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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...

HDFC Life Stocks | Sandip Sabharwal: See value in 2 insurance stocks; no value in Bikaji Foods: Sandip Sabharwal

"When a sector is no longer fancied, that gives an opportunity. Among the larger companies, does seem to have value as it has the potential of giving double digit returns over the next one year. ICICI Prudential Life also got sold out very substantially right from Rs 620-630 odd to Rs 460 in a straight line. At these prices, even there I see value," says Sandip Sabharwal asksandipsabharwal.com The insurance space has been doing nothing for the longest time. has been one such idea which has been around the Rs 600 mark. Do you finally think it is time for the insurance space to breakout because fundamentally, the space is quite under penetrated? Actually the under penetration story and growth story was always the story in insurance and it is not a new story. It is just that over the last one or two years, people have realized that the kind of value accretion that people thought could happen in the insurance companies is not happening and that has led to moderation in the va...

Massive Open Online Course (MOOC): Learning Without Boundaries

Massive Open Online Course (MOOC) is an online course that allows users to participate in courses for free and without boundaries. MOOC were first introduced in 2008, by George Siemens and Stephen Downs. It is known as Connectivism and Connective Knowledge 2008 (CCK08) and was created as a credit course at the University of Manitoba. CCK08 has approximately 25 fee-paying students and approximately 2,200 other students taking the course for free. In 2012, MOOCs gained popularity when Sebastian Thrun and Peter Norvig of Stanford University offered an online course called Introduction to Artificial Intelligence. This course has approximately 1,600,000 students participating from 190 countries. After the success of Introduction to Artificial Intelligence, Thrun and Nrovig (2012) started Udacity, a business model for online knowledge sharing. Until now there are several platforms that offer Massive Open Online Courses (MOOCs), among them are Coursera, iversity, edX, Future Learn, Can...

Pediatric vision and digital media: A bad combination

Research indicates that too much technology usage results in negative effects on eyesight. Pediatric eye health is important in all aspects of a child's life and development. Vision is not simply a matter of clarity; it is a functional system that ideally is flexible and efficient. It is a primary sensory input that influences a child's learning, development, demeanor, and stamina, and is biologically unsuited to the excessive near vision demands of the digital culture in which children find themselves. Today's families must manage an onslaught of digital media in children's lives, including television content, cellular phones, tablets, and computers. Digital media devices can expand communication tools, provide easy and immediate access to information, and accommodate children's strengths and challenges. But the benefits of technology are accompanied by risks. The current exposure to digital media has a profound effect on children. We have never had a generat...

What Rishi Sunak as PM means for the UK crypto industry

UK Prime Minister Rishi Sunak at 10 Downing Street. Dan Kitwood | Getty Images UK cryptocurrency firms and investors have high hopes that new prime minister Rishi Sunak could turn around Britain's fading crypto aspirations. The new UK leader, who was finance minister in former PM Boris Johnson's government, faces a daunting to-do list, which includes undoing the economic havoc wreaked by his predecessor Liz Truss. Crypto isn't exactly high up on his priority list, but industry insiders say there's reason to be optimistic. "The feeling among entrepreneurs is one of relief," said Christian Faes, co-founder of digital lending startup LendInvest. "There's a feeling that we finally have someone sensitive in Number 10, after the arrogance and incompetence of Liz Truss and Kwasi Kwarteng almost crashed the UK economy." "Rishi sees the opportunity and potential that crypto has, and wants the UK to be a leader in it," Faes, who also chairs t...

Reminders for Campus Regarding Political Activity and Facility Use

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Photo Submitted As this year's Election Day draws near, there may be questions about how University of Arkansas employees can participate in the political process. Now is a good time to review University policies regarding political activity as well as the use of university facilities and outdoor space. ENGAGING IN POLITICAL ACTIVITY The U of A respects the right of all employees to engage in political activity. However, employees may not involve the institution's name, symbols, property or supplies in political activities. For example, U of A employees cannot use their titles, emails, letterhead, logos, or any university-related communications to participate in political activity. It is also not permissible to engage in political activities during work hours or with U of A-issued technology and devices at any time. It is also advised that U...

Sports collectibles remain hot despite NFT boom

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In the sports collectibles world, cardboard is still king — for now. Despite the boom and subsequent semi-bust of digital sports collectibles in the past couple of years, the world of tangible sports collectibles — cards, jerseys, memorabilia and all things in between — has remained hot. The record for most ever paid for sports memorabilia has been broken three times this year, although prices for some popular cards have dipped from their peaks in 2020 and 2021. That market has been boosted by a thriving online content industry surrounding sports cards and memorabilia. Dozens of YouTube channels, podcasts and TikTok accounts track the market, with some offering a way for people to purchase cards, jerseys and even autographed football helmets. That's fueled some optimism that NFTs, or non-fungible tokens (blockchain-based tokens tied to digital art) aren't set to replace the thrill of opening a pack of cards anytime soon. "I would say the future is 100% tangible," sa...

What's a supercomputer? How the U.S. will decide who to punish with China tech curbs

Oct 7 (Reuters) - Deciding who gets hurt by sweeping new US curbs on selling technology to China will come down in part to what constitutes a "supercomputer," experts told Reuters. Around the world, the semiconductor industry on Friday began to wrestle with wide-ranging US restrictions on selling chips and chip manufacturing equipment to China. Shares of chip equipment makers drooped, but industry experts said a new US definition of a supercomputer could be pivotal to the new rules' impact on China. Register now for FREE unlimited access to Reuters.com register Supercomputers can be used in developing nuclear weapons and other military technologies, and experts say how to define them has long bedeviled regulators trying to pin down an ever-advancing technological target. The new American rules define supercomputers broadly in terms of computing power in a defined space: a machine with 100 petaflops - the ability to carry out 100 trillion operations per second - in 41,600 ...