Business Wire

Veristat Supports 12% of all FDA NME Approvals in 2018, a Record-Setting Year for FDA Approvals

Jaa

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.

About Veristat

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.

1 https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm592464.htm

Contact information

Veristat:
Gillian Dellacioppa, Marketing Director
gillian.dellacioppa@veristat.com or +1 508-306-6336

Tietoja julkaisijasta

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

Fishawack continues to build best-in-class service offering with Dudnyk acquisition20.3.2019 16:00:00 EETTiedote

Fishawack, a leading independent healthcare communications specialist, is excited to announce its acquisition of Dudnyk, the Philadelphia-based healthcare communications agency. Dudnyk is an award-winning, full-service agency that specializes in creating insight-driven, authentic brand experiences that unite specialty physicians and their patients. They leverage strategic, scientific, and creative capabilities to serve clients in the biotech, pharmaceutical, and medical device industries. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190320005204/en/ Dudnyk leadership team includes Christopher Tobias, PhD, President; Laurie Bartolomeo, EVP, Creative Director; Drew Desjardins, EVP, Chief Strategy Officer; Annemarie Armstrong, EVP, Director of Client Services; John Kemble, EVP, Creative Producer. (Photo: Business Wire) Fishawack’s goal is to increase the range of healthcare communications services that it can offer to commerc

ExaGrid Nominated in Six Categories for the 2019 Network Computing Awards20.3.2019 15:00:00 EETTiedote

ExaGrid ®, a leading provider of intelligent hyperconverged storage for backup, today announced that it has been nominated in six categories for the 2019 Network Computing Awards. ExaGrid has become a finalist for Data Centre Product of the Year, The Return on Investment Award, Hardware Product of the Year, Product of the Year, The Customer Service Award, and Company of the Year. Voting to determine the winner in each category is underway now and closes on April 23. The results will be revealed at an evening award ceremony in London on May 2. ExaGrid’s model EX63000E backup storage appliance with data deduplication is a nominee in four categories. The model provides the largest scale-out system and offers up to a 2PB full backup with an ingest rate of 432TB/hr, which is three times faster than any other backup storage on the market. “We are thrilled to be nominated by IT staff, and recognized by Network Computing, in six prestigious categories this year,” said Bill Andrews, CEO and Pre

Eos Biosciences Issued Patent for New Approach to Shuttle Therapeutics Across the Blood-Brain Barrier to Treat Brain Diseases20.3.2019 14:30:00 EETTiedote

Eos Biosciences, Inc. (Eos), a nanomedicines company developing an efficient and versatile nanobiologic particle-based platform technology (Eosomes), announced that the U.S. Patent and Trademark Office has granted Eos Biosciences Patent No. 10,183,078, relating to a novel approach of using HER3-targeted Eosomes as a shuttle system for transporting various classes of therapeutics across the blood-brain barrier for treatment of brain disorders, including brain cancer. The patent is owned by Cedars-Sinai Medical Center and is exclusively licensed to Eos Biosciences. Details of the system will be highlighted in an upcoming manuscript from Lali Medina-Kauwe, PhD, Professor, Department of Biomedical Sciences, Cedars-Sinai. Omar Haffar, Ph.D., Founder, President and Chief Executive Officer, commented, “We’re very excited by the issuance of this pivotal patent and look forward to receiving similar approvals in other countries. This patent adds to Eos’ considerable IP portfolio covering the Eos

Pfizer Secures Exclusive Option to Acquire Gene Therapy Company Vivet Therapeutics20.3.2019 13:45:00 EETTiedote

Vivet Therapeutics (“Vivet”), a privately held gene therapy biotech company dedicated to developing gene therapy treatments for inherited liver disorders with high unmet medical need, and Pfizer Inc. (NYSE: PFE) announced today that Pfizer has acquired a 15% equity interest in Vivet and secured an exclusive option to acquire all outstanding shares. Pfizer and Vivet will collaborate on the development of VTX-801, Vivet’s proprietary treatment for Wilson disease. Wilson disease is a devastating, rare, chronic, and potentially life-threatening liver disorder of impaired copper transport that causes serious copper poisoning. In patients with Wilson disease, a monogenetic mutation disables the normal copper biliary excretion pathway leading to excess copper accumulation in the liver and other organs including the central nervous system. Untreated, Wilson disease results in various combinations and severity of hepatic (fibrosis and cirrhosis), neurologic and psychiatric symptoms, which can b

Fintech Company Rimilia Appoints Kevin Kimber as CEO20.3.2019 13:00:00 EETTiedote

Rimilia, a fintech company helping finance departments simplify the complex, has appointed Kevin Kimber as CEO. The news follows another strong year for Rimilia. In 2018, Rimilia opened offices in Central London and Denver, Colorado in the U.S., and reported significant revenue growth on the previous year. Rimilia was founded in 2008 and its platform, created by finance professionals, uses RPA (robotic process automation) technology to help finance teams fast-track their cash flow by providing clearer information and better control. It has quickly become the industry leader, trusted by a number of global brands from HSBC to DHL and Santander, to provide visibility, improve efficiencies and guarantee cash flow. Rimilia works with any currency, any bank and in any language, and on average delivers 70% cost-savings and an 80% reduction in manual effort to its customers. Kevin joins Rimilia from Eight Roads Ventures (one of Rimilia’s investors), where he was a Venture Partner, advising its

Knopp Biosciences Enters Collaboration with Leading UK Investigators to Commence Phase 2 Clinical Trial of Dexpramipexole in Severe Eosinophilic Asthma20.3.2019 13:00:00 EETTiedote

Knopp Biosciences LLC, a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases with high unmet need, today announced a collaboration with a consortium of leading medical researchers in the United Kingdom to evaluate the ability of Knopp’s lead drug candidate, dexpramipexole, to reduce exacerbations in people with severe eosinophilic asthma. The project is chiefly funded by the National Institute for Health Research (NIHR) and Medical Research Council (MRC) of the UK. The Chief Investigator for the Phase 2 multi-center, 52-week trial is Professor Salman Siddiqui, Professor of Airway Diseases at the University of Leicester and Consultant Respiratory Physician at Leicester’s Hospitals. Dexpramipexole is an orally available small molecule shown to selectively reduce eosinophil levels in multiple clinical trials, including in a Phase 2 study in hypereosinophilic syndrome (HES) and a Phase 2 trial in chr

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