|By PR Newswire||
|January 24, 2014 02:52 PM EST||
MIAMI, Jan. 24, 2014 /PRNewswire/ -- NextSource BioTechnology, LLC, (NSB), an emerging Specialty Pharmaceutical Manufacturing and Marketing Company focused on Consolidating, Re-Branding and Launching "Matured & Orphan Drugs," has announced its most recent product Lomustine (CCNU), formerly known as CeeNu® by Bristol-Myers Squibb (BMS), which has officially been removed from the U.S. Food & Drug Administration (FDA) Drug Shortage List. As a result of this new status, Lomustine (CCNU) is now readily available through NextSource's Nationwide Authorized Distribution supply chain. Please visit us at: http://www.nextsourcebiotechnology.com/authorized_distributors.aspx
Due to the successful product re-launch and market availability of Lomustine (CCNU), there is no longer a need for continued use of the unregulated compound equivalent product. Pharmacies currently compounding this product are doing so against the FDA Code of Federal Regulations.
Lomustine (CCNU) will continue to be distributed under the current name, while the pending FDA "Brand" name is under review for approval. Lomustine (CCNU) is the first of many "Matured Drugs" to be launched under the NextSource Biotechnology portfolio.
"Our launch of LOMUSTINE," said Robert DiCrisci, President, CEO of NextSource Biotechnology, "is an example of the NextSource commitment to work proactively with the FDA in an effort to prevent the discontinuation of existing and future drugs that are vital in the application of a well balanced treatment plan of traditional proven therapies and New therapy options that healthcare providers and patients in the hospital settings require under the new healthcare guidelines."
About Lomustine (CCNU) - INDICATIONS AND USES
Lomustine (CCNU) is an oral chemotherapy medication that is used to treat Primary and Metastatic Brain Cancer. Lomustine belongs to a class of drugs known as nitrosourea anti-tumor alkylating agent. Unlike the more common nitrogen mustard alkylating agents, Lomustine (CCNU) crosses the blood-brain barrier quite effectively due to its high lipid solubility and the relative lack of ion-ization at physiological pH and is used in the treatment of both primary and metastatic brain tumors in patients. It works by bonding with DNA of rapidly dividing cells causing breakage of the DNA strands and eventually, the death of the cancer cell.
Lomustine (CCNU) has been shown to be useful as a single agent in addition to other treatment modalities, or in an established combination therapy with other approved chemotherapeutic agents in the following:
Brain tumors- Both primary and metastatic, in patients who have already received appropriate surgical and/or radio therapeutic procedures.
Hodgkin's disease- secondary treatment in combination with other approved drugs in patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.
About our Partner: CordenPharma is an expert Contract Manufacturing partner helping leading pharmaceutical and biotechnology companies link their requirements for product success with their patients' healthier lives. CordenPharma has subsequently been the long-term manufacturing partner of the Lomustine product for both NextSource Biotechnology and Bristol Myers Squibb (CeeNu®).
Formed as a pharmaceutical branch of International Chemical Investors Group in 2006, CordenPharma provides specialized technologies that are ideal for the development and manufacturing of oral, sterile, highly potent and antibiotic pharmaceutical Drug Products, their Active Pharmaceutical Ingredients, and associated Global Supply Chain and Packaging Services.
1. Lomustine Package Insert: www.nextsourcebio.com
2. U.S. Food and Drug Administration (FDA) Current Resolved Drug Shortages Index. Available at: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050793.htm
3. Press Release: http://www.nextsourcebiotechnology.com/news_and_media.aspx
SOURCE NextSource BioTechnology, LLC
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Feb. 8, 2016 08:00 PM EST Reads: 131
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
Feb. 8, 2016 06:30 PM EST Reads: 167
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...
Feb. 8, 2016 03:00 PM EST
SYS-CON Events announced today that VAI, a leading ERP software provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. VAI (Vormittag Associates, Inc.) is a leading independent mid-market ERP software developer renowned for its flexible solutions and ability to automate critical business functions for the distribution, manufacturing, specialty retail and service sectors. An IBM Premier Business Part...
Feb. 8, 2016 03:00 PM EST Reads: 574
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed...
Feb. 8, 2016 02:00 PM EST Reads: 342
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
Feb. 8, 2016 02:00 PM EST Reads: 378
In most cases, it is convenient to have some human interaction with a web (micro-)service, no matter how small it is. A traditional approach would be to create an HTTP interface, where user requests will be dispatched and HTML/CSS pages must be served. This approach is indeed very traditional for a web site, but not really convenient for a web service, which is not intended to be good looking, 24x7 up and running and UX-optimized. Instead, talking to a web service in a chat-bot mode would be muc...
Feb. 8, 2016 02:00 PM EST Reads: 210
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes ho...
Feb. 8, 2016 01:30 PM EST Reads: 175
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
Feb. 8, 2016 12:45 PM EST Reads: 357
Advances in technology and ubiquitous connectivity have made the utilization of a dispersed workforce more common. Whether that remote team is located across the street or country, management styles/ approaches will have to be adjusted to accommodate this new dynamic. In his session at 17th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., focused on the challenges of managing remote teams, providing real-world examples that demonstrate what works and what do...
Feb. 8, 2016 12:30 PM EST Reads: 237
As enterprises work to take advantage of Big Data technologies, they frequently become distracted by product-level decisions. In most new Big Data builds this approach is completely counter-productive: it presupposes tools that may not be a fit for development teams, forces IT to take on the burden of evaluating and maintaining unfamiliar technology, and represents a major up-front expense. In his session at @BigDataExpo at @ThingsExpo, Andrew Warfield, CTO and Co-Founder of Coho Data, will dis...
Feb. 8, 2016 12:30 PM EST Reads: 145
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
Feb. 8, 2016 12:00 PM EST Reads: 160
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
Feb. 8, 2016 10:45 AM EST Reads: 384
SYS-CON Events announced today that AppNeta, the leader in performance insight for business-critical web applications, will exhibit and present at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. AppNeta is the only application performance monitoring (APM) company to provide solutions for all applications – applications you develop internally, business-critical SaaS applications you use and the networks that deli...
Feb. 8, 2016 10:15 AM EST Reads: 366
It's easy to assume that your app will run on a fast and reliable network. The reality for your app's users, though, is often a slow, unreliable network with spotty coverage. What happens when the network doesn't work, or when the device is in airplane mode? You get unhappy, frustrated users. An offline-first app is an app that works, without error, when there is no network connection.
Feb. 8, 2016 09:45 AM EST Reads: 172