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News Article | May 22, 2017
Site: www.prweb.com

More than 200 leaders in healthcare and technology joined together for the Heart Science Forum and awarded Moving Analytics with the Judge’s Choice Award. The Moving Analytics team, lead by Ade Adesanya, featured a health IT platform that allows patients to complete a home-based cardiac rehab program delivered through their mobile device. This opportunity is enormous considering that of patients recommended to cardiac rehab programs, less than a third complete that course of treatment. Barriers cited for non-compliant patients included lack of transportation, high co-pays, conflicts with work schedules and no access to nearby facilities. Moving Analytics is a game changer, allowing systems of care to greatly increase patient cardiac rehab completion rates by removing those barriers to care and putting access to the program right in the palm of a patient’s hand. Locally the Moving Analytics team is working with hospital systems, including Lourdes Health System in Camden to implement homebased cardiac rehab programs. The Movn app that patients are utilizing through Lourdes’ partnership with Moving Analytics allows for remote monitoring by cardiac rehab staff as well as two-way communication so patients can ask questions or report concerns and clinical experts can deliver advice to manage their progress. The Heart Science Forum recognizes and celebrates the creative achievements of innovators working to improve cardiac and stroke care in the Delaware Valley and beyond. Celebrating its 4th year, the Forum has firmly established itself as the premier event for innovative healthcare excellence in our region and the opportunity for finalists to pitch during the Innovation Challenge portion of the event is a coveted honor. This year's panel of Innovation Challenge judges included: Tom Borger, CEO, T B Innovative Dan Dadourian, Executive Director, Medical Affairs, National Field Physician Head, Advocacy Head, AstraZeneca Anthony Green, Vice President, Technology Commercialization Group, Ben Franklin Technology Partners Matthew Plevelich, Vice President, NewSpring Capital Stephen Popielarski, PhD, CEO, SPHM Enterprises, LLC Companies were evaluated on a number of criteria including their likelihood of having a real-world impact on the prevention or management of cardiovascular disease or stroke. Innovativeness and clarity of unmet need were also considered, along with fundability and the team’s ability to execute. All pitching companies are addressing critical gaps in patient care, making selection that much more difficult. Winning the Innovation Challenge at this event is a significant accomplishment and one that has greatly affected Ade Adesanya of Moving Analytics personally. An immigrant from Nigeria, Adesanya dreamed of contributing to innovations that could make a positive impact on society. He has experience with a variety of new ventures but has committed himself to healthcare because of its global impact and hopes to one day expand his work to Africa. Adesanya tells us, “I often pinch myself because it is a miracle that I am here and living my dreams. It can at times be difficult for immigrants to become entrepreneurs but I look to my mom for motivation. Her hypertension motivates me and working on this product helps me keep up with the latest evidence in support of her.” “This year’s pitches were truly outstanding. We were excited to award these honors, make these financial investments and also revisit the winning projects from last year that have shown remarkable progress in the 12 months since our last Forum occurs. The Forum was a big part of positioning that project and we are thrilled with its success,” shared Popielarski. “We look forward to seeing what this year’s projects can achieve in the next 12 months and inviting you all to the Forum next April to see their impact and meet our next generation of innovators.” About Moving Analytics Moving Analytics is a digital health company based in San Francisco, CA. Moving Analytics helps hospitals implement evidence-based remote cardiopulmonary rehab programs delivered through patient’s mobile devices. Their solution Is is based on 20 years of research from Stanford University. Our customers include leading health systems including NYU Langone Medical Center, Keck School of Medicine and Our Lady of Lourdes Center, New Jersey. Moving Analytics is backed by Launchpad Digital Health, HealthX Ventures, OCA Ventures and Almond Tree Capital. About The American Heart Association The American Heart Association is devoted to saving people from heart disease and stroke – America’s No. 1 and No. 5 killers. The AHA teams with industry leaders and expert in healthcare and research, as well as millions of volunteers, to fund innovative research, fight for stronger public health awareness, and provide lifesaving tools and information on treatment and prevention. The Dallas-based association is the nation’s oldest and largest voluntary organization dedicated to fighting heart disease and stroke, and is committed to finding innovative and effective solutions to reduce risk and improve health outcomes for all patients.


Mitchell brings over forty years of experience in the medical field after a tenure and double fellowships at the Perelman School of Medicine at the University of Pennsylvania.  He practiced orthopaedic surgery and sports medicine. He also has a long history of administrative medicine which includes serving as Senior Vice President of Medical Affairs for a Philadelphia health system.  Mitchell is a retired Colonel of the U.S. Army.  Mitchell served as Commander of two Combat Support Hospitals (CSHs) and served as the Deputy Inspector General for the Department of Defense (DoD) at the Pentagon.  Mitchell also had three tours of duty during his military career.  Today, the man—the physician, and the soldier is working to provide healthcare to the masses one person at a time. "In assuming the position as Medical Director of AGRiMED Industries, LLC it will be my intent to develop AGRiMED as the number one premier pharmacological cannabis company in America" stated Mitchell.  "I want to move from population medicine of the 20th Century to individual real time face-to-face medicine in the 21st Century adding a medical science that has been in existence since the Fifth Dynasty. Telehealth came into vogue when medicine started looking at Prevention, Education and Treatment as a triad to better healthcare. Video, audio, and digital sensors were starting to be injected as an IT trio to deliver better health outcomes. VideoHealth™ is not a change in healthcare but a transformation of how we deliver and receive our healthcare." AGRiMED is opening operations in Puerto Rico summer 2017 and currently undergoing the application process to obtain a registered license through the Pennsylvania Department of Health to cultivate and process medical cannabis in the Southwestern region of Pennsylvania. For additional information or to coordinate an interview with a representative at AGRiMED Industries, please call (413) 247-4633 or email info@AGRiMEDindustries.com To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/eminent-physician-eric-i-mitchell-md-facpe-to-become-medical-director-of-agrimed-industries-llc-a-premier-medical-cannabis-company-300459312.html


News Article | May 25, 2017
Site: www.sciencedaily.com

Learning how to walk is difficult for toddlers to master; it's even harder for adults who are recovering from a stroke, traumatic brain injury, or other condition, requiring months of intensive, often frustrating physical therapy. With the recent boom of the robotic exoskeleton industry, more and more patients are being strapped into machines that apply forces to their legs as they walk, gently prodding them to modify their movements by lengthening their strides, straightening their hips, and bending their knees. But, are all patients benefiting from this kind of treatment? A group of scientists led by Paolo Bonato, Ph.D., Associate Faculty member at the Wyss Institute for Biologically Inspired Engineering at Harvard University and Director of the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital, has discovered a crucial caveat for rehabilitative exoskeletons: humans whose lower limbs are fastened to a typical clinical robot only modify their gait if the forces the robot applies threaten their walking stability. In a study published in the newest issue of Science Robotics, the researchers measured how test subjects' gait changed in response to forces applied by a robotic exoskeleton as they walked on a treadmill. To the team's surprise, the walkers adjusted their stride in response to a change in the length, but not the height, of their step, even when step height and length were disturbed at the same time. The scientists believe that this discrepancy can be explained by the central nervous system (CNS)'s primary reliance on stability when determining how to adjust to a disruption in normal walking. "Lifting your foot higher mid-stride doesn't really make you that much less stable, whereas placing your foot closer or further away from your center of mass can really throw off your balance, so the body adjusts much more readily to that disturbance," says Giacomo Severini, Ph.D., one of the three first authors of the paper, who is now an Assistant Professor at University College Dublin. In fact, the brain is so willing to adapt to instability that it will expend a significant amount of the body's energy to do so, most likely because the consequences of wobbly walking can be severe: a broken ankle, torn ligaments, or even a fall from a height. However, this prioritization of stability means that other aspects of walking, like the height of the foot off the ground or the angle of the toes, may require treatment beyond walking in a clinical exoskeleton. "To modify step height, for example, you'd need to design forces so that the change in height, which the brain normally interprets as neutral, becomes challenging to the patient's balance," says Severini. Most robots used in clinical settings today do not allow for that kind of customization. The brain appears to create an internal model of the body's movement based on the environment and its normal gait, and effectively predicts each step. When reality differs from that model (i.e., when a force is applied), the brain adjusts the body's step length accordingly to compensate until the force is removed and the body recalibrates to the mental model. "The results of our study give us insight into the way people adapt to external forces while walking in general, which is useful for clinicians when evaluating whether their patients will respond to clinical robot interventions," says Bonato, who is also an Associate Professor at Harvard Medical School (HMS). "The results of this research are very important from a clinical point of view," agrees Ross Zafonte, D.O., Chairperson of the Department of Physical Medicine and Rehabilitation at HMS and Senior Vice President of Medical Affairs Research and Education at Spaulding Rehabilitation Hospital. "It is thanks to advances in our understanding of the interactions between robots and patients, such as the ones investigated in this study, that we can design effective robot-assisted gait therapy." "As the human population ages, robotics is playing an increasing role in their care and treatment," says Donald Ingber, M.D., Ph.D., Founding Director of the Wyss Institute, who is also the Judah Folkman Professor of Vascular Biology at HMS and Boston Children's Hospital, and Professor of Bioengineering at Harvard's John A. Paulson School of Engineering and Applied Sciences (SEAS). "Studying how the human body interacts with robots can not only teach us how to build better clinical rehabilitation machines, but also how our own human bodies work."


ZUG, Switzerland--(BUSINESS WIRE)--The European Commission (EC) has granted a standard marketing authorization for FAMPYRA (prolonged-release fampridine tablets) for walking improvement in people with multiple sclerosis (MS), Biogen (NASDAQ: BIIB) announced today. The approval is based on the results of the Phase 3 ENHANCE study, which confirm the clinically meaningful benefits and safety of FAMPYRA over the long term in people with both relapsing and progressive forms of MS. The ENHANCE study was conducted following the EC’s conditional marketing authorization for FAMPYRA in 2011. FAMPYRA can be used alone or with existing MS therapies, including immunomodulatory drugs. “ Approximately 80 percent of people with MS experience walking impairment, one of the most common issues with the disease. We frequently hear from people living with MS that these walking challenges affect their independence, restrict their ability to work and negatively impact their overall quality of life,” said Jeremy Hobart, Ph.D., consultant neurologist at Plymouth Hospitals NHS Trust and professor of Clinical Neurology and Health Measurement at the Plymouth University Peninsula Schools of Medicine and Dentistry. “ Results from the ENHANCE study provided additional evidence that FAMPYRA is an effective treatment for MS and echo what I and other clinicians have observed in treating people with MS: FAMPYRA provides a clinically significant improvement in walking ability as well as on broader aspects of quality of life.” ENHANCE Results Reaffirm Clinically Meaningful Benefits of FAMPYRA Biogen initiated ENHANCE, the third Phase 3 study for FAMPYRA, to evaluate the long-term safety and efficacy of the therapy in walking improvement in people with MS who have walking disabilities (as measured by Expanded Disability Status Scores [EDSS] of 4.0 – 7.0). ENHANCE, the largest and longest randomized trial of FAMPYRA, included patients with primary-progressive, secondary-progressive, progressive-relapsing and relapsing-remitting MS. Results, first reported in 2016, show that over 24 weeks: “ FAMPYRA is a valued medication among MS patients and physicians that addresses one of the most prevalent and disruptive symptoms of the disease. For the past several years, Biogen has been focused on ensuring that FAMPYRA is available to MS patients in Europe who experience walking disability,” said Ferenc Tracik, M.D., vice president, EU+ Medical Affairs. “ The approval of the standard marketing authorization for FAMPYRA is validation of the substantial difference this therapy has made on the lives of people with MS, and speaks to our deep, long-standing commitment to the MS community.” About FAMPYRA® FAMPYRA® (prolonged-release fampridine tablets) is a treatment indicated to improve walking in adult patients with MS. Biogen has a license from Acorda Therapeutics, Inc. to develop and commercialise FAMPYRA in all markets outside the United States. FAMPYRA is the first treatment to both address the unmet medical need of walking improvement in adults living with MS, and demonstrate clinical efficacy in adults with MS. FAMPYRA can be used alone or in combination with disease modifying therapies, including immunomodulatory drugs. In clinical trials, patients responding to FAMPYRA had an average increase in walking speed of 25 percent and FAMPYRA was shown to provide a clinically meaningful improvement in walking. The highest incidence of adverse reactions identified from placebo-controlled trials in MS patients with FAMPYRA, given at the recommended dose, was urinary tract infection (in approximately 12% of patients), although infection was often not proven by culture. Adverse drug reactions identified were mainly divided between neurological disorders (such as insomnia, balance disorder, dizziness, paraesthesia, headache, anxiety and tremor) and gastrointestinal disorders (including nausea, vomiting, dyspepsia and constipation). Other common adverse drug reactions reported were asthenia, back pain, pharyngolaryngeal pain and dyspnea. In post-marketing experience, there have been reports of seizures, hypersensitivity reactions (including anaphylaxis) and exacerbations of trigeminal neuralgia (TN) in patients with a history of TN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. For further information on FAMPYRA in your country please click here. U.S. residents: For information, please visit Acorda Therapeutics. About Biogen Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics. For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube. Safe Harbor This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential benefits, safety and efficacy of FAMPYRA and the results of certain real-world data. These forward-looking statements may be accompanied by words such as “anticipate,” “believe,” “could,” “estimate,” “except,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will” and other words and terms of similar meaning. You should not place undue reliance on these statements or the scientific data presented. Drug development and commercialization involve a high degree of risk. 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 or analysis; regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of Biogen’s drug candidates or expansion of product labeling; or Biogen may encounter other unexpected hurdles which may be impacted by, among other things, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, failure to protect intellectual property and other proprietary rights, product liability claims or third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our 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 are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.


News Article | May 24, 2017
Site: www.eurekalert.org

(BOSTON) - Learning how to walk is difficult for toddlers to master; it's even harder for adults who are recovering from a stroke, traumatic brain injury, or other condition, requiring months of intensive, often frustrating physical therapy. With the recent boom of the robotic exoskeleton industry, more and more patients are being strapped into machines that apply forces to their legs as they walk, gently prodding them to modify their movements by lengthening their strides, straightening their hips, and bending their knees. But, are all patients benefiting from this kind of treatment? A group of scientists led by Paolo Bonato, Ph.D., Associate Faculty member at the Wyss Institute for Biologically Inspired Engineering at Harvard University and Director of the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital, has discovered a crucial caveat for rehabilitative exoskeletons: humans whose lower limbs are fastened to a typical clinical robot only modify their gait if the forces the robot applies threaten their walking stability. In a study published in the newest issue of Science Robotics, the researchers measured how test subjects' gait changed in response to forces applied by a robotic exoskeleton as they walked on a treadmill. To the team's surprise, the walkers adjusted their stride in response to a change in the length, but not the height, of their step, even when step height and length were disturbed at the same time. The scientists believe that this discrepancy can be explained by the central nervous system (CNS)'s primary reliance on stability when determining how to adjust to a disruption in normal walking. "Lifting your foot higher mid-stride doesn't really make you that much less stable, whereas placing your foot closer or further away from your center of mass can really throw off your balance, so the body adjusts much more readily to that disturbance," says Giacomo Severini, Ph.D., one of the three first authors of the paper, who is now an Assistant Professor at University College Dublin. In fact, the brain is so willing to adapt to instability that it will expend a significant amount of the body's energy to do so, most likely because the consequences of wobbly walking can be severe: a broken ankle, torn ligaments, or even a fall from a height. However, this prioritization of stability means that other aspects of walking, like the height of the foot off the ground or the angle of the toes, may require treatment beyond walking in a clinical exoskeleton. "To modify step height, for example, you'd need to design forces so that the change in height, which the brain normally interprets as neutral, becomes challenging to the patient's balance," says Severini. Most robots used in clinical settings today do not allow for that kind of customization. The brain appears to create an internal model of the body's movement based on the environment and its normal gait, and effectively predicts each step. When reality differs from that model (i.e., when a force is applied), the brain adjusts the body's step length accordingly to compensate until the force is removed and the body recalibrates to the mental model. "The results of our study give us insight into the way people adapt to external forces while walking in general, which is useful for clinicians when evaluating whether their patients will respond to clinical robot interventions," says Bonato, who is also an Associate Professor at Harvard Medical School (HMS). "The results of this research are very important from a clinical point of view," agrees Ross Zafonte, D.O., Chairperson of the Department of Physical Medicine and Rehabilitation at HMS and Senior Vice President of Medical Affairs Research and Education at Spaulding Rehabilitation Hospital. "It is thanks to advances in our understanding of the interactions between robots and patients, such as the ones investigated in this study, that we can design effective robot-assisted gait therapy." "As the human population ages, robotics is playing an increasing role in their care and treatment," says Donald Ingber, M.D., Ph.D., Founding Director of the Wyss Institute, who is also the Judah Folkman Professor of Vascular Biology at HMS and Boston Children's Hospital, and Professor of Bioengineering at Harvard's John A. Paulson School of Engineering and Applied Sciences (SEAS). "Studying how the human body interacts with robots can not only teach us how to build better clinical rehabilitation machines, but also how our own human bodies work." The study was co-authored by two of Severini's colleagues in the Department of Physical Medicine & Rehabilitation at HMS: Iahn Cajigas, M.D., Ph. D., who is now a Neurological Surgery resident at the University of Miami, and Alexander Koenig, Ph.D., who is now the CEO of ReActive Robotics. Maurice Smith, M.D., Ph.D., the Gordon McKay Professor of Bioengineering at SEAS, also co-supervised the research. The Wyss Institute for Biologically Inspired Engineering at Harvard University uses Nature's design principles to develop bioinspired materials and devices that will transform medicine and create a more sustainable world. Wyss researchers are developing innovative new engineering solutions for healthcare, energy, architecture, robotics, and manufacturing that are translated into commercial products and therapies through collaborations with clinical investigators, corporate alliances, and formation of new startups. The Wyss Institute creates transformative technological breakthroughs by engaging in high risk research, and crosses disciplinary and institutional barriers, working as an alliance that includes Harvard's Schools of Medicine, Engineering, Arts & Sciences and Design, and in partnership with Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Boston Children's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, the University of Massachusetts Medical School, Spaulding Rehabilitation Hospital, Boston University, Tufts University, Charité - Universitätsmedizin Berlin, University of Zurich and Massachusetts Institute of Technology. Spaulding Rehabilitation Network, a member of Partners HealthCare, includes Spaulding Rehabilitation Hospital, its main campus in Charlestown, as well as Spaulding Rehabilitation Hospital Cape Cod, Spaulding Hospital Cambridge and two skilled nursing facilities, as well as twenty-five outpatient sites throughout Eastern Massachusetts. In 2016, U.S. News & World Report named Spaulding a "Top Five" rehabilitation hospital in the nation. Spaulding is one of the few hospitals in the U.S. to be awarded the prestigious Model Systems designation in all three areas of care--Spinal Cord Injury, Traumatic Brain Injury, and Burn Injury--selected by the National Institute on Disability, Independent Living and Rehabilitation Research. A teaching hospital of Harvard Medical School, Spaulding has been recognized for fostering the #1 residency program in the country for research output by Doximity Residency Navigator.


News Article | May 23, 2017
Site: www.businesswire.com

NEW HAVEN, Conn.--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced the following changes to its executive leadership team: Ludwig Hantson, Alexion’s Chief Executive Officer, stated, “ We are delighted to welcome Brian to Alexion as our new Chief Commercial Officer and look forward to his leadership in developing and executing our strategies for long-term growth as we focus on creating value for all stakeholders. He brings to Alexion the expertise and proven track record that will help us continue to build on our global leadership position, as well as a passion for developing talent and cultivating a high-performing culture. At the same time, we thank Carsten for his many contributions to Alexion’s success over the past three years. He has played a critical role in bringing Alexion’s innovative therapies to patients with rare and devastating diseases around the world and establishing a solid foundation for the future.” Mr. Goff said, “ I am very excited to join Alexion and have long admired the Company’s leadership in rare diseases, commitment to breakthrough medical innovation, patient-centric focus, and successful growth trajectory. I look forward to leading the Commercial organization and to being part of the team that will take Alexion to its next chapter of growth.” With respect to Dave Anderson, Dr. Hantson commented, “ I have valued Dave’s partnership and we are grateful for his many contributions to the Company and the finance function during an important transition period. We also appreciate his continued dedication to Alexion as our active CFO until the end of August, at which time it is our expectation that we will have retained a new, world-class CFO.” Mr. Anderson added, “ With Ludwig now firmly onboard as our CEO and Alexion off to a strong start in 2017, this presents the opportunity for the Company to identify a top-talent CFO who can partner with Ludwig to drive growth and profitability over the long term. I look forward to supporting Alexion and the team in the coming months to execute a seamless transition.” With respect to identifying a new Head of R&D, Dr. Hantson said, “ The R&D function at Alexion is core to our business and to our future, and it is our intent to recruit a new Head of R&D who can build on Martin’s successes. During his time at Alexion, Martin distinguished himself as a leader in researching and developing promising therapies for rare diseases while building an outstanding R&D leadership team and organization. Martin also led the development of Strensiq, bringing the first enzyme replacement therapy to market for patients with hypophosphatasia, and significantly advanced our complement pipeline programs. All of us at Alexion appreciate his dedication to patients and his efforts to position Alexion on the leading edge of innovation as we work to address some of the rarest, life-threatening conditions.” Commenting on a new Head of Human Resources, Dr. Hantson said, “ As Alexion advances our pipeline and commercial growth priorities, we will appoint a new Head of Human Resources who will leverage Clare’s achievements in attracting and retaining the highest levels of talent required to serve patients across the globe. Since she joined the Company in 2011, Alexion has grown from approximately 800 to 3,000 employees, and we are grateful for Clare’s leadership in helping us design the structure and systems to operate globally in 50 countries. In addition, she significantly expanded our global talent initiatives, including talent management, training and development, and compensation and benefits. The Alexion team wishes Clare well and thanks her for her commitment to our mission and our people.” Mr. Goff is a proven global biopharmaceutical executive with a 25-year track record of consistently delivering sustainable growth through multiple business cycles. He has deep expertise in commercial operations across multiple therapeutic areas, as well as broad experience in managing a range of functions, including R&D, Medical Affairs, Manufacturing and Quality with a number of industry-leading biopharmaceutical companies. Most recently, Mr. Goff served as Chief Operating Officer and a Member of the Board of Directors of Neurovance, Inc., from December 2016 until the company was acquired by Otsuka Pharmaceuticals Co. in March 2017. Previously, Mr. Goff served as Baxalta’s Executive Vice President & President – Hematology Division, from the time of the company’s spin-off from Baxter International Inc. in 2015 until its combination with Shire in mid-2016. From June 2012-December 2014, he served with Baxter Healthcare Corporation as Global Hemophilia Franchise Head. Earlier in his career, Mr. Goff held positions of increasing responsibility in sales and marketing roles with Novartis Pharmaceuticals, and the pharmaceutical division of Johnson & Johnson. He earned his M.B.A. from the Wharton School at the University of Pennsylvania and his B.A. from Skidmore College. Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion is the global leader in complement inhibition and has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. In addition, Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). Alexion is advancing its rare disease pipeline with highly innovative product candidates in multiple therapeutic areas. This press release and further information about Alexion can be found at: www.alexion.com. This press release contains 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. These forward-looking statements often include words such as "anticipate," "believe," "expect," "will," or similar expressions. Forward-looking statements are subject to factors that may cause Alexion's results and plans to differ from those expected, including for example, risks related to potential disruptions to our business as a result of leadership changes, and a variety of other risks set forth from time to time in Alexion's filings with the U.S. Securities and Exchange Commission, including but not limited to the risks discussed in Alexion's Quarterly Report on Form 10-Q for the period ended March 31, 2017 and in our other filings with the U.S. Securities and Exchange Commission. Alexion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law.


INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim today announced the presentation of new analyses on the use of OFEV® (nintedanib) in treating idiopathic pulmonary fibrosis (IPF) at the 2017 American Thoracic Society (ATS) conference. Abstracts presented at the conference support the established efficacy and safety data for OFEV®, and offer further insights into its effect on lung function in IPF patients. Pooled data from the two Phase III INPULSIS® trials showed that OFEV®-treated patients were twice as likely as those given placebo to experience an improvement or no decline in lung function, as measured by forced vital capacity (FVC), at week 52 (36.8%, OFEV® vs. 18.0%, placebo).1 A subgroup analysis of the open-label INPULSIS®-ON study demonstrated a similar annual rate of FVC decline over 96 weeks among OFEV®-treated patients, regardless of the dosage they received based on individual tolerability (150 mg twice daily, 100 mg twice daily, or both doses).2 Additionally, a pooled analysis from the TOMORROW™ and INPULSIS® trials assessed the incidence rates for major adverse cardiovascular events (MACE) among patients treated with OFEV® and placebo. Most patients included in this analysis (90%) had a high cardiovascular (CV) risk at baseline, including a history of fatty-plaque build-up in the arteries (called atherosclerosis) and/or at least one CV risk factor such as high blood pressure, diabetes or elevated blood cholesterol levels. Overall, the incidence of MACE was similar between the treatment groups both in patients with a high CV risk (3.5%, OFEV® and 3.3%, placebo) and low CV risk (4.5%, OFEV® and 5.3%, placebo) at baseline.3 “IPF is a progressive disease that requires ongoing treatment. So it is important to assess the long-term efficacy and safety of IPF treatments like OFEV® to ensure we are maintaining lung function and reducing disease progression while not exacerbating co-existing conditions,” said Imre Noth, M.D., professor of medicine and director of the Interstitial Lung Disease Program at the University of Chicago. “These new data help to further strengthen the science supporting the efficacy and safety of OFEV® for up to 96 weeks of treatment, and offer physicians additional evidence to support their treatment decisions.” A separate analysis presented at ATS examined data from the IPF-PRO patient registry at 18 pulmonary care sites to identify the clinical characteristics of IPF patients who have advanced lung function impairment. Most clinical studies have included IPF patients with mild to moderate lung function impairment, and investigators wanted to understand how patients with more advanced disease differed. Patients with advanced IPF at baseline had greater physical impairment versus patients with mild to moderate disease, including lower six-minute walk distance (320 feet vs. 397 feet). The more advanced IPF patients also had an increased prevalence of hypoxaemia (low blood oxygen), both at rest (36.6% vs. 7.4%) and while active (62.4% vs. 20.2%), requiring more supplemental oxygen, as well as a history of pulmonary arterial hypertension, or high blood pressure in the lungs (14.0% vs. 6.4%). In addition, health-related quality of life (HRQL) scores were significantly worse in those with advanced lung function impairment.6 “Boehringer Ingelheim remains committed to research in IPF with the goal of providing further medical advances for patients suffering from this devastating disease,” said Dr. Susanne Stowasser, M.D., Global Team Lead Medical Affairs ILD, Therapeutic Area Respiratory, Boehringer Ingelheim Pharma GmbH & Co KG. “Building on our recent medical progress, we are expanding our research and development activities to other fibrosing interstitial lung diseases to address the high unmet medical need of patients affected by these conditions.” Ongoing research is being conducted for the treatment of OFEV® in patients with IPF and other interstitial lung diseases. Nintedanib is also being investigated for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD), as well as progressive fibrosing interstitial lung disease (PF-ILD). Additionally, the first Phase IV trial following the approval of OFEV® for the treatment of IPF is completed and will add evidence to the safety and tolerability of nintedanib with add-on pirfenidone. Results from the 12 week, randomised INJOURNEY® trial will be presented at an upcoming international medical congress. The corresponding abstracts can be found within the online programme, here: https://cms.psav.com/ats2017/confcal Please click on the link below for ‘Notes to Editors’ and ‘References’: This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business.


News Article | May 24, 2017
Site: phys.org

The robotic exosuit delivered forces on the right foot in 19 different directions and angles, interrupting both step length (compromising balance and stability) and step height (compromising stride pattern and energy expenditure). Credit: Cajigas et al., Sci. Robot. 2, eaam7749 (2017) Learning how to walk is difficult for toddlers to master; it's even harder for adults who are recovering from a stroke, traumatic brain injury, or other condition, requiring months of intensive, often frustrating physical therapy. With the recent boom of the robotic exoskeleton industry, more and more patients are being strapped into machines that apply forces to their legs as they walk, gently prodding them to modify their movements by lengthening their strides, straightening their hips, and bending their knees. But, are all patients benefiting from this kind of treatment? A group of scientists led by Paolo Bonato, Ph.D., Associate Faculty member at the Wyss Institute for Biologically Inspired Engineering at Harvard University and Director of the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital, has discovered a crucial caveat for rehabilitative exoskeletons: humans whose lower limbs are fastened to a typical clinical robot only modify their gait if the forces the robot applies threaten their walking stability. In a study published in the newest issue of Science Robotics, the researchers measured how test subjects' gait changed in response to forces applied by a robotic exoskeleton as they walked on a treadmill. To the team's surprise, the walkers adjusted their stride in response to a change in the length, but not the height, of their step, even when step height and length were disturbed at the same time. The scientists believe that this discrepancy can be explained by the central nervous system (CNS)'s primary reliance on stability when determining how to adjust to a disruption in normal walking. "Lifting your foot higher mid-stride doesn't really make you that much less stable, whereas placing your foot closer or further away from your center of mass can really throw off your balance, so the body adjusts much more readily to that disturbance," says Giacomo Severini, Ph.D., one of the three first authors of the paper, who is now an Assistant Professor at University College Dublin. In fact, the brain is so willing to adapt to instability that it will expend a significant amount of the body's energy to do so, most likely because the consequences of wobbly walking can be severe: a broken ankle, torn ligaments, or even a fall from a height. However, this prioritization of stability means that other aspects of walking, like the height of the foot off the ground or the angle of the toes, may require treatment beyond walking in a clinical exoskeleton. "To modify step height, for example, you'd need to design forces so that the change in height, which the brain normally interprets as neutral, becomes challenging to the patient's balance," says Severini. Most robots used in clinical settings today do not allow for that kind of customization. The brain appears to create an internal model of the body's movement based on the environment and its normal gait, and effectively predicts each step. When reality differs from that model (i.e., when a force is applied), the brain adjusts the body's step length accordingly to compensate until the force is removed and the body recalibrates to the mental model. "The results of our study give us insight into the way people adapt to external forces while walking in general, which is useful for clinicians when evaluating whether their patients will respond to clinical robot interventions," says Bonato, who is also an Associate Professor at Harvard Medical School (HMS). "The results of this research are very important from a clinical point of view," agrees Ross Zafonte, D.O., Chairperson of the Department of Physical Medicine and Rehabilitation at HMS and Senior Vice President of Medical Affairs Research and Education at Spaulding Rehabilitation Hospital. "It is thanks to advances in our understanding of the interactions between robots and patients, such as the ones investigated in this study, that we can design effective robot-assisted gait therapy." "As the human population ages, robotics is playing an increasing role in their care and treatment," says Donald Ingber, M.D., Ph.D., Founding Director of the Wyss Institute, who is also the Judah Folkman Professor of Vascular Biology at HMS and Boston Children's Hospital, and Professor of Bioengineering at Harvard's John A. Paulson School of Engineering and Applied Sciences (SEAS). "Studying how the human body interacts with robots can not only teach us how to build better clinical rehabilitation machines, but also how our own human bodies work." Explore further: Researchers developing robotic prosthetics to help restore balance in fall victims More information: I. Cajigas el al., "Robot-induced perturbations of human walking reveal a selective generation of motor adaptation," Science Robotics (2017). robotics.sciencemag.org/lookup/doi/10.1126/scirobotics.aam7749

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