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Does this one actually work?What really mattersIn a world with too much noise and too little context We don’t flood you with panic-inducing headlines or race to be first We focus on being useful to you — breaking down the news in ways that inform We rely on readers like you to fund our journalism Will you support our work and become a Vox Member today A promising new Alzheimer’s treatment must escape the shadow of its controversial predecessor by Dylan Scott given the present paucity of effective treatments has been complicated by fresh revelations about the FDA’s prior controversial approval of an Alzheimer’s drug — and lingering concerns among some experts that the hype could once again get out ahead of the science The federal agency decided Friday to grant accelerated approval to lecanemab an intravenous injection developed by the Japanese biopharma company Eisai and the American manufacturer Biogen Accelerated approval can be granted to new drugs with promising preliminary clinical trial results that meet an unmet medical need with the signs that patients who received the drug in clinical trials experienced less cognitive decline than those who did not An effective drug would be a godsend for the more than 6 million people with Alzheimer’s and their families a breakthrough after many decades of false starts and disappointments in finding a real treatment to slow the disease’s uniquely devastating deterioration of a person’s sense of self A recent House report on the drug’s approval revealed the extent of the FDA and Biogen’s cooperation in pushing the drug to market Two months after the clinical trials were halted in 2019 a Biogen executive and a senior FDA official met at a pharma conference and decided Biogen would push ahead with seeking approval What followed was highly unusual coordination between a private company and its regulators who met dozens of times to review Biogen’s data and even cooperated on briefing documents for the FDA scientific advisers who would give a final recommendation on approval the opinions of the applying company and the FDA regulators are kept separate with the FDA even asking Biogen to insert FDA-drafted language into the company’s section of the report “The findings in this report raise serious concerns about FDA’s lapses in protocol and Biogen’s disregard of efficacy and access in the approval process for Aduhelm,” the House committee wrote “The criticism surrounding Aduhelm’s approval may have been avoided had FDA adhered to its own guidance and internal practices.” After the FDA’s scientific advisers pointed to the lack of clear evidence that aducanemab slowed the development of dementia Biogen and its FDA partners switched gears and sought accelerated approval instead — which has a lower threshold for approval Biogen just needed to show that the drug did reduce the amount of amyloid plaque in a patient’s brain not that the reduction then in fact stalled the decline in cognition Company and FDA staff worked together to produce a statistical analysis that demonstrated the desired result despite federal officials saying previously that they would not use such a secondary metric to authorize an Alzheimer drug’s approval Accelerated approval was granted for aducanemab — for which Biogen initially planned to charge $56,000 — in July 2021. But the drug’s momentum post-approval quickly slowed. Major health care institutions said they would not administer the drug, given the lack of empirical support for its effectiveness. Eventually, Medicare, which had been expected to be the largest purchaser of the drug said it would generally not cover aducanemab except in a clinical trial setting That has led to minimal patient uptake over the last 18 months The approval of this breakthrough treatment purported to meaningfully improve the prognosis for Alzheimer’s patients instead became a major embarrassment for the pharmaceutical company that had developed it and the federal regulators who approved it But there were more treatments in the pipeline and the next one to come before the FDA was lecanemab The leading theory of Alzheimer’s disease has been that the accumulation of amyloid plaques in the brain disrupts normal brain functions and leads to its telltale dementia But some experts have challenged that hypothesis and accused drug companies and academia of overlooking other avenues for trying to treat the disease and aducanemab are both premised on the so-called amyloid hypothesis and target those plaques in the hope of alleviating dementia symptoms The evidence for lecanemab’s effectiveness is stronger than aducanemab’s. The results of its clinical trials published this week in the New England Journal of Medicine show that the patients who were given the drug over 18 months saw less cognitive decline using a broad measure of dementia compared to patients given a placebo and the Alzheimer’s advocacy community optimistic that the FDA will ultimately sign off on its accelerated approval Some experts have urged caution given the relatively small size of the measured effect, however, with the editors of the Lancet writing in December that “whether lecanemab is the game changer that some have suggested remains to be seen.” Like aducanemab, this new drug is probably best targeted to people in the early stages of the disease. And like aducanemab, there have been reports of serious side effects, including a number of deaths, as Science reported last month though the exact interaction in those fatalities remains unclear I asked doctors and social workers who work with Alzheimer’s patients about their perception of the new drug’s approval so soon after the disastrous aducanemab saga director of social work at the Penn Memory Center told me that she’d heard from excited caregivers and patients “Our docs seem very optimistic about the more promising data on lecanemab “Some of the concerns from the debacle with Aduhelm remain the same Concerns about equitable access are paramount. Will Medicare cover this drug, unlike aducanemab? If not, access could be limited to the very wealthy, given an estimated price between $9,200 and $35,600 for an annual course of treatment patients would receive a brain scan for amyloid plaque before receiving lecanemab but that procedure is typically not covered by Medicare and can cost upward of $20,000 out of pocket Patients will still need to go to a hospital to receive the injection every two weeks which presents another barrier to access for people who struggle with dementia “What will we do when someone with more advanced dementia comes in and asks for this drug even though the data really only supports early-stage use?” Lynn said there are concerns about the logistics and ethics of access.” The approval of a new Alzheimer’s treatment should be cause for celebration And there is good reason to believe that lecanemab will prove to be more successful than aducanemab But recent events also give good reason to be cautious That is the unfortunate legacy of aducanemab for future Alzheimer’s drugs: It is a shadow from which they must escape 2:25 pm ET: This story has been updated with the news of lecanemab’s approval Understand the world with a daily explainer plus the most compelling stories of the day The most surprising consequence of Trump’s trade war Today, Explained podcastMay 4Love on the Spectrum stars call on RFK Jr. to resignTwo cast members of the hit Netflix reality TV show on what the HHS secretary misunderstands about autism The Gray AreaMay 3Did our politics fail us during Covid?Political scientist Frances Lee examines the “noble lies” and truth-seeking failures of the pandemic. 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You may not be able to find the page you were after because of: You might find one of the following links useful: Gain insights on a modern flash point test method that enhances safety and reduces sample volume requirements AFM can provide new insights into 2D materials to better understand their potential applications Kyocera's Fine Ceramics enable next-gen renewable energy solutions offering exceptional stability and performance in hydrogen and nuclear fusion applications Micro-XRF is the key method used for the highly sensitive and non-destructive elemental analysis of a number of samples including in-homogenous and irregular samples Optimize compounding and masterbatch processes to boost efficiency while maintaining top material quality AirBreather is the solution the gas monitoring challenges across applications The global semiconductor market has entered an exciting period Demand for chip technology is both driving the industry as well as hindering it with current chip shortages predicted to last for some time Current trends will likely shape the future of the industry The primary distinction between graphene-based batteries and solid-state batteries lies in the composition of either electrode carbon allotropes can also be employed in fabricating anodes the IoT is rapidly being introduced into almost all sectors but it has particular importance in the EV industry you can trust me to find commercial scientific answers from AZoNetwork.com please log into your AZoProfile account first Registered members can chat with Azthena, request quotations, download pdf's, brochures and subscribe to our related newsletter content A few things you need to know before we start Read the full "The world can't imagine what people already make with our machines." This year, Munich-based EOS is celebrating 30 years in business founder of EOS and now Executive Chairman of the EOS GROUP He founded EOS back in 1989 shortly after his former employer rejected a project he had suggested The company then went through years of patent litigations surrounding EOS’ sale of stereolithography platforms during the 1990s It was settled when EOS decided to focus on powder-based additive manufacturing (AM) only During this timeframe the company also introduced its first system for metal 3D printing What followed were years of tech development and the introduction of rapid prototyping and metal 3D printing technologies to a plethora of customers But it was in 2014 when Langer’s long-held ambition began to be realised GE Aviation introduced its additively manufactured Leap fuel nozzle tip in which 20 assembled pieces were reduced to one It was the result of ten years' work since Morris Technologies the service provider acquired by GE in 2012 “We work with the engineering teams of our large customers on solutions that production people cannot even think of,” Langer told TCT “Innovation must go beyond just innovating the EOS serial production system It needs a big picture approach to support customers in generating totally new applications that were not thinkable before.” In subsequent conversations between senior management of GE and other OEMs and EOS, it was agreed it should not take ten years to go from early application development to serial production. A 3D printing system alone was not going to cut it. So, EOS introduced its ‘Additive Minds’ consulting unit to speed up customers’ learning and innovation curves supporting them to find the right applications for 3D printing But Langer was thinking even bigger – that a whole ecosystem has dictated most of the decisions made by Langer since At the forefront of his mind is a seamless efficient AM integration in existing production environments the combination of industrial 3D printing with conventional manufacturing technologies and the continuous optimisation of part and data flow but their implementation is of the utmost importance The EOS Ecosystem today comprises of innovators and venture groups the Additive Minds consultancy division and external business partners In 2015, Langer founded AM Ventures a strategic investor focusing on start-ups which develop solutions along the whole value chain in industrial 3D printing and have respective expertise in design It has been established as a separate business alongside the EOS GROUP Langer convinced that start-ups need to operate independently to give the project the best chance of succeeding is now offering support to customers on their way from the initial product idea to the final Revisit TCT's last trip to Krailling, Munich: 'EOS - Two decades of risk and reward.' To fully concentrate on the further development of the EOS Ecosystem, Langer stepped away from the position of CEO of EOS GmbH in 2017, with Adrian Keppler assuming the role. As Executive Chairman of the EOS GROUP, Langer initiated some new companies: Advanced Metal Powders (AMP), which develops new metal powders for industrial players; Additive Manufacturing Customized Machines (AMCM) which develops platforms according to customer specifications with the potential that they are later made available through EOS as standard platforms; and Additive Manufacturing Metals (AMM) a team focused on customer-specific metal applications “We have seen that our customers are now on the way to build up digital factories it turned out that the biggest hurdle for the customer to get to production is to collect all the skills and know-how that is necessary to integrate the complete production process This is why we started to set up EOS Additive Minds and the EOS Ecosystem and constantly expand it,” Langer explained “What we want to offer to the customer is a highly productive self-learning AM cell where we increase the overall equipment efficiency have clear interfaces upstream and downstream where we can then interlink with post-processing technologies This will allow an optimised flow of data and parts end to end along the production process,” Dr and consultancy divisions EOS hopes to ‘change the world’ what could potentially be achieved by using AM what is already possible with existing AM technology Airbus Helicopters announced the start of the large scale additive manufacturing of A350 XWB components which are set to take to the skies in 2020 more than 30,000 Leap fuel nozzle tips have been additively manufactured in five years For EOS, it’s about making breakthroughs like that more commonplace, converting application by application from traditional technology to 3D printing to add value, offer better performance, faster access, lower costs. Its participation in the NextGenAM project alongside Premium AEROTEC and Daimler is another example of that the partners are aiming to enable an automated and efficient metal additive manufacturing serial production solution harnessing the advances in automatic design and robotics to facilitate connected end-to-end production processes EOS is increasingly supplying its customer base with all the solutions they need “The world can't imagine what people already make with our machines.” Get your FREE print subscription to TCT Magazine Exhibit at the UK's definitive and most influential 3D printing and additive manufacturing event, TCT 3Sixty Contact Us Media Kit About Us Twitter LinkedIn Med-Tech Innovation News Manufacturing Quality European Pharmaceutical Manufacturer Medical Plastics News Terms & Conditions Privacy Policy Part of Rapid News Group This website is using a security service to protect itself from online attacks The action you just performed triggered the security solution There are several actions that could trigger this block including submitting a certain word or phrase You can email the site owner to let them know you were blocked Please include what you were doing when this page came up and the Cloudflare Ray ID found at the bottom of this page OutDoor100 Kilometers in 24 Hours - When Hiking Becomes a Borderline ExperienceSilvia KochSeptember 30 2019Credits cover image: Mammutmarsch UGMy everyday life consists of work and mostly sport And yet the mammoth march in Munich brought me to my limits 100 kilometers should be covered in 24 hours From Krailling to the top of Lake Starnberg The weather played along; my physical conditions were good Learn here how my first mammoth march ended By Silvia KochSilvia Koch is a professional editor and loves to do sports outside and to experience nature Sport is a big part of my life - but the mammoth march in Munich pushed me to my limits My goal: to complete 100 kilometres in one day It was a challenge I am proud to have taken on Although I am not one of the 30 per cent who made it I don't consider my participation a failure It was an extraordinary experience and I am thinking of trying again My daily urge to move is what shapes my everyday life and defines my personality Jogging 25 kilometers whilst sleep-deprived is no problem for me weight training - this is the description of my free time I have already participated successfully in many obstacle races and half marathons But the Mammutmarsch 2019 in Munich brought me close to my psychological limits With an average speed of 5 km/h you would reach your destination after 22 hours in this mammoth march But three days before the march I had a queasy feeling I didn't know about myself It was more the fact that I didn't know what was coming A 50-kilometer trial march a few weeks earlier had given me a foretaste of what to expect 2.500 participants joined the march in Munich in 2019Image credit: Mammutmarsch UG / Mammutmarsch UGThe Toughest March of Our LivesOn 27 July at 15:45 our group started and I calculated that with a march duration of 22 hours we would cover the 100th kilometer at 13:45 on the following day and cross the finish line The starting point was a sports club in Krailling near Munich The route should lead once to the southerly end of Lake Starnberg once around it and again back to the starting point The usual hustle and bustle at the start and the preceding drummers nevertheless provided a cheerful atmosphere Then it was finally time: My two friends and I started what was probably the hardest march of our lives I found it strange to walk across the starting line armed with my backpack I was used to starting a race with 100 percent power and speed But after ten kilometers the strangeness gave way to another Almost 2,500 participants had started in Munich This gigantic hiking group created a unique atmosphere The first four hours we chatted about everything we could think of After 25 kilometers we reached the first marshal muscles and shoulders didn't cause any problems either but in a good mood we set off again after a short break Around 8 pm we reached the Isartrails and only a short time after the path in front of us and behind us was illuminated by many headlamps The route led us through the Bavarian landscape around Munich.Image credit: Mammutmarsch UG / Mammutmarsch UGWhy Am I Doing This?The feeling was indescribable I noticed that the conversations around us ebbed away While in the early evening a group behind us had been joking about the enjoyment of a fresh lasagna A shuttle bus had been readied by the organizers The first participants were giving up the race water and fresh tapes for knees and joints Particularly irritating: pickled gherkins were also in the repertoire electrolytes that the body loses when sweating The volunteer who distributed the pickled vegetables shouted cheerfully to the crowd: "People always remember: sport is fun!" In spite of exhaustion I gave him a tired smile After we took off our shoes for a moment and examined the extent of the blisters At midnight we sang a short Happy Birthday to a friend That's when the question first appeared in my head: Why am I doing this A buddy celebrated his 27th birthday that Saturday and what did I do The feeling during the hike was indescribable The group photo before the start gives an idea of the atmosphere.Image credit: Mammutmarsch UG / Mammutmarsch UGEvery Step like Torture: Panic Sets InWe reached Lake Starnberg The route led us past several bars where people were apparently having a good time. Would I have traded places with them the feeling so unique that it almost seemed magical I realized that my feet were starting to get sore I wanted to make it through the march so badly For months we had been looking forward to it So far we had seen paramedics and volunteers at regular intervals along the way But this stretch of forest seemed to be endless Even if we hadn't thought it possible with the muggy temperatures of the afternoon After about 45 kilometers I noticed two blisters bursting on my left foot I began to calculate: "In five hours the sun rises Then the worst will be behind you." That's what I kept trying to tell myself Every movement was like torture to me my mind defeated my body and I gave up halfway through the course.Image credit: Mammutmarsch UG / Mammutmarsch UGThe EndI made the decision to abandon the march from one second to the next I was in pain and afraid I might harm my body in the long run So I hobbled next to my girlfriends until a red truck caught our eye The driver belonged to a group of participants from Basel He followed his friends and collected those who could not continue Meanwhile we were almost an hour by car away from the starting point sat down on the floor next to the car and hardly said a word because of exhaustion and pain My mammoth march was over after 50 kilometers At around 5 o'clock in the morning I entered my apartment in Munich limping - more than 13 hours after the start One day later I still asked myself the same questions: Was it the shoes I'm sorry I didn't make it through to the end continuing to walk would not have been an option 30 percent of the participants in Munich walked the 100 kilometers Because it was a special experience in any case EOS (Krailling, Germany), a technology supplier in the field of industrial 3D printing for metals and polymers, has delivered and installed an AMCM M 4K from EOS’ AMCM business unit. This large scale, four-laser, high-productivity system was sold to metal additive manufacturer Sintavia (Davie where it will be focused on the production of advanced propulsion systems for the aerospace Unique to this machine is its ability to 3D print applications up to 1 m high “While this AMCM M4K represents the 1000th machine in North America for EOS it also represents the 17th EOS machine for Sintavia Their machines form the foundation of our company’s manufacturing technology and we are thrilled to be part of this milestone achievement in EOS’ history.” “We remain the leading innovator of hardware and education aimed at strengthening the successful adoption and advancement of additive manufacturing as a mainstream manufacturing process.” EOS was founded in April 1989 in Gräfelfing founding its North American headquarters in Novi EOS North America also has its technical center in Pflugerville and its materials engineering and production center at Advanced Laser Materials (ALM) in Temple and worked to advance the capabilities of additive manufacturing Its experience and end-to-end offerings of products and training are designed to support organizations at each step of their additive manufacturing journey David Belforte (1932-2023) was an internationally recognized authority on industrial laser materials processing and had been actively involved in this technology for more than 50 years served clients interested in advanced manufacturing applications David held degrees in Chemistry and Production Technology from Northeastern University (Boston he conducted basic studies in material synthesis for high-temperature applications and held increasingly important positions with companies involved with high-technology materials processing He co-founded a company that introduced several firsts in advanced welding technology and equipment David's career in lasers started with the commercialization of the first industrial solid-state laser and a compact CO2 laser for sheet-metal cutting he led the development of very high power CO2 lasers for welding and surface treating applications David was the Founder and Editor-in-Chief of Industrial Laser Solutions magazine (1986-2022) and contributed to other laser publications He retired from Laser Focus World in late June 2022 The DIVIDOS laser depaneling system from InnoLas Solutions (Krailling Germany) meets all the requirements in laser depaneling of rigid and flexible printed circuit boards (PCBs) the system reportedly can produce up to 30% efficiency gains on PCB separation compared to other depaneling systems which operates without physical contact and is subject to almost no wear using a second galvanometer can up to double its throughput capability Another advantage is the possibility to process substrates with a size up to 18 × 18 in EOS an improved version of its own additive manufacturing systems for metals The new system EOSINT M 280 is available with either a 200 W fiber laser This higher power laser can melt more metal powder per second thus achieving shorter build times and higher system productivity Especially for heavy use in a manufacturing environment the newest system enables reduced costs-per-part thereby increasing the competitiveness of laser sintering compared to other technologies and opening up new viable application areas Another improvement of the EOSINT M 280 compared to its predecessor is the increase of the maximum building height up to 325 mm This enables taller parts to be placed in the process chamber This is particularly interesting for hybrid part building complex parts are produced by building additional material on top of a prefabricated part Based on extensive process investigations and supported by fluid dynamics simulations EOS has optimized the gas management system of the EOSINT M 280 The EOSINT M 280 also builds on the Part Property Management concept which enables standardization and comparability of building processes based on the so-called Part Property Profiles (PPP) By ensuring a consistent quality assurance along the entire process chain EOS enables machine users to reliably produce parts based on defined material and part properties The EOSINT M 280 supports all the materials of its predecessor with the same or with optimized parameter sets including the most recent EOS NickelAlloy IN625 new parameter sets with corresponding Part Property Profiles will be introduced Customers can either use the pre-qualified EOS parameter sets or develop and modify their own “The EOSINT M 280 adopts all features and advantages of the well-established EOSINT M 270 system and makes it even more attractive for a wide range of demanding applications including tooling and series production," said Peter Klink