9/2/2023 0 Comments Itrace freshThe disease has developed resistance, causes impaired vision, blindness, or perhaps blindness, and frequently necessitates single or repeated corneal transplant treatments. Immediate medical action is essential to save the patient’s sight. “Avanzanite’s management team brings a substantial track record in delivering orphan medicines to niche European markets, which we expect will result in an accelerated return on investment for Sifi.”Īcanthamoeba Keratitis (AK) is a rare, severe, and progressive parasitic corneal illness caused by the free-living amoeba Acanthamoeba. As we advance towards a regulatory approval in dozens of European countries, we are excited to partner with Avanzanite, as this collaboration promises to accelerate access to our drug candidate to patients in several markets that are outside of our current commercial focus,” Fabrizio Chines, Sifi Chairman and CEO, said in a company news release. “We made significant investments on Akantior throughout 15 years of rigorous research and are looking for ways to maximize our asset’s potential. ![]() The completed phase 3 trial's detailed good results and fresh data were presented at the American Academy of Ophthalmology Annual Meeting in Chicago in October 2022. Sifi anticipates that the EMA Committee for Medicinal Products for Human Use will provide a favorable opinion in 2023. In May 2022, the European Medicines Agency (EMA) approved Sifi's Marketing Authorization Application (MAA) for Akantior. Sifi and Avanzanite also agreed to expand the existing Early Access Program (EAP) for the main five European nations to selected countries within the scope of Avanzanite's license. Sifi will continue to focus and invest in market access and commercial activities related to Akantior in existing and new European countries such as Italy, France, Germany, the United Kingdom, Spain, Romania, and Turkey, while also evaluating various options for Akantior commercialization globally, including potential license agreements outside of its core markets. The collaboration will provide commercial access to Akantior to an estimated 500 patients in these territories who suffer from acanthamoeba keratitis (AK) each year. Sifi will manage all ongoing regulatory activities under the terms of the agreement, while Avanzanite will focus on market entry, distribution, and commercial activity in those markets. ![]() If young users stick with letters, numbers, and kids' names for a while and modify assessments for older tracers, they can avoid the pitfalls and enjoy iTrace's strengths.Italy-based Sifi formed a collaboration with Avanzanite Bioscience, a Dutch specialty pharmaceutical business, to commercialize and distribute Akantior (polihexanide) exclusively in 26 European Economic Area and Swiss countries. Some terms used in the assessment ("too shaky," "out of bounds," and "overextended") may be descriptive but not necessarily helpful to say to kids trying to master that letter. Also, the app says only the name of the letter and doesn't sound it out. There are some odd word choices in the word-tracing mode that young kids aren't likely to be familiar with or use, such as "yacht" and "stilts," although you can add your own words. On the downside, once a word appears the letters enlarge so parts of the word often confusingly fall off the right side of the screen. ![]() The My Name module allows kids to practice writing their own names in many color combinations - sure to be a favorite choice for many kids. As kids progress, the app selects the next appropriate exercise automatically. ![]() The ability to customize letters to left- or right-handed tracing as well as to different writing styles is especially impressive. Overall, ITRACE - HANDWRITING FOR KIDS provides lots of good tracing exercises to help kids get familiar with letter formation.
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