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Philips expands its healthcare customer services portfolio with the introduction of integrated Cybersecurity Services

November 30, 2020

Philips partners with CyberMDX, a leader in connected medical device security, to provide vendor-neutral solutions to protect connected medical systems and devices

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the introduction of the Philips Cybersecurity Services for seamlessly integrating and enhancing strategic security solutions for Philips customers. The Philips Cybersecurity Services comprise an end-to-end suite of technologies and services to safeguard customers’ medical systems, devices and related software solutions regardless of their manufacturer, helping empower digital transformation in healthcare.

Created as a platform for partnership with healthcare customers, the Cybersecurity Services help define and implement strategic and tactical software and device protection. The Cybersecurity Services are designed to be customized and optimized for present and emerging individual customer needs for their healthcare environments. As requirements evolve, the Cybersecurity Services will provide guidance on how to adapt to provide optimum protection and support. The services will initially be deployed in the U.S., with expansion to other geographies planned for 2021.

Philips’ integrated Cybersecurity Services are supported by a new partnership with CyberMDX, a leading provider of healthcare cybersecurity capabilities for hospital digital environment mapping and evaluation, medical device risk assessment, security prioritization, threat detection and intelligence, intrusion prevention, and related support. Data and insights collected through CyberMDX form a core foundation for development and implementation of a full cybersecurity plan for individual customers.

“Successfully preventing cyber-threats and future-proofing digital healthcare environments requires a systemic, disciplined approach in both design and implementation, as well as strong partnerships,” said Conrad Smits, Head of Global Services and Solutions at Philips. “We are pleased to partner with CyberMDX, and through our complementary tools and expertise, we will be able to provide an integrated cybersecurity service offering for our customers.”

“Both CyberMDX and Philips strive to make healthcare a safer place by continuously building out more robust cybersecurity solutions,” said Amir Magner, Co-founder and CEO of CyberMDX. “Our industry leading multi-vendor Healthcare Security Suite works to protect all connected devices in hospital environments, whether managed or unmanaged, by leveraging a combination of risk assessment, detection, threat intelligence and prevention capabilities.”

“The digitization of healthcare presents both opportunities and threats,” said Gal Gnainsky, Head of Security at Philips. “Connectivity plays a transformational role in healthcare, but potentially exposes patients and organizations to safety and security risks. Assuring the integrity of these devices, systems, and associated data requires a cohesive cybersecurity program based on comprehensive risk assessment and robust implementation.”

The Philips Cybersecurity Services comprise:

Cybersecurity Consulting – Security experts provide risk and vulnerability assessments of medical systems, regulatory compliance support, and guidance for seamlessly integrating security response and recovery across suppliers.

Cybersecurity Protection and Upgrade Services – Technology and service offerings work to keep systems secure through software upgrades to the latest security standards, medically validated OS patching, and network segmentation. Philips navigates the balance between required security protections, minimizing downtime, as well as maximizing the lifetime usage of systems and devices.

Cybersecurity Detection and Recovery Services – Identifying and monitoring the security posture of medical assets and systems 24/7. When needed, these services trigger response and recovery workflows. The services identify incidents with a focus on a healthcare context to avoid data overload, and then initiates remediation actions enabling operations to resume as soon as possible.

Cybersecurity Access & Audit Services – Access and audit services help maintain control over employee and vendor system access, and allow for streamlined/compliant auditing of procedures and data. This provides essential insights into a hospital’s security profile – indicating strengths and potential vulnerabilities.

Philips’ cybersecurity approach is defined by its end-to-end “Security by Design” principles, infusing security from product design and development, through testing and deployment – followed up with robust policies and procedures for monitoring, effective updates, and incident response management. Philips has also contributed to the development of national and international cybersecurity standards for medical devices. The Philips Cybersecurity Services aligns with global cybersecurity best practices and internationally recognized standards.

Visit Philips Live at RSNA 2020 for more information on Philips integrated workflow solutions to connect data, technology and people across the diagnostic enterprise, helping to redefine radiology workflow efficiencies.

Philips’ triple duty of care
The COVID-19 pandemic continues to highlight how interconnected the world’s social, economic and environmental challenges are. Philips remains fully focused on delivering against its triple duty of care: meeting critical customer needs, safeguarding the health and safety of its employees, and ensuring business continuity. As a purpose-driven health technology company, Philips is applying its innovation strength to improve the health and well-being of people. The company is deeply committed to doing business responsibly and sustainably, recently setting out a range of challenging new environmental, social and governance targets.

For further information, please contact:

Mario Fante
Philips Global Press Office
Tel.: +1 603 560 9226
E-mail: mario.fante@philips.com

Steve Klink
Philips Global Press Office
Tel. : +31 6 10888824
E-mail : steve.klink@philips.com

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2019 sales of EUR 19.5 billion and employs approximately 81,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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Philips introduces next generation of Advanced Visualization Workspace – IntelliSpace Portal 12 – with AI capabilities at RSNA 2020

November 30, 2020

  • Next generation of Philips’ advanced radiology visualization platform leverages image post-processing and artificial intelligence (AI) to deliver quantitative clinical insights, drive increased diagnostic confidence, simplify workflows, and reduce time-to-report
  • New features include AI algorithms for lung nodule detection, cardiac functional analysis, and quantification of pulmonary infiltrates associated with COVID-19 patients
  • Intelligent, automated and connected multi-modality, multi-vendor suite of applications supports follow-up and communication across clinical care pathways

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the next generation of Philips Advanced Visualization Workspace – IntelliSpace Portal 12 for radiologists. Launched at this year’s virtual Radiological Society of North America Scientific Assembly and Annual Meeting (RSNA 2020), IntelliSpace Portal features a robust set of new AI-assisted quantitative assessment and automatic results generation features to support the diagnostic workflow, including follow-up and communication across cardiology, pulmonology, oncology and neurology. Its AI-assisted pulmonary capabilities include the assessment of complex lung conditions associated with COVID-19.

“In the COVID era, the automatic detection and characterization of pulmonary infiltrates, especially in viral pneumonia, is very important,” said Hans-Ulrich Kauczor, professor and chairman of radiology at the University of Heidelberg in Germany. “IntelliSpace Portal’s AI-assisted quantitative assessment capabilities allow general radiologists and residents on call to get the necessary support to help identify COVID pneumonia, which is differentiated from other diagnoses. This also plays a significant role for longitudinal analysis and follow-up.“

“The immediate and complex long-term needs of COVID-19 patients, combined with the growth of elective care, has highlighted the continued need for advanced fully-integrated radiology solutions that support efficient diagnosis, follow-up and communication across multiple clinical domains,” said Calum Cunningham, General Manager of Enterprise Diagnostic Informatics at Philips. “The new generation of IntelliSpace Portal adds numerous AI-enabled features that automatically generate quantitative measurements, simplify workflows, and make radiology data available anywhere it’s clinically relevant in an organization.”

Expanding its ecosystem for radiology solutions, new clinical software packages [1] in cardiology, pulmonology, oncology and neurology being launched with IntelliSpace Portal 12, several of which have been integrated in collaboration with Pie Medical Imaging BV or Riverain Technologies, include:

Cardiology
MR Cardiac Analysis – Pre-processing images to deliver AI-based right ventricle and left ventricle segmentation to ensure accurate volumetric and functional measurements, enabling completion of a full cardiac MRI functional analysis in less than 5 minutes [2].

MR Caas™ 4D Flow Analysis – To reduce analysis time and improve reliability of valvular flow quantification [3], Caas [4] MR 4D Flow visualizes and quantifies blood flow patterns in a patient’s heart and main arteries.

Pulmonology
CT Pulmo Auto Results [5] – Featuring AI algorithms trained on complex pulmonary CT scans, including those of COVID-19 patients, CT Pulmo Auto Results software performs automatic lung segmentation and lesion segmentation, together with classification of ground glass opacities/consolidation. Its automatically generated reports include volume summaries and lesion distribution data to help in the quantitative assessment of pulmonary infiltrates, enhancing diagnostic confidence without increasing reading time.

Oncology
CT ClearRead™ CAD Lung Nodule Analysis [6] – featuring AI-based detection and characterization for various nodule types including solid, part-solid and ground-glass lung nodules, enabling to perform nodule searches 26% faster and detect 29% of previously missed nodules [7].

Neurology
CT Brain Perfusion Analysis – IntelliSpace Portal 12 now supports automatic brain perfusion measurements instantly available on PACS with the option of automatically emailing perfusion results to a stroke patient’s clinicians within two minutes to reduce door-to-needle time.

Additional Enhancements
The software also includes a new photorealistic volume rendering [8] technology using an interactive virtual light source to improve the visualization of volumes in terms of their depth and relationship to other key anatomies – enhancing its use as an educational and communication tool.

Other enhancements in IntelliSpace Portal include workflow innovations for vascular analysis to deliver faster results, new automatic lesion segmentation propagation between time-points for longitudinal tumor tracking, new CaasTM [4] myocardial strain quantification software, and enhanced automatic capabilities for CT coronaries analysis.

Philips Radiology Workflow Suite at RSNA 2020
At RSNA 2020, Philips will showcase an integrated suite of offerings for the first time, introducing key solutions that come together to enhance the entire radiology workflow to address the most pressing operational challenges across diagnostic and interventional radiology. Philips Advanced Visualization Workspace – IntelliSpace Portal – is a key component for Image and data interpretation within Philips Radiology Workflow Suite, connecting patient data across departments to create interoperability for greater clinical intelligence and analysis, supported by AI-tools such as an algorithm for the detection of COVID-19 lesions. Visit Philips Live at RSNA 2020 for more information on Philips integrated workflow solutions to connect data, technology and people across the diagnostic enterprise, helping to redefine radiology workflow efficiencies.

Philips’ triple duty of care
The COVID-19 pandemic continues to highlight how interconnected the world’s social, economic and environmental challenges are. Philips remains fully focused on delivering against its triple duty of care: meeting critical customer needs, safeguarding the health and safety of its employees, and ensuring business continuity. As a purpose-driven health technology company, Philips is applying its innovation strength to improve the health and well-being of people. The company is deeply committed to doing business responsibly and sustainably, recently setting out a range of challenging new environmental, social and governance targets.

[1] Some IntelliSpace Portal functionalities may not be available in all territories.
[2] Average RV/LV analysis time measured on validation study 4.2 min +/- 0.4
[3] V.P. Kamphuis et al., Automated Cardiac Valve Tracking for Flow Quantification with Four-dimensional Flow MRI, Radiology, 2019 Jan;290(1):70-78
[4] Caas is a trademark of Pie Medical Imaging BV.
[5] The functionality may not be available in all territories. In the United States of America, the CT Pulmo Auto Results can only be used during the National Emergency Concerning the Novel Coronavirus Disease (COVID-19). The CT Pulmo Auto Results functionality is exempt from premarket notification according to the FDA Guidance document for Imaging Systems During the Coronavirus Disease 2019 (COVID-19), and was therefore not cleared by the FDA. It is offered via a trial license only for the duration of the national emergency, until further notice.
[6] ClearRead CT is a trademark of Riverain Technologies.
[7] ShihChung et al. AJR 2018; 210:480-488
[8] IntelliSpace Portal’s Photorealistic Volume Rendering is not intended for diagnostic image review

For further information, please contact:

Kathy O’Reilly
Philips Global Press Office
Tel.: +1 978-221-8919
E-mail : kathy.oreilly@philips.com
Twitter: @kathyoreilly

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2019 sales of EUR 19.5 billion and employs approximately 81,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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Bombardier Appoints Bart Demosky Executive Vice President and Chief Financial Officer

MONTREAL, Nov. 30, 2020 (GLOBE NEWSWIRE) — Bombardier (TSX: BBD.B) announced today the appointment of Bart Demosky as Executive Vice President and Chief Financial Officer, effective immediately. Bart will report to Éric Martel, President and Chief Executive Officer, Bombardier Inc., replacing John Di Bert who will be leaving the Company.

“We are very excited to welcome Bart to the Bombardier leadership team,” said Éric Martel. “He is an accomplished leader with broad financial experience and an impressive track record of success at some of Canada’s largest corporations. Bart’s deep knowledge and expertise in all aspects of corporate finance will serve us well as we complete our strategic repositioning to a leaner, more focused company. I’m confident that Bart will provide strong leadership as we manage through the current economic challenges and continue to position Bombardier for the future.”

Bart brings over 30 years of experience leading organizational transformations and building high-performing financial organizations in the transportation, energy, infrastructure and services industries. His previous leadership roles include serving as the President and Chief Executive Officer of Universal Rail Systems Inc., Executive Vice President and Chief Financial Officer for Canadian Pacific Railway and Chief Financial Officer for Suncor Energy. He holds a Bachelor’s degree in Economics from the University of Calgary and is an Honours graduate from the University of Calgary’s Management Development Program.

“As we welcome Bart to the Bombardier team, I also want to acknowledge and thank John Di Bert for his many contributions to Bombardier,” Martel added. “We wish John continued success in all his future endeavours.”

About Bombardier
With over 52,000 employees across two business segments, Bombardier is a global leader in the transportation industry, creating innovative and game-changing planes and trains. Our products and services provide world-class transportation experiences that set new standards in passenger comfort, energy efficiency, reliability and safety.

Headquartered in Montréal, Canada, Bombardier has production and engineering sites in over 25 countries across the segments of Aviation and Transportation. Bombardier shares are traded on the Toronto Stock Exchange (BBD). In the fiscal year ended December 31, 2019, Bombardier posted revenues of $15.8 billion. News and information are available at bombardier.com or follow us on Twitter @Bombardier.

Bombardier is a trademark of Bombardier Inc. and its subsidiaries.

For Information
Jessica McDonald Patrick Ghoche
Advisor, Media Relations Vice President, Corporate Strategy
and Public Affairs Investor Relations
Bombardier Inc. Bombardier Inc.
+1 514 861 9481 +1 514 861 5727
jessica.mcdonald@bombardier.com

Algernon Pharmaceuticals Announces Enrollment of Final Patient in its Multinational Phase 2b/3 Human Study of Ifenprodil for COVID-19

VANCOUVER, British Columbia, Nov. 30, 2020 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company, is pleased to announce that the final patient has been enrolled in its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19. The aggregate total number of patients enrolled from all countries participating in the study is 168.

The Company recently announced that it would be providing interim data from 75 patients from day 15 of their participation in the study, in the first week of December. Since the treatment period after enrollment is two weeks, with a two-week follow-up thereafter, the interim data readout date has now been moved to the third week of December to ensure that the patients who recently enrolled, can complete their treatment regimen before data is presented.

The Company will update the market shortly on the date when the final data readout will be available.

“I want to thank to the entire AGN team, including all of our clinical trial investigators and their staff, for helping us reach the goal of 100% patient enrollment,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals. “Our next big step is to see how the preliminary data is trending and we remain hopeful it will show that Ifenprodil is reducing both the severity and duration of a COVID-19 infection. Even with the recent success of certain vaccines in clinical trials, medical doctors need to have effective therapeutic treatment options as well.”

The Company advises that it is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure or contain COVID-19 (or the SARS-2 Coronavirus) at this time.

Phase 2b/3 Study Protocol Summary

The Company’s multinational Phase 2b/3 human trial for COVID-19 is entitled, “A Randomized Open Label Phase 2b/3 Study of the Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patients with Confirmed COVID-19 Disease.”

The trial has begun as a Phase 2b study of an aggregate of 150 patients. With positive preliminary data, the clinical trial will move directly into a Phase 3 trial. The data from the Phase 2b study will determine the number of patients needed to reach statistical significance in the Phase 3 trial.

Patients are being randomized in a one-to-one manner and will either be treated using an existing standard of care, or standard of care plus Ifenprodil 60 mg (taken as one 20 mg tablet three-times daily) for one arm or standard of care plus Ifenprodil 120 mg (taken as two 20 mg tablets three-times daily) for two weeks.

Over the testing period, doctors will observe whether there is an improvement in a number of secondary endpoints, including mortality, blood oxygen levels, time spent in intensive care and time to mechanical ventilation.

About NP-120 (Ifenprodil)

NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils.

The Company believes Ifenprodil can reduce the infiltration of neutrophils and T-cells into the lungs where they can release glutamate and cytokines respectively. The latter can result in the highly problematic cytokine storm that contributes to the loss of lung function and ultimately death as has been reported in COVID-19 infected patients.

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

Algernon has filed new intellectual property rights globally for NP-120 (Ifenprodil) for the treatment of respiratory diseases and is working to develop a proprietary injectable and slow release formulation.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. The Canadian Securities Exchange has not in any way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this press release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

Novavax Announces COVID-19 Vaccine Clinical Development Progress

  • Pivotal Phase 3 trial in United Kingdom completes enrollment
  • Phase 2b efficacy trial in South Africa completes enrollment
  • U.S./Mexico Phase 3 trial expected to begin in the coming weeks

GAITHERSBURG, Md., Nov. 30, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. NVX‑CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix‑M™.

“Novavax is in a leading position to significantly contribute to the need for safe and efficacious vaccines that will ultimately end the worldwide COVID-19 pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide.”

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. The primary efficacy endpoints for these trials have been harmonized and reviewed by global regulatory agencies in order to facilitate regulatory approval and ensure that the results are generalizable across global populations. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

United Kingdom (U.K.) pivotal Phase 3 trial update

Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K. to determine efficacy and safety of NVX-CoV2373. The U.K. Vaccines Taskforce and National Institute for Health Research played pivotal roles in the rapid recruitment and enrollment of volunteers.

Interim data in this event-driven trial are expected as soon as early first quarter 2021, although the timing depends on the overall COVID-19 rate in the region. These data are expected to serve as the basis for licensure application in the U.K., European Union and other countries. More than 25 percent of enrollees in the trial are over the age of 65, while a large proportion of volunteers had underlying co-morbid medical conditions generally representative of the population.

South Africa Phase 2b trial update

The Phase 2b trial taking place in South Africa to evaluate safety and provide an early indication of efficacy is now fully enrolled. A total of 4,422 volunteers are taking part in the trial, which includes 245 medically stable, HIV-positive participants.

This trial is expected to increase the body of efficacy data of NVX-CoV2373 in racially and geographically diverse populations as well as in older adults. As in the U.K., availability of efficacy data depends on the illness rate in South Africa and may be available as soon as the first quarter 2021. The trial is being conducted in collaboration with Professor Shabir Mahdi and Wits University and is funded in part by the Bill & Melinda Gates Foundation. The Coalition for Epidemic Preparedness Innovations (CEPI) funded the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial.

U.S./Mexico pivotal Phase 3 trial update

Novavax expects its pivotal Phase 3 clinical trial in the United States and Mexico to begin in the coming weeks. More than 100 trial sites have been selected with some alternate sites in place, should they be needed.

Preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase 3 has previously been positively reviewed by the Food and Drug Administration (FDA). Additional clinical data from the Phase 2 trial conducted in the U.S. and Australia are expected to be unblinded in Q1 and will be targeted for publication.

Novavax will use vaccine material produced at commercial scale for this trial. Therefore, the Company has been working closely with the FDA to complete trial-initiation gating activities related to its commercial-scale production at FUJIFILM Diosynth Biotechnologies in Research Triangle Park, North Carolina.

Novavax was awarded $1.6 billion in funding from the U.S. government to meet its Operation Warp Speed goals to expedite the delivery of millions of doses of safe, effective vaccines for COVID-19. The award is funding the U.S. and Mexico pivotal Phase 3 trial and manufacturing scale-up.

About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is being evaluated in a Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and more than $1.6 billion from the U.S. Government’s Operation Warp Speed program.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Novavax Forward Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:
Investors
Erika Trahan
ir@novavax.com
240-268-2022

Media
Edna Kaplan
media@novavax.com
617-974-8659

 

Fauci Warns of COVID ‘Surge Upon a Surge’

The top U.S. infectious disease expert warned Sunday of a possible, upcoming spike of the coronavirus.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaking on “This Week” on ABC-TV, said the infection rate would not “all of a sudden turn around” and in the coming weeks, following the recent Thanksgiving holiday, “We may see a surge upon a surge.”

Also Sunday, Dr. Deborah L. Birx, the White House coronavirus response coordinator, said on “Face the Nation” on CBS-TV, that people who traveled during the holiday “have to assume that you were exposed, and you became infected and you really need to get tested in the next week.” She also called on people who had traveled during the holiday to avoid people older than 65 or who have an underlying disease.

 

The doctors’ warnings come as the U.S. on Saturday recorded more than 4 million infections for November alone, more than doubling the 1.9 million record set in October.

The U.S. has 13.3 million of the world’s 62.7 million COVID-19 cases, according to the Johns Hopkins Coronavirus Resource Center. The U.S. has more cases of the virus than any other country in the world. India and Brazil follow the U.S. in case numbers with 9.3 million and 6.3 million respectively.

India recorded nearly 42,000 new COVID infections Sunday, according to Johns Hopkins.

In Europe, some countries are hoping for a continent wide agreement to shut down ski resorts during the Christmas holidays to help prevent spreading the coronavirus.  No unified pact, however, has yet been reached.

The World Health Organization warned Monday that malaria deaths will likely exceed COVID deaths in Africa because of the health care disruptions caused by the pandemic.

 

 

Source: Voice of America

 

Moderna to Seek Quick Approval of Coronavirus Vaccine in US, Europe

WASHINGTON – Drugmaker Moderna said Monday it is seeking emergency authorization in the United States and Europe to distribute its coronavirus vaccine after tests showed it is 94% effective.

The U.S. biotechnology company’s request could mean that health workers will be able to inoculate patients against the virus as soon as mid-December with either of two coronavirus preventatives — Moderna’s or another equally successful test drug produced by the corporate tandem of Pfizer-BioNTech — if the companies win approval from drug regulators.

Moderna said it conducted a 30,000-person clinical trial, and its results were on a par with the best pediatric vaccines.

The drugmaker said that of the 196 volunteers who contracted COVID-19, 185 had received a placebo versus 11 who received the vaccine. Moderna reported 30 severe cases — all in the placebo group — including one COVID-19-related death.

The Moderna and Pfizer requests for emergency use of their vaccines come as the number of coronavirus cases is surging in the U.S., where tens of thousands of new cases are being recorded daily.

Health officials say they are especially worried about an even further spread of the virus because millions of people ignored warnings against traveling for last week’s Thanksgiving holiday and could travel again over the upcoming Christmas and New Year’s holiday weekends.

 

The U.S. has 4% of the world’s population but nearly a fifth of its recorded coronavirus deaths — more than 266,000 — the most in any country, according to Johns Hopkins University. Worldwide, the death toll has topped 1.46 million.

Top U.S. health experts say 20 million Americans could get vaccine shots in the latter half of December, possibly with front-line health care workers targeted initially, followed by elderly people living in nursing homes. An advisory committee at the Centers for Disease Control and Prevention is meeting Tuesday to lay out the order in which Americans will be able to get vaccinated.

Millions of people will likely be able to get one of the vaccines in the first months of 2021, although polls show that about four in 10 Americans say they will refuse to get a shot, either because they are opposed to vaccinations in general or are particularly wary of coronavirus inoculations.

The U.S. Food and Drug Administration is considering the Pfizer vaccine on December 10, with consideration of Moderna’s a week later. In addition to seeking U.S. approval, Moderna said it would apply for conditional approval from the European Medicines Agency.

 

 

Source: Voice of America