Asserts Certara’s leadership in advancing the development and approval of new drugs for patients
PRINCETON, N.J.— 4월 27, 2023 – Certara, Inc. 글로벌 바이오시뮬레이션 선두기업(Nasdaq: CERT), a global leader in biosimulation, today announced that 90 percent of new drug approvals by the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Review (CDER) were received by Certara’s customers in 2022.* 이는 Certara의 바이오시뮬레이션 소프트웨어와 기술 기반 서비스를 사용하는 당사의 고객이 종양학에서 희귀 질환에 이르는 광범위한 치료 적응증에서 9년 연속으로 FDA(Food and Drug Administration)의 신약 승인을 받은 것입니다.
“Our biosimulation platform continues have an extraordinary impact on our client’s drug development programs and the industry at-large,” said Certara’s CEO William Feehery, Ph.D. “We remain committed to our mission of safely accelerating the drug development process by lowering the cost and increasing the probability of success in trials, to improve the health and well-being of millions of people, globally.”
Certara’s Simcyp™ PBPK Simulator has now been used to inform more than 300 drug label claims for over 100 novel drugs, in lieu of conducting clinical studies. Phoenix™ PK/PD software is also used extensively by biopharmaceutical companies to understand how a drug moves through and out of the body. Both Simcyp and Phoenix software are used by the FDA to evaluate drug applications. Certara’s technology-driven services, including model-informed drug development and regulatory writing and submission support, contributed to eight oncology drugs, two drugs for orphan diseases, two drugs that received priority review or accelerated approval in 2022, and one EUA for treatment of moderate/severe COVID-19.
*excludes diagnostic agents
Certara 소개
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. 2,00062 Certara의 고객으로는 전 세계 62개국에 걸쳐 2,000개 이상의 글로벌 바이오 제약 회사, 선도적인 학술 기관 및 주요 규제기관들이 있다.
Certara Contact
Ron DiSantis
ron.disantis@certara.com
Media Contact:
Ariane Lovell
Finn Partners
ariane.lovell@finnpartners.com
Investor Relations Contact:
David Deuchler
Gilmartin Group
ir@certara.com
