businesswire | August 31, 2023
Nexus Pharmaceuticals LLC announced it has received U.S. Food and Drug Administration (FDA) approval for 0.9% Sodium Chloride Injection, USP in 10mL and 20mL Single-Dose Vials.
“This product is part of an expanding portfolio of products that address critical healthcare challenges,” said Omair Ahmed, Chief Operating Officer. “Sodium Chloride Injection is used to treat patients every day in every hospital in the United States. We are grateful to be able to bolster the supply of this critical-need product.”
Nexus Pharmaceuticals’ 0.9% Sodium Chloride Injection, USP is expected to launch in October and will be available in cartons of 25 vials.
About 0.9% Sodium Chloride Injection, USP
Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection.
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
About Nexus Pharmaceuticals LLC
Nexus Pharmaceuticals LLC, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.
prnewswire | July 06, 2023
Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of seven abstracts in Parkinson's disease (PD) at the 9th Congress of the European Academy of Neurology (EAN), which was held in Budapest, July 1-3, and the 6th World Parkinson Congress (WPC), being held in Barcelona, July 4-7.
"Our presence at EAN and WPC this year underscores MTPA's dedication to investigating potential treatment options to tackle the current unmet needs and challenges of Parkinson's disease," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "We're excited to share our progress with the global scientific community, including the presentation of key findings from a number of clinical trials evaluating ND0612 in people with Parkinson's disease experiencing motor fluctuations."
Clinical development of investigational ND0612 is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), MTPA's parent company. If regulatory approval for ND0612 is obtained, MTPA intends to commercialize the therapy in the U.S.
Presentations at EAN
Presentations highlighted findings from two ongoing studies of investigational ND0612 in people with PD with motor fluctuations, including topline results from the Phase 3 multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial evaluating the efficacy, safety and tolerability of ND0612, in addition to three-year outcomes from the Phase 2b open-label BeyoND study evaluating the long-term safety of ND0612. Additionally, results were shared from an open-label pharmacokinetic study assessing the relative bioavailability of levodopa when administered with ND0612 vs. oral levodopa/carbidopa (LD/CD).
Summary of results from a Phase 3 study of subcutaneous levodopa/carbidopa infusion with ND0612
(Nelson Lopes, M.D.; NeuroDerm)
Continuous subcutaneous levodopa/carbidopa infusion for PD: Summary of results from the 3-Year data from the BeyoND study
(Nelson Lopes, M.D.; NeuroDerm)
Relative bioavailability of levodopa administered as a subcutaneous infusion with ND0612 versus oral IR levodopa/carbidopa
(Sophia Sopromadze, M.D.; NeuroDerm)
Presentations at WPC
New data from a post-hoc analysis from the 28-day open-label Study 006 will be presented, evaluating the early efficacy of investigational ND0612 in reducing motor fluctuations in study participants treated with a 24-hour ND0612 infusion regimen, along with findings from four case studies describing the long-term (up to five years) experience of participants in the Phase 2b BeyoND study receiving ND0612 treatment. Additional presentations will highlight the development of a Motor Fluctuations Patient Journey Map (MFPJM) for people with PD to describe the holistic patient experience from pre-diagnosis through hospice care with a focus on motor fluctuations, and details on enrollment characteristics of randomized study participants in the Phase 3 BouNDless study. All posters will be on display in the Exhibit Hall during Poster Session 1 from 11:30 a.m. – 1:30 p.m. CEST on July 5.
ND0612 is an investigative drug-device combination therapy – a 24 hours/day, continuous subcutaneous infusion of liquid levodopa/carbidopa (LD/CD) for people with Parkinson's disease (PD) experiencing motor fluctuations.
About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to commercialize approved pharmaceutical products in North America.
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future". MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction and additionally working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis.
About NeuroDerm, Ltd.
NeuroDerm, Ltd. is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), based in Israel, inspired to reduce disease burden and improve the quality of life of patients and their families through innovative drug-device combination therapies and technologies. NeuroDerm is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates.
PRNewswire | August 17, 2023
Frontage Laboratories, Inc. and its wholly-owned subsidiary, Frontage Canada, Inc., completed the acquisition of Nucro-Technics Inc. and its affiliate Nucro-Technics Holdings, Inc.
Nucro-Technics is a pharmaceutical contract research organization that conducts analytical chemistry, microbiology, toxicology, bioanalytical, and stability sample storage and testing services. In addition, it provides consulting services, especially in quality control and assurance as well as in Natural Health Product Regulations.
Nucro-Technics, located in the Toronto, Canada metropolitan area, operates in a state-of-the-art 60,000 square foot facility and employs personnel having expertise in testing both large and small molecules designed to treat various medical conditions. For over 50 years, Nucro-Technics has been conducting studies for various clients including major pharmaceutical, biotech, and medical device companies, as well as smaller organizations including industry trade groups and academia. Nucro-Technics has successfully developed and validated numerous methods, as well as participated in providing comprehensive IND packages to clients for regulatory submissions. Nucro-Technics, an ISO 9001:2015 certified organization, conducts studies that are in compliance with GLP and GMP regulations.
"Today marks a momentous and an exciting occasion. It is a day to celebrate two great companies coming together. It is with great pleasure that I welcome the extraordinary Nucro-Technics team to the Frontage family," said Dr. Abdul Mutlib, CEO of Frontage. "Nucro-Technics has been recognized as a leader in the Canadian CRO market for over 50 years, and its unparalleled client services is a perfect match for the culture of Frontage Laboratories. This acquisition not only significantly strengthens our presence in Canada, but also will enable the combined organization to offer a more expansive suite of services to clients across the globe. We are looking forward to partnering with the Nucro team to deliver the world-class expertise that clients have come to expect from us."
According to Dr. Song Li, Founder and Chairman of Frontage: "Nucro has developed a remarkable platform with a truly impressive team of experts. The closing of this transaction marks the next step in our ongoing effort to build Frontage into one of the major players in the global CRO market. In doing so, we will continue our focus on delivering the highest levels of quality, technology and expertise to our clients."
"I'm delighted to announce that we will be partnering with Frontage Labs for the next phase of Nucro Technics' growth journey. Since founding the business in 1970, we've worked hard to become the North American boutique in pre-clinical and drug product release testing services. Partnering with Frontage Labs marks an exciting chapter in the evolution of our efforts to support and accelerate pharmaceutical research and development," said John Fanaras of Nucro Technics.
Frontage was advised by Borden Ladner Gervais LLP (BLG) while Nucro-Technics was advised by Dentons and PricewaterhouseCoopers Corporate Finance Inc.
Frontage Holdings Corp (1521.HK), together with its wholly owned subsidiary Frontage Laboratories, Inc., is a global Contract Research Organization (CRO) which provides integrated, science-driven, product development services from drug discovery to late phase clinical process to enable biopharmaceutical companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions.