Mydayis, which is now available in the U.S., demonstrated improvements lasting up to 16 hours post-dose, beginning at 2 or 4 hours post-dose, compared to placebo, in total score on a skill-adjusted math test that measures attention in ADHD
Lexington, Mass., USA, 01-Sep-2017 — /EuropaWire/ — Shire plc (LSE:SHP, NASDAQ: SHPG) announced today that MYDAYIS™ (mixed salts of a single-entity amphetamine product), a once-daily, extended-release treatment comprised of three types of drug-releasing beads, is now available by prescription in the United States. The U.S. Food and Drug Administration (FDA) approved Mydayis on June 20, 2017 for patients 13 years and older with Attention Deficit Hyperactivity Disorder (ADHD). Mydayis is not for use in children 12 years and younger.
“In my practice, my patients remind me every day that each individual’s needs vary; this has made it increasingly important to have different approaches to help my patients manage their ADHD symptoms,” said Dr. Matthew Brams, Assistant Professor of Clinical Psychiatry at Baylor College of Medicine. “The availability of Mydayis is a new addition to the options healthcare professionals have to consider as they help patients who continually struggle with ADHD symptoms.”
Mydayis, other amphetamine containing medicines, and methylphenidate have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with Mydayis. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
The U.S. FDA approval of Mydayis was based on results from 16 clinical studies evaluating Mydayis in more than 1,600 subjects, including adolescents (aged 13 to 17 years) and adults with ADHD. In pivotal, placebo-controlled clinical studies, Mydayis significantly improved symptoms of ADHD, as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP), in adults and adolescents. Improvement on the PERMP, an objective, validated, skill-adjusted math test that measures attention in ADHD patients, reached statistical significance at up to 16 hours post-dose, beginning at 2 to 4 hours post-dose. People living with ADHD should work with a healthcare professional to determine whether a pharmacological treatment is appropriate for them, and if so, which one meets their individual needs.
In pivotal Phase 3 clinical studies where efficacy was the primary endpoint, a morning dose of Mydayis demonstrated superiority to placebo based on the change from baseline in the ADHD-RS-IV total score for adult and adolescent patients, respectively. The most common adverse reactions associated with Mydayis (incidence greater than or equal to 5% and at a rate at least twice placebo) in adults were insomnia, decreased appetite, decreased weight, dry mouth, increased heart rate, and anxiety. For pediatric patients (13 years and older), the most common adverse reactions were insomnia, decreased appetite, decreased weight, irritability, and nausea.
“We recognize that patients with ADHD have varied needs when it comes to managing their symptoms,” said Perry Sternberg, Head, U.S. Commercial. “Mydayis, which has shown efficacy at up to 16 hours post-dose, beginning at 2 to 4 hours post-dose, provides a new once-daily option for appropriate patients.”
In Phase 2 studies (two studies in adults and one in adolescents), patients treated with Mydayis demonstrated improved attention compared to placebo, as assessed by the total PERMP score, with results reaching statistical significance beginning at 2 or 4 hours post-dose and lasting up to 16 hourspost-dose. Across all clinical studies, adverse events were generally mild to moderate in severity and similar to those observed with other amphetamine compounds.
An estimated 4.4% of adults have ADHD in the U.S. When applied to the full U.S. adult population aged 18 and over, approximately 10.5 million adults are estimated to have ADHD. Approximately 50 to 66% of children with ADHD may continue to have ADHD symptoms as adults. Medication is not appropriate for all individuals diagnosed with ADHD.
With the availability of Mydayis, Shire has patient-focused resources to share information about prescription coverage and savings, including a co-pay savings offer. This savings offer will be available for eligible commercially insured patients to help save on their Mydayis prescriptions.
Mydayis (mixed salts of a single-entity amphetamine product) Important Safety Information
What is MYDAYIS™?
Mydayis is a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older. Mydayis is not for use in children 12 years and younger.
IMPORTANT SAFETY INFORMATION
Abuse and dependence. Mydayis, other amphetamine containing medicines, and methylphenidate have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with Mydayis.
- Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
Who should not take Mydayis?
Do not take Mydayis if you or your child is:
- allergic to amphetamine or any of the ingredients in Mydayis. See the end of the Medication Guide for a complete list of ingredients in Mydayis.
- taking, or have taken within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).
Serious problems can occur while taking Mydayis. Tell your healthcare provider:
- if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in people with heart problems or defects taking stimulant medicines, and sudden death, stroke and heart attack have happened in adults taking stimulant medicines. Your healthcare provider should check you or your child carefully for heart problems before starting Mydayis. Since increases in blood pressure and heart rate may occur, your healthcare provider should regularly check these during treatment. Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Mydayis.
- if you or your child have mental (psychiatric) problems, or a family history of suicide, bipolar illness, or depression. This is important because new or worse behavior and thought problems or new or worse bipolar illness may occur. New symptoms such as hearing voices, seeing or believing things that are not real, or new manic symptoms may occur. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
- if your child is having slowing of growth (height and weight); Mydayis may cause this serious side effect. Your child should have height and weight checked often while taking Mydayis. Your healthcare provider may stop treatment if a problem is found during these check-ups.
- if you or your child have circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may feel numb, cool, painful, sensitive totemperature and/or change color from pale, to blue, to red. Tell your healthcare provider if you or your child have any numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Call your healthcare provider if you or your child have any signs of unexplained wounds appearing on fingers or toes while taking Mydayis.
- if you or your child have a seizure. Your healthcare provider will stop treatment.
- if you or your child have symptoms of serotonin syndrome such as agitation, hallucinations, coma, or other changes in mental status; problems controlling your movements or muscle twitching; fast heartbeat; sweating or fever; nausea, vomiting or diarrhea; or muscle stiffness or tightness. Call your healthcare provider or go to the nearest hospital emergency room if you have these symptoms. Serotonin syndrome may happen when Mydayis is taken with certain other medicines and may be life-threatening.
- if you or your child are or become pregnant or plan to become pregnant. It is not known if Mydayis may harm your unborn baby.
- if you or your child are breastfeeding or plan to breastfeed. You should not breastfeed while taking Mydayis. Mydayis passes into breast milk.
What are possible side effects of Mydayis?
The most common side effects of Mydayis include:
- trouble sleeping
- decreased appetite
- dry mouth
- increased heart rate
- anxiety
- nausea
- irritability
- weight loss
For additional safety information, click here for Medication Guide, including Warning about Abuse, and discuss with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
About ADHD
Attention Deficit Hyperactivity Disorder (ADHD) impacts people in multiple settings – even beyond work into daily tasks, at home or in social settings.
The specific etiology of ADHD is unknown. The diagnosis is made utilizing criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5®). Only a trained healthcare professional can evaluate and diagnose ADHD.
Although there is no cure for ADHD, there are accepted treatments that have demonstrated improvement in ADHD symptoms. A comprehensive approach is often advised, which may include a combination of medication, psychotherapy and educational approaches. Ongoing assessment of ADHD management plans is recommended.
About the Mydayis Phase 3 Studies
Efficacy of Mydayis in adults (aged 18-55 years) was evaluated in a pivotal randomized, double-blind, placebo-controlled study of Mydayis 12.5 mg or 37.5 mg in 275 adult patients (Study 1) who met the DSM-5® criteria for ADHD. The primary endpoint was defined as the change from baseline in the ADHD-RS-IV with prompts total score compared to placebo. When administered as a daily morning dose, Mydayis was superior compared to placebo for both the 12.5 mg and 37.5 mg doses, respectively. In addition, patients treated with either 12.5 mg or 37.5 mg of Mydayis also showed significantly greater improvement compared to placebo on the Clinical Global Impression of Improvement (CGI-I) score, a key secondary endpoint.
In a pooled analysis of three Phase 3 clinical trials conducted in 626 adult ADHD patients, the most commonly reported TEAEs (reported in >5% of Mydayis-treated patients) were insomnia, decreased appetite, dry mouth, decreased weight, increased heart rate, and anxiety. Nine percent of Mydayis-treated patients discontinued due to adverse reactions compared to 2% of placebo-treated patients. The most frequent adverse reactions leading to discontinuation (i.e., leading to discontinuation in at least 1% of Mydayis-treated patients and at a rate at least twice that of placebo) were insomnia (2%), increased blood pressure (2%), decreased appetite (1%), and headache (1%).
The efficacy of Mydayis was further assessed in a study that included 157 adolescent (13 to 17 years old) patients (Study 4). This was a randomized, double-blind, placebo-controlled, dose-optimization study of Mydayis in patients who met the DSM-IV-TR® criteria for ADHD. Subjects were titrated from a dose of 12.5 mg/day until an optimal dose was reached (up to a maximum dose of 25 mg/day). The primary efficacy endpoint was defined as the change from baseline in the ADHD-RS-IV total score when compared to placebo. The primary efficacy analysis demonstrated that Mydayis, administered as a daily morning dose, was superior to placebo with respect to the change from baseline on the ADHD-RS-IV total score. In addition, Mydayis also showed significantly greater improvement on the CGI-I score at Week 4, the key secondary endpoint in this study.
Among adolescent patients in Study 4, the most commonly reported TEAEs (reported in >5% of Mydayis-treated patients) were decreased appetite, nausea, insomnia, irritability, and decreased weight. Five percent of Mydayis-treated patients discontinued due to adverse reactions compared to zero percent of placebo-treated patients. The most frequent adverse reaction leading to discontinuation (i.e., leading to discontinuation in at least 1% of Mydayis-treated patients and at a rate at least twice that of placebo) were dizziness, depression, upper abdominal pain, and viral infection (all 1%). Safety and effectiveness of Mydayis have not been established in pediatric patients ages 12 years and younger.
About the Mydayis Phase 2 Studies
The efficacy of Mydayis in adults (aged 18-55 years) was also evaluated in two workplace analog studies. These were multi-center, randomized, double-blind, placebo-controlled, crossover studies in adult patients that evaluated 50 mg (Study 2, N=86, 42 of whom were treated with 50 mg) or 25 mg (Study 3, N=79, 76 of whom were treated with 25 mg) of Mydayis who met DSM-IV-TR® criteria for ADHD. Efficacy was assessed by the PERMP total score, calculated as the sum of the number of math problems attempted plus the number of math problems answered correctly. The PERMP was administered at 2, 4, 8, 12, 14, and 16 hours post-dose. Mydayis treatment reached statistical significance compared to placebo at either 2 hours (Study 2) or 4 hours (Study 3) post-dose and lasting up to 16 hours post-dose in both studies.
In Study 2, no patients in the Mydayis 50 mg treatment group experienced a serious TEAE. The most commonly reported TEAEs (reported in >5% of patients) in the Mydayis 50 mg treatment group included fatigue, insomnia, anorexia, decreased appetite, headache, dry mouth, hypertension. In Study 3, no patients experienced a serious TEAE. Two patients reported treatment-emergent adverse events (TEAEs) that led to study discontinuation. The most commonly reported TEAEs (reported in >5% of patients) in the Mydayis 25 mg treatment group were insomnia, decreased appetite, dry mouth, headache, and anorexia.
The efficacy of Mydayis in adolescents was also evaluated in a classroom analog study (Study 5, 13 to 17 years, N=84 adolescents). The study was a multi-center, randomized, double-blind, placebo-controlled, crossover study of Mydayis 12.5 mg or 25 mg who met DSM-IV-TR® criteria for ADHD. Efficacy was assessed using the PERMP which was administered at 2, 4, 8, 12, 14, and 16 hours post-dose. Mydayis treatment, compared to placebo, resulted in a statistically significant treatment effect compared with placebo, beginning at 2 hours and continued for up to 16 hours post-dose. In Study 5, TEAEs that were more common in the Mydayis treatment arms (i.e., frequency >5% in either Mydayis treatment arm) were upper abdominal pain, dry mouth, nausea, anorexia, decreased appetite, dizziness, headache, insomnia, irritability, and dysmenorrhea. There were no reported serious TEAEs and no TEAEs led to study discontinuation.
DSM-5 and DSM-IV-TR are registered trademarks of the American Psychiatric Association.
About Mydayis
Mydayis is a once-daily treatment comprised of three different types of drug-releasing beads for patients 13 years and older with ADHD. Mydayis is not for use in children 12 years and younger. Mydayis is available in 12.5, 25, 37.5 and 50 mg capsules. Visit www.mydayis.com for more information.
Shire’s Commitment to ADHD
Shire is a global leader in ADHD education and treatment. We have more than 20 years of experience in providing treatments for ADHD. We regularly share our expertise with healthcare professionals, patients, care givers and policymakers in order to raise awareness and broaden understanding of this condition. Learn more at www.shire.com.
For further information please contact:
Investor Relations | ||
Ian Karp | ikarp@shire.com | +1 781 482 9018 |
Robert Coates | rcoates@shire.com | +44 1256 894874 |
Media | ||
Lisa Adler | lisa.adler@shire.com | +1 617 588 8607 |
Debbi Ford | debbi.ford@shire.com | +1 617 949 9083 |
SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
MYDAYIS is a trademark of Shire LLC.
NOTES TO EDITORS
About Shire
Shire is the leading global biotechnology company focused on serving people with rare diseases. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Forward-Looking Statements
Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:
- Shire’s products may not be a commercial success;
- increased pricing pressures and limits on patient access as a result of governmental regulations and market developments may affect Shire’s future revenues, financial condition and results of operations;
- Shire conducts its own manufacturing operations for certain of its products and is reliant on third party contract manufacturers to manufacture other products and to provide goods and services. Some of Shire’s products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of Shire’s products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time;
- the manufacture of Shire’s products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to, among other things, significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
- certain of Shire’s therapies involve lengthy and complex processes, which may prevent Shire from timely responding to market forces and effectively managing its production capacity;
- Shire has a portfolio of products in various stages of research and development. The successful development of these products is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
- the actions of certain customers could affect Shire’s ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely affect Shire’s revenues, financial conditions or results of operations;
- Shire’s products and product candidates face substantial competition in the product markets in which it operates, including competition from generics;
- adverse outcomes in legal matters, tax audits and other disputes, including Shire’s ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on the Company’s revenues, financial condition or results of operations;
- inability to successfully compete for highly qualified personnel from other companies and organizations;
- failure to achieve the strategic objectives, including expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all with respect to Shire’s acquisitions, including NPS Pharmaceuticals Inc., Dyax Corp. or Baxalta Incorporated may adversely affect Shire’s financial condition and results of operations;
- Shire’s growth strategy depends in part upon its ability to expand its product portfolio through external collaborations, which, if unsuccessful, may adversely affect the development and sale of its products;
- a slowdown of global economic growth, or economic instability of countries in which Shire does business, as well as changes in foreign currency exchange rates and interest rates, that adversely impact the availability and cost of credit and customer purchasing and payment patterns, including the collectability of customer accounts receivable;
- failure of a marketed product to work effectively or if such a product is the cause of adverse side effects could result in damage to Shire’s reputation, the withdrawal of the product and legal action against Shire;
- investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire’s activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines;
- Shire is dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on Shire’s revenues, financial condition or results of operations;
- Shire incurred substantial additional indebtedness to finance the Baxalta acquisition, which has increased its borrowing costs may decrease its business flexibility; and a further list and description of risks, uncertainties and other matters can be found in Shire’s most recent Annual Report on Form 10-K and in Shire’s subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in “ITEM 1A: Risk Factors”, and in Shire’s subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire’s website.
All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE: Shire
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- Digi Communications NV announces Investors Call for the H1 2022 Financial Results
- Digi Communications N.V. Announces the update of its 2022 Financial Calendar
- Digi Communications N.V. Announces the conclusion by the Company’s Spanish subsidiary of an amendment agreement to the facility agreement dated 26 July 2021
- Customer Data Platform Industry Grew Strongly in First Half of 2022: CDP Institute Report
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- HBC Consulting Expert considers senseless the involvement of the Cypriot court in the case of inheritance by the widow of oligarch Bosov
- Fusion BPO Services is Opening New Center in Kosovo
- Hi-SIDE demonstrates an integrated high speed satellite data chain architecture at data rates exceeding 10 Gigabits per second
- Digi Communications N.V. announces that a joint venture of its subsidiary in Romania designated as one of the winners of the auction organized by the Belgian Institute for Postal Services and Telecommunications for the allocation of mobile spectrum frequency user rights
- KI-basierte Geldanlage für Privatpersonen – Velvet AutoInvest erhält 1,3 Mio. USD Seed-Investment
- Haizol Now Offer 3D Printing Services to Customers Worldwide
- Caravel Capital Fund Showcased At Secure Spectrum’s Hedge Fund Seminar
- Diabeloop, a key player in therapeutic AI applied to insulin delivery, announces 70 million euros new financing round to accelerate its international expansion
- Digi Communications NV Announces Availability of the 2021 Preliminary Annual Report (including the Company’s audited non-statutory Consolidated financial statements issued as per IFRS EU)
- Digi Communications N.V. Announces that conditional stock options were granted to executive directors of the Company and to directors and employees of the Company’s Romanian Subsidiary
- Caravel Capital Investments Inc. Founding Partner to Speak at Secure Spectrum Hedge Fund Seminar
- Digi Communications NV announces a correction of clerical errors by Amending the Q1 2022 Financial Report
- Digi Communications NV announces the release of Q1 2022 Financial Results
- Digi Communications N.V. announces Investors Call for the Q1 2022 Financial Results presentation
- Yield Crowd Tokenizes US $50M Real Estate Portfolio on Stellar Blockchain
- Digi Communications N.V. Announces an Amendment to the Financial Calendar for 2022
- Diabeloop presents new real-life results of DBLG1® System: Confirmed improvement in Time In Range +18.4 percentage points; Reduction of time spent in hypoglycemia to only 0.9%
- How two female entrepreneurs are redefining the lake travel industry
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- Προκαλέστε τον εαυτό σας στο 3ο CASSINI Hackathon και στοχεύστε την αναζωογόνηση του τουρισμού!
- Participez au 3e Hackathon CASSINI et relevez le défi de redynamiser le tourisme!
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- Diabeloop adapts its self-learning, personalized insulin automatization software to be used with insulin pens
- Amadeus unveils five defining trends for the US group travel and events industry in 2022
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- Global & Europe Mental Health Software and Devices Market to Witness a Revenue of USD 13367.12 Million by 2030 by Growing with a CAGR of 13.28% During 2021-2030; Increasing Concern for Mental Health Disorders to Drive Market Growth
- Digi Communications NV announces the release of the 2021 Preliminary Financial Results
- Digi Communications NV announces Investors Call for the 2021 Preliminary Financial Results presentation
- At MWC in Barcelona, Amphenol will be exhibiting its wide offering for wireless service providers – including Open RAN compatible active 5G antennas
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- Tableau comparatif des pays : les caractéristiques à connaître avant de se développer à l’international
- Smart exosomes from an Australian technology leader
- Bucharest Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
- Transmetrics AI is Applied by DB Schenker to Improve Land Transport Network in Bulgaria
- Digi Communications N.V.: Announces repayment of an aggregate amount of approx. EUR 272 million of the Group’s financial debt
- El Liceo Europeo vence el Premio Zayed a la Sustentabilidad 2022 en Europa y Asia Central
- Framework rebrands to daappa, heralding a new phase in fintech solutions designed for private markets
- Digi Communications N.V. Announces the publishing of the Financial Calendar for 2022
- Manufacturing giant Haizol expands their offices in China
- Patients and R&D Leaders Jointly Present at EU Conference on Progress with Patient-Input to Transform Medicine Development
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- Maya Miranda Ambarsari launches InterconnectDATA information platform for authentic data
- Digi Communications N.V. Announces that the offer of the Company’s Romanian subsidiary was designated winner of the auction organised for the allocation of certain radio frecquency entitlements
- New dating site aimed at people with mental health problems launches in Switzerland
- BITSCore Tests Satellite Cyber-Security and Ride-Share Algorithms on Australian Rocket
- StatusMatch.com ed Emirates collaborano per aiutare i frequenti viaggiatori italiani a tornare in volo
- StatusMatch.com and Emirates partner up to help Italian frequent flyers get back in the air
- MinDCet drivers and FTEX powertrain solutions enable EV GaN applications
- Digi Communications NV announces the release of the Q3 2021 Financial Results
- Origami and citoQualis Team up for Startups
- Digi Communications NV announces Investors Call for the Q3 Financial Results presentation
- Digi Communications N.V. announces the extraordinary general meeting’s resolution from 4 November 2021, approving the appointment of KPMG N.V. as the Company’s statutory auditor for the 2021 financial year
- Digi Communications N.V. announces The solution reached by the Bucharest Court of Appeal regarding the investigation conducted by the Romanian National Anticorruption Directorate with respect to RCS & RDS S.A., Integrasoft S.R.L. and certain of their directors
- Digi Communications N.V. Announces the results of the auction organised by the Portuguese Authority for Telecommunications
- Haizol expands its capabilities to include component assembly and product development
- EIC, the World’s Largest Multinational Innovation Program, to Invest €13.4M in Wi-Charge, a Game Changing Wireless Power Company
- European Weightlifting Federation on its way for Electoral Congress
- “Without women, We are unable to solve the world’s greatest challenges” — She Loves Tech 12 Hot Finalists ready to get their chance at the Local Pitch in South Europe!
- Significant improvement in increasing Time In Range and reducing hypoglycemia among people equipped with Diabeloop DBLG1
- Digi Communications N.V. Announces the Convocation of the Company’s Extraordinary General Meeting of Shareholders on 4 November 2021 in order to appoint KPMG N.V. as the Company’s new statutory auditor for the financial year 2021
- Unit of Measure enters partnership with Stibo Systems
- Haizol, metal manufacturing giant, launch a brand new website which is both user friendly and interactive
- Groundbreaking Immersive Experience from Samsung and Artist Michael Murphy Reveals a New Perspective for Visual Entertainment Through the Stunningly Slim Neo QLED TV
- Collaboration between Airbus and Neural Concept
- Archpriest Nikolay Balashov on Patriarch Bartholomew’s speeches in Kiev
- ABB's Peter Voser joins Xynteo's Europe Delivers partnership as it new Chairman
- Digi Communications NV announces that a new stock option programme was approved
- Leverage the benefits of digital manufacturing with Haizol
- Digi Communications NV announces the release of the H1 2021 Financial Results
- Digi Communications NV announces Investors Call on the Financial Results for H1 2021
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- Customer Data Platform Industry Accelerated During Pandemic: CDP Institute Report
- Digi Communications N.V. announces that two of its subsidiaries entered into two facility agreements
- Introducing Cap Expand Partners, Helping Business Leaders Break International Barriers
- Hong Kong’s Innovation and Technology Venture Fund Becomes Strategic Financial Investor of Ignatica
- Cure for prostate cancer on the horizon
- Fanpictor signs multi-year partnership with Royal Belgian Football Association
- Fanpictor unterzeichnet mehrjährige Partnerschaft mit dem Königlich Belgischen Fussballverband
- Fanpictor signe un partenariat pluriannuel avec la Royal Belgian Football Association
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- Fanpictor firma una partnership pluriennale con la Royal Belgian Football Association
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- Launch of the New Akenza Platform
- De zelflerende algoritme DBLG1®: eenvoudig te gebruiken voor een optimale en gepersonaliseerde behandeling van diabetes type 1
- Launch of the Anna Lindh Foundation Virtual Marathon for Dialogue!
- Digi Communications N.V. announces the exercise of stock options by the Executive Director of the Company pursuant to the decision of the Company’s general meeting of shareholders dated 30 April 2020 and in accordance with the stock option plan approved at the level of the Company in 2017
- New research unlocks long tail growth opportunity for the tech industry
- Digi Communications NV announces the availability of the instructions on the 2020 share dividend payment
- Digi Communications NV announces that conditional stock options were granted to several Directors of the Company based on the approval of the general meeting of shareholders from 18 May 2021
- Digi Communications N.V. Announces the Company’s General Shareholders Meeting resolutions adopted on 18 May 2021 approving, amongst others, the 2020 Annual Accounts
- Digi Communications N.V. (“Digi”) announces the Q1 2021 Financial results
- Digi Communications NV announces Investors Call for the Q1 2021 Financial Results
- Digi Communications N.V. announces an Amendment to the 2021 Financial Calendar
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- Mono Solutions recognizes Norwegian small business agency with best website 2021 award
- Mono Solutions and Xrysos Odigos unlock new opportunities for small businesses
- Behind the scenes of a 10,000-people online conference: creating a live-event atmosphere and leveraging cybersecurity software
- Largest Supply Chain for Face masks, FFP2, FFP3 and cloth masks
- TRANSMAR AND TRANSMETRICS SIGN DEAL FOR STATE-OF-THE-ART LOGISTICS COLLABORATION
- Amendment of Digi Communications N.V. Financial Calendar for 2021
- 4iG and Digi Communications NV’s Romanian subsidiary have entered into a term sheet with regards to a potential acquisition by 4iG of DIGI Group’s Hungarian operations
- “Building Healthy Relationships and Enhancing Gender Equality”: Young women from Cyprus, Egypt, Lebanon and Jordan come together
- Bring Ventures investit dans Crossborderit (CBIT), DDP et une solution de commerce électronique
- Bring Ventures investiert in Crossborderit (CBIT), eine DDP (geliefert verzollt) und E-Commerce Lösung
- Bring Ventures invests in Crossborderit (CBIT), DDP and ecommerce solution
- Lionspeed GP with Patrick Kolb and Lorenzo Rocco joins forces with CarCollection Motorsport in 2021
- Eurekos, ein klassenbester LMS-Anbieter, hat seine Position im renommierten Fosway 9-Grid™ für Lernsysteme verbessert
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- Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
- Digi Communications N.V.: Announces an Amendment to the Financial Calendar for 2021
- Ideanomics Invests $13M in Italian EV Motorcycle Company, Energica
- DigiSky and Asman Technology Announce Global Reseller Agreement
- Neowintech - O Marketplace Da Sua Próxima Solução Financeira
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- Digi Communications NV announces the release of the 2020 Preliminary Financial Results
- Fraunhofer IGD develops automated robotic arm to scan cultural objects in 3D, now cooperating with Phase One
- Adapt Fast or Disappear – Choosing the Right Supplier
- Digi Communications NV announces Investors Call for the 2020 Preliminary Financial Results
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- Henrik Stampe Appointed CEO for Mono Solutions
- Anna Mossberg leder Nordens största privata AI-lab i Sverige: "Utan AI riskerar svenska företag att förlora sin konkurrensfördel."
- What COVID-19 has taught us about manufacturing & the importance of a digital online marketplace
- Digi Communications N.V. announces: the Supreme Court of Hungary dismissed the Company’s appeal related to the 5G Tender procedure
- Customer Data Platform Industry to Reach $1.5 Billion in 2021: CDP Institute Report
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