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TOKYO and CAMBRIDGE, Mass. , Dec. 4, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts , CEO: Christopher A. Viehbacher , "Biogen") announced today that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI ® " (lecanemab) for the treatment of early Alzheimer's disease (AD)*. LEQEMBI selectively binds to soluble Aβ aggregates (protofibrils**), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. LEQEMBI is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. LEQEMBI is also approved and being marketed in the U.S., Japan , China , South Korea , Hong Kong , Israel , the United Arab Emirates, and Great Britain . LEQEMBI's approval is based on the large global Phase 3 Clarity AD study. In the Clarity AD study, LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results. 1,2 Approximately 1.3 million people in Mexico are estimated to suffer from AD, accounting for 60-70% of all dementia diagnoses. 3 AD most commonly affects individuals over the age of 65. 3 Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. Eisai and Biogen will co-commercialize and co-promote LEQEMBI in Mexico . * Collectively referred to mild cognitive impairment due to AD or mild AD dementia. ** Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition. 4 Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction. 5 Notes to Editors 1. About lecanemab (LEQEMBI ® ) Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab is approved and being marketed in the U.S., Japan , China , South Korea , Hong Kong , Israel , the United Arab Emirates and Great Britain for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). The treatment's approvals in these countries was based on Phase 3 data from Eisai's global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. 1,2 The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall. Lecanemab is under regulatory review in 16 countries and regions, including the European Union. In November 2024 , the treatment received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval. Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022 , the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis , is ongoing and includes lecanemab as the backbone anti-amyloid therapy. 2. About the Collaboration between Eisai and Biogen for AD Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. 3. About the Collaboration between Eisai and BioArctic for AD Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007 . The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015 . 4. About Eisai Co., Ltd. Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care ( hhc ) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners. For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai. Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai, Inc.) or www.eisai.eu (for Europe , Middle East , Africa , Russia , Australia and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on X ( global and U.S ), LinkedIn (for global , U.S. and EMEA ) and Facebook ( global ). 5. About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. The company routinely posts information that may be important to investors on its website at www.biogen.com . Follow Biogen on social media – Facebook , LinkedIn , X , YouTube . Biogen Safe Harbor This news release contains forward-looking statements, about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; and third party collaboration risks, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements. References View original content to download multimedia: https://www.prnewswire.com/news-releases/leqembi-lecanemab-approved-for-the-treatment-of-early-alzheimers-disease-in-mexico-302322515.html SOURCE Eisai Inc.
RICHMOND, Va. , Nov. 22, 2024 /PRNewswire/ -- Universal Corporation (NYSE:UVV) ("Universal" or the "Company"), a global business-to-business agriproducts company, today announced that, as expected, on November 19, 2024 , it received a notice (the "NYSE Notice") from the New York Stock Exchange (the "NYSE") that the Company is not in compliance with Section 802.01E of the NYSE Listed Company Manual as a result of its failure to timely file its Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2024 (the "Form 10-Q") with the U.S. Securities and Exchange Commission (the "SEC") prior to November 18, 2024 , the end of the extension period provided by Rule 12b -25 under the Securities Exchange Act of 1934, as amended. The NYSE Notice has no immediate effect on the listing of the Company's common stock on the NYSE. The NYSE Notice informed the Company that, under NYSE rules, the Company has six months from November 18, 2024 , to regain compliance with the NYSE listing standards by filing the Form 10-Q with the SEC. If the Company fails to file the Form 10-Q within the six-month period, the NYSE may grant, in its sole discretion, an extension of up to six additional months for the Company to regain compliance, depending on the specific circumstances. The NYSE Notice also noted that the NYSE may nevertheless, in its own discretion, commence delisting proceedings at any time during such period. As previously disclosed in the Company's Notification of Late Filing on Form 12b-25, filed on November 12, 2024 (the "Form 12b-25") with the SEC, the Company was unable to file the Form 10-Q on a timely basis due to an ongoing internal investigation. As a result of the additional time required to complete its internal investigation, the process of finalizing financial statements for the second quarter of fiscal year 2025 could not be completed on a timely basis. The Company is committed to completing a deliberate, thorough investigation while diligently working to fulfill all reporting obligations and currently expects to file the Form 10-Q within the six-month period granted by the NYSE Notice; however, there can be no assurance that the Form 10-Q will be filed within such period. About Universal Corporation Universal Corporation (NYSE: UVV) is a global agricultural company with over 100 years of experience supplying products and innovative solutions to meet our customers' evolving needs and precise specifications. Through our diverse network of farmers and partners across more than 30 countries on five continents, we are a trusted provider of high-quality, traceable products. We leverage our extensive supply chain expertise, global reach, integrated processing capabilities, and commitment to sustainability to provide a range of products and services designed to drive efficiency and deliver value to our customers. For more information, visit www.universalcorp.com . CAUTIONARY STATEMENTS REGARDING FORWARD-LOOKING INFORMATION This release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Among other things, these statements include statements regarding expectations about the Company's filing of its Form 10-Q for the quarter ended September 30, 2024 . These forward-looking statements are generally identified by the use of words such as we "expect," "believe," "anticipate," "could," "should," "may," "plan," "will," "predict," "estimate," and similar expressions or words of similar import. These forward-looking statements are based upon management's current knowledge and assumptions about future events and involve risks and uncertainties that could cause actual results, performance, or achievements to be materially different from any anticipated results, prospects, performance, or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, the uncertainty of the ultimate findings of the ongoing internal investigation, as well as the timing of its completion and costs and expenses arising out of the ongoing internal investigation process and its results; the impact of the ongoing internal investigation on us, our management and operations, including financial impact as well as any litigation or regulatory action that may arise from the ongoing internal investigation; the impact of the internal investigation on our conclusions regarding the effectiveness of our internal control over financial reporting and our disclosure controls and procedures; our ability to regain compliance with NYSE listing requirements; success in pursuing strategic investments or acquisitions and integration of new businesses and the impact of these new businesses on future results; product purchased not meeting quality and quantity requirements; our reliance on a few large customers; our ability to maintain effective information technology systems and safeguard confidential information; anticipated levels of demand for and supply of our products and services; costs incurred in providing these products and services including increased transportation costs and delays attributed to global supply chain challenges; timing of shipments to customers; higher inflation rates; changes in market structure; government regulation and other stakeholder expectations; economic and political conditions in the countries in which we and our customers operate, including the ongoing impacts from international conflicts; product taxation; industry consolidation and evolution; changes in exchange rates and interest rates; impacts of regulation and litigation on its customers; industry-specific risks related to its plant-based ingredient businesses; exposure to certain regulatory and financial risks related to climate change; changes in estimates and assumptions underlying our critical accounting policies; the promulgation and adoption of new accounting standards, new government regulations and interpretation of existing standards and regulations; and general economic, political, market, and weather conditions. Actual results, therefore, could vary from those expected. Please also refer to such other factors as discussed in Part I, Item 1A. "Risk Factors" of Universal's Annual Report on Form 10-K for the fiscal year ended March 31, 2024 , and related disclosures in other filings which have been filed with the U.S. Securities and Exchange Commission and are available on the SEC's website at www.sec.gov . All risk factors and uncertainties described herein and therein should be considered in evaluating forward-looking statements, and all of the forward-looking statements are expressly qualified by the cautionary statements contained or referred to herein and therein. Universal cautions investors not to place undue reliance on any forward-looking statements as these statements speak only as of the date when made, and it undertakes no obligation to update any forward-looking statements made, except as required by law. View original content to download multimedia: https://www.prnewswire.com/news-releases/universal-corporation-receives-nyse-notice-regarding-filing-of-form-10-q-for-the-fiscal-quarter-ended-september-30-2024-302314579.html SOURCE Universal CorporationNoneNORMAN, Okla. (AP) — Oklahoma appears to have borrowed from the past to cure its recent offensive ills. The Sooners , best known this century for a passing prowess that has produced four Heisman Trophy-winning quarterbacks, took it back to the 20th century against then-No. 7 Alabama. Oklahoma ran 50 times for 257 yards while only throwing 12 times in a 24-3 win over the Crimson Tide that took coach Brent Venables off the hot seat. The Sooners more resembled Barry Switzer’s squads that dominated the old Big 8 with the wishbone offense in the 1970s and ’80s than the more recent Air Raid teams. Venables said the change was a matter of necessity for a unit that has been besieged by injuries at receiver and offensive line. “I think this staff has done a really good job with trying to figure that out, get better every week, put together a great gameplan but also figure out, ‘OK, what does this group of guys, what does this team — what do we need to do?'” Venables said. To make it work, Oklahoma needed to trust that such a change would work in the modern Southeastern Conference. They had to implement it with an interim play-caller in Joe Jon Finley, who stepped in after the Sooners fired Seth Littrell last month. Oklahoma (6-5, 2-5 SEC) pulled it off, and LSU coach Brian Kelly has taken notice ahead of their game on Saturday. “This is now much more about controlling the football, running the football, playing with physicality," Kelly said. "They've got perimeter skill, but I think it's centered around much more of a run-centric, quarterback run and take care of the football." The Sooners started to see success on the ground against Maine. They ran 52 times for 381 yards in a 59-14 win that got the wheels turning. Jovantae Barnes ran for career highs of 203 yards and three touchdowns that day. Venables said the timing of the opportunity to play that non-conference game against Maine in early November and figure some things out was perfect. “Everybody has some degree of vulnerability and maybe some self-doubt,” he said. “And just developing some confidence and putting something on tape other than practice, like, ‘Man, look, see what you’re capable of?’ And executing against, again, a well-coached team — certainly, we played off of that in all the right ways like you would expect us to. And so there’s a real place for that.” After a bye week, the Sooners tried the same approach against Missouri. It wasn't as successful — they ran 36 times for 122 yards — but they hung tough before losing 30-23 . The Sooners went all in against Alabama. Jackson Arnold — the same guy who threw 45 times in the Alamo Bowl last year, ran 25 times for 131 yards and threw just 11 passes. The Sooners found something in running back Xavier Robinson. With Barnes out with an injury, Robinson carried 18 times for career highs of 107 yards and two touchdowns. Suddenly, a team that had been forcing the pass and getting sacked at an alarming rate was moving the line of scrimmage and controlling the tempo. Oklahoma had the ball for more than 34 minutes against the Crimson Tide, lending support to a talented defense that had been spending way too much time on the field. The new approach could be helpful on Saturday — LSU (7-4, 4-3) ranks 14th out of 16 conference teams against the run. Venables said the Sooners still need to throw the ball well to win, but he's glad to know his squad can run with force when necessary. “I think that’s the art of having a system that’s adjustable, flexible, adaptable, week in and week out, but also has an identity — toughness, physicality," he said. "You’ve got to be able to run the ball at every level of football, but you do have to throw it. You can’t just do one thing. But we need to be efficient.” Get poll alerts and updates on the AP Top 25 throughout the season. Sign up here . AP college football: https://apnews.com/hub/ap-top-25-college-football-poll and https://apnews.com/hub/college-football
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Manmohan Singh: The Man Who Shaped India, And The Family That Carried His LegacyAlberta rolling out next step in mandatory literacy and numeracy screening to kindergarten studentsUnlike the seamless Thanksgiving miracles depicted on Hallmark TV programs, real life often involves frantic last-minute grocery runs, burnt turkeys and the juggling act of family tensions simmering just beneath the surface. But people can take steps now to limit the holiday stress, says University of Michigan psychology professor Stephanie Preston. "Give yourself and others grace," she said. "It's fine to laugh when things go awry. We've all seen the perfect Hallmark family gathering, but those are fictional. Real life is complicated and messy. We're all human and need to savor the moment." One way to keep the stress at bay is to set an intention for the day or week, said Preston, who admits that she tries to keep her expectations reasonable while hosting a Thanksgiving dinner for family. To keep things relaxed, each person contributes a dish (even the kids), the dress code is casual, the start time is flexible, and we end with a short walk and some games. "What do you most want to get out of the holiday? Most people want to be present and thankful while spending time with loved ones more than they want to craft the perfectly browned turkey or decorative tablescape," Preston said. Can you provide communication strategies that can be effective in dealing with difficult conversations or conflicts among family members? Family members who don't agree or get along—particularly in divisive political time—can be a major source of stress for everyone. In advance, consider what issues might arise and how you will deal with them. Aim to focus on sharing food and thanks above resolving long-held differences. Some families cannot talk about politics without a fight, so know your limits. Even if it seems satisfying to get off that snide remark, it's better to have a few phrases ready that can quickly deflect negativity while honoring your feelings. Have an ally at the event or someone you can text or call when your patience wears thin. Just knowing someone understands how you feel and has your back will extend your patience. Remember, we cannot control other people or how they view the world—and the Thanksgiving table might not be the place to try even if we could. But we can control our contribution to the holiday spirit How important is it to set boundaries during holiday gatherings, and what are some polite ways to establish them? Boundaries are essential for maintaining your sanity but can increase conflict if not done right. Consider any boundaries you need and alert people in advance so they know what to expect, e.g., you'll take a long walk each day or go to bed early. As long as you genuinely make time for the essentials (find out when dinner is before setting your schedule), people usually don't mind. No need to explain yourself. If pressed, just keep it simple with something like, "I just find it helps me feel like myself." For people who feel lonely or isolated during the holidays, what can they do to feel more connected? The important thing about a holiday is to rest, fill your soul and connect with people you care about. Not everyone has the picture-perfect family that gathers around a huge table though. People are often geographically displaced from family or do not have much family to speak of. Others use isolation as a way to deal with anxiety or stress and need to counter this instinct in order to enjoy the festivities. Remember that it really doesn't matter who you spend time with or how you connect. Friendsgivings are popular alternatives. If you are not invited to a meal, consider asking someone else who is isolated to join you. Even if you eat takeout alone on a holiday, try to plan another way to connect, like volunteering, attending a service or public event, going to a movie, or calling a friend. Research shows that loneliness damages our physical and mental health. It feels good to help and connect with people—even strangers. Push yourself a little bit to let some of that magic of human connection in, however you can. How can individuals balance the desire to spend time with family and friends with the need to have some personal downtime? It all comes down to balance, and each person is different. The key is to give enough space in your heart, mind and calendar to savor the togetherness of a holiday, without making yourself crazy or exhausted. Knowing your own body and mind, how much sleep, exercise or downtime do you need? It's not rude to step away or miss some things, as long as you let people know, express your appreciation, and are present when you are together. It's easier to set a plan early than to wiggle out of something in the moment. How can people avoid unhealthy coping mechanisms? Unhealthy coping mechanisms are trouble even in good times, but can spiral during holidays. People are pushed out of their comfort zones, set high expectations, and interact with many more people. Drinking excessively is a common one, as people rely on the social lubricant, give themselves something to do during uncertain moments and recover from stress. Avoiding people is another coping strategy. Most coping mechanisms are fine in moderation and may provide some benefits. But when your desire to drink, take drugs, shop, eat or avoid people undermines your own goal of enjoying the holiday , it's time to adjust. Find a friend or relative who gets your issue and let them help you navigate your choices. If you need, call a crisis hotline to tell someone how you feel or ask for help.
Man denies drugs charges after raid in affluent Wellington suburbTOKYO and CAMBRIDGE, Mass. , Dec. 4, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts , CEO: Christopher A. Viehbacher , "Biogen") announced today that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI ® " (lecanemab) for the treatment of early Alzheimer's disease (AD)*. LEQEMBI selectively binds to soluble Aβ aggregates (protofibrils**), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. LEQEMBI is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. LEQEMBI is also approved and being marketed in the U.S., Japan , China , South Korea , Hong Kong , Israel , the United Arab Emirates, and Great Britain . LEQEMBI's approval is based on the large global Phase 3 Clarity AD study. In the Clarity AD study, LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results. 1,2 Approximately 1.3 million people in Mexico are estimated to suffer from AD, accounting for 60-70% of all dementia diagnoses. 3 AD most commonly affects individuals over the age of 65. 3 Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. Eisai and Biogen will co-commercialize and co-promote LEQEMBI in Mexico . * Collectively referred to mild cognitive impairment due to AD or mild AD dementia. ** Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition. 4 Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction. 5 Notes to Editors 1. About lecanemab (LEQEMBI ® ) Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab is approved and being marketed in the U.S., Japan , China , South Korea , Hong Kong , Israel , the United Arab Emirates and Great Britain for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). The treatment's approvals in these countries was based on Phase 3 data from Eisai's global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. 1,2 The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall. Lecanemab is under regulatory review in 16 countries and regions, including the European Union. In November 2024 , the treatment received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval. Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022 , the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis , is ongoing and includes lecanemab as the backbone anti-amyloid therapy. 2. About the Collaboration between Eisai and Biogen for AD Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. 3. About the Collaboration between Eisai and BioArctic for AD Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007 . The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015 . 4. About Eisai Co., Ltd. Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care ( hhc ) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners. For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai. Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai, Inc.) or www.eisai.eu (for Europe , Middle East , Africa , Russia , Australia and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on X ( global and U.S ), LinkedIn (for global , U.S. and EMEA ) and Facebook ( global ). 5. About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. The company routinely posts information that may be important to investors on its website at www.biogen.com . Follow Biogen on social media – Facebook , LinkedIn , X , YouTube . Biogen Safe Harbor This news release contains forward-looking statements, about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; and third party collaboration risks, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements. References View original content to download multimedia: https://www.prnewswire.com/news-releases/leqembi-lecanemab-approved-for-the-treatment-of-early-alzheimers-disease-in-mexico-302322515.html SOURCE Eisai Inc.Manmohan Singh's father may have believed his bookworm son would one day lead India, but the understated technocrat with the trademark blue turban, who died Thursday at the age of 92, never dreamed it would actually happen. Singh was pitchforked into leading the world's largest democracy in 2004 by the shock decision of Congress leader Sonia Gandhi to turn down the role after leading the party to an upset win over the ruling Hindu nationalists. He oversaw an economic boom in Asia's fourth-largest economy in his first term, although slowing growth in later years marred his second stint. Known as "Mr Clean", Singh nonetheless saw his image tarnished during his decade-long tenure when a series of corruption cases became public. As finance minister in the early 1990s, he was hailed at home and abroad for initiating big-bang reforms that opened India's inward-looking economy to the world. Known as a loyalist to the Gandhi political dynasty, Singh studied economics to find a way to eradicate poverty in the vast nation and never held elected office before becoming PM. But he deftly managed the rough and tumble of Indian politics -- even though many said Sonia Gandhi, the Italian-born widow of the assassinated Rajiv Gandhi, was the power behind the throne. Born in 1932 in the mud-house village of Gah in what is now Pakistan, Singh moved to the holy Sikh city of Amritsar as a teenager around the time the subcontinent was split at the end of British rule into mainly Hindu India and Muslim Pakistan. His father was a dry-fruit seller in Amritsar, and he had nine brothers and sisters. He was so determined to get an education he would study at night under streetlights because it was too noisy at home, his brother Surjit Singh told AFP in 2004. "Our father always used to say Manmohan will be the prime minister of India since he stuck out among the 10 children," said Singh. "He always had his nose in a book." Singh won scholarships to attend both Cambridge, where he obtained a first in economics, and Oxford, where he completed his PhD. He worked in a string of senior civil posts, served as a central bank governor and also held various jobs with global agencies such as the United Nations. Singh was tapped in 1991 by then Congress prime minister P.V. Narasimha Rao to reel India back from the worst financial crisis in its modern history -- currency reserves had sunk so low the country was on the brink of defaulting on foreign loans. Singh unleashed sweeping change that broke sharply with India's Soviet-style state-directed economy. In his first term he steered the economy through a period of nine-percent growth, lending the country the international clout it had long sought. He also sealed a landmark nuclear deal with the US that he said would help India meet its growing energy needs. But by 2008 there was growing disquiet among the ruling alliance's left-leaning parties about the pact, while high inflation -- notably food and fuel prices -- hit India's poor hard. Still, voters remained drawn to his calm, pragmatic persona, and in 2009 Congress steered its alliance to a second term. Singh vowed to step up financial reforms to drive economic growth, but he came under increasing fire from critics who said he had done nothing to stop a string of corruption scandals on his watch. Several months before the 2014 elections, Singh said he would retire after the polls, with Sonia Gandhi's son Rahul earmarked to take his place if Congress won. But Congress crashed to its worst-ever result at that time as the Hindu-nationalist Bharatiya Janata Party, led by Narendra Modi, won a landslide. More recently, an unflattering book by a former aide titled "The Accidental Prime Minister" portrayed him as timid and controlled by Sonia Gandhi. Singh -- who said historians would be kinder to him than contemporary detractors -- became a vocal critic of Modi's economic policies, and more recently warned about the risks that rising communal tensions posed to India's democracy. pmc-grk/abh/fox/leg/sms
DFCC Bank has listed its pioneering Green Bond on the Luxembourg Stock Exchange (LuxSE) – Luxembourg Green Exchange on 20 December. The listing is on the Securities Official List (SOL) of LuxSE. The bank said while the Green Bond listing on the Colombo Stock Exchange (CSE) will continue, the listing on LuxSE will make this a dual listing and is the first Sri Lankan Green Bond to have a dual listing. “The trading and settlement of the Green Bond will continue to be through the Colombo Stock Exchange and in LKR. The Green Bond will not be traded on the Luxembourg Stock Exchange,” DFCC Bank said. The Green Bond was listed on CSE on 30 September. The senior, listed, rated, unsecured, redeemable three-year Green Bonds offered by DFCC Bank, aiming to raise up to Rs. 2.5 billion, were oversubscribed on the opening day in September. The initial issue of 20,000,000 bonds, each with a par value of Rs. 100 and offering a fixed interest rate of 12% per annum, paid annually, drew substantial investor interest with applications worth Rs. 3.16 billion, reflecting strong confidence in sustainable investment opportunities.
PM Modi, Amit Shah, Gautam Adani & others condole Manmohan Singh’s demiseMorgan Rogers’ fourth goal of the season, an Ollie Watkins penalty and Matty Cash’s finish put Villa 3-0 up after 34 minutes. Mikkel Damsgaard pulled one back for Brentford in the second half but the damage had been done as Villa ended their eight-match winless run in all competitions. Emery was relieved to end the unwanted streak but quickly turned his attention to the next fixture against Southampton on Saturday. “We broke a spell of bad results we were having,” the Villa boss said. “We started the first five or 10 minutes not in control of the game but then progressively we controlled. “Today we achieved those three points and it has given us confidence again but even like that it’s not enough. We have to keep going and think about the next match against Southampton on Saturday. “The message was try to focus on each match, try to forget the table. How we can recover confidence and feel comfortable at home. Today was a fantastic match.” Tyrone Mings returned to the starting line-up in the Premier League for the first time since August 2023. Emery admitted it has been a long road back for the 31-year-old and is pleased to have him back. He added: “Mings played in the Champions league but it’s the first time in the league for a year and three months. “I think he played fantastic – he might be tired tomorrow but will be ready for Saturday again. “It was very, very long, the injury he had. His comeback is fantastic for him and everybody, for the doctor and physio and now he’s training everyday.” Brentford fell to a sixth away defeat from seven games and have picked up only a solitary point on the road this season. They have the best home record in the league, with 19 points from seven matches, but they have the joint worst away record. Bees boss Thomas Frank is confident form will improve on the road. He said: “On numbers we can’t argue we are better at home than away, but on numbers it’s a coincidence. I think two of the seven away games have been bad. “The other games we performed well in big spells. I’m confident at the end of the season we will have some wins away from home.” Frank felt Villa should not have been given a penalty when Ethan Pinnock brought Watkins down. He added: “I want to argue the penalty. I don’t think it is (one). I think Ollie kicked back and hit Ethan, yes there is an arm on the shoulder but threshold and all that – but that’s not the reason we lost.”
Rail Maintenance Equipment Market Industry Dynamics and Contributions by Matisa, Gradall, ProgressRail, Wabtec, Harsco, Geismar, Epiq Machinery
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