Latest news with #EUHorizonEurope
Fibre2Fashion
5 days ago
- Business
- Fibre2Fashion
Avantium joins EU project to scale up biobased 5-HMF production
Avantium N.V., a leader in renewable and circular polymer materials, has been awarded a €200,000 grant by the EU Horizon Europe program to participate in a consortium for the large-scale production of the biobased chemical 5-Hydroxymethylfurfural (5-HMF). The consortium, consisting of 12 European partners and led by Michelin Engineered Polymers, aims to construct and operate an HMF Flagship Plant to demonstrate the wide range of applications for HMF. The project also plans to assess synergies with Avantium's FDCA Flagship Plant. Avantium has received a €200,000 EU Horizon Europe grant to join CERISEA, a €20M consortium led by Michelin to build an industrial-scale plant for biobased 5-HMF. The project aims to showcase HMF's applications and synergies with Avantium's FDCA technology, supporting a sustainable EU chemical ecosystem with 12 partners from industry and academia. HMF is a biobased chemical derived from sugars, such as fructose. Due to its versatility and ability to replace a broad range of conventionally produced building blocks, HMF serves as a key intermediate between biomass and biochemicals. Despite its significant potential, there are currently no large-scale industrial processes to produce HMF. Michelin Engineered Polymers, specialized in developing advanced polymer materials, plans to engineer and construct an industrial-scale HMF plant under the grant program. The grant consortium will also explore a wide range of bio-based sustainable applications for HMF. HMF can for example be used as an intermediate in the production of FDCA. This creates a direct link between Michelin's planned HMF plant and Avantium's FDCA Technology. The foreseen synergies will help to create an integrated and sustainable European production ecosystem that reduces environmental impact and strengthens the economic resilience of the European chemical industry. The consortium, known under the name CERISEA, has received a €20 million EU Horizon Europe grant in total. Michelin Engineered Polymers will lead the consortium, which includes Avantium and 10 other industry and academic organizations: IFP Energies Nouvelles, ADM Bazancourt SASU, ARKEMA, Kraton Chemical B.V., Université de Technologie de Compiègne (UTC), Centre National de la Recherche Scientifique (CNRS), IFEU - Institut für Energie- und Umweltforschung Heidelberg, Instituto Tecnológico del Embalaje, Transporte y Logística, Energieinstitut an der Johannes Kepler Universität Linz Verein, and Bioeconomy for Change. Note: The headline, insights, and image of this press release may have been refined by the Fibre2Fashion staff; the rest of the content remains unchanged. Fibre2Fashion News Desk (HU)
Irish Independent
08-05-2025
- Business
- Irish Independent
Local medtech company pumps up expansion plans with new name and new jobs
Heart Rhythm Ireland, which will rebrand as Heart Rhythm International (HRI), plans to grow its presence in the UK healthcare market by partnering with more than 30 hospitals and adding approximately 50,000 patients to its network by 2029. The company also has its sights set on expansion in the the US, Australia and New Zealand. The company also plans to grow its team to 30 staff members in the coming years. Founded over 15 years ago, HRI operates a cloud-based cardiac rhythm management platform that supports and provides real-time access to cardiac device data for patients, clinicians, hospitals, and device manufacturers, delivering accurate, accessible and actionable data to patients and their medical teams. This improves patient outcomes by making device data more accessible, enabling timely clinical decisions and more coordinated care. HRI's system also provides patients with secure access to their information anytime and anywhere, making it easier to share critical data with healthcare providers in emergencies. The company is also developing artificial intelligence and predictive analytics features to enable more personalised and earlier interventions in cardiac care. The platform currently supports over 65,000 patients and is deployed in more than 50 cardiac hospitals across Ireland. The company also provides national coverage, working with leading institutions such as the Mater Misericordiae University Hospital, Bon Secours Health System, Beaumont Hospital, Mater Private Network, University Hospital Galway, Blackrock Health, and Cork University Hospital. It already manages Ireland's national electronic health record for cardiac devices, maintaining a registry of over 100,000 implant procedures and nearly one million clinical follow-up records. 'Every 20 seconds someone receives a cardiac implant, but the systems supporting their care haven't kept pace,' said Robert Kelly, CEO of HRI. 'HRI was set up to change that, by operating at the centre of a unique ecosystem, supporting patients, hospitals and clinicians and cardiac device manufacturers. Through our system, patients receive greater peace of mind and better health outcomes, while medical personnel can make better informed and more efficient decisions. Ultimately that improves patient care and helps save lives.' In addition to commercial growth, HRI is actively contributing to international research and innovation projects. These include Project CARAMEL, a €12 million initiative funded under the EU Horizon Europe programme, helping to develop AI-powered predictive models for cardiovascular risk in women aged 40 to 60. The company is also an industry partner in the new Health Frontiers Technology Innovation Centre (HF-TIC), led by Ulster University and supported by €9.1 million in PEACEPLUS funding. Both initiatives reinforce HRI's leadership in AI-driven digital health innovation on an international scale. 'We've already demonstrated how we can enhance cardiac care in Ireland by supporting over 65,000 patients and working with more than 50 hospitals nationwide. Now, we're bringing that capability overseas. A key strength of our system is that it was built on scalable, cloud-based infrastructure in partnership with IBM, allowing it to be rapidly deployed by healthcare providers anywhere in the world,' said Kelly. 'We're managing our expansion step by step, focusing initially on the UK market. However we are already discussing partnerships and opportunities with healthcare providers in the US and Australia/ New Zealand. We believe there is real opportunity for HRI to grow, to support more patients and doctors overseas, while helping advance cardiac care internationally in the years ahead,' Mr. Kelly concluded.
Associated Press
31-03-2025
- Health
- Associated Press
Valneva Submits Adolescent Label Extension Application for its Chikungunya Vaccine, IXCHIQ®, to UK MHRA
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) to potentially expand the use of its chikungunya vaccine, IXCHIQ®, currently approved in adults1, to adolescents aged 12 to 17 years in the UK. This submission follows the recent positive opinion of the European Medicines Agency (EMA) on extension of IXCHIQ® label to adolescents in the European Union (EU)2. IXCHIQ® is the world's first licensed chikungunya vaccine available to address this significant unmet medical need. It is approved in the U.S.3, Europe4, Canada5 and the UK for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. Chikungunya has become an increasingly pressing public health issue, with outbreaks currently ongoing in India, Brazil and the French Island of La Réunion. Valneva announced last week that it has responded to the French government's call for supply of IXCHIQ® in La Réunion and that it will provide 40,000 doses to the Island's wholesalers, with an option to provide more6. Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, 'Given the substantial risk that chikungunya presents to people residing in or traveling to endemic regions, it's imperative to ensure the vaccine is available to all age groups. Broader accessibility would certainly help provide protection and mitigate the burden of this debilitating illness, which is currently spreading in areas that were previously unaffected. The long-term durability of the immune response is also extremely important, especially for endemic countries where access to immunization can be difficult.' Valneva is focused on expanding the vaccine's label and access. Label extension applications to adolescent were submitted in Europe, the United-States, Canada and the UK based on positive six-month adolescent Phase 3 data which showed that a single-dose vaccination with IXCHIQ® induces a high and sustained immune response in 99.1% of adolescents, and that the vaccine was generally well tolerated7. Valneva reported further positive Phase 3 data in adolescents earlier this year, which showed a sustained 98.3% sero-response rate one-year after single vaccination with IXCHIQ®8. The Lancet Infectious Diseases, a world leading infectious diseases journal, also published an article showing that the vaccine was well tolerated in adolescents aged 12 to 17 years 28 days after a single injection, regardless of previous chikungunya virus (CHIKV) infection. Additionally, in the third quarter of 2024, the Company expanded its partnership with the Coalition for Epidemic Preparedness (CEPI)9, with support from the EU Horizon Europe program, through a $41.3 million grant to advance broader access to the vaccine in Low- and Middle-Income Countries (LMICs), post-marketing studies and research to support potential label extensions in children, adolescents and pregnant women. Within the framework of this partnership, Valneva recently announced the signing of an exclusive license agreement with the Serum Institute of India (SII)10, the world's largest manufacturer of vaccines by number of doses, enabling the supply of the vaccine in Asia, with a commitment to priority supply of the chikungunya vaccine at an affordable price to public health markets in LMICs. This new agreement complements the license agreement Valneva signed in 2021 with Instituto Butantan in Brazil for the development, manufacturing and marketing of a local chikungunya vaccine at an affordable price for distribution in Latin American countries and selected LMICs affected by the disease. About Chikungunya Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years11. In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas12. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas13 and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.14 About Valneva SE We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions. We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world's first chikungunya vaccine, as well as certain third-party vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world's most clinically advanced tetravalent Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at About CEPI CEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organizations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI has supported the development of more than 50 vaccine candidates or platform technologies against multiple known high-risk pathogens or a future Disease X. Central to CEPI's pandemic-beating five-year plan for 2022-2026 is the '100 Days Mission' to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days. Learn more at Follow us on X (@CEPIvaccines), LinkedIn and Facebook. About Horizon Europe Horizon Europe — #HorizonEU — is the European Union's flagship Research and Innovation programme, part of the EU-long-term Multiannual Financial Framework (MFF) with a budget of €95.5 billion to spend over a seven-year period (2021-2027). Under Horizon Europe, health research will be supported with the aim to find new ways to keep people healthy, prevent diseases, develop better diagnostics and more effective therapies, use personalised medicine approaches to improve healthcare and wellbeing, and take up innovative health technologies, such as digital ones. CEPI Media Contact +44 7387 055214 Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to possible additional sales in an outbreak context, the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as 'could,' 'should,' 'may,' 'expects,' 'anticipates,' 'believes,' 'intends,' 'estimates,' 'aims,' 'targets,' or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 13 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017).. Last accessed 01 Aug 2023.
Yahoo
24-03-2025
- Health
- Yahoo
Valneva Responds to French Government's Call for Vaccine Supply of IXCHIQ® against Chikungunya Outbreak in La Réunion
Saint Herblain (France), March 24, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it is responding to the chikungunya outbreak that is rapidly intensifying in France's Island of La Réunion with its vaccine IXCHIQ®. In agreement and with support from the local public health agency, the Agence Régionale de Santé La Réunion, Valneva will provide 40,000 doses starting early April, with an option to provide more, through distribution agreements with the Island's wholesalers. This supply of doses, paid for by the French authorities, is in line with the recommendation of France's national public health agency, the Haute Autorité de Santé (HAS), to prioritize for vaccination adults aged 65 and over, with co-morbidities. IXCHIQ® remains available for purchase in France (mainland and overseas). Chikungunya cases have spiked substantially in La Réunion since early 2025, with 8,600 cases recorded and almost 3,000 new cases during the week of March 3 to 9, 20251. Similar to the 2005-2006 chikungunya outbreak, there is a risk of transmission to mainland France and other French overseas territories. Local authorities of La Réunion have published a Level 4 emergency crisis management plan to contain the outbreak, while the Centers for Disease Control and Prevention (CDC) agency of the United States (U.S.) also issued a travel alert as millions of international travelers visit France's southern resorts and La Réunion Island annually. Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, 'Chikungunya outbreaks spread rapidly, so it is crucial to vaccinate as many people as possible to help contain the virus. We have the capacity to supply more doses and will continue working closely with Agence Régionale de Santé La Réunion to manage this outbreak locally and prevent its spread to other regions through international travel." IXCHIQ® is the world's first licensed chikungunya vaccine available to address this significant unmet medical need. It is approved in the United States2, Europe3, Canada4 and the United Kingdom5 for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The European Medicines Agency (EMA) recently adopted a positive opinion recommending authorization of a label extension for IXCHIQ® to individuals 12 years of age and older6. On March 5, 2025, the Haute Autorité de Santé recommended to prioritize for vaccination adults aged 65 and over, especially those with comorbidities, followed by adults aged 18 and over with comorbidities, and vector control workers7. Valneva is focused on expanding the vaccine's label and access. In the third quarter of 2024, the Company expanded its partnership with the Coalition for Epidemic Preparedness (CEPI)8, with support from the EU Horizon Europe program, through a $41.3 million grant to advance broader access to the vaccine in Low- and Middle-Income Countries (LMICs), post-marketing studies and research to support potential label extensions in children, adolescents and pregnant women. Within the framework of this partnership, Valneva recently announced the signing of an exclusive license agreement with the Serum Institute of India (SII)9, the world's largest manufacturer of vaccines by number of doses, enabling the supply of the vaccine in Asia, with a commitment to priority supply of the chikungunya vaccine at an affordable price to public health markets in LMICs. This new agreement complements the license agreement Valneva signed in 2021 with Instituto Butantan in Brazil for the development, manufacturing and marketing of a local chikungunya vaccine at an affordable price for distribution in Latin American countries and selected LMICs affected by the disease. About ChikungunyaChikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years10. In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas11. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas12 and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.13 About Valneva SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world's first and only chikungunya vaccine, as well as certain third-party from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world's most clinically advanced tetravalent Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at Valneva Investor and Media ContactsLaetitia Bachelot-FontaineVP Global Communications & European Investor RelationsM +33 (0)6 4516 Joshua Drumm, Global Investor RelationsM +001 917 815 About CEPICEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organizations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI has supported the development of more than 50 vaccine candidates or platform technologies against multiple known high-risk pathogens or a future Disease X. Central to CEPI's pandemic-beating five-year plan for 2022-2026 is the '100 Days Mission' to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 more at Follow us on X (@CEPIvaccines), LinkedIn and Facebook. About Horizon EuropeHorizon Europe — #HorizonEU — is the European Union's flagship Research and Innovation programme, part of the EU-long-term Multiannual Financial Framework (MFF) with a budget of €95.5 billion to spend over a seven-year period (2021-2027). Under Horizon Europe, health research will be supported with the aim to find new ways to keep people healthy, prevent diseases, develop better diagnostics and more effective therapies, use personalised medicine approaches to improve healthcare and wellbeing, and take up innovative health technologies, such as digital ones. CEPI Media Contactpress@ +44 7387 055214 Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to possible additional sales in an outbreak context, the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as 'could,' 'should,' 'may,' 'expects,' 'anticipates,' 'believes,' 'intends,' 'estimates,' 'aims,' 'targets,' or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 Chikungunya à La Réunion : semaine du 3 au 9 mars 2025 | Agence Régionale de Santé La Réunion2 Valneva Announces U.S. FDA Approval of World's First Chikungunya Vaccine, IXCHIQ®3 Valneva Receives Marketing Authorization in Europe for the World's First Chikungunya Vaccine, IXCHIQ®4 Valneva Announces Health Canada Approval of the World's First Chikungunya Vaccine, IXCHIQ®5 Valneva Receives Marketing Authorization in the UK for the World's First Chikungunya Vaccine, IXCHIQ®6 Valneva Receives EMA's Positive CHMP Opinion for Adolescent Label Extension for Chikungunya Vaccine IXCHIQ® - Valneva7 8 CEPI Expands Partnership with Valneva with a $41.3 Million Grant to Support Broader Access to the World's First Chikungunya Vaccine - Valneva9 Valneva Successfully Expands Access to Asia for its Chikungunya Vaccine with Serum Institute of India - Valneva10 11 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). Last accessed 01 Aug 2023.13 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas ( Attachment 2025_03_24_IXCHIQ_La Reunion_Outbreak_Response_PR_EN_FinalSign in to access your portfolio
