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Astellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe Disease

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TOKYO , Jan 20, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa Ph.D., "Astellas") announced today that the US Food and Drug Administration (FDA) has lifted the clinical hold on Jan 19 th for the FORTIS Ph1/2 clinical trial evaluating the safety, tolerability and efficacy of investigational AT845 in adults with late-onset Pompe disease (LOPD). "With that same spirit and focus on patient safety, we look forward to resuming the FORTIS clinical trial and the continued development of AT845 as an important potential new treatment for adults living with LOPD," said ha tran , Executive Medical Director for Astellas. "As always, we are grateful to the patients participating in the FORTIS clinical trial and we remain committed to developing novel therapies for those with a high unmet medical need." Following the clinical hold lift, Astellas is working on completing the clinical and regulatory activities necessary to resu

Open call: ACC Residency 2023 - Announcements

Asia Culture Center (ACC) is seeking participants for ACC Residency 2023. ACC has been organizing international residency programs not just as a form of artistic support policy, but a superlative creation/production program to produce novel and diverse content with creative talents from all over the world. As a forum for experimentation and exchange it envisions alternative futures based on a spirit of artistic engagement with reality. This year, the residency will be held in collaboration with ACC Sound Art Lab under the theme “Futures of Listening” which is also a long-term project led by ACC Sound Art Lab. As part of the collaboration, the two programs will be jointly organizing creative support programs for participants including talks and workshops by four world-renowned soundscape experts. Based on these, residency participants are to develop and present concepts for individual projects exploring the theme. This will be followed by the actual production and realization of t

Should class participation be graded in college?

Students who enroll in William Altman's psychology classes at the State University of New York's Broome Community College sometimes find themselves hooked up to an electroencephalograph—a device that measures electrical activity of the brain—while driving simulated cars either with or without texting. Others in the class participate by monitoring the device's output or the number of accidents or driving errors both for drivers who text and those who refrain. "You don't get the excitement of students driving at 75 miles an hour into a parked fire truck if they're not in the room," Altman said. At the end of every class, Altman asks students to reflect in writing about what they learned or what confused them that day. Those who are present and submit the reflection receive participation credit that, over the semester, typically constitutes “a couple percent” of their course grade—an amount Altman deems negligible but effective. That is, students general

South Korea's Yoon slams response to North drones, vows to create drone unit

SEOUL, Dec 27 (Reuters) - South Korean President Yoon Suk-yeol said on Tuesday he would advance the creation of a military unit specializing in drones, criticizing the military response to a border intrusion by North Korean drones. Five North Korean drones crossed into South Korea on Monday, prompting Seoul to scramble fighter jets and attack helicopters, and try to shoot them down, in the first such intrusion since 2017. The incident rekindled questions about South Korea's air defenses at a time when it is trying to rein in the North's evolving nuclear and missile threats. The military fired warning shots and some 100 rounds from a helicopter equipped with a machine gun, but failed to bring down any of the drones while they flew over several South Korean cities, including the capital, Seoul, for about five hours. "The incident showed a substantial lack of our military's preparedness and training for the past several years, and clearly confirmed the need for more inten

How Iran is accessing the social media accounts of protesters to incriminate them, experts say

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CNN — In between being blindfolded, locked in solitary confinement, and interrogated in a wheelchair while she was on a hunger strike following her late September arrest, Negin says she had a realization: Iranian officials were using her private Telegram chats, phone logs and text messages to incriminate her. “They told me 'Do you think you can get out of here alive? We will execute you. Your sentence is death penalty. We have evidence, we are aware of everything,'” said Negin, whose name CNN changed at her request, for her safety. Negin, who says she has been accused by Iranian authorities of running an anti-regime activist group on Telegram (an allegation she denies), said she has “some friends” who were political prisoners. “They put in front of me transcribed printouts of my phone conversations with those friends,” she said, and “questioned me on what my relationship with tho

China’s new space station opens for business in an increasingly competitive era of space activity

The International Space Station is no longer the only place where humans can live in orbit. On Nov. 29, 2022, the Shenzhou 15 mission launched from China's Gobi Desert carrying three taikonauts – the Chinese word for astronauts. Six hours later, they reached their destination, China's recently completed space station, called Tiangong, which means "heavenly palace" in Mandarin. The three taikonauts replaced the existing crew that helped wrap up construction. With this successful mission, China has become just the third nation to operate a permanent space station. China's space station is an achievement that solidifies the country's position alongside the US and Russia as one of the world's top three space powers. As scholars of space law and space policy who led the Indiana University Ostrom Workshop's Space Governance Program, we have been following the development of the Chinese space station with interest. Unlike the collaborative, US-led Inte

Who are the leading innovators in blockchain-based ticketing platforms for the travel & tourism industry?

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The travel & tourism industry continues to be a hotbed of innovation, with activity driven by a greater desire from consumers for personalized offerings that heighten the traveler experience. Delivering this requires the collection and effective use of large amounts of personal data, which has significant cybersecurity implications. Technologies such as artificial intelligence, cybersecurity, Internet of Things, and cloud solutions are all growing in importance. In the last three years alone, there have been over 15,000 patents filed and granted in the travel & tourism industry, according to GlobalData's report on Cybersecurity in Travel: Blockchain-based ticketing platforms. According to GlobalData's Technology Foresights, which uses over 21,000 patents to analyze innovation intensity for the travel & tourism industry, there are 20+ innovation areas that will shape the future of the industry. Blockchain-based ticketing platforms is a key innovation a