Veristat Supported Marketing Applications for 12% of all FDA Novel Drug Approvals in 2021
Veristat, a scientific-minded global clinical research organization (CRO), announced today that the Company supported clients in preparing marketing applications for 12% of the 2021 U.S. Food and Drug Administration (FDA) novel drug approvals. This surpasses the number of approvals supported in 2020. In 2021, the FDA approved 50 novel drugs, defined as New Molecular Entities (NMEs).
Veristat’s bold thinking, focus, and extensive experience supporting complex drug development in rare and ultra-rare diseases significantly impacted these transformational medicines designed for patients with few or no treatment options. The work of Veristat’s innovative regulatory, statistical, and medical writing experts was vital in preparing six of these NME New Drug Applications (NDAs) and Biologics License Applications (BLAs). Veristat also prepared one supplemental New Drug Application (sNDA) for a non-NME that received FDA approval and one Marketing Authorization Application (MAA) that received approval in Europe. All but one of these 2021 approvals are for rare diseases.
“Throughout 2021 and in collaboration with our sponsors, we were able to successfully overcome the many scientific, regulatory, and data challenges that novel therapy research presents. We are grateful for the opportunity to have collaborated with our clients to achieve their goals and to bring novel therapies to patients,” stated Patrick Flanagan, Chief Executive Officer at Veristat. “Despite the remarkable advances in recent years in the understanding of rare diseases and in the approval of medicines to treat them, many unmet needs of patients remain. Our work continues with efforts such as the expansion of decentralized clinical trials that bring clinical research closer to the patient’s home.”
Since the Company’s founding 27 years ago, Veristat has collaborated with hundreds of biopharmaceutical clients around the globe to prepare more than 140 marketing applications. More than 65% of these marketing applications for rare and ultra-rare diseases. While a large majority of these engagements were with the FDA, the Company also holds an impressive track record with Health Canada and the European Medicines Agency (EMA). And with the recent acquisition of European regulatory consultancy agency Drug Development and Regulation (DDR) — and with it Dr. Xavier Luria, former Head of Safety and Efficacy of Medicines at the EMA— Veristat can provide clients with a deep understanding of the EMA and other key regulators.
“Advancing complex therapies for challenging diseases is what motivates us every day,” said John Balser, Ph.D., President & Chief Statistical Officer at Veristat. “It is gratifying to know that our scientific-minded teams were instrumental in helping clients prepare these marketing applications for therapies that received approval, thereby helping to improve the lives of patients and their families. A large part of our success, and what distinguishes Veristat, is the ability of our multi-disciplinary project teams to draw the appropriate connections amongst the fundamental constructs of the science, the practical and operational requirements of the clinical program, and the regulatory pathway, that combined provide the evidentiary basis for product approval. In 2022, Veristat will build upon our world-class biometrics, clinical, and regulatory capabilities to successfully tackle challenging diseases and meet the goals of our clients.”
Veristat, a scientific-minded global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 27 years of experience in clinical trial planning and execution, Veristat is equipped to support any development program.
Veristat's focus on novel drug development has led to success when handling the unknowns that arise across complicated therapeutic areas, such as rare/ultra-rare disease, advanced therapies, oncology, and infectious disease trials. Every day, we apply this knowledge base to solve any clinical program's challenges, from the simplest to the most complex. Veristat has assembled an extraordinary team of experts worldwide who have mastered therapeutic development intricacies, enabling sponsors to succeed in extending and saving lives.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Lauren L. Brennan, Director of Marketing
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Gunma Prefecture's Geographical Indication “GI Tone-Numata” Sake Kicks Off Its Overseas Sales on January 17!17.1.2022 09:00:00 CET | Press release
Sake’s geographical indication, “GI Tone-Numata,” which consists of four sake breweries in the Tone-Numata area of Gunma Prefecture in Japan, requires that the breweries make the most of the local water and climate, and that the type of rice used as the raw material be one of the following: Yukihotaka, Gohyakumangoku, or Koshihikari. In addition, only yeast from the local area (Gunma KAZE yeast, Gunma G2 yeast, and brewer's house yeast) can be used, and vintage can be indicated under certain conditions, so only those that meet the extremely strict criteria are certified. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220111006144/en/ 7 types of GI Tone-Numata certified sake (Photo: Business Wire) According to Mr. Shinya Tasaki, Chairman of the Japan Sommelier Association, "GI Tone-Numata is equivalent to PDO in Europe or AOC in French wine and is expected to attract worldwide attention in the future." On January 17, "GI Tone
EcoFlow Launches the DELTA Pro, its Pioneering Portable Power Station, in Europe17.1.2022 08:00:00 CET | Press release
EcoFlow, a portable power and renewable energy solutions company, has launched the industry-leading DELTA Pro portable home battery in Europe. Originally a Kickstarter campaign, it smashed records to become the most-funded tech project at the time and still ranks sixth among all projects to date. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220116005003/en/ EcoFlow DELTA Pro Portable Home Battery (Photo: Business Wire) With a base capacity of 3.6kWh and expandable to 25kWh, the DELTA Pro is the industry’s first portable home battery and can provide multiple days’ worth of backup energy to families in the case of emergencies. In September 2021, EcoFlow launched the DELTA Max and the DELTA mini in Europe, both of which are designed to offer backup power for shorter blackout periods. “DELTA Pro’s highly successful Kickstarter campaign overwhelmingly demonstrates the consumer desire for portable clean energy power and storage
TaiwanPlus Features Namewee and ABAO’s Music-Creation Journey on Its Indie Music Docuseries, “Road to Legacy”17.1.2022 07:51:00 CET | Press release
TaiwanPlus, a new global English-language video streaming platform, launches a 2022 TaiwanPlus Original Series titled “Road to Legacy,” which is a 10-episode docuseries detailing the journey to fame of these 10 bands in Taiwan. On January 17, 2022, TaiwanPlus holds the world premiere at Legacy Taipei, with the docuseries launched exclusively and free to stream worldwide via www.TaiwanPlus.com on the same day. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220116005075/en/ The TaiwanPlus Original Series will be released in three installments, kicking off with the episodes on Tizzy Bac, 88BALAZ and Nighteentael on January 17th. (Graphic: Business Wire) Since its inception, “TaiwanPlus strives to provide a platform to showcase the diverse, creative culture that flourished under Taiwan’s vibrant democracy. Following the positive reception from the TaiwanPlus Film Festival, which was an online curation of 10 iconic Taiwanese film
Seoul Semiconductor Proves the Effect of SunLike Lighting on Myopia Improvement17.1.2022 06:16:00 CET | Press release
Seoul Semiconductor Co., Ltd. (KOSDAQ 046890), a global optical semiconductor company, announced on the 17th that it has confirmed SunLike lighting’s effect on improving myopia, along with SERI_Singapore Eye Research Institute. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220116005060/en/ Experimental results on the correlation between lighting and myopia, conducted by Seoul Semiconductor and Singapore Eye Research Institute (Graphic: Business Wire) In order to prove the correlation between health and SunLike, a natural lighting technology developed through years of R&D, Seoul Semiconductor has been conducting experiments with Seoul National University, Basel University, and Harvard University since 2017. This time, with Singapore SERI, the effect of natural lighting on myopia improvement was tested. In this experiment, chicks, whose eyes are similar to humans’, were exposed to different lightings and then the length of th
Megaport Announces Expansion to Mexico, Bringing Network as a Service (NaaS) and Direct Access to Leading Cloud Services to KIO Networks16.1.2022 22:00:00 CET | Press release
Megaport Limited (ASX: MP1) ("Megaport"), a global leading Network as a Service (NaaS) provider, today announces plans to expand services to Mexico via a partnership with KIO Networks, the country’s largest data centre provider. Cloud connectivity services to Microsoft Azure and Google Cloud are expected to be available in March 2022 to local enterprises via on-ramps from KIO Networks’ data centres in Mexico City and Queretaro, subject to approvals. Customers of KIO Networks in Mexico will be able to access Megaport’s leading ecosystem of more than 700 enabled data centres worldwide and over 360 service providers, including 230+ cloud on-ramps from the world's leading clouds such as AWS, Google Cloud, Microsoft Azure, IBM Cloud, and Oracle Cloud. Businesses in Mexico can seamlessly and directly connect to cloud and IT services on a global level without the need to manage complex network infrastructure. According to IDC, Mexico is the second largest market in Latin America when it comes
Hanshow Makes US Market Debut at 2022 NRF Big Show14.1.2022 21:00:00 CET | Press release
Global digital retail solutions provider Hanshow is making its US market debut this week at the annual NRF Big Show in New York where it’s showcasing a series of new products, announcements, and partnerships. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220114005005/en/ 2022 NRF venue, the Javits Center in New York (Photo: Business Wire) Hanshow was founded ten years ago with an initial focus on just electronic shelf labels (ESL). After often triple digit annual growth, expansion across Europe, Asia Pacific and 50 countries around the world, the company is now bringing its impressive suite of digital retail solutions to the world’s largest retail market. Now after a decade of tested results with some of the world’s leading retailers including Auchan, Ahold Delhaize, Yamada Denki and many more, Hanshow believes it has the solutions US retailers need to evolve and thrive in this period of uncertainty for the retail. The comp
CI&T Acquires Somo to Accelerate Its Growth in EMEA14.1.2022 18:27:00 CET | Press release
CI&T (NYSE: CINT), a global digital specialist, announces today the execution of a sale and purchase agreement to acquire Somo Global Ltd ("Somo"), an award-winning digital product agency headquartered in the UK, to accelerate its growth in EMEA, the second-largest market for digital services. In this strategic move, Somo will join CI&T’s EMEA operation and enhance its growing operations by adding almost 300 digital specialists with deep expertise in digital products, working with some of the world’s largest brands including Audi, Vanguard, Vodafone and Virgin Media, among others. Somo is one of the UK’s leading independent digital product agencies, recognized by Econsultancy's prestigious Top 100 ranking (2019). With offices in the UK, USA and Colombia, Somo delivers digital ambitions at pace and scale across several verticals including automotive, financial services, utilities and telecom. Its strong leadership team brings a proven track record of delivering business performance, win
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom