Veristat Congratulates Origin Biosciences for FDA Approval of Nulibry during the Week of Rare Disease Day 2021
Strengthening its Track Record of Successful Client Regulatory Approval Outcomes
SOUTHBOROUGH, MA – January 14, 2021 – Veristat, a scientific-minded global clinical research organization (CRO), announced today that they supported the marketing applications for 10% of the 2020 US Food and Drug Administration (FDA) novel drug approvals. The FDA approved 53 novel drugs, defined by the FDA as New Molecular Entities (NMEs)[i], and Veristat regulatory, statistical, and medical writing experts were integral in preparing five of these NME New Drug Applications. Veristat also prepared NDA/BLAs for three non-NME FDA approvals and one Marketing Authorization Application (MAA) that received approval in Europe.
In early 2019, Veristat helped Antibe Therapeutics, a biotech company with a drug platform of game-changing therapeutics in pain and inflammation, initiate the second part of their phase 2B dose-ranging, efficacy study for ATB-346. To date, this is one of the largest studies completed in Canada consisting of 360 patients with osteoarthritis (“OA”) of the knee, across 40 clinical sites.
Upon receiving approval from Health Canada, Antibe Therapeutics selected Veristat to immediately begin work on part one of a Phase 2B dose-ranging, efficacy study for their lead drug candidate ATB-346. The study will run in Canada and is expected to conclude in December 2018.
Veristat’s Continued Innovation of Its Clinical Development Strategies and Services Allow the Company to Execute High Quality Trials That Reach Regulatory Approval
SOUTHBOROUGH, MA – August 15, 2018 – Veristat, a full service Clinical Research Organization (CRO), proudly announces its recognition once again by Inc. Magazine as one of the 5000 fastest-growing private companies in the United States.
Veristat’s Growth Positively Impacts Our Ability to Help Clients Achieve Regulatory Approval of their Life-Changing and Life-Saving Therapies
SOUTHBOROUGH, MA – August 21, 2017 – Veristat announced today that it has been recognized for a third consecutive year by Inc. Magazine as one of America’s fastest-growing private companies. Veristat joined the list in 2015.
SOUTHBOROUGH, MA – June 19, 2017 – Veristat, a full service Clinical Research Organization (CRO), announced today that Veristat and AOBiome, a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions, have entered into a Preferred Provider Agreement (PPA).