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Firma Clinical Research, an ISO quality management-certified clinical research organization (CRO), is pleased to announce its contribution to the FDA approval of Melinta Therapeutics’ lead antibiotic, Baxdela™ (delafloxacin), for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria.
Firma was selected by Melinta to provide clinical pharmacology consulting, medical writing, and statistical services for the clinical trials and regulatory submission of their drug Baxdela™. “We’re thrilled to support the Melinta team in this FDA approval, and gratified this product will be available for patients suffering with ABSSSI,” noted Christina Fleming, Ph.D., Chief Scientific Officer and President, Clinical Research Services for Firma. “Applying our specialized services to provide direct client value is what our team members strive to accomplish.”
“The approval of Baxdela is a significant milestone for the company, and for our valued partners,” said Eugene Sun, M.D., CEO of Melinta. “We thank you for your efforts in helping us secure Baxdela approval.”
“This project marks the 49th NDA submission our team has successfully supported,” notes Eugenia Henry, Ph.D., President, Biostatistics and Data Management Services for Firma. “The Melinta team has been great to work with, and we’re proud our collaborative partnership allowed us to ensure accurate study results and speed quality submission for approval.”
About Melinta Therapeutics
Melinta Therapeutics, Inc. is dedicated to saving lives threatened by the global public health crisis of bacterial infections, through the discovery, development and commercialization of novel antibiotics that provide new and better therapeutic solutions. Melinta’s lead product is Baxdela, an antibiotic approved for use in the treatment of acute bacterial skin and skin structure infections (ABSSSI). The company is headquartered in New Haven, CT with offices in Lincolnshire, IL. Visit www.melinta.com for more information or contact email@example.com.
About Firma Clinical Research
An ISO 9001:2015 quality-certified organization, Firma Clinical supports the drug development efforts of pharmaceutical and biotech companies through advanced in-home patient visits, data management & biostatistics, medical writing, regulatory consulting, clinical pharmacology, and clinical operations. Built on decades of clinical leadership and expertise, Firma is dedicated to a collaborative approach that accelerates the development of safe and effective treatments for the pharmaceutical, biotechnology, and medical device industries. For more information, please visit www.firmaclinical.com.
Firma Clinical Research
Michael Keens, 434-249-5225
Chief Commercial Officer
Clinical Research Organization
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