Veristat Supports 12% of all FDA NME Approvals in 2018, a Record-Setting Year for FDA Approvals
Veristat, a scientifically oriented clinical development and regulatory submission partner, announced today that it supported its biopharmaceutical clients on 12% of the US Food and Drug Administration (FDA) approvals granted in 2018, a record-setting year. In 2018, the FDA approved 59 drug and biologics therapeutic submissions for New Molecular Entities (NMEs)1. Veristat provided strategic planning as well as statistical analysis and medical writing for 12% of those approvals, including breakthrough oncology products as well as therapies for rare genetic-based disorders and infectious diseases.
Over the past 10 years, Veristat has prepared regulatory submissions for nearly 7% of all the NMEs approved by the FDA. In that time, our teams supported a total of 56 global regulatory submission projects. Of those, 40 have received approvals to date from the FDA, the European Medicines Agency (EMA), Health Canada and the Pharmaceuticals and Medical Devices Agency of Japan (PMDA) in a wide range of therapeutic areas, with many pending.
“From our first FDA submission nearly 25 years ago, we have continued to provide our clients with collaborative strategic thinking and scientific insight into the regulatory submission planning and preparation required for submission to the FDA and other regulatory agencies,” said John P. Balser, Ph.D., President and Co-Founder of Veristat. “We are then able to implement the submission strategy through the efforts of our biometrics and regulatory medical writing divisions, providing a seamless submission process. But regardless of our successes, we never lose sight of our ultimate goal of helping our clients get therapies approved quickly to improve the lives of patients and their families.”
The FDA approvals that our clients achieved in 2018 led to new treatment options for numerous cancers, hard-to-treat bacterial infections, and other rare diseases. Approvals from 2018 included TIBSOVO®, the first and only targeted therapy for adult patients with relapsed/refractory Acute Myeloid Leukemia and an IDH1 mutation, and ONPATTRO™ (patisiran), a lipid complex injection for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.
“Preparing regulatory submissions to achieve approval is a core strength for Veristat and our impact in 2018 and throughout the course of the past decade is impressive,” stated Patrick Flanagan, Chief Executive Officer at Veristat. “As we launch into 2019, our impact will improve with the further strategic growth of our clinical, biometric, medical writing and regulatory expertise that is specifically designed to plan and run more efficient clinical trials enabling the preparation of successful marketing applications.”
Veristat delivers integrated submission preparation, full service clinical program expertise and the ability to achieve seemingly impossible deadlines. Our success lies in our ability to strategically navigate conceptually and operationally complex submissions, overcome data analysis challenges, and streamline the medical writing process with an integrated team focused on creativity, flexibility, and quality. Learn more at: https://www.veristat.com/services/medical-and-regulatory-affairs/regulatory-submissions.
Veristat is a scientifically oriented and impactful full-service clinical research organization (CRO) that is committed to partnering with pharmaceutical, biotechnology, and medical device firms to advance their therapies throughout the entire clinical development and regulatory submission process. Veristat helps clients solve the unique and complex challenges that arise when trying to accelerate therapies along the development pathway to successful regulatory approval, beginning with study design, protocol development, site selection and start-up through to clinical monitoring, data collection, analysis and reporting. Veristat provides experience-based strategic decision-making, the operational efficiencies to manage and monitor international trials, the biometrics expertise to collect, analyze and report clinical trial data to various regulatory agencies, and the therapeutic and medical proficiency to oversee the entire process. Ultimately, we guide our clients to market success so that their therapies become available to improve and save people’s lives. For more information, visit https://www.veristat.com.
Gillian Dellacioppa, Marketing Director
email@example.com or +1 508-306-6336
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
IHS Markit to Integrate Cappitech Technology In SFTR Reporting Solution25.6.2019 19:23:00 EEST | Tiedote
Cappitech, a leading provider of regulatory reporting and intelligence solutions for the financial services industry and IHS Markit, a world leader in critical information, analytics and solutions, today announced an alliance to deliver the IHS Markit Securities Financing Transactions Regulation (SFTR) solution. The IHS Markit SFTR solution will integrate Cappitech’s award-winning platform CapptivateTM to offer a best-of-breed solution that will meet the industry’s SFTR trade reporting needs by automating and streamlining transaction reporting to trade repositories for all securities finance instruments. It will also support out-of-the-box MiFID II reporting for additional instruments that will be in scope when SFTR goes live. Pierre Khemdoudi, Managing Director & Global Co-Head of Equities, Data and Analytics at IHS Markit, said: “We look forward to leveraging Cappitech’s technology to deliver a regulatory reporting solution that can help manage the comprehensive requirements of SFTR.
Moody’s Analytics CreditLens™ Solution Adopted by Over 100 Firms25.6.2019 16:00:00 EEST | Tiedote
Moody’s Analytics, a leading provider of financial intelligence, announced today that the CreditLens credit-lifecycle-management solution has been adopted by over 100 firms since its launch. Built on the latest cloud-based technology, the CreditLens platform helps businesses digitally transform their commercial credit processes to make faster and better-informed decisions. The platform uses the latest AI and machine learning technology to facilitate process automation, and help clients improve efficiency, reduce errors, and streamline workflows. "We are honored that our clients have embraced the CreditLens solution and enabled us to reach this milestone,” said Annie Choi, Senior Director at Moody’s Analytics. “Our goal is to provide the best credit lifecycle management solution in the market, informed by our award-winning proprietary data, and enabled by the modern technologies our clients want to use.” “Technological innovation is accelerating at a rapid pace, creating opportunities f
Modern Governance 3.0: Modern Governance Extends Beyond the Boardroom to Allow Secure Sharing of Files and Collaboration with Auditors, Regulators and Other Third Parties25.6.2019 16:00:00 EEST | Tiedote
In its next major extension to support modern governance, Diligent announced today the launch of Secure File Sharing and Secure Meeting Workflow applications, as part of the Diligent Governance Cloud. These groundbreaking applications enable completely secure collaboration not only between board members and executives, but also reaching beyond the boardroom including auditors, regulators and other key third party stakeholders. This significantly raises the bar on security and information governance for organizations operating in this digital, mobile and social era. In today’s fast-paced world, threats come at light speed – from every angle. Leading organizations must set increasingly higher standards to protect against cyber attacks and leaks, while at the same time work collaboratively with more outside parties. Even competent leaders can have blind spots when it comes to the handling of highly sensitive files, specifically in preparation for a board meeting, sharing documents haphaza
Transphorm Strengthens 900 V GaN Portfolio with Second FET25.6.2019 16:00:00 EEST | Tiedote
Transphorm Inc.—the leader in the design and manufacturing of the highest reliability high-voltage (HV) Gallium Nitride (GaN) semiconductors—today introduced its second 900 V FET, the Gen III TP90H050WS, enhancing the industry’s only 900 V GaN product line. These devices now enable three-phase industrial systems and higher voltage automotive electronics to leverage GaN’s speed, efficiency and power density. Further, the new FET’s platform is based on Transphorm’s 650 V predecessor, the only JEDEC- and AEC-Q101-qualified HV GaN technology. As such, system developers can design with confidence in its quality and reliability. The TP90H050WS has a typical on-resistance of 50 mOhm with a 1000 V transient rating, offered in a standard TO-247 package. The TP90H050WS can reach power levels of 8 kW in a typical half bridge while maintaining greater than 99 percent efficiencies. Its figures of merit for Ron*Qoss (resonant switching topologies) and Ron*Qrr (hard switching bridge topologies) are t
BOC Group Announces the Release of ADONIS NP 7.1 – Igniting A New Era of User Inclusion, Insights & BPM Experience25.6.2019 15:26:00 EEST | Tiedote
Today, BOC Group released the latest version of its revolutionary BPM suite, ADONIS NP 7.1. Focusing specially on enriching the ADONIS NP experience for every user, transparency, simplicity and openness were kept at the core of this version’s design. And this release’s flagship feature, the Process Insights Dashboard, is a direct embodiment of that, with its powerful visualization and representation of all key process management information. Tobias Rausch, ADONIS NP product manager, elaborates: “We carefully designed the Insights Dashboard in a way that provides that one-click-access to everything you would need to know about your processes – from process hierarchy, responsible roles, inputs, outputs, to IT, risks, KPIs, as well as quick-links to analyses and reports”. “Essentially, the Insights Dashboard brings an entirely new and simplified way of interacting with the process content, ultimately making ADONIS NP even more user-friendly and intuitive than befo re!" What’s more, the la
MATRIXX Software Joins Linux Foundation Networking to Advance Next Generation of Telco Services25.6.2019 15:05:00 EEST | Tiedote
MATRIXX Software , an innovation powerhouse committed to transforming global commerce, today announced it has joined Linux Foundation Networking (LFN) as a silver member. MATRIXX is participating in the foundation’s programs to provide guidance related to advancing a new generation of services inspired by web-scale best practices. With over 100 members, LFN continues its global drumbeat of ecosystem growth for accelerated development and adoption of open source and open standards-based networking technologies. The Linux Foundation supports the creation of sustainable open source ecosystems by providing financial and intellectual resources, infrastructure, services, events and training. “The LF Networking community is working together to foster industry collaboration and innovation across the entire open networking stack, and increase harmonization across platforms, ecosystems and communities,” said Arpit Joshipura, general manager, Networking, Automation, Edge & IOT, the Linux Foundati
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme