Welcome!

News Feed Item

Helsinn Announces European Medicines Agency Acceptance of Regulatory Submission for Netupitant-palonosetron Fixed Dose Combination (NEPA)

LUGANO, Switzerland, January 29, 2014 /PRNewswire/ --

NEPA is currently under development for the treatment of chemotherapy-induced nausea and vomiting

The Swiss pharmaceutical Helsinn Group announced today that on January 22nd the European Medicines Agency (EMA) determined netupitant-palonosetron fixed dose combination (NEPA)  Marketing Authorisation Application (MAA) to be valid.

"With the EMA submission, and the recently submitted New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), we are close to bringing a new potentially effective treatment for improving the quality of life of many patients with cancer worldwide. Our netupitant-palonosetron fixed dose combination is designed to prevent one of the most dreaded effects of emetogenic chemotherapy and is part of our pipeline of pharmaceutical and nutritional supplement products dedicated to cancer supportive care, still an area of significant unmet medical needs", said Riccardo Braglia, CEO of the Helsinn Group.

About netupitant-palonosetron fixed dose combination (NEPA)

NEPA is a novel single-day fixed-dose combination of a highly selective NK1 receptor antagonist, netupitant, and a pharmacologically and clinically distinct

5-HT3 receptor antagonist, palonosetron targeting two critical pathways associated with chemotherapy induced nausea and vomiting (CINV).

The phase III investigational clinical program has recently been concluded.

In November 2013 and in January 2014, respectively, the FDA and the EMA have accepted for substantive review the applications. The proposed indication is prevention of acute and delayed CINV in highly and moderately emetogenic cancer chemotherapy.

About the Helsinn Group

Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and operating subsidiaries in Ireland, the United States and a representative office in China. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in therapeutic niche areas. Helsinn is an important player in cancer supportive care. Helsinn Group in-licenses early-to-late stage new chemical entities, completes their development through the performance of pre-clinical/clinical studies and Chemistry, Manufacturing, and Control (CMC) development, and files and attains their market approvals worldwide. Helsinn's products are out-licensed to its network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how whom Helsinn assists and supports by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice. The active pharmaceutical ingredients and the finished products are manufactured according to the highest quality, safety, and environmental standards at Helsinn's GMP facilities in Switzerland and Ireland and supplied worldwide to its customers.

Further information on Helsinn Group is available at http://www.helsinn.com.

Helsinn Group
Paola Bonvicini
Head of Communication & Press Office
PH +41-91-985-21-21
[email protected]

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Recently, REAN Cloud built a digital concierge for a North Carolina hospital that had observed that most patient call button questions were repetitive. In addition, the paper-based process used to measure patient health metrics was laborious, not in real-time and sometimes error-prone. In their session at 21st Cloud Expo, Sean Finnerty, Executive Director, Practice Lead, Health Care & Life Science at REAN Cloud, and Dr. S.P.T. Krishnan, Principal Architect at REAN Cloud, discussed how they built...
When talking IoT we often focus on the devices, the sensors, the hardware itself. The new smart appliances, the new smart or self-driving cars (which are amalgamations of many ‘things'). When we are looking at the world of IoT, we should take a step back, look at the big picture. What value are these devices providing. IoT is not about the devices, its about the data consumed and generated. The devices are tools, mechanisms, conduits. This paper discusses the considerations when dealing with the...
Bill Schmarzo, author of "Big Data: Understanding How Data Powers Big Business" and "Big Data MBA: Driving Business Strategies with Data Science," is responsible for setting the strategy and defining the Big Data service offerings and capabilities for EMC Global Services Big Data Practice. As the CTO for the Big Data Practice, he is responsible for working with organizations to help them identify where and how to start their big data journeys. He's written several white papers, is an avid blogge...
Business professionals no longer wonder if they'll migrate to the cloud; it's now a matter of when. The cloud environment has proved to be a major force in transitioning to an agile business model that enables quick decisions and fast implementation that solidify customer relationships. And when the cloud is combined with the power of cognitive computing, it drives innovation and transformation that achieves astounding competitive advantage.
Sanjeev Sharma Joins November 11-13, 2018 @DevOpsSummit at @CloudEXPO New York Faculty. Sanjeev Sharma is an internationally known DevOps and Cloud Transformation thought leader, technology executive, and author. Sanjeev's industry experience includes tenures as CTO, Technical Sales leader, and Cloud Architect leader. As an IBM Distinguished Engineer, Sanjeev is recognized at the highest levels of IBM's core of technical leaders.
When building large, cloud-based applications that operate at a high scale, it's important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. "Fly two mistakes high" is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Le...
Machine learning has taken residence at our cities' cores and now we can finally have "smart cities." Cities are a collection of buildings made to provide the structure and safety necessary for people to function, create and survive. Buildings are a pool of ever-changing performance data from large automated systems such as heating and cooling to the people that live and work within them. Through machine learning, buildings can optimize performance, reduce costs, and improve occupant comfort by ...
René Bostic is the Technical VP of the IBM Cloud Unit in North America. Enjoying her career with IBM during the modern millennial technological era, she is an expert in cloud computing, DevOps and emerging cloud technologies such as Blockchain. Her strengths and core competencies include a proven record of accomplishments in consensus building at all levels to assess, plan, and implement enterprise and cloud computing solutions. René is a member of the Society of Women Engineers (SWE) and a m...
JETRO showcased Japan Digital Transformation Pavilion at SYS-CON's 21st International Cloud Expo® at the Santa Clara Convention Center in Santa Clara, CA. The Japan External Trade Organization (JETRO) is a non-profit organization that provides business support services to companies expanding to Japan. With the support of JETRO's dedicated staff, clients can incorporate their business; receive visa, immigration, and HR support; find dedicated office space; identify local government subsidies; get...
With 10 simultaneous tracks, keynotes, general sessions and targeted breakout classes, @CloudEXPO and DXWorldEXPO are two of the most important technology events of the year. Since its launch over eight years ago, @CloudEXPO and DXWorldEXPO have presented a rock star faculty as well as showcased hundreds of sponsors and exhibitors! In this blog post, we provide 7 tips on how, as part of our world-class faculty, you can deliver one of the most popular sessions at our events. But before reading...
Containers and Kubernetes allow for code portability across on-premise VMs, bare metal, or multiple cloud provider environments. Yet, despite this portability promise, developers may include configuration and application definitions that constrain or even eliminate application portability. In this session we'll describe best practices for "configuration as code" in a Kubernetes environment. We will demonstrate how a properly constructed containerized app can be deployed to both Amazon and Azure ...
This is going to be a live demo on a production ready CICD pipeline which automate the deployment of application onto AWS ECS and Fargate. The same pipeline will automate deployment into various environment such as Test, UAT, and Prod. The pipeline will go through various stages such as source, build, test, approval, UAT stage, Prod stage. The demo will utilize only AWS services including AWS CodeCommit, Codebuild, code pipeline, Elastic container service (ECS), ECR, and Fargate.
Behera Rasananda is a technologist, a leader, a key note speaker has more than 20 years experience in across Government, Financial, Heath Care and Insurance Verticals. Mr. Behera has vast experience in Enterprise Cloud and Big Data solutions and Enterprise Architecture. Currently he works closely for Government Solutions on Enterprise Cloud for Federal Government Agency. Scientist Behera managed and partner with clients to make complete end to end solution and Migration to cloud both private sec...
Digital Transformation: Preparing Cloud & IoT Security for the Age of Artificial Intelligence. As automation and artificial intelligence (AI) power solution development and delivery, many businesses need to build backend cloud capabilities. Well-poised organizations, marketing smart devices with AI and BlockChain capabilities prepare to refine compliance and regulatory capabilities in 2018. Volumes of health, financial, technical and privacy data, along with tightening compliance requirements by...
Today, we have more data to manage than ever. We also have better algorithms that help us access our data faster. Cloud is the driving force behind many of the data warehouse advancements we have enjoyed in recent years. But what are the best practices for storing data in the cloud for machine learning and data science applications?