharmacodynamic profiles of PHA121 (PHA-022121) for the treatment of HAE. “The data continue [...]
Positive Results for Phase 2 of Oral On-Demand Treatment
KalVista Pharmaceuticals, Inc. announces positive topline data from a Phase 2 clinical trial demonstrating statistically and clinically significant efficacy of KVD900 as an oral on-demand treatment for HAE attacks. “We are very excited to share [...]
Working on a humanized monoclonal antibody plasma kallikrein inhibitor
After the acquisition of Quellis Biosciences Inc., Catabasis Pharmaceuticals, Inc. expects to enable the completion of IND-enabling studies, Phase 1a, and Phase 1b/2 clinical trials for the lead program QLS-215 in HAE. “Our mission has always [...]
Welcome back
12 months ago, Steen Bjerre left HAE International to pursue other opportunities. However, he has missed his many good HAE contacts, so by mutual agreement, he will return to the role of HAE International's [...]
US launch of generic Icatibant injection pre-filled syringe
Sandoz Inc. has launched its generic Icatibant injection pre-filled syringe to treat acute attacks of HAE in adults 18 years and older. It is available immediately for US patients. Sandoz has signed a US commercialization [...]
Encouraging results of oral HAE treatment study
From its Phase 1 multiple-ascending-dose study demonstrating PHA121’s pharmacokinetics and tolerability Pharvaris announces that PHA121 was well tolerated at all doses studied, with approximately dose-proportional exposure. “We are encouraged by these results to continue development [...]
Approval of Orladeyo in Japan for Prophylactic HAE Treatment
The Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing approval for BioCryst Pharmaceuticals, Inc.’s oral, once-daily Orladeyo (berotralstat) 150 mg for prophylactic treatment of HAE in adults and pediatric [...]
Survey sheds light on affect on daily life
A recent Harris Poll, commissioned by CSL Behring, asked patients who have HAE to assess how the unpredictable condition affects them. In the survey, patients also gave their thoughts on treating the condition, which causes [...]
HAEi Webinar Brief about HAE and COVID-19 vaccine
“Have no fear. Take the vaccine.” That is, in short, the main message from HAEi’s Chief Medical Advisor Prof. Marcus Maurer, during an interview with HAEi’s President and CEO Tony Castaldo. Prof. Maurer says [...]
Intellia anticipate first-in-human regulatory submission in 2021
Intellia Therapeutics, Inc. outlines its expected 2021 milestones and strategic priorities regarding HAE therapy: “Since our founding, we set out to develop modular platform components that could serve as the engine powering an expansive portfolio [...]
News from China
From HAE China Winner of seed fund: April 2020, the first public benefit innovation competition for rare diseases was officially launched. Through online courses, an offline entrepreneurship camp and project supervision, rare disease organizations [...]
News from Austria
From President Adelheid Huemer, HAE Austria 2020 has given us a lot of new challenges, and no real face to face meetings are possible. Therefore, 27 November 2020 HAE Austria went virtual and hosted the [...]
News from Switzerland
From HAE Switzerland Again, the coronavirus has its grip on Switzerland. By the end of October 2020, restrictions and measures against the virus have been reinforced due to increasing infection numbers. Newspapers and online [...]
News from Australia and New Zealand
From CEO Fiona Wardman, HAE Australasia: HAE Australasia held a webinar for patients and carers in New Zealand with Dr. Karen Lindsay, Dr. Hilary Longhurst for physicians and research updates. The webinar was recorded [...]
News from the UK
From CEO Laura Szutowicz, HAE UK Much to my surprise, I am already writing another report for Global Perspectives. At the time of the last one, we in the UK had come out of [...]
News from USA
From Patient Advocate/Social Media Manager Ianice Viel, US HAEA HAE Research: The US HAEA continues to sponsor, produce, and disseminate scientific information that leads to better care for people with HAE. Some of our [...]
News from South Korea
HAE Korea took a meaningful first step as a non-profit, voluntary organization on 7 November 2020 after a year of activities, starting with its first meeting of friends on 9 November 2019. We elected [...]
News from Russia
From Chairman Elena Bezbozhnaya, HAE Russia During the challenging time of the COVID-19 pandemic, HAE Russia keeps in touch with patients and supports its members through all available means. In the fall, we have [...]
News from Canada
From the HAE Canada Team We are kicking off this update with an exciting announcement: Canada now has a representative on the HAE International Youth Advisory Group. We would like to formally introduce Jacob [...]
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