- The EC approval is based on the first global CAR-T registration trials, which included patients from eight European countries and demonstrated durable responses and a consistent safety profile in r/r pediatric B-cell ALL and r/rDLBCL
- Novartis is the only company with an approved CAR-T cell therapy for pediatric r/r B-cell ALL and the first to receive approval in two distinct indications, both in the EU and the US
- Novartis continues its strategy to expand manufacturing facilities with agreements with external collaborators, such as CELLforCURE in France
BASEL, 30-Aug-2018 — /EuropaWire/ — Novartis today (Aug 27, 2018) announced that the European Commission (EC) has approved Kymriah® (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Kymriah developed in collaboration with the University of Pennsylvania (Penn) is a ground-breaking one-time treatment that uses a patient’s own T cells to fight cancer, and the only chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in the EU for these two distinct B-cell malignancies. Kymriah was also the first CAR-T cell therapy ever approved by the US Food and Drug Administration (FDA).
“The Kymriah approval is a transformational milestone for patients in Europe in need of new treatment options,” said Liz Barrett, CEO, Novartis Oncology. “Novartis will continue to build a global infrastructure for delivering CAR-T cell therapies where none existed before remaining steadfast in our goal of reimagining cancer.”
Kymriah, a cell dispersion for infusion with doses varying between 1.2 x 106 6 x 108CAR- positive viable T cells, is a living medicinal product, manufactured individually for each patient by reprogramming the patient’s own immune system cells. Kymriah is the only approved CAR-T cell therapy built using the 4-1BB costimulatory domain, which is critical for full activation of the therapy, enhancement of cellular expansion and durable persistence of the cancer-fighting cells.
This approval was based on the review of the only two global registration CAR-T clinical trials, JULIET and ELIANA, which included patients from eight European countries. In these trials, Kymriah demonstrated strong and durable response rates and a consistent safety profile in two difficult-to-treat patient populations. In 2012, Novartis and Penn entered into a global collaboration to further research, develop and commercialize CAR-T cell therapies, including Kymriah, for the investigational treatment of cancers. This collaboration between industry and academia was the first-of-its-kind in CAR-T research and development.
“When the University of Pennsylvania and Novartis agreed to work together to develop CAR-T therapy, our main goal was clear and ambitious to address unmet needs for patients and to extend, improve and save lives,” said Carl June, MD, the Richard W. Vague Professor in Immunotherapy in the Department of Pathology and Laboratory Medicine at Penn and Director of the Center for Cellular Immunotherapies in the Abramson Cancer Center. “We are proud that our efforts in CAR-T now offer the European blood cancer community a breakthrough that brings new hope.”
Kymriah was designated as an orphan medicinal product and is one of the first PRIME-designated therapies to receive EU approval; PRIME (PRIority MEdicines) is a program launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need and help patients benefit as early as possible from therapies that may significantly improve their quality of life.
“Bringing Kymriah to patients in the EU advances the treatment paradigm in an unprecedented way and delivers a lifesaving therapy to young patients with ALL who have not been successfully treated with existing therapies, and who have limited options left,” said Prof. Peter Bader, Head of the Division for Stem Cell Transplantation and Immunology and Principal Investigator of the ELIANA study at the University Hospital for Children and Adolescents in Frankfurt/Main.
Both B-cell ALL and DLBCL are aggressive malignancies with significant treatment gaps for patients. In Europe, ALL accounts for approximately 80% of leukemia cases among children, and for patients who relapse from standard of care therapies, the outlook is poor. This low survival rate is in spite of patients having to undergo multiple treatments, including chemotherapy, radiation, targeted therapy or stem cell transplant, and further highlights the need for new treatment options. DLBCL is the most common form of non-Hodgkin lymphoma, accounting for up to 40% of all cases globally. For patients who relapse or don’t respond to initial therapy, there are limited treatment options that provide durable responses, and survival rates are low for the majority of patients due to ineligibility for autologous stem cell transplant (ASCT) or because salvage chemotherapy or ASCT have failed.
Novartis expects to launch initially in the pediatric ALL indication, as we continue to ramp up capacity. Moreover, timing for Kymriah availability in each country will depend on multiple factors, including the onboarding of qualified treatment centers for the appropriate indications, as well as the completion of national reimbursement procedures. Training is already underway at key qualified treatment centers to facilitate safe and seamless delivery to patients; and Novartis continues to collaborate with national health and reimbursement authorities across Europe on a fair, value-based pricing approach that is sustainable for national healthcare systems.
As this innovative treatment is made available to more patients globally, Novartis has been actively pursuing options to expand manufacturing capabilities beyond our facility in Morris Plains, New Jersey. This includes our agreement with CELLforCURE, based in France and one of the first and largest contract development and manufacturing organizations (CDMOs) producing cell and gene therapies in Europe, the expanded alliance with Fraunhofer Institute which currently supports the manufacturing of Kymriah for global clinical trials and for post approval manufacturing , as well as technology transfer efforts to a CDMO in Japan.
About Kymriah ELIANA Pivotal Study
The EC approval of Kymriah in pediatric and young adult patients with r/r B-cell ALL is based on the pivotal Phase II ELIANA clinical trial, the first pediatric global CAR-T cell therapy registration study for Kymriah in children and young adults with r/r B-cell ALL. ELIANA was conducted in collaboration with the University of Pennsylvania and Children’s Hospital of Philadelphia, evaluating Kymriah in patients in 25 centers in the US, Canada, Australia, Japan, and in Europe, in Austria, Belgium, France, Germany, Italy, Norway and Spain.
In this Novartis-sponsored, global, multi-center study evaluating 75 patients infused with Kymriah with three or more months of follow-up, 81% of patients achieved overall remission (95% CI: 71% – 89%) with 80% of responders still in remission at 6 months. Sixty percent of patients achieved complete response (CR) and 21% of patients achieved CR with incomplete blood count recovery (CRi). Of those patients in remission, 100% had no minimal residual disease (MRD) detected in the bone marrow. Overall survival (OS) was 90% at six months, and 76% at 12 months. Median OS was 19.1 months (95% CI: 15.2 – NE) in this difficult-to-treat patient population.
In ELIANA, 47% percent of patients experienced Grade 3 or 4 CRS. CRS was managed according to the global CRS management protocol at clinical sites adequately trained for the safe administration and management of Kymriah. There were two deaths within 30 days of Kymriah infusion: one due to progressive disease with CRS and one death with resolving CRS from intracranial hemorrhage. Within eight weeks of treatment, 13% of patients experienced Grade 3 or 4 neurological events. The most common severe (Grade 3 or 4) neurological events were encephalopathy and/or delirium. Severe (Grade 3 or 4) febrile neutropenia and infection occurred in 36% and 44% of patients, respectively.
About Kymriah JULIET Pivotal Study
The EC approval of Kymriah in adult patients with r/r DLBCL is based on the pivotal Phase II JULIET clinical trial, the first multi-center global registration study for Kymriah in adult patients with r/r DLBCL. JULIET was conducted in collaboration with the University of Pennsylvania, and is the largest study examining a CAR-T therapy in DLBCL, enrolling patients from 27 sites in 10 countries across the US, Canada, Australia, Japan, and Europe in Austria, France, Germany, Italy, Norway and the Netherlands. In the JULIET trial, patients were infused in the inpatient and outpatient setting.
In this Novartis-sponsored, global, multi-center study, among 93 evaluable patients who were followed for at least three months or discontinued earlier, Kymriah demonstrated an overall response rate (ORR) of 52% (95% confidence interval [CI], 41% – 62%), with 40% achieving a complete response (CR) and 12% achieving a partial response (PR). The relapse-free probability at 6 and 12 months was 68% and 65%, respectively; and the median duration of response was not reached at the time of data cut-off, indicating sustainability of response. The OS rate at 12 months was 49% and median OS was 11.7 months among all infused patients (n=111) (95% CI, 6.6-NE).
In JULIET, 22% of all treated patients experienced Grade 3 or 4 CRS within eight weeks of infusion with Kymriah, as defined by the Penn Grading Scale, a rigorous scale for grading CRS. CRS was successfully managed globally using site education on implementation of the CRS treatment protocol. Twelve percent of patients had Grade 3 or 4 neurologic adverse events, which were managed with supportive care. Grade 3 or 4 cytopenias lasting more than 28 days were reported based on laboratory findings and included thrombocytopenia (41%), lymphopenia (28%), neutropenia (24%), leukopenia (21%) and anemia (14%), Grade 3 or 4 infections and Grade 3 or 4 febrile neutropenia occurred in 32% and 15% of patients, respectively.
Important Safety information from the Kymriah SmPC
Kymriah (tisagenlecleucel) is an autologous, immunocellular cancer therapy which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing cells. It is administered as intravenous infusion.
Kymriah is indicated for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse as well as for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Kymriah must not be administered in case of hypersensitivity to the active substance or to any of the excipients of the product. In addition, contraindications of the lymphodepleting chemotherapy that is usually preceding the Kymriah infusion to prepare the patient’s body, must be considered.
For details please see the Summary of Product Characteristics (SmPC).
Reasons to delay Kymriah treatment
Kymriah treatment should be delayed, if a patient has any of the following conditions:
- Unresolved serious adverse reactions (especially pulmonary reactions, cardiac reactions or hypotension) from preceding chemotherapies.
- Active uncontrolled infection.
- Active graft-versus-host disease (GVHD).
- Significant clinical worsening of leukemia burden or lymphoma following lymphodepleting chemotherapy.
Monitoring after Kymriah infusion
Kymriah may cause side effects that could be severe, life-threatening or fatal. Therefore, patients should be monitored daily for the first 10 days following infusion for signs and symptoms of potential cytokine release syndrome, neurological events and other toxicities. Physicians should consider hospitalization for the first 10 days post infusion or at the first signs/symptoms of cytokine release syndrome and/or neurological events. After the first 10 days following the infusion, the patient should be monitored at the physician’s discretion.
Patients should be instructed to remain within proximity (i.e., 2 hours of travel) of a qualified clinical facility for at least 4 weeks following infusion. They should be advised to contact their healthcare provider right away, if they experience any of signs and symptoms of cytokine release syndrome, neurological events, infections and tumor lysis syndrome or if other severe or serious side effects occur.
Patients are advised to take their body temperature twice a day for 3-4 weeks after treatment with Kymriah, and if the temperature is high to contact their doctor immediately.
Important side effects
Kymriah may cause side effects that could be severe, life-threatening or fatal. They usually happen in the first eight weeks after the infusion, but can also develop later. The following main side effects can occur after Kymriah infusion:
Cytokine release syndrome has been frequently observed and almost always occurred within the first 10 days after Kymriah infusion. Patients may experience high fever, chills, difficulty breathing, nausea, vomiting, diarrhea, muscle pain, joint pain, low blood pressure, dizziness/light headedness, and issues with blood coagulation. Adverse reactions of multiple body organs, such as the heart, the liver or kidney, may occur.
Neurological events, in particular encephalopathy, confusional state or delirium, can occur frequently with Kymriah. Other manifestations can also include altered or decreased consciousness, agitation, seizures, difficulty speaking, understanding speech, or loss of balance. The majority of neurological events occurred within eight weeks following Kymriah infusion and were transient. Because of the risk of neurological side effects, patients should not drive, operate heavy machinery, or do other activities that require alertness for eight weeks after receiving Kymriah.
Infections can occur frequently after Kymriah infusion. As appropriate, prophylactic antibiotics should be administered and surveillance testing should be employed prior to and during treatment with Kymriah. Infections are known to complicate the course and management of concurrent cytokine release syndrome. Vaccination with live virus vaccines is not recommended at least six weeks prior to the start of lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery following treatment with Kymriah.
Febrile neutropenia was frequently observed in patients after Kymriah infusion. In the event of febrile neutropenia, infection should be evaluated and managed appropriately with broad-spectrum antibiotics, fluids and other supportive care, as medically indicated.
Tumor lysis syndrome is a rapid breakdown of tumor cells and release of their contents into the bloodstream. This can interfere with the workings of various body organs, especially the kidneys, heart and nervous system. To minimize risk of tumor lysis syndrome, patients with elevated uric acid or high tumor burden should receive allopurinol, or an alternative prophylaxis, prior to Kymriah infusion.
Prolonged cytopenias, which is a low count of one or more types of blood cells such as red blood cells, white blood cells, or platelets, can persist for several weeks following Kymriah. The majority of patients who had cytopenias at day 28 following Kymriah treatment improved or resolved within three months after treatment. Prolonged neutropenia has been associated with increased risk of infection.
Hypogammaglobulinemia or Agammaglobulinemia, a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infections is increased, can occur in patients treated with Kymriah. Infection precautions, antibiotic prophylaxis and immunoglobulin replacement should be managed per age and standard guidelines.
Secondary malignancies: After treatment with Kymriah, patients will be monitored life-long by their healthcare provider, as they may develop secondary cancers.
Pregnancy and breast-feeding: It is not known, whether Kymriah has the potential to be transferred to the fetus via the placenta and could cause fetal toxicity, including B-cell lymphocytopenia. Kymriah is not recommended during pregnancy and in women of childbearing potential not using contraception. It is unknown, whether Kymriah is excreted in human milk. A risk to the breast-fed infant cannot be excluded. Women, who are breast-feeding, should be advised of the potential risk to the breast-fed infant.
Blood, organ, tissue and cell donation: Patients treated with Kymriah should not donate blood, organs, tissues and cells for transplantation.
Please see the full Summary of Product Characteristics (SmPC) for KYMRIAH, www.KYMRIAH.com
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “launches,” “launching,” “strategy,” “potential,” “can,” “will,” “plan,” “expect,” “investigational,” “launched,” “transformational milestone,” “goal,” “breakthrough,” “hope,” “may,” “underway,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Kymriah, regarding our ability to scale and sustain commercial manufacturing for Kymriah, regarding our ability to onboard and sustain a network of qualified treatment centers, regarding our ability to obtain reimbursement approval from national health and reimbursement authorities, or regarding potential future revenues from Kymriah. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Kymriah will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that we will successfully scale and sustain commercial manufacturing for Kymriah, or successfully onboard and sustain a network of qualified treatment centers to offer Kymriah. Nor can there be any guarantee that we will successfully obtain reimbursement approval for Kymriah from relevant national health and reimbursement authorities, or at any particular time. Neither can there be any guarantee that Kymriah will be commercially successful in the future. In particular, our expectations regarding Kymriah could be affected by, among other things, our ability to successfully scale and sustain commercial manufacturing; our ability to onboard and sustain a network of treatment centers; our ability to obtain reimbursement approval from national health and reimbursement authorities; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 125,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis
For Novartis multimedia content, please visit www.novartis.com/news/media-library
For questions about the site or required registration, please contact firstname.lastname@example.org
 Kymriah (tisagenlecleucel) Summary of Product Characteristics (SmPC), 2018.
 Ronson, A., Tvito, A., Rowe, JM., “Treatment of Relapsed/Refractory Acute Lymphoblastic Leukemia in Adults.” Current Oncology Reports, 2016 Jun;18(6):39. https://www.ncbi.nlm.nih.gov/pubmed/27207612. Accessed August 2018.
 World Health Organization and European Environment and Health Information System, “Incidence of Childhood Leukaemia.” December 2009. Available at: http://www.euro.who.int/__data/assets/pdf_file/0005/97016/4.1.-Incidence-of-childhood-leukaemia-EDITED_layouted.pdf. Accessed August 2018.
 World Health Organization. Diffuse large B-cell lymphoma. Review of cancer medicines on the WHO list of essential medicines. Available at: http://www.who.int/selection_medicines/committees/expert/20/applications/DiffuseLargeBCellLymphoma.pdf. Accessed August 2018.
 Crump M, Neelapu S, Farooq U, Van Den Neste E, Kuruvilla J et al. (2017) Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. E-pub ahead of print August 03. doi: https://doi.org/10.1182/blood-2017-03-769620. Accessed August 2018.
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
||+41 61 324 7944
||+1 212 830 2448
||+41 61 324 1065
||+1 212 830 2417
||+41 61 324 8425
||+41 61 324 7188
SOURCE: Novartis AG
- 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
- 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
- Vil du være med å utvikle fremtidens bærekraftige reiseliv?
- Mettiti alla prova con la terza edizione del CASSINI Hackathon per rivitalizzare il settore turistico
- 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!
- 3. CASSINI Hackathon zur Neubelebung des Tourismus: Stellen Sie sich der Herausforderung!
- Írd újra Európa turizmusát a 3. CASSINI Hackathonon!
- Aceita o desafio do 3º CASSINI Hackathon para revitalizar o turismo!
- Podejmij wyzwanie! Weź udział w 3. Hackathonie CASSINI i pomóż ponownie ożywić turystykę!
- Daag jezelf uit op de 3e CASSINI Hackathon en blaas toerisme nieuw leven in
- 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
- On World Bipolar Day ALCEDIAG announces EIT Health supported EDIT-B Consortium validating innovative blood diagnostic test for bipolar disorder
- 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
- ELIOS combined with cataract surgery delivers significant IOP reduction out to 8 years
- 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
- Seminário Bíblico sobre “O Cumprimento da Palavra de Jesus no Mundo de Hoje”
- 'I Love fruit & veg from Europe': Weihnachten in der Schweiz ist gesund und voller Aromen
- Fidupar Now Live on Framework’s Core Solution
- 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
- Rockegitarist-Sensasjon Rocky Kramer Har Fått Hovedrollen I Mutt Productions Filmen Rockin’ In Time
- Dispatch.d Offers Unique US Market Entry Services for European Impact Brands
- CSA Research’s New Localization Intelligence Analyzer, powered by LocHub, Helps Organizations Improve their Website’s Effectiveness for Global Customers
- 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
- Fanpictor firma una colaboración de varios años con la Real Federación Belga de Fútbol
- Fanpictor firma una partnership pluriennale con la Royal Belgian Football Association
- Fanpictor tekent meerjarige partnership met Koninklijke Belgische Voetbalbond
- 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
- Fastpayhotels Hits an Industry Milestone by Connecting 500 Hotels Per Day Through DerbySoft Technology
- 4 ways to build a more flexible supply chain
- Join the world's leading virtual CBD event for FREE
- DEEPENING STRATEGIC RELATIONSHIP BETWEEN UBC AND PIONEERING DECENTRALISED PLATFORM, MANYONE
- 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
- Eurekos, en førsteklasses LMS-udbyder, har forstærket sin position på den prestigefyldte Fosway 9-Grid™ for læringssystemer
- Eurekos, ein erstklassiger LMS-Anbieter, hat seine Position auf dem renommierten Fosway 9-Grid™ für Lernsysteme weiter ausgebaut
- Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
GreenMantra Technologies Announces Exclusive Distribution Relationship with HARKE GROUP
- 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
- Neowintech - Il Marketplace per la tua prossima soluzione finanziaria
- PIONEERING DECENTRALISED SECURE MESSAGING PLATFORM MANYONE ANNOUNCES STRATEGIC RELATIONSHIP WITH UNIVERSITY COLLEGE LONDON CENTRE BLOCKCHAIN TECHNOLOGY
- 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
- A URSAPHARM Arzneimittel e a CEBINA anunciam uma parceria com vista a reaproveitar o anti-histamínico azelastina para combater a COVID-19
- URSAPHARM Arzneimittel et CEBINA annoncent un partenariat pour reconvertir l'antihistaminique azélastine afin de lutter contre la COVID-19
- URSAPHARM Arzneimittel y CEBINA anuncian una colaboración para readaptar el antihistamínico azelastine para combatir la COVID-19
- URSAPHARM Arzneimittel and CEBINA announce partnership to repurpose the antihistamine azelastine to combat COVID-19
- ANIL UZUN Will Launch Bass Guitar Lessons Series on Youtube
- 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
- Donna Thomas Joins Visual Data Media Services as Senior Vice President of Sales, Americas
- Discover how business proposals almost write themselves with the use of Artificial Intelligence in a new update from Offorte.com
- Haizol, Where Buyers Meet Suppliers
- Digi Communications N.V. announces the publishing of the Financial Calendar for 2021
- Digi Communications NV announces: Final dismissal by the US Court of the claim brought by certain US citizens against all the initial defendants, including i-TV Digitális Távközlési Zrt
- Firebolt Group Joins Top 1% of Companies Recognized for Sustainability Efforts
- Electriq Global and GVG Oil Trade B.V. to partner in fuelling Passenger Canal Boats with Electriq Fuel
- Haizol Deliver Fast Lead Times & Quality Parts at speed in the lead up to Chinese New Year
- Digi Communications N.V. announces the conclusion a MVNO agreement between the Company’s Italian subsidiary (Digi Italy) and Vodafone regarding the access to Vodafone’s radio spectrum and mobile communication network and infrastructure
- Experts demand for more transparency for medical treatment of politicians
- Electriq Global will launch its Zero Emissions, Hydrogen-Rich Fuel in the Netherlands by powering passenger canal boats with an Electriq PowerPack in compliance with the Amsterdam municipality requirement that all passenger vessels will be emission-free from 2025
- Spanish team wins the Farming by Satellite Prize 2020
- Digi Communications N.V. announces the senior facility agreement concluded between Digi Group and a syndicate of banks
- Corma.de launches Social Links OSINT Academy
- Can Chinese save the world economy?
- Pleme social network has been building throughout the Pandemic
- Visual Data Media Services to Partner with Endeavour Capital for Next Phase of Growth
- Digi Communications NV announces the release of the Q3 2020 Financial Results
- Haizol Expand its Capabilities into Motorcycle Manufacturing & Custom Made Bike Parts
- Digi Communications NV announces Investors Call on the Financial Results for Q3 2020
- Dutch Police selects bodycams from Zepcam to support police officers on the street
- Palette Life Sciences expands availability of online education and resources for paediatric urologists across Europe
- Sumitomo Corporation Europe Limited and NORCE Norwegian Research Centre AS sign Memorandum of Understanding
- Syniti & SAP Expand Partnership to Increase Client Options for Moving Harmoniously to SAP S/4HANA
- China’s manufacturing industry continues to expand according to the latest Purchasing Managers’ Index figures, with Haizol at the forefront of the growth
- AutoSock sono conformi alla regolamentazione Svizzera riguardante le catene da neve
- Introverts, nerds and geeks make the best salespeople
- Digi Communications NV announces the extension of the agreement entered into between the Company’s subsidiary from Spain (Digi Spain) and Telefonica Moviles España, S.A. regarding the access to TME’s radio spectrum and mobile communication network and infrastructure
- Tiqets’ US Awakens Week Highlights Exclusive New Experiences From Newly Reopened Museums and Attractions
- Haizol Boosts Companies Operational Agility
- Eveliqure announces the initiation of a Phase 1 clinical study of its combined Shigella and ETEC vaccine candidate
- eFax führt das EMEA-Kanalprogramm ein
- eFax lance un programme de distribution dans la région EMEA
- Mono Solutions partners with Lokale Internetwerbung to launch in leadhub platform
- Syniti Launches Podcast Series to Address Growing Focus on Mergers, Acquisitions and Divestitures, featuring Leading CEOs
- Mono Solutions and Ecwid partner for the seamless delivery of websites with e-commerce for small businesses
- Galata Chemicals to produce Tin Stabilizers and Intermediates at Dahej, India
- Sintecs selected as Mentor’s value-added reseller of its HyperLynx® products in Europe focused on serving Altium Designer® users
- INFOCUS CORPORATION AND CELEXON EUROPE SIGN EXCLUSIVE EUROPEAN MASTER DISTRIBUTION AGREEMENT
- L’Awakening Week de Tiqets en France met en avant les nouvelles expériences exclusives de plus de 15 musées et attractions qui ont récemment rouvert
- Tiqets UK Awakens Celebrates Reopened Museums & Attractions and Sponsors Visits for NHS Staff
- Tiqets Awakening Weeks Brings Together 100+ Museums and Attractions to Celebrate Their Reopenings
- A Jewish-Bedouin Partnership is bringing the Negev cuisine to Europe
- Digi Communications NV announces the release of the H1 2020 Financial Results
- New Chief Financial Officers appointed at Mono Solutions & Bauer Media Group SME Services
- Digi Communications NV announces Investors Call on the Financial Results for H1 2020
- Palette Life Sciences AB and Gedeon Richter Plc. Receive National Marketing Authorization in the United Kingdom for Novel Pain Relief Product, LIDBREE™
- Palette Life Sciences launches Deflux.com/UK, an online resource for paediatric urologists, parents and caregivers in the United Kingdom
- Digi Communications N.V. announces the publishing of Independent Limited Assurance Report issued by the external auditor of the Company on 30 July 2020 regarding the information included in the current reports issued by the Company under Law 24/2017 (Article 82) and FSA Regulation no. 5/2018
- The Pavilions Hotels & Resorts Excited To Announce First Luxury Resort Brand In El Nido, Palawan Island Philippines
- New Customer Data Platform Options Emerge During Pandemic Slowdown: CDP Institute Report
- Digi Communications N.V. announces The Competition Council authorized the economic concentration accomplished by the Company’s Romanian subsidiary („RCS&RDS”) by gaining control over some of the assets held by Akta Telecom S.A., Digital Cable Systems S.A. and ATTP Telecommunications S.R.L.
- TABS Score™ Expands its European Footprint; Begins Partnership Discussions Amongst Key Players in EU Venture Ecosystem
- Mono and Brandify partner to bring appointment booking to local businesses
- Digi Communications N.V. announces ANCOM approval for RCS & RDS S.A. to continue to apply a surcharge for certain roaming services provided in the EEA for a renewed maximum period of 12 months
- DerbySoft Expands Metasearch Coverage for Hotels Around the World
- Palette Life Sciences Announces European Distribution Expansion for Deflux® and Solesta® for More Than Twenty Countries Through Five Leading Distributors and Direct Sales Effort
- Pierre Koukjian and Cedric Koukjian, Designer Duo in Collaboration with Bulgari
- Pierre Koukjian et Cédric Koukjian, Duo de designers en collaboration avec Bulgari
- Former Duff & Phelps EMEA Leader Yann Magnan joins 73 Strings as Co-founder and CEO
- Concern for the oceans drives consumers to 'vote with their forks' for sustainable seafood
- Digi Communications N.V.: Exercise of stock option by Marius Catalin Vărzaru, a Non-Executive Director and VP of the Board of Directors of the Company
- SecurLine Certified to Protect Classified Communications
- Digi Communications N.V. announces that a stock option programme was approved for employees and managers of the Romanian Subsidiary of the Company
- Digi Communications NV announces the exercise of stock options by the Executive Directors of the Company
- Matvil Corp. продолжает бороться с противозаконными действиями юридической системы Молдовы
- Digi Communications NV announces the release of the Q1 2020 Financial Results
- Digi Communications NV announces that conditional stock options were granted to several Directors of the Company based on the general shareholders’ meeting approval from 30 April 2020
- MEDIS medical imaging systems acquires Advanced Medical Imaging Development S.r.l. (AMID) and secures further investment from Van Herk Ventures
- Digi Communications NV announces Investors Call on the Financial Results for Q1 2020
- Digi Communications N.V. announces the availability of the instructions on the 2019 share dividend payment
- Mono Solutions hires Chief Product Officer
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 27 – 30 Apr 2020
- Digi Communications N.V.: GSM resolutions from 30 Apr 2020 approving, amongst others, the 2019 Annual Accounts; availability of the adopted Annual Financial Report for the year ended Dec 31, 2019 for the Group
- RCH Embark on Lasting Partnership with Culinary Institute JRE
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 20 – 24 Apr 2020
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 13 – 17 Apr 2020
- COVID-19: Digi Communications N.V. recommendation regarding participation of shareholders to the AGM convened for 30 April 2020
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 6 – 10 Apr 2020
- DIGI COMMUNICATIONS N.V.: Exercise of stock option by a Non-Executive Director of the Company
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 30 Mar – 3 Apr 2020
- Chief Commercial Officer joins Mono Solutions
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 23 – 27 Mar 2020
- Digi Communications N.V. reports the admission to trading on the regulated market operated by the Irish Stock Exchange plc (trading as Euronext Dublin) of the senior secured notes issued by RCS & RDS S.A., its Romanian subsidiary
- Delft University of Technology Purchases its Second WebClip2Go Video Production System
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 16 – 20 Mar 2020
- Integrated Services Monitoring Capability Launched by Bridge Technologies
- Digi Communications N.V. announces Convocation of the Company’s general shareholders meeting for 30 April 2020 for the approval of, among others, the 2019 Annual Report and of the 2019 Financial Statements
- Digi Communications N.V. announces The Hungarian Competition Council’s decision to issue a new decision approving the Invitel transaction
- Digi Communications N.V. announces Business continuity in light of the novel coronavirus (“COVID-19”) outbreak
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 9 – 13 Mar 2020
- Reporting of legal documents concluded by DIGI Communications N.V. in February 2020 or in other period but effective in February 2020, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 2 – 6 Mar 2020
European Customer Data Platform Industry Grows Quickly Despite Limited Funding: CDP Institute
- « La levée du pilon sur la plate-forme » peut faire la différence entre le saint et l’ordinaire
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 24 – 28 Feb 2020
- EH GROUP ENGINEERING awarded EU Horizon 2020
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 17 – 21 Feb 2020
- Digi Communications NV announces the release of the Preliminary Financial Results for year ended 31 December 2019
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 10 – 14 Feb 2020
- Reporting of legal documents concluded by DIGI Communications N.V. in January 2020 or in other period but effective in January 2020, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018
- Digi Communications NV announces Investor Call on the Preliminary Financial Results for the year ended 31 December 2019
- Consolidation Looms for Fast-Growing Customer Data Platform Industry: CDP Institute Report
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 3–7 Feb 2020
- Digi Communications N.V. hereby reports successful closing of the offering of senior secured notes by RCS & RDS S.A., its Romanian subsidiary
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 27 – 31 Jan 2020
- Digi Communications N.V.: Independent Limited Assurance Report issued by the external auditor on 30 Jan 2020 regarding the information included in the current reports under Law 24/2017 (Article 82) and FSA Regulation no. 5/2018
- Digi Communications N.V.: Rectification of the report published on 15 Jan 2020, regarding legal documents concluded by DIGI COMMUNICATIONS N.V. in other periods but effective in Dec 2019, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018
- Digi Communications N.V. reports the upsize and successful pricing of the offering of senior secured notes by RCS & RDS S.A., its Romanian subsidiary
- RCH To Present New Smart ECR, Robust and Vintage POS Systems at EuroShop 2020
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 20 – 24 Jan 2020
- Digi Communications N.V.: (i) launch of an offering by RCS & RDS S.A. of senior secured notes; (ii) issuance of a notice of conditional full redemption of all outstanding €550.0m 5.0% senior secured notes due 2023 issued by the Company and (iii) restatement by the Company of its unaudited interim condensed consolidated financial statements for the 9-month period ended 30 Sep 2019
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 13 – 17 Jan 2020
- Reporting of legal documents concluded by DIGI Communications N.V. in December 2019 or in other period but effective in December 2019, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 6 – 10 Jan 2020
- Berlin-based SuitePad named Best Places to Work in Hotel Tech 2020 category at HotelTechReport.com’s HotelTechAwards
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 30 Dec 2019 – 3 Jan 2020
- Editor's pick archive....