mind Can a Form Letter from FDA "Blow Your Mind"? By www.placebocontrol.com Published On :: Mon, 06 Jan 2014 22:14:00 +0000 Adam Feuerstein appears to be a generally astute observer of the biotech scene. As a finance writer, he's accosted daily with egregiously hyped claims from small drug companies and their investors, and I think he tends to do an excellent job of spotting cases where breathless excitement is unaccompanied by substantive information. However, Feuerstein's healthy skepticism seems to have abandoned him last year in the case of a biotech called Sarepta Therapeutics, who released some highly promising - but also incredibly limited - data on their treatment for Duchenne muscular dystrophy. After a disappointing interaction with the FDA, Sarepta's stock dropped, and Feuerstein appeared to realize that he'd lost some objectivity on the topic. However, with the new year comes new optimism, and Feuerstein seems to be back to squinting hard at tea leaves - this time in the case of a form letter from the FDA. He claims that the contents of the letter will "blow your mind". To him, the key passage is: We understand that you feel that eteplirsen is highly effective, and may be confused by what you have read or heard about FDA's actions on eteplirsen. Unfortunately, the information reported in the press or discussed in blogs does not necessarily reflect FDA's position. FDA has reached no conclusions about the possibility of using accelerated approval for any new drug for the treatment of Duchenne muscular dystrophy, and for eteplirsen in particular. Feuerstein appears to think that the fact that FDA "has reached no conclusions" may mean that it may be "changing its mind". To which he adds: "Wow!" Adam Feuerstein: This time, too much froth, not enough coffee? I'm not sure why he thinks that. As far as I can tell, the FDA will never reach a conclusion like this before its gone through the actual review process. After all, if FDA already knows the answer before the full review, what would the point of the review even be? It would seem a tremendous waste of agency resources. Not to mention how non-level the playing field would be if some companies were given early yes/no decisions while others had to go through a full review. It seems fair to ask: is this a substantive change by FDA review teams, or would it be their standard response to any speculation about whether and how they would approve or reject a new drug submission? Can Feuerstein point to other cases where FDA has given a definitive yes or no on an application before the application was ever filed? I suspect not, but am open to seeing examples. A more plausible theory for this letter is that the FDA is attempting a bit of damage control. It is not permitted to share anything specific it said or wrote to Sarepta about the drug, and has come under some serious criticism for “rejecting” Sarepta’s Accelerated Approval submission. The agency has been sensitive to the DMD community, even going so far as to have Janet Woodcock and Bob Temple meet with DMD parents and advocates last February. Sarepta has effectively positioned FDA as the reason for it’s delay in approval, but no letters have actually been published, so the conversation has been a bit one-sided. This letter appears to be an attempt at balancing perspectives a bit, although the FDA is still hamstrung by its restriction on relating any specific communications. Ultimately, this is a form letter that contains no new information: FDA has reached no conclusions because FDA is not permitted to reach conclusions until it has completed a fair and thorough review, which won't happen until the drug is actually submitted for approval. We talk about "transparency" in terms of releasing clinical trials data, but to me there is a great case to be made for increase regulatory transparency. The benefits to routine publication of most FDA correspondence and meeting results (including such things as Complete Response letters, explaining FDA's thinking when it rejects new applications) would actually go a long way towards improving public understanding of the drug review and approval process. Full Article accelerated approval Adam Feuerstein DMD FDA Sarepta Therapeutics transparency
mind DeepMind открыл код AlphaFold 3, AI-системы моделирования структуры белков By www.opennet.ru Published On :: Tue, 12 Nov 2024 14:05:27 +0300 Компания Google DeepMind опубликовала исходные тексты системы машинного обучения AlphaFold 3, предназначенной для предсказания трёхмерной структуры белков и моделирования взаимодействия белков с другими типами молекул. За создание алгоритмов машинного обучения, реализованных во второй версии AlphaFold, в этом году присуждена Нобелевская премия по химии. Связанный с AlphaFold 3 инструментарий написан на Python и C++, и распространяется под лицензией CC BY-NC-SA 4.0. Натренированные модели предоставляются на основе пользовательского соглашения. Отдельно запущен сервер, позволяющий экспериментировать с AlphaFold 3 в online-режиме. Full Article
mind Yer mind’s playing them shifty tricks again. By thisisindexed.com Published On :: Wed, 23 Oct 2024 16:23:41 +0000 The post Yer mind’s playing them shifty tricks again. appeared first on Indexed. Full Article booze consumption monsters
mind Faisal Islam: Reeves doesn't mind if you don't like her Budget By www.bbc.com Published On :: Thu, 31 Oct 2024 18:08:55 GMT The Budget is about the long game on the economy and Reeves believes the current pain is a price worth paying. Full Article
mind Tax-News.com: Isle of Man Reminds Of Tax Payment Deadlines By www.tax-news.com Published On :: Wed, 13 Jan 2021 00:00:00 GMT The Isle of Man has issued a reminder of the deadlines for 2019 corporate tax returns and for certain personal tax payments. Full Article
mind Tax-News.com: US IRS Reminds Of FBAR Filing Obligation By www.tax-news.com Published On :: Thu, 15 Apr 2021 00:00:00 GMT The Internal Revenue Service is reminding US citizens, resident aliens, and any domestic legal entity that the deadline to file their annual Report of Foreign Bank and Financial Accounts (FBAR) is still April 15, 2021. Full Article
mind Indian Actor Abhimanyu Singh on 'How to Maintain a Healthy Mind and Body' By www.medindia.net Published On :: Highlights: Abhimanyu Singh is a well-known Indian actor Despite his hectic schedule, he offers advice on how yo Full Article
mind Sri Lanka hosts meeting of minds on the Indus Basin By www.iwmi.org Published On :: Thu, 06 Jul 2017 11:30:45 +0000 Experts identify key steps to strengthen knowledge on climate change and other water-related challenges The post Sri Lanka hosts meeting of minds on the Indus Basin first appeared on International Water Management Institute (IWMI). Full Article Press releases indus basin indus basin knowledge platform
mind Improve Your Cognitive Health With the MIND Diet By www.medindia.net Published On :: Highlights: People following the MIND diet experienced slower cognitive decline High diet adherence linked to a Full Article
mind Mindfulness: Zoom Sessions Beneficial for Sexual Health After Cancer By www.medindia.net Published On :: Zoom-based mindfulness group provides better intervention programs for patients' post-cancer sexual health, reveals a new study. bSexual dysfunction/b Full Article
mind Mindfulness Ease Chronic Pain in Veterans By www.medindia.net Published On :: Veterans (military persons) with chronic pain can benefit from mindfulness-based interventions given in an upgraded style via telehealth, which can reduce pain and improve their overall health. Full Article
mind Hope Vs. Mindfulness: Impact on Stress Management By www.medindia.net Published On :: Hope tends to be more helpful than mindfulness in assisting people in managing their stress and maintaining their professional engagement during extended Full Article
mind Neuroscience of Pain: Mindfulness Meditation Eases Pain By www.medindia.net Published On :: Pain is a complicated, multilayered experience that is influenced by aspects other than physical sensation, such as a person's psyche and pain expectations. Full Article
mind Aspen Dental Practices Remind Patients, Caregivers About Importance of Regular Oral Care for Mature Adults in Recognition of Older Americans Month By www.medindia.com Published On :: Aspen Dental Practices Remind Patients, Caregivers About Importance of Regular Oral Care for Mature Adults in Recognitio Full Article
mind Heal Your Body and Mind With Yoga By www.medindia.net Published On :: Yoga has gained widespread popularity. International Yoga Day has been observed worldwide on June 21st, acknowledging yoga as an ancient discipline that Full Article
mind Navigating Workplace Stress With Mindfulness By www.medindia.net Published On :: Workers who practice mindfulness in the digital workplace experience enhanced protection against medlinkstress/medlink, medlinkanxiety/medlink, and overload (!--ref1--). Full Article
mind International Day of Yoga: A Worldwide Celebration of Mind and Body By www.medindia.net Published On :: The International Day of Yoga (!--ref1--) is being celebrated in numerous countries worldwide, including Japan, New Zealand, Thailand, and Malaysia, Full Article
mind citizenM Inspires Guests To Embrace The Sunshine State Of Mind By www.hospitalitynet.org Published On :: Tue, 12 Nov 2024 16:11:50 +0200 citizenM - the pioneer of affordable luxury hotels - has launched a new opening campaign for its third property in Miami, providing guests the opportunity to embrace their sunny side. Located steps away from the buzzing retail and restaurants of Lincoln Road, citizenM Miami South Beach is where the positive effects of sun meet the positive effects of citizenM’s sleep experience. Full Article
mind What entrepreneurs can do to reduce their stress and find peace of mind By blogs.siliconindia.com Published On :: There is a cure for stress. It is not a drug and it is not a fantasy. It won't cost you money, but it is not for free. Many people who try it out feel born again, others rejuvenated. The... Full Article
mind IPL auctions will linger in the back of players' mind during India-SA T20Is, says Uthappa By www.ibtimes.co.in Published On :: Fri, 08 Nov 2024 16:49:13 +0530 At first glance, the four-match T20I series between India and South Africa, kicking off in Durban on Friday, seems like another bilateral series for both teams to test players in preparation for the 2026 Men's T20 World Cup. Full Article
mind Stacklok donates its Minder supply chain security project to the OpenSSF By techcrunch.com Published On :: Mon, 28 Oct 2024 16:00:00 +0000 Stacklok, the open source software supply chain company founded by Kubernetes co-creator Craig McLuckie and Sigstore creator Luke Hinds, is donating Minder, one of its key projects, to the Open Source Security Foundation (OpenSSF). Minder helps development teams set up a system of proactive checks and policies to minimize supply chain risks by enforcing best […] © 2024 TechCrunch. All rights reserved. For personal use only. Full Article TC Enterprise open source Stacklok Minder openssf
mind How Your Diet Impacts Your Mind: Nutrition And Mental Wellness Explained By Expert By Published On :: Tuesday, November 05, 2024, 18:48 +0530 Nutrition is a key tool for maintaining and improving mental health. A well-balanced, nutrient-dense diet not only improves physical health but also emotional and cognitive well-being. By making informed food choices, we can take proactive actions to improve our mental health and overall well-being. Full Article
mind Elon Musk's Mind-Blowing 20-Seater Tesla Robovan Is About To Change How You Travel Forever By www.gizbot.com Published On :: Fri, 11 Oct 2024 13:15:30 +0530 Tesla CEO Elon Musk made headlines again by introducing a revolutionary electric vehicle named the Robovan at the company's "We, Robot" launch event. Besides Robovan, billionaire Musk also introduced the Cybercab - Tesla's most innovative self-driving electric vehicle. Distinguished by its Full Article
mind The Flip Side Of Finding Your Inner Peace : The Dark Reality Of Meditation And Mindfulness By www.boldsky.com Published On :: Sat, 26 Oct 2024 22:15:34 +0530 Life can often feel like a whirlwind of chaos, with the pressures of work, relationships, and daily responsibilities weighing us down. As we seek for balance and inner peace, many of us turn to practices like meditation and mindfulness, trying to Full Article
mind Is Your Mindset Keeping You Broke? The Psychology Behind Middle-Class Financial Struggles By www.boldsky.com Published On :: Fri, 08 Nov 2024 18:48:20 +0530 Have you ever bought something you didn't really need, just because it felt like the right moment? Or skipped checking your bank balance to avoid facing the truth? Life often feels like a series of small decisions that seem harmless at Full Article
mind Is Your Job Playing Mind Games? How To Spot And Conquer Gaslighting In The Workplace By www.boldsky.com Published On :: Tue, 12 Nov 2024 20:29:25 +0530 Ever had that feeling where everything seems off at work, but you can't quite put your finger on it? Maybe a colleague's comments leave you questioning your own memory, or you start second-guessing your performance after an offhand remark from your Full Article
mind Reading Shakespeare's mind [Electronic book] / Steve Sohmer. By encore.st-andrews.ac.uk Published On :: Manchester : Manchester University Press, [2019] Full Article
mind Phrenitis and the Pathology of the Mind in Western Medical Thought : (Fifth Century BCE to Twentieth Century CE) [Electronic book] / Chiara Thumiger. By encore.st-andrews.ac.uk Published On :: Cambridge : Cambridge University Press, 2023. Full Article
mind A mind of one's own : feminist essays on reason and objectivity [Electronic book] / edited by Louise M. Antony and Charlotte E. Witt. By encore.st-andrews.ac.uk Published On :: New York, NY ; London : Routledge, 2018. Full Article
mind The Ecology of Biotic Interactions in Echinoids : Modern Insights into Ancient Interactions [Electronic book] / Elizabeth Petsios, Lyndsey Farrar, Shamindri Tennakoon, Fatemah Jamal, Roger W. Portell, Michał Kowalewski, Carrie L. Tyler. By encore.st-andrews.ac.uk Published On :: Cambridge : Cambridge University Press, 2023. Full Article
mind 'Television has become mindless trash' By www.rediff.com Published On :: Thu, 13 Apr 2017 10:53:31 +0530 Ananth Mahadevan takes on the audience. Full Article Ananth Mahadevan Gour Hari Dastaan IMAGE Yashraj Vil Pyar Vyar Shah Rukh Khan Baazigar Mee Sindhutai Sapkal Dr Rakhmabai San Francisco bridge Doctor Rakhmabai Mumbai Saurabh Shukla Aamir Khan Tannishtha Chatterjee Jyoti Chandekar
mind Is Hina Khan the mastermind in Bigg Boss 11? By www.rediff.com Published On :: Tue, 07 Nov 2017 12:29:23 +0530 Missed yesterday's episode? Fear not. Rohan Shinde brings you up-to-date. Full Article Bigg Boss Hina Khan Benafsha Soonawala Priyank Sharma Arshi Khan Puneesh Sharma Luv Tyagi Shilpa Shinde Mehjabi Siddiqi Sabyasachi Satpathy Hiten Tejwani Bandgi Kalra Akash Dadlani Sapna Choudhary Ka Vaar Rohan Shinde
mind Is Shiv The MASTERMIND Of Bigg Boss 16? By www.rediff.com Published On :: Tue, 29 Nov 2022 13:26:46 +0530 As soon as Shiv announced Nimrit as the captain, Tina lost her cool and started fighting with both of them. Full Article
mind 'Bigg Boss plays with your mind' By www.rediff.com Published On :: Tue, 08 Aug 2023 12:34:21 +0530 'Pooja Bhatt is definitely going to lift that trophy.' Full Article
mind Mind power By www.thehindu.com Published On :: Sun, 13 Dec 2015 16:01:51 +0530 Distraction dissipates energy. Learn how to tap the mind’s potential and tackle challenges. Full Article Schools
mind Selling 3G with 2G mindset By www.thehindubusinessline.com Published On :: Wed, 27 Feb 2013 16:15:08 +0530 Old world systems hamper the 3G user experience Full Article Thomas K Thomas
mind Mind over matter : hard-won battles on the road to hope / Jordin Tootoo with Stephen Brunt By darius.uleth.ca Published On :: Tootoo, Jordin, 1983- author Full Article
mind Food-mind connection By www.thehindu.com Published On :: Mon, 14 Nov 2016 00:04:11 +0530 Full Article Faith
mind Why I Won't Mind Campaigning For Kangana By www.rediff.com Published On :: Wed, 22 May 2024 10:14:01 +0530 'Since we are in the same party now, there has to be political camaraderie if nothing more.' Full Article
mind In the mind of an artist By www.thehindu.com Published On :: Thu, 11 Aug 2016 19:40:17 +0530 Sharmila Biswas and her co-artists discuss with Anjana Rajan the thought behind “Antar Yatra”, a cross-genre production that shares the journey of a woman dancer. Full Article Friday Review
mind Counselling: Overcoming the defences of your mind for peace, productivity By www.thehindubusinessline.com Published On :: Tue, 23 Jun 2015 22:22:39 +0530 Learning to recognise the impact past experiences have on present behaviour can unlock your true potential Full Article New Manager
mind Mind your own.... EYES By www.thehindubusinessline.com Published On :: Tue, 04 Jun 2013 14:42:59 +0530 Full Article Divya Pushkarna
mind How Google's DeepMind is Using AI to Tackle Climate Change By www.wired.com Published On :: Mon, 18 Feb 2019 06:47:18 +0000 AI is often seen as a magical fix-all. It's not, but it is, says Sims Witherspoon, a powerful tool for unlocking communities' problem-solving capacities. Witherspoon is a program manager at Google's DeepMind, which made headlines when it reduced energy required to cool Google Data Centres by 40 per cent. Energy consumption is one of the problems AI can be used for, and DeepMind is working on it. ABOUT WIRED SMARTER Experts and business leaders from the worlds of Energy, Money and Retail gathered at Kings Place, London, for WIRED Smarter on October 9, 2018. Discover some of the fascinating insights from speakers here: http://wired.uk/V29vMg ABOUT WIRED EVENTS WIRED events shine a spotlight on the innovators, inventors and entrepreneurs who are changing our world for the better. Explore this channel for videos showing on-stage talks, behind-the-scenes action, exclusive interviews and performances from our roster of events. Join us as we uncover the most relevant, up-and-coming trends and meet the people building the future. ABOUT WIRED WIRED brings you the future as it happens - the people, the trends, the big ideas that will change our lives. An award-winning printed monthly and online publication. WIRED is an agenda-setting magazine offering brain food on a wide range of topics, from science, technology and business to pop-culture and politics. CONNECT WITH WIRED Web: http://po.st/WiredVideo Twitter: http://po.st/TwitterWired Facebook: http://po.st/FacebookWired Google+: http://po.st/GoogleWired Instagram: http://po.st/InstagramWired Magazine: http://po.st/MagazineWired Newsletter: http://po.st/NewslettersWired Full Article
mind DeepMind’s Demis Hassabis on its breakthrough scientific discoveries | WIRED Live By www.wired.com Published On :: Fri, 05 Mar 2021 01:00:04 +0000 Deepmind, Co-founder and CEO, Demis Hassabis discusses how we can avoid bias being built into AI systems and what's next for DeepMind, including the future of protein folding, at WIRED Live 2020. "If we build it right, AI systems could be less biased than we are." Full Article
mind Aphantasia: The People Without a Mind's Eye | 'Out of Mind' | Wired UK By www.wired.com Published On :: Wed, 14 Apr 2021 06:02:54 +0000 If you close your eyes and picture an apple, how clear is that apple in your mind? Most people can visualise images in their head instantaneously - this known as the mind's eye. But in 2015, a scientific study shed new light on the relatively unheard-of phenomenon known as aphantasia, a mental blindness where the brain is unable to call images to the mind eye. This short documentary uncovers the root cause of a person's emotional detachment from people and events - and the unexpected advantages that come with it. Alex Wheeler shares the story of how his experiences with aphantasia have affected his life, particularly his grieving process after losing his mum, as he seeks answers from Adam Zeman, Professor of Cognitive and Behavioural Neurology at the University of Exeter Medical School. WIRED also talks to artist and YouTuber Amy Right, better known as @AmyRightMeow, who shares their experiences with aphantasia and how it feeds their creative process. Produced as part of WIRED Health https://www.wired.co.uk/partnerships/wired-health Director: @Simon Mulvaney Producer: Anna O'Donohue Featuring: Alex Wheeler , Adam Zeman, Amy Right Field Producer: Lewis Faithfull Studio Cinematographer: Dan McPake Studio Art Director: Deborah Du Vernay Animation & VFX: Run Zebra Run Original Music Composition: Liam Hennessy and Joe Danher VHS Digitised by EachMoment – https://eachmoment.co.uk Subscribe to WIRED UK ► https://www.youtube.com/wireduk?sub_confirmation=1 Visit the WIRED website ► https://www.wired.co.uk Subscribe to WIRED Magazine ► https://www.wired.co.uk/subscribe Sign up for one or more of our WIRED newsletters: https://www.wired.co.uk/newsletters CONNECT WITH WIRED Facebook: https://www.facebook.com/wireduk Instagram: https://www.instagram.com/wireduk Twitter: https://twitter.com/wireduk LinkedIn: https://www.linkedin.com/company/wired-uk ABOUT WIRED WIRED brings you the future as it happens - the people, the trends, the big ideas that will change our lives. An award-winning printed monthly and online publication. WIRED is an agenda-setting magazine offering brain food on a wide range of topics, from science, technology and business to pop-culture and politics. Full Article
mind How Mind-Controlled Bionic Arms Fuse To The Body By www.wired.com Published On :: Fri, 15 Dec 2023 17:00:00 +0000 A game-changer in prosthetics has been introduced to the world, and for the first time, amputees are regaining sensation through an electrical signal from their prosthetic arm. Max Ortiz-Catalan, a professor of bionics, explains the process of implanting these mind-controlled bionic arms through direct skeletal attachment. The researcher takes us through every step of this groundbreaking advancement in bionic medicine, from surgically implanting electrodes to fitting the prosthesis and training for everyday use. Director: Lisandro Perez-Rey Editor: Jordan Calig Expert: Prof. Max Ortiz Catalan Line Producer: Joseph Buscemi Associate Producer: Kameryn Hamilton Production Manager: D. Eric Martinez Production Coordinator: Fernando Davila Post Production Supervisor: Alexa Deutsch Post Production Coordinator: Ian Bryant Supervising Editor: Doug Larsen Assistant Editor: Justin Symonds Full Article
mind Mind mapping the new Indian consumer By www.thehindubusinessline.com Published On :: Sun, 03 Mar 2024 17:54:50 +0530 BrandXcel’s research reveals changing Indian consumer trends, from pride in Indian products to premiumisation and individualistic decision-making Full Article Marketing
mind Rohini Nilekani Centre for Brain and Mind launched at NCBS Bengaluru By www.thehindu.com Published On :: Tue, 04 Jul 2023 14:39:54 +0530 The centre is an outcome of a ₹100 crore grant to NCBS and NIMHANS for long-term research, and to build capacity for both research and practice in the mental health field Full Article Bengaluru
mind Using the Engineering Method to Teach Important Thinking and Problem-Solving Skills to Vibrant Minds By catswhocode.com Published On :: Mon, 05 Jun 2023 00:00:00 +0000 The technological innovation process is acknowledged as a sequence of procedures that engineers follow to find the best solution to a problem. That allows designers to use math concepts, applied research and technological innovation sciences to obtain a high level of optimization that meets the requirements of an goal. The steps incorporate defining the situation, […] Full Article Blog