NOVAREMED-AG
18.12.2020 10:34:14 CET | Business Wire | Press release
Novaremed AG (Novaremed), a clinical-stage Swiss biopharmaceutical company, announced today that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the development of NRD135S.E1 for the treatment of Painful Diabetic Peripheral Neuropathy (PDPN).
“By awarding Fast Track Designation to NRD135S.E1, an investigational candidate for the treatment of PDPN, the FDA has recognized its potential to meaningfully improve outcomes for patients with this debilitating disease. This is an excellent acknowledgement as we plan to initiate our Phase 2b study,” said Sara Mangialaio, MD, PhD, Head of R&D and CMO of Novaremed. “FTD is designed to facilitate the development and expedite the review of investigational treatments that demonstrate the potential to address unmet medical needs in serious conditions.”
About Fast Track Designation
Fast Track Designation is an FDA process designed to facilitate the development, and expedite the review of, medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier, and it covers a broad range of serious illnesses. Fast Track Designation can lead to an Accelerated Approval and Priority Review, if certain criteria are met.
Notes to the Editor:
About Novaremed
Novaremed Ltd, a wholly owned subsidiary of Novaremed AG was founded in 2008 in Israel and Novaremed AG was founded in 2017 in Switzerland. Novaremed Ltd is developing NRD135S.E1, an orally active non-opioid small molecule with a novel mechanism of action against PDPN. In a Phase 2a Proof of Concept study, NRD135S.E1 showed clinically relevant reduction in patient-reported pain and an excellent safety and tolerability profile. Novaremed Ltd is currently preparing to conduct a Phase 2b study in PDPN patients in USA.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201218005198/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
IQM Named Among Quantum Collaborators in HPE's New Hybrid Quantum-HPC Platform22.6.2026 15:22:00 CEST | Press release
The collaboration will advance practical and scalable hybrid classical-quantum applications. This follows IQM's first on-premises quantum computer installation in the United States, at Oak Ridge National Laboratory. IQM has sold 23 quantum systems globally to date and intends to list on Nasdaq in the United States by mid 2026. Hewlett Packard Enterprise has named IQM Quantum Computers among the companies collaborating on its hybrid classical-quantum computing platform, announced at HPE Discover Las Vegas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260622035759/en/ IQM Radiance quantum computer at HPE Discover Las Vegas 2026 IQM, a global leader in full-stack superconducting quantum computers, is contributing superconducting quantum processor technology to the effort, in which HPE is integrating multiple quantum modalities with its Cray supercomputing infrastructure. This collaboration strengthens IQM's global expansion p
Return Abuse Goes Mainstream as Nearly Half of Consumers Use AI in Return Claims, New Riskified Research Finds22.6.2026 14:30:00 CEST | Press release
New global study shows normalization of strategic returns, widening regional differences, and rapid AI adoption reshaping ecommerce post-purchase risk Riskified (NYSE: RSKD), a global leader in ecommerce fraud detection and risk intelligence, today released a new global report, “Rewriting the Rules on Returns”, exploring how consumer attitudes and behaviors around ecommerce returns are evolving in the age of artificial intelligence (AI). The Riskified-commissioned study, conducted by eTail Insights, is based on a survey of 2,091 consumers across seven countries, alongside in-depth interviews with senior leaders from many of the largest retail companies in the world. The research finds that return abuse behaviors are increasingly normalized, while nearly half of consumers already use generative AI tools to assist with return or refund claims. At the same time, merchants are responding by tightening return policies, shortening return windows, and deploying advanced AI detection to better
Forrester Unveils Agendas For 2026 Technology & Innovation Forums In North America And EMEA22.6.2026 14:00:00 CEST | Press release
The Forums will equip technology leaders with the capabilities needed to operationalize AI and build high-performing IT organizations that deliver measurable business outcomes Forrester (Nasdaq: FORR) today announced the full conference agendas for its Technology & Innovation Forum Central (Austin, September 14–15, 2026), Technology & Innovation Forum EMEA (London, September 30–October 1, 2026), and Technology & Innovation Forum East (New York City, November 4–5, 2026). This year’s theme, “The IT Singularity,” dives into the new AI era in which AI has become ubiquitous and no longer a competitive advantage on its own. To succeed, technology leaders including chief information officers, chief data officers, and chief AI officers need to integrate AI into their operating models, modernize software development and IT operations, strengthen data and governance practices, and align technology investments with business strategy. Across the Forums, tech leaders and their teams will learn how
AdvanCell Establishes U.S. Global Headquarters and Secures Flagship Manufacturing Facility in Greater Boston to Drive Growth Strategy22.6.2026 14:00:00 CEST | Press release
New 128,000-square-foot facility in Andover will serve as U.S. global headquarters and future manufacturing center supporting the development and commercialization of ADVC001 and the Company’s pipeline of Lead-212 targeted alpha therapies Expanding U.S. operations complement the Company’s established Australian R&D and manufacturing capabilities to create a global, vertically integrated platform for radiopharmaceutical development and commercial supply AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, today announced the establishment of its U.S. Global Headquarters in the Greater Boston area, and the lease of a new 128,000-square-foot facility that will become the Company’s U.S. flagship manufacturing center supporting its long-term growth and commercialization strategy. The expansion marks an important milestone in the Company’s evolution into a U.S.-based radiopharmaceutical company with integrated operations spanning
Print Creates an Enterprise Dark Data Problem. VasionⓇ Innovated Again to Find the Solution.22.6.2026 14:00:00 CEST | Press release
Intelligent Print Automation Turns the File > Print Workflow Into an AI-Ready Data Pipeline Every time employees click File > Print to send documents to printers, save them to PDFs or scan them to unmanaged folders, enterprise data becomes unstructured and quietly goes dark. Dark data escapes compliance controls, bypasses AI workflow and quickly becomes a liability. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260622562749/en/ Vasion is the Intelligent Print Automation leader making digital transformation attainable for all by eliminating print servers, consolidating print environments, digitizing and automating workflows. Gartner® reports that “roughly 80% of enterprise information is unstructured, spread across documents, files, and rich content in dozens of systems.” Gartner® also predicts that “by 2028, large enterprises will triple their unstructured data capacity across their on-premises, edge and public cloud locati
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom