|By PR Newswire||
|March 13, 2014 03:30 AM EDT||
FRIMLEY, England, March 13, 2014 /PRNewswire/ --
- Australian recommendation adds to clinical recommendations in the Czech Republic, Poland and funding decisions in regions of Germany and Italy
- Recommendations highlight support for inclusion of Bexsero on routine childhood immunisation schedules to help protect against this devastating disease
- Bexsero is licensed in the EU, Canada and Australia and has been available privately since 2013, with more than 500,000 doses shipped to date,,,,
Novartis has announced that Australia has joined the growing number of countries where following licensure, Bexsero®▼ (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) has received a clinical recommendation for the vaccine's routine use to help protect against meningitis B. These recommendations follow recent access milestones for Bexsero in multiple regions across Europe, including some regions of Italy and Germany. Bexsero is the only broad coverage vaccine to help protect against meningitis B, a potentially deadly disease that disproportionately affects infants and adolescents,.
Australia's advisory body on immunisation matters, the Australian Technical Advisory Group on Immunisation (ATAGI), has recommended Bexsero for all young Australians, with an emphasis on infants and children under 2 years of age and adolescents 15-19 years of age. Inclusion in the National Immunisation Program is under consideration.
In Europe, Bexsero continues to gain endorsements from health authorities and experts:
- In Italy, the Basilicata region recommends Bexsero for the routine vaccination of infants and will have an active call to parents that includes providing the vaccine free of charge. The Board of Calendario per la Vita, comprised of the country's foremost scientific societies, has recommended Bexsero for all infants with three doses in the first year of life and one dose at 13 months of age.
- In Germany, more than 35 statutory sickness funds (semi-public health insurance providers) have chosen to voluntarily reimburse Bexsero for all children (ages 2 months to 18 years). Bexsero is also recommended by the German Academy of Child and Adolescent Medicine (DAKJ), a leading paediatric association,.
- Poland has a clinical recommendation for routine vaccination with Bexsero for infants, children and adolescents (starting at 2 months of age).
- In addition, the Czech Vaccinology Society has recommended vaccination with Bexsero for infants, toddlers and children (aged 2 months to 10 years), adolescents (ages 13-15 years) and other high-risk individuals.
"For a vaccine-preventable disease, every child lost or disabled is one too many," said Andrin Oswald, Division Head, Novartis Vaccines. "These regional milestones are a testament to the public health benefits of Bexsero and we are hopeful that governments around the world will continue to act with a sense of urgency to help protect those most vulnerable from the devastation of meningitis B."
Meningitis B is a rare but aggressive and often deadly disease; it is the leading cause of meningococcal disease and septicaemia in the developed world,. Meningitis B can kill or cause serious life-long disabilities within 24 hours of onset, leaving little time for intervention. Vaccination is therefore the best defence against this aggressive disease.
Bexsero is the only licensed broad coverage vaccine approved in the European Union, Canada and Australia to help protect against meningitis B,,,, and has been available privately since 2013 in an ever-increasing number of countries with more than 500,000 doses shipped to date. Bexsero was also recently provided to students at Princeton University and the University of California Santa Barbara (UCSB) in the United States (US) under an Investigational New Drug (IND) designation from the US Food and Drug Administration (FDA) which was issued in response to meningitis B outbreaks on these campuses,. To date, over 30,000 doses of Bexsero have been distributed in the US.
The foregoing release contains forward-looking statements that can be identified by words such as "recommendation," "recommendations," "potentially," "recommended," "under consideration," "continues," "recommends," "will," "call," "hopeful," "continue," "can," or similar terms, or by express or implied discussions regarding potential additional marketing approvals for Bexsero, or regarding potential future revenues from Bexsero. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialise, 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 Bexsero will be submitted or approved for sale in any additional markets, or at any particular time. Nor can there be any guarantee that Bexsero will be commercially successful in the future. In particular, management's expectations regarding Bexsero could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; global trends toward health care cost containment, including ongoing pricing pressures; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; unexpected manufacturing issues, 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, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortisation charges). Novartis Group companies employ approximately 136,000 full-time-equivalent associates and operate in more than 140 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.
- EMA. Authorization Details for Bexsero. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002333/human_med_001614.jsp& mid=WC0b01ac058001d124. Accessed March 2014.
- EMA. EU Member States. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_000219.jsp&mid=WC0b01ac058003174e. Accessed March 2014.
- Health Canada. Bexsero. Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_bexsero_147275-eng.php. Accessed March 2014.
- Australian Government: Department of Health: Therapeutic Goods Administration. Available at: http://www.tga.gov.au/pdf/auspar/auspar-meningococcal-131031.pdf. Accessed March 2014.
- Novartis Data on File.
- World Health Organization. Meningococcal Meningitis. Fact sheet 141. November 2012. Available at: http://www.who.int/mediacentre/factsheets/fs141/en/index.html. Accessed March 2014.
- Cohn, A. et al. Changes in Neisseria meningitides Disease Epidemiology in the United States, 1998-2007: Implications for Prevention of Meningococcal Disease. Clinical Infectious Diseases 2010:50. Accessed March 2014.
- Australian Technical Advisory Group on Immunisation. Advice for immunisation providers regarding the use of Bexsero. http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/85A6879534C02B4DCA257B640002F38E/$File/ATAGI-advice-bexsero.pdf. Accessed March 2014.
- Proposta del Board del 'Calendario per la Vita' (Sltl, SIP, FIMP e FIMMG) sull'inserimento del vaccine anti-meningococco B nel calendario delle vaccinazioni dell'infanzia. Available at: http://www.panoramasanita.it/docs/documentocongiuntositifimpsipfimmg.pdf. Accessed on March 2014.
- Novartis Data on File.
- Deutsche Akademie fur Kinder - und Jugendmedizin E.V. Impfprophylaxe invasiver Erkrankungen mit Meningokokken der Serogruppe B. Available at: http://dakj.de/media/stellungnahmen/infektionskrankheiten-impffragen/2013-meningokokkenB-impfprophylaxe.pdf. Accessed March 2014.
- Poland Ministry of Health. W sprawie Programu Szczepień Ochronnych na rok 2014. http://www.gis.gov.pl/ckfinder/userfiles/files/EP/informacje%20dla%20podr%C3%B3%C5%BCuj%C4%85cych/PSO%202014.pdf. Accessed March 2014.
- Novartis Data on File.
- World Health Organization. Bacterial Meningitis. Available at: http://apps.who.int/nuvi/meningitis/en/. Accessed March 2014.
- Centers for Disease Control and Prevention. Princeton University Meningococcal Disease Outbreak. December 2013. Available at: http://www.cdc.gov/meningococcal/outbreaks/princeton.html. Accessed March 2014.
- Centers for Disease Control and Prevention. University of California, Santa Barbara Meningococcal Disease Outbreak. January 2014. Available at: http://www.cdc.gov/meningococcal/outbreaks/ucsb.html. Accessed March 2014.
- Novartis Data on File.
Date of preparation: March 2014
Whether you like it or not, DevOps is on track for a remarkable alliance with security. The SEC didn’t approve the merger. And your boss hasn’t heard anything about it. Yet, this unruly triumvirate will soon dominate and deliver DevSecOps faster, cheaper, better, and on an unprecedented scale. In his session at DevOps Summit, Frank Bunger, VP of Customer Success at ScriptRock, discussed how this cathartic moment will propel the DevOps movement from such stuff as dreams are made on to a practic...
Feb. 21, 2017 02:00 AM EST Reads: 4,559
As software becomes more and more complex, we, as software developers, have been splitting up our code into smaller and smaller components. This is also true for the environment in which we run our code: going from bare metal, to VMs to the modern-day Cloud Native world of containers, schedulers and micro services. While we have figured out how to run containerized applications in the cloud using schedulers, we've yet to come up with a good solution to bridge the gap between getting your contain...
Feb. 21, 2017 01:15 AM EST Reads: 3,252
The modern software development landscape consists of best practices and tools that allow teams to deliver software in a near-continuous manner. By adopting a culture of automation, measurement and sharing, the time to ship code has been greatly reduced, allowing for shorter release cycles and quicker feedback from customers and users. Still, with all of these tools and methods, how can teams stay on top of what is taking place across their infrastructure and codebase? Hopping between services a...
Feb. 21, 2017 01:00 AM EST Reads: 6,255
Niagara Networks exhibited at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. Niagara Networks offers the highest port-density systems, and the most complete Next-Generation Network Visibility systems including Network Packet Brokers, Bypass Switches, and Network TAPs.
Feb. 21, 2017 12:30 AM EST Reads: 702
Zerto exhibited at SYS-CON's 18th International Cloud Expo®, which took place at the Javits Center in New York City, NY, in June 2016. Zerto is committed to keeping enterprise and cloud IT running 24/7 by providing innovative, simple, reliable and scalable business continuity software solutions. Through the Zerto Cloud Continuity Platform™, organizations can seamlessly move and protect virtualized workloads between public, private and hybrid clouds. The company’s flagship product, Zerto Virtual...
Feb. 21, 2017 12:30 AM EST Reads: 1,029
Without a clear strategy for cost control and an architecture designed with cloud services in mind, costs and operational performance can quickly get out of control. To avoid multiple architectural redesigns requires extensive thought and planning. Boundary (now part of BMC) launched a new public-facing multi-tenant high resolution monitoring service on Amazon AWS two years ago, facing challenges and learning best practices in the early days of the new service. In his session at 19th Cloud Exp...
Feb. 20, 2017 10:15 PM EST Reads: 3,328
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
Feb. 20, 2017 10:15 PM EST Reads: 5,915
WebRTC is about the data channel as much as about video and audio conferencing. However, basically all commercial WebRTC applications have been built with a focus on audio and video. The handling of “data” has been limited to text chat and file download – all other data sharing seems to end with screensharing. What is holding back a more intensive use of peer-to-peer data? In her session at @ThingsExpo, Dr Silvia Pfeiffer, WebRTC Applications Team Lead at National ICT Australia, looked at differ...
Feb. 20, 2017 10:15 PM EST Reads: 6,192
"Plutora provides release and testing environment capabilities to the enterprise," explained Dalibor Siroky, Director and Co-founder of Plutora, in this SYS-CON.tv interview at @DevOpsSummit, held June 9-11, 2015, at the Javits Center in New York City.
Feb. 20, 2017 09:15 PM EST Reads: 4,506
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Feb. 20, 2017 09:15 PM EST Reads: 905
Security, data privacy, reliability and regulatory compliance are critical factors when evaluating whether to move business applications from in-house client hosted environments to a cloud platform. In her session at 18th Cloud Expo, Vandana Viswanathan, Associate Director at Cognizant, In this session, will provide an orientation to the five stages required to implement a cloud hosted solution validation strategy.
Feb. 20, 2017 08:45 PM EST Reads: 4,335
SYS-CON Events announced today that CA Technologies has been named "Platinum Sponsor" of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, New York, and 21st International Cloud Expo, which will take place in November in Silicon Valley, California.
Feb. 20, 2017 08:30 PM EST Reads: 1,513
The security needs of IoT environments require a strong, proven approach to maintain security, trust and privacy in their ecosystem. Assurance and protection of device identity, secure data encryption and authentication are the key security challenges organizations are trying to address when integrating IoT devices. This holds true for IoT applications in a wide range of industries, for example, healthcare, consumer devices, and manufacturing. In his session at @ThingsExpo, Lancen LaChance, vic...
Feb. 20, 2017 07:00 PM EST Reads: 8,234
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @CloudExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
Feb. 20, 2017 06:15 PM EST Reads: 1,003
Wooed by the promise of faster innovation, lower TCO, and greater agility, businesses of every shape and size have embraced the cloud at every layer of the IT stack – from apps to file sharing to infrastructure. The typical organization currently uses more than a dozen sanctioned cloud apps and will shift more than half of all workloads to the cloud by 2018. Such cloud investments have delivered measurable benefits. But they’ve also resulted in some unintended side-effects: complexity and risk. ...
Feb. 20, 2017 06:15 PM EST Reads: 855