At the Intellia Therapeutics, Inc. operational highlights and financial results for the first quarter ended 31 March 2022, President and CEO John Leonard, M.D., says: “We continue to advance our second in vivo candidate, NTLA-2002, which benefits from the modularity of our platform. We look forward to another important clinical milestone in the second half of [...]
From the BioCryst Pharmaceuticals, Inc. financial results for the first quarter ended 31 March 2022: “We are now over a year into the ORLADEYO launch and are excited to see strong and continuing patient demand and steady expansion in our prescriber base among both new and existing prescribers. These trends continued in the first quarter [...]
Héma-Québec has awarded a two-year tender for TAKHZYRO® (lanadelumab injection) as the sole option for prophylaxis subcutaneous treatment for type I/II HAE patients. The two-year term which began 1 April 2022, includes the option for Héma-Québec to extend the tender for an additional two years. “My team and I took part in the clinical trials [...]
TAKHZYRO® (lanadelumab-flyo) injection single-dose prefilled syringe is now available in the U.S. to prevent attacks of HAE in adult and pediatric patients 12 years of age and older. Approved by the U.S. Food and Drug Administration on 8 February 2022, the TAKHZYRO prefilled syringe is ready to use and requires fewer preparation steps than the single-dose [...]
The Phase 3 SHP643-301 study evaluating the safety profile and pharmacokinetics of TAKHZYRO® (lanadelumab) in patients 2 to <12 years of age is complete and has met its objectives. The safety profile was consistent with that seen in the clinical program for patients 12 years of age and older; there were no serious adverse events [...]
At the presentation of the financial results for the quarter and year ended 31 December 2021, Orchard Therapeutics CEO Bobby Gaspar, M.D., Ph.D., says that a promising early-stage research program that apply a hematopoietic stem cell (HSC) gene therapy approach in HAE will remain an important part of the portfolio going forward given the promise [...]
At the presentation of the company’s financial results for the fourth quarter and year ended 31 December 2021, Pharvaris CEO Berndt Modig says: “The time since our initial public offering in February 2021 has been transformational for Pharvaris, enabling us to reach clinical development milestones. We look forward to our next milestones and will continue [...]
Early in the pandemic, HAE patient Scott McCoy described his encounter with COVID-19 in a webinar for US HAEA. It was a bad news-good news story. The bad news was that McCoy had become infected with the novel coronavirus prior to vaccines being available. But the good news was that his infection did not cause [...]
At the American Academy of Allergy, Asthma and Immunology (AAAAI) 78th Annual Meeting Takeda presents four abstracts including interim real-world data from the observational Phase 4 EMPOWER study of TAKHZYRO® (lanadelumab) as a treatment for people with HAE Type I or II in North America, as well as findings from a post-hoc analysis of the [...]
Takeda has received approval from the Ministry of Health, Labour and Welfare (MHLW) for TAKHZYRO® (lanadelumab) subcutaneous injection 300mg syringes for prophylaxis against acute attacks of HAE in adult and pediatric patients 12 years of age and older in Japan. This approval is primarily based on results of the global Phase 3 HELP (Hereditary Angioedema [...]
HAE International (HAEi) is a global non-profit network of patient associations dedicated to raising awareness of hereditary angioedema (HAE) around the world and improving the lives of people with HAE.
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