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News Article | May 2, 2017
Site: www.theguardian.com

The long road to Greece emerging from its worst financial crisis in modern times reached another milestone on Tuesday as the country concluded a crucial compliance review that will allow it to avert default in July. At the cost of yet more painful austerity – in the form of extra pension cuts and tax increases – international creditors agreed to disburse €7.5bn (£6.3bn) in emergency loans to enable Athens to honour maturing debt repayments. More importantly, lenders accepted to set talks in motion on making Greece’s debt mountain more manageable – vital if the country is to gain access to the capital markets from which it has been almost completely exiled since 2009. The breakthrough, after marathon 12-hour talks, became apparent only when the Greek finance minister, Euclid Tsakalotos, announced in the small hours that “white smoke” had been achieved. “There is white smoke … The negotiation is finished with agreement on all the issues,” he said. “We now have a decision that the Greek government will be called to enforce with laws and decisions.” The deal ends more than six months of intense wrangling over the fiscal and structural reforms that Athens must implement in exchange for loans from its third, €86bn bailout programme. Although the programme was outlined in 2015 when Greece came closest to crashing out of the eurozone and reverting to the drachma, the conditions attached to the lifeline remained open to negotiation. Discord most recently had focused on labour reforms and pensions – two issues that Tsakalotos, a British-trained Marxist economics professor, had felt especially strongly about. Under the agreement, the leftist-led government undertook to further slash pensions by 18% as of 2019. Pension payments have now been reduced 12 times since the start of the crisis, and cut by 40% in the past six years. With poorer out-of-work families often depending on them, news of a further drop was met with fury by union leaders, who immediately announced industrial action. The two-party coalition led by the prime minister, Alexis Tsipras, also agreed to broaden the tax-free threshold by effectively dispensing with tax breaks as of 2020. Both measures are expected to produce savings worth €3.6bn or 2% of gross domestic product. “It will be a very hot spring,” Odysseus Trivalas, acting president of the union of public sector employees, told the Guardian. “We have yet to see the details of this agreement but what we know is that it will mean further cuts. There will be a lot of strikes and a general 24-hour lockdown when the measures are brought to parliament for vote.” Greece’s main opposition leader, Kyriakos Mitsotakis, said with better negotiation the painful cutbacks could have been avoided and were tantamount to a “fourth memorandum” or bailout accord. The agreement, which also included opening up the energy market to competitors and liberalising Sunday trade, is likely to be finalised at the next meeting of eurozone finance ministers on 22 May. Legislation is expected no later than 17 May, with the ruling leftist Syriza party anticipating full endorsement from MPs. “The government believes that this road, despite the difficulties, will lead to the country’s exits from bailouts,” interior minister Panos Skourletis told state-run ERT TV. “What’s important after closing the bailout review is to have a roadmap for debt relief.” The International Monetary Fund, which has argued vociferously that Greece’s debt load is unsustainable and has balked at even joining the latest bailout programme, hinted that it could soon sign up to it. IMF participation is viewed as vital by Berlin, the biggest provider of Greece’s rescue funds. Angela Merkel, the German chancellor, faces general elections in September and a crisis-weary electorate that does not want more Greek drama. In a joint statement with Greece’s European lenders, the IMF said: “The Greek authorities have confirmed their intention to swiftly implement this policy package. This preliminary agreement will now be complemented by further discussions in the coming weeks on a credible strategy for ensuring Greece’s debt is sustainable.” Debt relief would come in the form of extended maturities and less punishing interest payments than a one-off write-down. At 180% of GDP, Greece’s debt burden is not only staggering but by far the highest in the 27-member EU. The country’s economy has shrunk by about 27% since the start of the crisis – far greater than the contraction experienced by the US during the Great Depression. Once debt relief was in place, Greece would aim to re-enter markets again, the government said. The European Central Bank has signalled it will include the country in its bond-buying programme if its debt becomes more manageable. “The Greek government is aiming at tapping the markets as soon as possible after wrapping up the second [bailout] review and a comprehensive deal on the medium-term [measures] for the debt,” the government spokesman Dimitris Tzanakopoulos told reporters after the agreement was announced.


E4D-RT: Real-Time Four-Dimensional Subsurface Imaging Software is the only commercially available ERT imaging software that can run on distributed memory supercomputing systems—multiprocessor computer systems in which each processor has its own private memory—making it scalable where others are not. E4D-RT’s nimble ability to scale according to the resources of the computing system running the software allows it to continue to produce excellent results on both small and large computing systems, provided the computer processing unit—or CPU—has a minimum of two processor cores, which is currently common even among standard laptops. By linking field data collection hardware to a supercomputing system, E4D-RT can process data fast enough to provide this imaging in real-time—something other commercial ERT programs can’t do. In 2015, the U.S. Department of Energy (DOE) spent about $6 billion on clean-up and remediation; world-wide, the cost of these activities is even larger. Real-time imaging allows scientists to see subsurface processes and solutions as they occur, such as remediation processes that are working to limit the movement of contaminants below the surface and toward water resources. Each year for more than 50 years, R&D Magazine has honored the 100 best innovations in research and development. We are currently accepting applications for the 2017 R&D 100 Awards. Innovators with an exceptional product developed between January 1, 2016 and March 31, 2017 should apply. Submissions close May 12, 2017. For information on the 55th Annual R&D 100 Awards visit the R&D 100 Conference website.


E4D-RT: Real-Time Four-Dimensional Subsurface Imaging Software is the only commercially available ERT imaging software that can run on distributed memory supercomputing systems—multiprocessor computer systems in which each processor has its own private memory—making it scalable where others are not. E4D-RT’s nimble ability to scale according to the resources of the computing system running the software allows it to continue to produce excellent results on both small and large computing systems, provided the computer processing unit—or CPU—has a minimum of two processor cores, which is currently common even among standard laptops. By linking field data collection hardware to a supercomputing system, E4D-RT can process data fast enough to provide this imaging in real-time—something other commercial ERT programs can’t do. In 2015, the U.S. Department of Energy (DOE) spent about $6 billion on clean-up and remediation; world-wide, the cost of these activities is even larger. Real-time imaging allows scientists to see subsurface processes and solutions as they occur, such as remediation processes that are working to limit the movement of contaminants below the surface and toward water resources. Each year for more than 50 years, R&D Magazine has honored the 100 best innovations in research and development. We are currently accepting applications for the 2017 R&D 100 Awards. Innovators with an exceptional product developed between January 1, 2016 and March 31, 2017 should apply. Submissions close May 12, 2017. For information on the 55th Annual R&D 100 Awards visit the R&D 100 Conference website.


News Article | February 15, 2017
Site: globenewswire.com

New Phase 3 Retrospective Analysis Shows Correlation between Reduction in Disease Substrate (Kidney Interstitial Capillary GL-3) and Improved Diarrhea in Fabry Patients with Amenable Mutations treated with Migalastat Supportive Study for Japanese New Drug Application (J-NDA) Demonstrates Migalastat Exposure is Similar in Japanese and non-Japanese Individuals SAN DIEGO and CRANBURY, N.J., Feb. 14, 2017 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biotechnology company at the forefront of therapies for rare and orphan diseases, today announced new positive data analyses for the oral small molecule pharmacological chaperone migalastat HCl (“migalastat”) for Fabry disease at WORLDSymposium™ 2017 in San Diego, California. Jay Barth, Chief Medical Officer of Amicus Therapeutics, Inc., stated, “The new analyses highlighted at this year’s WORLDSymposium add to the already significant body of data which demonstrate the multiple benefits of treatment with migalastat in Fabry patients with amenable mutations. Here, the correlation of the reduction in disease substrate with the reduction in diarrhea symptoms provides further evidence that migalastat is having a positive effect on an important gastrointestinal symptom in Fabry. These findings in diarrhea symptoms support our current Fabry regulatory strategy for migalastat in the U.S., which is based upon improvement in diarrhea in this patient population. Also, we remain on track in Japan with our submission to the Pharmaceuticals and Medical Devices Agency based on completed Phase 1 and Phase 3 studies. We also remain committed to providing access to this important medicine to patients in the EU, where it is already approved, in addition to other major geographies.” Data Highlights for Migalastat for Fabry Disease at WORLDSymposium 2017 Phase 3 Retrospective Analysis - Correlation between Substrate Reduction and Reduction in Diarrhea In a poster1 from Study 011 (FACETS) in Fabry patients who were naïve to ERT, a retrospective analysis from baseline to month 6 demonstrated that migalastat reduces disease substrate (KIC GL-3) and improves diarrhea symptoms (GSRS-D) in patients with Fabry disease with amenable mutations. Key highlights were as follows: To support full approval in the U.S., which represents approximately 25% of the global Fabry market, Amicus plans to confirm the clinical beneficial effects of migalastat in a GI symptom study. The GI study is anticipated to begin in 2017 in approximately 35 Fabry patients who are naïve to treatment and who have an amenable mutation and diarrhea and other GI symptoms. More than 50% of patients with Fabry disease report or show GI signs and symptoms, including diarrhea, abdominal pain, constipation, nausea, and vomiting.2 Supportive Pharmacokinetics (PK) Study for Japanese Regulatory Submission As previously announced, Amicus plans to submit a J-NDA in Japan in the first half of 2017. The J-NDA will be based on data from completed clinical studies with migalastat, including two pivotal Phase 3 studies as well as a Phase 1 study that evaluated the pharmacokinetics (PK) of migalastat in Japanese volunteers. The results from this Phase 1 study are being highlighted in a poster3 at WORLDSymposium 2017 with key highlights as follows: Japan represents the second largest Fabry market in the world by country, with approximately 13% of the $1.2B global Fabry ERT sales generated in Japan in 2015.4 The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan previously confirmed that completed studies of migalastat meet J-NDA submission requirements without the need to conduct an additional clinical study in Japan. The PMDA took into account data from Japanese patients included in the Phase 3 program and the similar PK properties in Japanese and non-Japanese individuals. Migalastat is designed to selectively and reversibly bind with high affinity to the active sites of certain mutant forms of alpha-Gal A, the genotypes of which are referred to as amenable mutations. On May 30, 2016, the European Commission granted full approval for migalastat, under the trade name Galafold™, as a first line therapy for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation. This EU approval may serve as the basis for regulatory approvals in more than two-thirds of the global Fabry market that is outside the U.S. Amicus has commenced the commercial launch of Galafold in Germany and is undergoing the EU country-by-country processes to launch in the majority of EU countries throughout 2016 and 2017. The Company has also initiated expanded access programs (EAP) in the EU and other territories outside the U.S. that provide this mechanism for reimbursed access prior to formal approval. Galafold™ (migalastat) is a first-in-class chaperone therapy approved in the EU as a monotherapy for Fabry disease in patients with amenable mutations. Galafold works by stabilizing the body’s own dysfunctional enzyme, so it can clear the accumulation of disease substrate in patients who have amenable mutations.  A proprietary in vitro assay (Galafold Amenability Assay) was used to classify more than 800 known GLA mutations as “amenable” or “not amenable” to treatment with Galafold. The current EU label includes 313 GLA mutations that have been identified and determined to be amenable based on the Galafold Amenability Assay, which represent between 35% and 50% of the currently diagnosed Fabry population. Healthcare providers in the EU may access the website www.galafoldamenabilitytable.com to quickly and accurately identify which mutations are categorized as “amenable” or “not amenable” to Galafold. Amicus expects to submit updates to the label as additional GLA mutations are identified and tested in the Galafold Amenability Assay. Treatment with GALAFOLD should be initiated and supervised by specialists experienced in the diagnosis and treatment of Fabry disease. GALAFOLD is not recommended for use in patients with a nonamenable mutation. For further important safety information for Galafold, including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European SmPC for Galafold available from the EMA website at www.ema.europa.eu. Fabry disease is an inherited lysosomal storage disorder caused by deficiency of an enzyme called alpha-galactosidase A (alpha-Gal A), which is the result of mutations in the GLA gene. The primary biological function of alpha-Gal A is to degrade specific lipids in lysosomes, including globotriaosylceramide (referred to here as GL-3 and also known as Gb ). Lipids that can be degraded by the action of alpha-Gal A are called "substrates" of the enzyme. Reduced or absent levels of alpha-Gal A activity lead to the accumulation of GL-3 in the affected tissues, including the central nervous system, heart, kidneys, and skin. Progressive accumulation of GL-3 is believed to lead to the morbidity and mortality of Fabry disease, including pain, kidney failure, heart disease, and stroke. The symptoms can be severe, differ from patient to patient, and begin at an early age. All Fabry disease is progressive and may lead to organ damage regardless of the time of symptom onset. Amicus Therapeutics (Nasdaq:FOLD) is a global biotechnology company at the forefront of therapies for rare and orphan diseases. The Company has a robust pipeline of advanced therapies for a broad range of human genetic diseases. Amicus’ lead programs in development include the small molecule pharmacological chaperone migalastat as a monotherapy for Fabry disease, SD-101 for Epidermolysis Bullosa (EB), as well as novel enzyme replacement therapy (ERT) and biologic products for Fabry disease, Pompe disease, and other rare and devastating diseases. 1D. Germain, WORLDSymposium 2017, Effects of Treatment With Migalastat on the Combined Endpoint of Kidney Globotriaosylceramide Accumulation and Diarrhea in Patients With Fabry Disease: Results From the Phase 3 FACETS Study 2Hoffmann B et al. Clin Gastroenterol Hepatol. 2007;5(12):1447-1453. 3F. Johnson, WORLDSymposium 2017, Migalastat exposures in Japanese healthy volunteers and non-Japanese subjects provide evidence that they are similar to Japanese patients with Fabry disease 4Company filings and Amicus estimates Forward Looking Statements This press release contains "forward- looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to data, future studies and ongoing regulatory strategies for migalastat.  Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” "confidence," "encouraged," “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements.  The forward looking statements included in this press release are based on management's current expectations and belief's which are subject to a number of risks, uncertainties and factors, including that the data reported herein will not be predictive of future results, that later study results will not support  further development of migalastat, or even if such later  results are favorable, that the Company will not be able to successfully complete the development of, obtain regulatory approval for, or successfully commercialize migalastat.  In addition, all forward looking statements are subject to the other risks and uncertainties detailed in our Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on 10-Q for the Quarter ended September 30, 2016.  As a consequence, actual results may differ materially from those set forth in this press release or the accompanying conference call or webcast.  You are cautioned not to place undue reliance on these forward looking statements, which speak only of the date hereof.  All forward looking statements are qualified in their entirety by this cautionary statement and we undertake no obligation to revise this press release to reflect events or circumstances after the date hereof.


News Article | February 28, 2017
Site: www.prnewswire.co.uk

According to a new market research report "Cognitive Assessment and Training in Healthcare Market by Assessment Type (Pen-and-Paper Based, Hosted, and Biometrics), Components, Application (Clinical Trial, Screening & Diagnostics, Brain Training, Academic Research), & Region - Global forecast to 2021", published by MarketsandMarkets, the market size estimated to grow from USD 962.0 Million in 2016 to USD 4,127.2 Million by 2021, at a Compound Annual Growth Rate (CAGR) of 33.8%. Browse 56 market data Tables and 44 Figures spread through 138 Pages and in-depth TOC on "Cognitive Assessment and Training in Healthcare Market" http://www.marketsandmarkets.com/Market-Reports/cognitive-assessment-training-healthcare-market-191532711.html Early buyers will receive 10% customization on this report. The major forces driving this market are aging global population, increasing awareness about brain fitness, and advancements in technology. The growing market for cognitive solutions and increasing demand for brain training by next-generation tech-savvy population are contributing to the growth of the Cognitive Assessment and Training in Healthcare Market. Clinical trials in terms of application is expected hold the largest market share in the Cognitive Assessment and Training in Healthcare Market during the forecast period Clinical trials are mainly used to identify, measure, or monitor cognitive impairments and cognitive changes. The assessment of cognitive functions is an integral part of decision making during clinical drug development, as certain drugs can have an impact on the cognitive capabilities of the brain. The market is expected to contribute the highest revenue for vendors offering clinical trials. Service segment is expected to grow at the highest CAGR in the Cognitive Assessment and Training in Healthcare Market and the current trend is expected to continue during the forecast period An Increasing demand for cognitive assessment and training tests and procedures in the global healthcare market also provides a significant scope for associated services as well. The growth of the services segment is expected to accelerate, due to an increasing level of awareness regarding the brain fitness. With the increasing utilization of cognitive assessment and training solutions, the services act as an add-on to these solutions making them more valuable. Providers of cognitive assessment and training solutions and services offer training and coaching services to deliver balanced cognitive rehabilitation solutions. North America is expected to contribute the largest market share and Asia-Pacific (APAC) to grow at the highest rate North America is expected to hold the largest market share and to dominate the Cognitive Assessment and Training in Healthcare Market from 2016 to 2021, due to the increasing awareness among population about adopting medication for cognitive diseases. The new generation in this region is more concerned towards the benefits of cognitive training, which is not just limited to patients with cognitive dysfunctions. The U.S. market holds a majority of the market share in terms of adoption as well as revenue generation in the North American market, due to the rapidly aging population vulnerable to cognitive diseases in the region. The APAC region is expected to witness the highest growth rate during the forecast period, as the population in the region is more inclined towards adopting a healthier lifestyle. Hence, the concerns regarding cognitive diseases are growing in the region. The major vendors in the Cognitive Assessment and Training in Healthcare Market include Cambridge Cognition Ltd. (Cambridge, U.K.), Cogstate Ltd. (New Haven, U.S.), Bracket (Pennsylvania, U.S.), MedAvante Inc. (New Jersey, U.S.), Quest Diagnostic (New Jersey, U.S.), ProPhase, LLC (New York, U.S.), CogniFit (New York, U.S.), ERT Clinical (Pennsylvania, U.S.), NeuroCog Trials (North Carolina, U.S.), and Brain Resource Company (New South Wales, Australia). Cognitive Computing Market by Technology (Natural Language Processing, Machine Learning, Automated Reasoning), by Deployment Model (On-Premises, Cloud) & by Regions - Global Forecast to 2019 http://www.marketsandmarkets.com/Market-Reports/cognitive-computing-market-%20136144837.html Cognitive Assessment and Training Market by Assessment Type (Pen & Paper Based, Hosted, Biometrics), Service, Application (Clinical Trials, Classroom Learning, Brain Training, Corporate Learning, Academic Research), Vertical and Region - Global Forecast to 2020 http://www.marketsandmarkets.com/Market-Reports/cognitive-assessment-market-1039.html Know More About our Knowledge Store @ http://www.marketsandmarkets.com/Knowledgestore.asp MarketsandMarkets is the largest market research firm worldwide in terms of annually published premium market research reports. Serving 1700 global fortune enterprises with more than 1200 premium studies in a year, M&M is catering to a multitude of clients across 8 different industrial verticals. We specialize in consulting assignments and business research across high growth markets, cutting edge technologies and newer applications. Our 850 fulltime analyst and SMEs at MarketsandMarkets are tracking global high growth markets following the "Growth Engagement Model - GEM". The GEM aims at proactive collaboration with the clients to identify new opportunities, identify most important customers, write "Attack, avoid and defend" strategies, identify sources of incremental revenues for both the company and its competitors. M&M's flagship competitive intelligence and market research platform, "RT" connects over 200,000 markets and entire value chains for deeper understanding of the unmet insights along with market sizing and forecasts of niche markets. The new included chapters on Methodology and Benchmarking presented with high quality analytical infographics in our reports gives complete visibility of how the numbers have been arrived and defend the accuracy of the numbers. We at MarketsandMarkets are inspired to help our clients grow by providing apt business insight with our huge market intelligence repository. Visit MarketsandMarkets Blog @ http://www.marketsandmarketsblog.com/market-reports/telecom-it Connect with us on LinkedIn @ http://www.linkedin.com/company/marketsandmarkets


Growing Momentum for EU Galafold (Migalastat) Launch for Fabry Disease Tracking Toward 300 Patients by Year-End 2017 Target Enrollment Achieved in Phase 1/2 Pompe Study – Additional Data Expected in 2Q17 and 3Q17 Phase 3 EB Program Remains on Track for Topline Data in Mid-2017 CRANBURY, N.J., March 01, 2017 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biotechnology company at the forefront of therapies for rare and orphan diseases, today announced financial results for the full year ended December 31, 2016. The Company also provided program updates and reiterated full-year 2017 financial guidance. “Throughout 2016 we made significant progress with the international launch of our first commercial product Galafold and continued to advance and expand our robust pipeline of first- and/or best-in-class medicines for people living with devastating rare diseases,” stated John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc. “During 2017 we are laser focused on five key strategic priorities to advance our vision to develop and deliver great medicines for patients and to create significant shareholder value: 1) advancing the international launch of Galafold for Fabry disease, 2) completing our regulatory submission for migalastat in Japan (J-NDA), 3) establishing our novel Pompe treatment paradigm ATB200/AT2221 as a highly differentiated therapy, 4) successfully completing our Phase 3 clinical study in patients with epidermolysis bullosa, and 5) maintaining our financial strength. With one commercial-stage medicine and two medicines in clinical development, as well as a biologics platform for future growth, we are building a leading global biotechnology company focused on delivering meaningful benefits for patients living with devastating rare diseases.” Cash, cash equivalents, and marketable securities totaled $330.4 million at December 31, 2016. As previously announced, the Company strengthened the balance sheet during 2016 with a $100 million at-the-market (ATM) equity financing as well as a $250 million convertible debt offering. The Company expects full-year 2017 net operating cash spend of between $175 million to $200 million and expects full-year 2017 total net cash spend (including third-party milestone payments and capital expenditures) of between $200 million and $225 million. The current cash position is anticipated to fund ongoing operations into the second half of 2018. Migalastat is an oral precision medicine intended to treat Fabry disease in patients who have amenable genetic mutations. As previously announced, the European Commission (EC) has granted full approval for migalastat under the trade name Galafold. The EC approval may serve as the basis for regulatory approvals in more than two-thirds of the global Fabry market that is outside the U.S. The Company has also defined a U.S. pathway to support full approval. ATB200/AT2221 is a novel treatment paradigm that consists of ATB200, a unique recombinant human acid alpha-glucosidase (rhGAA) enzyme with optimized carbohydrate structures, particularly mannose-6 phosphate (M6P), to enhance uptake, co-administered with AT2221, a pharmacological chaperone. Positive preliminary data were reported in the fourth quarter of 2016  and during the 13th Annual WORLDSymposium™ in San Diego, CA in February 2017 from a global clinical study (ATB200-02) to evaluate safety, tolerability, PK, and pharmacodynamics (PD) of ATB200/AT2221. The study is enrolling 3 cohorts of patients, including ambulatory ERT-switch patients (Cohort 1), non-ambulatory ERT-switch patients (Cohort 2), and ERT-naïve patients (Cohort 3). Key Preliminary Data Highlights from ATB200-02 Study in Initial ERT-Switch and ERT-Naïve Patients: SD-101 is a novel, late-stage, proprietary topical treatment and potential first-to-market therapy for EB. SD-101 is currently being investigated in a registration-directed Phase 3 study (ESSENCE, also known as SD-005) to support global regulatory submissions. SD-101 was granted FDA Breakthrough Therapy designation in 2013 based on results from a Phase 2a study for the treatment of lesions in patients suffering with EB. SD-101 is the first-ever treatment in clinical studies to show improvements in wound closure across all major EB types. Conference Call and Webcast Amicus Therapeutics will host a conference call and audio webcast today, March 1, 2017 at 8:30 a.m. ET to discuss full-year 2016 financial results and corporate updates. Interested participants and investors may access the conference call at 8:00 a.m. ET by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international) participant code 77299407. An audio webcast can also be accessed via the Investors section of the Amicus Therapeutics corporate web site at http://www.amicusrx.com, and will be archived for 30 days. Web participants are encouraged to go to the web site 15 minutes prior to the start of the call to register, download and install any necessary software. A telephonic replay of the call will be available for seven days beginning at 11:30 a.m. ET today. Access numbers for this replay are 855-859-2056 (U.S./Canada) and 404-537-3406 (international); participant code 77299407. Important Safety Information Treatment with GALAFOLD should be initiated and supervised by specialists experienced in the diagnosis and treatment of Fabry disease. GALAFOLD is not recommended for use in patients with a nonamenable mutation. For further important safety information for Galafold, including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European SmPC for Galafold available from the EMA website at www.ema.europa.eu. About Amicus Therapeutics Amicus Therapeutics (Nasdaq:FOLD) is a biotechnology company at the forefront of therapies for rare and orphan diseases. The Company has a robust pipeline of advanced therapies for a broad range of human genetic diseases. Amicus’ lead programs in development include the small molecule pharmacological chaperone migalastat as a monotherapy for Fabry disease, SD-101 for Epidermolysis Bullosa (EB), as well as novel enzyme replacement therapy (ERT) and biologic products for Fabry disease, Pompe disease, and other rare and devastating diseases. Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to preclinical and clinical development of our product candidates, the timing and reporting of results from preclinical studies and clinical trials, the prospects and timing of the potential regulatory approval of our product candidates, commercialization plans, financing plans, and the projected cash position for the Company. In particular, this press release relates to the preliminary data from a global Phase 1/2 study (ATB200-02) to investigate ATB200/AT2221. The inclusion of forward-looking statements arising from this preliminary data and study should not be regarded as a representation by us that any of our plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. For example, with respect to statements regarding the goals, progress, timing, and outcomes of discussions with regulatory authorities, and in particular the potential goals, progress, timing, and results of preclinical studies and clinical trials, actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation: the potential that results of clinical or preclinical studies indicate that the product candidates are unsafe or ineffective; the potential that it may be difficult to enroll patients in our clinical trials; the potential that regulatory authorities, including the FDA, EMA, and PMDA, may not grant or may delay approval for our product candidates; the potential that we may not be successful in commercializing Galafold in Europe or our other product candidates if and when approved; the potential that preclinical and clinical studies could be delayed because we identify serious side effects or other safety issues; and the potential that we will need additional funding to complete all of our studies. Further, the results of earlier preclinical studies and/or clinical trials may not be predictive of future results for any of our product candidates. The preliminary data and Phase 1/2 study discussed herein is inherently preliminary and early in the study, derived from a limited patient set, and later trial results with this patient set or others may not be consistent with these preliminary results. With respect to statements regarding projections of the Company's cash position, actual results may differ based on market factors and the Company's ability to execute its operational and budget plans. In addition, all forward-looking statements are subject to other risks detailed in our previous filings with the SEC and in our Annual Report on Form 10-K for the year ended December 31, 2016 to be filed later today. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update this news release to reflect events or circumstances after the date hereof.


News Article | March 2, 2017
Site: globenewswire.com

CRANBURY, N.J., March 02, 2017 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a global biotechnology company at the forefront of therapies for rare and orphan diseases, today announced that management will present at two upcoming investor conferences. John Crowley, Chairman and Chief Executive Officer, will present at the Cowen & Company 37th Annual Health Care Conference in Boston, MA on Wednesday, March 8, 2017 at 9:20 a.m. ET. Chip Baird, Chief Financial Officer, will present at the Barclays Global Healthcare Conference 2017 in Miami, FL on Tuesday, March 14, 2017 at 11:15 a.m. E.T. A live webcast of both presentations can be accessed through the Investors section of the Amicus Therapeutics corporate web site at http://ir.amicustherapeutics.com/events.cfm, and will be archived for 90 days. About Amicus Therapeutics Amicus Therapeutics (Nasdaq:FOLD) is a biotechnology company at the forefront of therapies for rare and orphan diseases. The Company has a robust pipeline of advanced therapies for a broad range of human genetic diseases. Amicus’ lead programs in development include the small molecule pharmacological chaperone migalastat as a monotherapy for Fabry disease, SD-101 for Epidermolysis Bullosa (EB), as well as novel enzyme replacement therapy (ERT) and biologic products for Fabry disease, Pompe disease, and other rare and devastating diseases.


CRANBURY, N.J., Feb. 22, 2017 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a global biotechnology company at the forefront of therapies for rare and orphan diseases, today announced a conference call and live audio webcast on Wednesday, March 1, 2017 at 8:30 a.m. ET to discuss financial results for the year ended December 31, 2016. The call will be hosted by John F. Crowley, Chairman and Chief Executive Officer. He will be joined on the call by additional members of the Amicus management team. Interested participants and investors may access the conference call by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international). A live audio webcast can also be accessed via the Investors section of the Amicus Therapeutics corporate website at http://ir.amicusrx.com/, and will be archived for 30 days. Web participants are encouraged to go to the website 15 minutes prior to the start of the call to register, download, and install any necessary software. A telephonic replay of the call will be available for seven days beginning at 11:30 a.m. ET on March 1, 2017. Access numbers for this replay are 855-859-2056 (U.S./Canada) and 404-537-3406 (international); conference ID: 77299407. Amicus Therapeutics (Nasdaq:FOLD) is a global biotechnology company at the forefront of therapies for rare and orphan diseases. The Company has a robust pipeline of advanced therapies for a broad range of human genetic diseases. Amicus’ lead programs in development include the small molecule pharmacological chaperone migalastat as a monotherapy for Fabry disease, SD-101 for Epidermolysis Bullosa (EB), as well as novel enzyme replacement therapy (ERT) and biologic products for Fabry disease, Pompe disease, and other rare and devastating diseases.


MAHWAH, N.J., Feb. 14, 2017 (GLOBE NEWSWIRE) -- Radware® (NASDAQ:RDWR), a leading provider of cyber security and application delivery solutions, today announced that it has secured a multi-million dollar deal to support the network security infrastructure for one of the world’s largest Content Delivery Network (CDN) services providers’ Security-as-a-Service business for the next three years. Radware’s family of DDoS security solutions provides integrated application and network security solutions for a best of breed, multi-layered security architecture and DDoS attack prevention.  The solution provides the highest protection accuracy with patent-protected behavioral based detection to protect legitimate traffic and real-time signature creation for zero-day attack protection.  Radware's DDoS protection offers the highest mitigation capacity in the industry with devices handling up to 400Gbps of traffic at 330M PPS (packets-per-second). “Security as a service is a significant revenue stream for this CDN,” said Igal Toledano, Vice President of global service contracts for Radware. “An operation of its size requires vigilant and ongoing updates to its security infrastructure.  Radware’s security solutions will ensure that the CDN can provide the fastest and highest quality DDoS detection and mitigation to its clients without latency, downtime or slowness.” The agreement provides the CDN with subscription to the Radware Emergency Response Team’s weekly and ad-hoc Security updates, full maintenance of the Radware install base across the world and priority response time and SLA to the Radware ERT team to assist in attack mitigation in real time. Radware® (NASDAQ:RDWR), is a global leader of application delivery and cyber security solutions for virtual, cloud and software defined data centers. Its award-winning solutions portfolio delivers service level assurance for business-critical applications, while maximizing IT efficiency. Radware’s solutions empower more than 10,000 enterprise and carrier customers worldwide to adapt to market challenges quickly, maintain business continuity and achieve maximum productivity while keeping costs down. For more information, please visit www.radware.com. Radware encourages you to join our community and follow us on: Facebook, Google+, LinkedIn, Radware Blog, SlideShare, Twitter, YouTube, Radware Connect app for iPhone® and our security center DDoSWarriors.com that provides a comprehensive analysis on DDoS attack tools, trends and threats. ©2017 Radware Ltd. All rights reserved. Radware and all other Radware product and service names are registered trademarks or trademarks of Radware in the U.S. and other countries. All other trademarks and names are property of their respective owners. The Radware products and solutions mentioned in this press release are protected by trademarks, patents and pending patent applications. For more details please see: https://www.radware.com/LegalNotice/. This press release may contain statements concerning Radware’s future prospects that are “forward-looking statements” under the Private Securities Litigation Reform Act of 1995. Statements preceded by, followed by, or that otherwise include the words "believes", "expects", "anticipates", "intends", "estimates", "plans", and similar expressions or future or conditional verbs such as "will", "should", "would", "may" and "could" are generally forward-looking in nature and not historical facts. For example, we cannot guarantee such deals in the future. Because such statements deal with future events, they are subject to various risks and uncertainties and actual results, expressed or implied by such forward-looking statements, could differ materially from Radware's current forecasts and estimates. Factors that could cause or contribute to such differences include, but are not limited to: the impact of global economic conditions and volatility of the market for our products; changes in the competitive landscape; inability to realize our investment objectives; timely availability and customer acceptance of our new and existing products; risks and uncertainties relating to acquisitions; the impact of economic and political uncertainties and weaknesses in various regions of the world, including the commencement or escalation of hostilities or acts of terrorism; Competition in the market for Application Delivery and Network Security solutions and our industry in general is intense; and other factors and risks on which we may have little or no control. This list is intended to identify only certain of the principal factors that could cause actual results to differ. For a more detailed description of the risks and uncertainties affecting Radware, reference is made to Radware’s Annual Report on Form 20-F which is on file with the Securities and Exchange Commission (SEC) and the other risk factors discussed from time to time by Radware in reports filed with, or furnished to, the SEC. Forward-looking statements speak only as of the date on which they are made and, except as required by applicable law, Radware undertakes no commitment to revise or update any forward-looking statement in order to reflect events or circumstances after the date any such statement is made. Radware’s public filings are available from the SEC’s website at www.sec.gov or may be obtained on Radware’s website at www.radware.com.


News Article | February 15, 2017
Site: www.prweb.com

ERT, a global data and technology company that minimizes risk and uncertainty in clinical trials, today announced the launch of its refreshed eCOA technology environment, which dramatically simplifies the implementation and management of trials that require collection of Clinical Outcomes Assessments. Designed to support simple to the most complex studies, ERT’s eCOA environment collects patient data anywhere, anytime, and in any language, and can be provisioned across mobile devices, web browsers and patients’ own devices (known as BYOD or bring your own device). On-device calculations and medical device integrations enable real-time access to operational and clinical data, so sponsors see how their study is performing, and ensure patient safety. “We are shattering the commonly-held misconception that a paper-based solution is easier or less expensive than technology,” said Ron Sullivan, Executive Vice President, eCOA at ERT. “ERT’s eCOA environment has all the quality, consistency and administrative benefits inherent with an electronic solution, and now is easy to implement and even easier to manage.” ERT’s eCOA environment provides uniform data collection with more efficient study change management and mitigates the need for manual data reconciliation. Formerly customized features are now included as standard, and pre-configured study components are widely available. Additionally, complimentary protocol review by ERT’s expansive team of patient reported outcomes (PRO)/eCOA Clinical Scientists ensures fit-for-purpose design on every study. “Now we can enable sponsors to focus on clinical research – not the minutiae of data collection and assimilation,” continued Sullivan. “Trial leaders can reduce uncertainty and have confidence in their collected data, while keeping studies on time and on budget.” About ERT ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence. With more than 40 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards. Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement, and measure the efficacy of new clinical treatments while ensuring patient safety. Over the past four years, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs, and CROs have relied on ERT solutions in 9,500+ studies spanning three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly – and with confidence. For more information, go to ert.com or follow us on LinkedIn, Twitter, and Facebook.

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