{"id":752035,"date":"2023-04-27T08:58:38","date_gmt":"2023-04-27T12:58:38","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/certara-customers-received-90-percent-of-us-fda-novel-drug-approvals-for-9th-consecutive-year\/"},"modified":"2023-04-27T08:58:38","modified_gmt":"2023-04-27T12:58:38","slug":"certara-customers-received-90-percent-of-us-fda-novel-drug-approvals-for-9th-consecutive-year","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/certara-customers-received-90-percent-of-us-fda-novel-drug-approvals-for-9th-consecutive-year\/","title":{"rendered":"Certara Customers Received 90 Percent of US FDA Novel Drug Approvals for 9th Consecutive Year"},"content":{"rendered":"

\nAsserts Certara\u2019s leadership in advancing the development and approval of new drugs for patients
\n<\/h2>\n
\n

PRINCETON, N.J., April 27, 2023 (GLOBE NEWSWIRE) — Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that 90 percent of new drug approvals by the U.S. Food and Drug Administration\u2019s (FDA) Center for Drug Evaluation and Review (CDER) were received by Certara\u2019s customers in 2022.*<\/sup> This is the 9th consecutive year that Certara\u2019s customers, who use the Company\u2019s biosimulation software and technology-driven services, have had novel drugs approved by the FDA in a wide range of therapeutic indications, from oncology to rare diseases.<\/p>\n

\u201cOur biosimulation platform continues have an extraordinary impact on our client\u2019s drug development programs and the industry at-large,\u201d said Certara\u2019s CEO William Feehery, Ph.D. \u201cWe 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.\u201d<\/p>\n

Certara\u2019s Simcyp\u2122 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\u2122 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\u2019s 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.<\/p>\n

\n View FDA Approvals for 2022<\/a>\n <\/p>\n

*excludes diagnostic agents<\/p>\n

About Certara<\/p>\n

Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.<\/p>\n

Certara Contact<\/p>\n

Ron DiSantis
ron.disantis@certara.com<\/p>\n

Media Contact:<\/p>\n

Ariane Lovell
Finn Partners
ariane.lovell@finnpartners.com<\/p>\n

Investor Relations Contact:<\/p>\n

David Deuchler
Gilmartin Group
ir@certara.com<\/p>\n

\n
\n
\n \n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Asserts Certara\u2019s leadership in advancing the development and approval of new drugs for patients PRINCETON, N.J., April 27, 2023 (GLOBE NEWSWIRE) — Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that 90 percent of new drug approvals by the U.S. Food and Drug Administration\u2019s (FDA) Center for Drug Evaluation and Review (CDER) were received by Certara\u2019s customers in 2022.* This is the 9th consecutive year that Certara\u2019s customers, who use the Company\u2019s biosimulation software and technology-driven services, have had novel drugs approved by the FDA in a wide range of therapeutic indications, from oncology to rare diseases. \u201cOur biosimulation platform continues have an extraordinary impact on our client\u2019s drug development programs and the industry at-large,\u201d said Certara\u2019s … <\/p>\n

Continue reading “Certara Customers Received 90 Percent of US FDA Novel Drug Approvals for 9th Consecutive Year”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-752035","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nCertara Customers Received 90 Percent of US FDA Novel Drug Approvals for 9th Consecutive Year - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/certara-customers-received-90-percent-of-us-fda-novel-drug-approvals-for-9th-consecutive-year\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Certara Customers Received 90 Percent of US FDA Novel Drug Approvals for 9th Consecutive Year - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Asserts Certara\u2019s leadership in advancing the development and approval of new drugs for patients PRINCETON, N.J., April 27, 2023 (GLOBE NEWSWIRE) — Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that 90 percent of new drug approvals by the U.S. Food and Drug Administration\u2019s (FDA) Center for Drug Evaluation and Review (CDER) were received by Certara\u2019s customers in 2022.* This is the 9th consecutive year that Certara\u2019s customers, who use the Company\u2019s biosimulation software and technology-driven services, have had novel drugs approved by the FDA in a wide range of therapeutic indications, from oncology to rare diseases. \u201cOur biosimulation platform continues have an extraordinary impact on our client\u2019s drug development programs and the industry at-large,\u201d said Certara\u2019s … Continue reading "Certara Customers Received 90 Percent of US FDA Novel Drug Approvals for 9th Consecutive Year"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/certara-customers-received-90-percent-of-us-fda-novel-drug-approvals-for-9th-consecutive-year\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2023-04-27T12:58:38+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODgyNjQwOSM1NTU5NzY0IzIyMDQ3MTY=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/certara-customers-received-90-percent-of-us-fda-novel-drug-approvals-for-9th-consecutive-year\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/certara-customers-received-90-percent-of-us-fda-novel-drug-approvals-for-9th-consecutive-year\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Certara Customers Received 90 Percent of US FDA Novel Drug Approvals for 9th Consecutive Year\",\"datePublished\":\"2023-04-27T12:58:38+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/certara-customers-received-90-percent-of-us-fda-novel-drug-approvals-for-9th-consecutive-year\\\/\"},\"wordCount\":349,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/certara-customers-received-90-percent-of-us-fda-novel-drug-approvals-for-9th-consecutive-year\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODgyNjQwOSM1NTU5NzY0IzIyMDQ3MTY=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/certara-customers-received-90-percent-of-us-fda-novel-drug-approvals-for-9th-consecutive-year\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/certara-customers-received-90-percent-of-us-fda-novel-drug-approvals-for-9th-consecutive-year\\\/\",\"name\":\"Certara Customers Received 90 Percent of US FDA Novel Drug Approvals for 9th Consecutive Year - 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