Endo | November 20, 2021
Endo International plc today announced that its subsidiary, Par Sterile Products, LLC (Par Sterile), has entered into a cooperative agreement to expand its sterile fill-finish manufacturing production capacity and capabilities at its Rochester, Michigan plant to support the U.S. government's national defense efforts regarding production of critical medicines advancing pandemic preparation.
Under the terms of the agreement, Par Sterile's Rochester facility will establish a new sterile fill-finish manufacturing asset capable of processing liquid or lyophilized products requiring Biosafety Level (BSL) 2 containment. It will also provide expanded product inspection and packaging capacity as well as sterile fill-finish manufacturing services to the U.S. Government. Under the terms of the agreement, the U.S. government will fund approximately $90 million of the program's total expected cost of approximately $120 million.
"Endo strives to be a force for good, and we are proud to partner with the U.S. government in its efforts to expand and accelerate domestic manufacturing in support of future pandemic preparedness. This collaboration underscores our longstanding history as a U.S. manufacturer of high-quality medicines."
Blaise Coleman, President and CEO of Endo
The agreement is a result of efforts defined under the Defense Production Act to address vulnerabilities in critical product supply chains and strengthen the advancement of manufacturing and on-shoring of domestic essential medicines production.
The Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) Joint Assisted Acquisition team in partnership with Army Contracting Command– Aberdeen Proving Ground (ACC - APG) – COVID Response are the awarding and administering acquisition offices. This work was supported by the ACC - APG – COVID Response, under the authority of 31 U.S.C. 6305 pursuant to Section 3101 of the American Rescue Plan Act (Public Law 117-2) and Title III of the Defense Production Act of 1950 (50 U.S.C. 4533) under Award No. W58P05-22-2-0001. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the JPEO-CBRND or ACC – APG – COVID Response.
Endo is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them.
Acalvio Technologies | October 27, 2021
Acalvio Technologies, the leader in Autonomous Deception, today announced that it has been approved as “FedRAMP Ready” for Agency Authorization. Acalvio achieved FedRAMP Ready status at the Moderate Impact Level for its ShadowPlex platform on Amazon Web Services (AWS). ShadowPlex is now listed in the FedRAMP Marketplace.
Acalvio’s award-winning Autonomous Deception™ platform, ShadowPlex, enables organizations to detect, investigate and respond to malicious activity inside the perimeter. Acalvio’s solutions are anchored on innovations in Distributed Deception, and Artificial Intelligence (AI), enabling security teams to cut through the cycle of endless alerts and accelerate threat detection by focusing on high fidelity detections, all while minimizing the incidence of potential false positives.
ShadowPlex patented architecture allows distributed and autonomous deployment of effective deception, with minimal IT overhead across On-premises and Cloud workloads and remote user machines. A comprehensive and extensible deception palette covers both IT and OT environments and reduces attacker dwell time by detecting malicious activity with precision and speed.
Solutions authorized at the FedRAMP Moderate Impact Level protect the government’s sensitive unclassified data in cloud environments, including data where the loss of confidentiality, integrity, and availability would result in serious adverse effects on a Federal agency’s operations, assets, or individuals.
“Acalvio ShadowPlex provides an effective and differentiated solution to detect and respond to advanced threats, even zero-day attacks. U.S. government departments and agencies need active defense solutions in place today to be ready for the increasing sophistication of cyberattacks facing our Nation. By achieving the FedRAMP Ready designation, Acalvio has demonstrated they are a valued partner for entities who wish to defend against cyber threats today.”
Ram Varadarajan, co-Founder & CEO at Acalvio Technologies
The FedRAMP Ready status adds to the SOC 2 and NIST 800-171 certifications previously achieved by Acalvio Technologies.
The Federal Risk and Authorization Management Program (FedRAMP) is a government-wide program that provides a standardized approach to security assessment, authorization, and continuous monitoring for cloud products and services. Using a “do once, use many times” framework, the program ensures information systems/services used government-wide have adequate information security; eliminates duplication of effort and reduces risk management costs; and enables rapid and cost-effective procurement of information systems/services for federal agencies.
About Acalvio Technologies
Acalvio invented breakthrough Deception Technology based on 25+ issued patents and integrated it with advanced AI to provide industry leading autonomous deception solution that is effective, easy to use, and enterprise scale. Acalvio ShadowPlex reduces attacker dwell time by early detection of advanced threats and increases SOC efficiency by sophisticated investigation and active threat-hunting capabilities. Extensive partner integrations allow ShadowPlex to leverage customer’s security ecosystem for rapid and comprehensive threat containment. The Silicon Valley based company is led by an experienced team with a track record of innovation and market leadership and backed by marquee investors.
American Robotics | January 19, 2021
American Robotics, a main engineer of completely robotized business drone frameworks, turned into the primary organization affirmed by the Federal Aviation Administration (FAA) to work computerized drones without human administrators on location. The organization's Scout System™ highlights progressed acoustic Detect-and-Avoid (DAA) innovation that empowers its drones to keep a protected separation from other airplane consistently. By building up a layered, repetitive arrangement of security that incorporates exclusive specialized and operational danger alleviations, American Robotics has demonstrated that its robot based ethereal insight stage works securely in the National Airspace System (NAS), in any event, when it conducts trips Beyond-Visual-Line-of-Sight (BVLOS) of the administrator.
This endorsement speaks to a huge articulation point in the business drone industry. Earlier waivers and confirmations granted by the FAA required visual eyewitnesses (VOs) positioned along the flight way to keep eyes on the airspace consistently, or required other troublesome limitations, for example, foundation covering. Therefore, the worth and versatility of business drone use in the U.S. has, as of not long ago, been radically hindered or much of the time wiped out.
“With these approvals, American Robotics is ushering in a new era of widespread automated drone operations,” said Reese Mozer, CEO and co-founder of American Robotics. “Decades worth of promise and projection are finally coming to fruition. We are proud to be the first company to meet the FAA’s comprehensive safety requirements, which had previously restricted the viability of drone use in the commercial sector. We are very grateful for the FAA’s willingness to work closely with American Robotics over the past four years on this precedent-setting authorization. With this set of approvals, American Robotics can begin safely operating our automated Scout platform for the benefit of the energy, infrastructure, agriculture, and security market verticals, helping unlock the projected $100 billion commercial drone market.”