CSL Behring receives U.S. Food and Drug Administration (FDA) approval for its supplemental request for co-packaging of a convenience administration kit along with its product Berinert, indicated for the treatment of acute abdominal, facial, or laryngeal attacks of HAE in adult and pediatric patients. Combination product packaging will improve the patient experience by providing ready-to-go, [...]
From the Ionis Pharmaceuticals, Inc. financial results for the second quarter of 2021 and recent business achievements: "Since our last quarterly update, we continued to execute on our strategic objectives to prepare for multiple commercial launches, expand our drug delivery capabilities and advance new products towards the market. Looking ahead, we expect data from multiple [...]
At the presentation of the financial results for the second quarter ended 30 June 2021, Pharvaris co-founder and CEO Berndt Modig says: “We made significant clinical advancements this quarter as we seek to offer novel treatments to HAE patients that are both convenient and efficacious. The data presented recently at two medical meetings continue to demonstrate [...]
Pharming Group N.V. has entered into an exclusive licence agreement with NewBridge Pharmaceuticals for the distribution of Ruconest (conestat alfa) in the Middle East and North Africa. NewBridge, headquartered in Dubai, United Arab Emirates, is a regional specialty company, with a comprehensive pharmaceutical platform of services and expertise, established to bridge the access gap and [...]
In an operational update released together with the financial results for the fiscal year ended 30 April 2021, KalVista Pharmaceuticals, Inc. CEO Andrew Crockett says: “This past fiscal year we made great strides in providing data to support the development of the candidates in our oral HAE franchise. Now we are at an important inflection point as [...]
At the EAACI Hybrid Congress 2021, KalVista Pharmaceuticals, Inc. presented its oral drug candidates. Data presentations included a late-breaking poster for the Phase 2 data for KVD900, KalVista’s lead drug program for oral on-demand treatment of HAE attacks, two posters on the prevalence and clinical management of normal C1-INH HAE in the US, and two posters on [...]
At the EAACI Hybrid Congress 2021, Takeda Pharmaceutical Company Limited presented results from two final analyses from the Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study™ Open-label Extension (OLE), which evaluated the long-term safety (primary endpoint) and efficacy of Takhzyro (lanadelumab) 300 mg every two weeks for up to 2.5 years. In the first analysis, the [...]
At the EAACI Hybrid Congress 2021, BioCryst Pharmaceuticals, Inc. announced that HAE patients who were randomized to receive 150 mg of oral, once-daily Orladeyo® (berotralstat) at the start of the APeX-2 trial had an 80 percent average reduction in their mean attack rate per month during weeks 25-96 of the trial, compared to baseline. Median attack [...]
Orchard Therapeutics and Pharming Group N.V. enters into a strategic collaboration to research, develop, manufacture and commercialize OTL-105, a newly disclosed investigational ex vivo autologous hematopoietic stem cell (HSC) gene therapy for the treatment of HAE. OTL-105 is an investigational HSC gene therapy designed to increase C1 esterase inhibitor (C1-INH) in HAE patient serum to [...]
The Israeli Ministry of Health has accepted the regulatory submission of Orladeyo for the prevention of recurrent attacks in patients with HAE 12 years and older. The Ministry also has granted an accelerated review. In addition, BioCryst Pharmaceuticals, Inc. has entered into a distribution and supply agreement granting Neopharm Ltd., a corporation organized under the [...]
