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
Study: Heatwaves Increase Cough Urge, Which Salt Aerosols Reduce15.9.2026 15:15:00 CEST | Press release
New Study Indicates Non-Pharmacological Aerosol May Provide Therapeutic Relief for Respiratory Conditions Provoked by the Atmospheric Aridity Inherent to Heatwaves SC Therapeutics, with University North Carolina, Imperial College London, and Boston University, announced publication on Tuesday in Nature Scientific Reports of results from a multi-institutional study indicating that the aridity inherent in heatwaves increases cough hypersensitivity in human airways by collapsing mucus onto cilia in a manner common to chronic respiratory diseases, such as cystic fibrosis, and asthma. The researchers find that alkaline aerosols of magnesium salts reverse mucosal collapse for several hours, and reduce cough hypersensitivity as reflected in placebo-adjusted suppression of daily cough bout rate (59%, p=0.03) and persistence of suppression post treatment for 1 to 3 weeks in a randomized, double-blind, placebo-controlled study of 10 refractory chronic cough patients. “Paris recorded 5,764 excess
ADM’s Fourth Annual Regenerative Agriculture Report Highlights Growing Resilience Across the Food System15.9.2026 15:00:00 CEST | Press release
2025 programs engaged more than 56,000 farmers across 4.6 million acres in 11 countries ADM (NYSE: ADM), a global leader in innovative solutions from nature, today released its fourth annual regenerative agriculture report, showing how its programs are supporting farmers, strengthening agricultural supply chains and delivering measurable environmental outcomes around the world. “Resilience starts on the farm. By improving and protecting soil health, farmers can be better equipped to adapt to changing conditions and maintain productive operations,” said Greg Morris, SVP and President, Ag Services and Oilseeds, ADM. “That resilience can extend across the value chain, helping strengthen the food system we all depend on.” In 2025, ADM’s regenerative agriculture programs engaged more than 56,000 farmers across approximately 4.6 million acres, 11 countries and 10 crops. Compared with regional benchmarks, the programs resulted in approximately 946,000 metric tons of CO₂e reductions. “ADM view
Diligent Unveils New Agentic Capabilities in Diligent One to Power the Future of Governance, Risk and Compliance15.9.2026 15:00:00 CEST | Press release
New capabilities help organizations move from fragmented information to confident action while keeping people in control Diligent, the AI leader in governance, risk and compliance (GRC) solutions, today announced a major enhancement to Diligent One, its native AI platform, at Gartner’s Enterprise Risk, Audit and Compliance Conference (ERAC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260915941016/en/ “For many organizations, GRC work is slowed by fragmented systems, manual coordination and time-consuming reporting processes,” said Brian Stafford, President and CEO of Diligent. “Our latest agentic capabilities help teams cut through that complexity by connecting context, surfacing what matters and driving faster execution — while keeping governance and professional judgement at the center." An orchestration agent that coordinates work and approvals The orchestration agent in Diligent One gives GRC professionals a natural-
Unifocus Launches AI-Powered Platform to Transform Workforce and Operations Management in Hospitality15.9.2026 15:00:00 CEST | Press release
Combining enterprise-grade labor and operations technology on an AI-native platform, Unifocus Claira redefines workforce management and enables hospitality teams to make faster, more informed decisions. The global hospitality technology provider, Unifocus, has announced the launch of its newest AI platform, Unifocus Claira. Unifocus Claira is an industry first end-to-end workforce management and operations platform, purpose-built to give hoteliers and above-property hospitality organizations complete visibility across the workforce lifecycle through one cohesive system. By replacing the patchwork of disconnected tools, multiple technology stacks and siloed data systems that have traditionally been used to manage labor and operations processes, Unifocus Claira delivers one connected AI-native platform, providing customers with a comprehensive and organized view of their workforce and operations data. This unified data foundation powers advanced AI capabilities designed to accelerate dec
Rochester Electronics Heads to electronica Munich 2026, Sponsors Women in Tech Forum15.9.2026 15:00:00 CEST | Press release
Meet Rochester Electronics in Hall C4, Booth 161, with WE United onsite | Munich Trade Fair Center Rochester Electronics, LLC, a premier continuous source of authorized semiconductors and licensed semiconductor manufacturing, will exhibit at electronica 2026 in Munich, Germany — the world's leading trade fair and conference for electronics — from Hall C4, Booth 161. WE United, a nonprofit leadership organization serving the global technology and electronics industry, will co-exhibit at Rochester's booth as part of Rochester's ongoing sponsorship of the organization. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260915116544/en/ Rochester Electronics Heads to electronica Munich 2026, Sponsors Women in Tech Forum Rochester will also sponsor the Women in Tech Forum, hosted by Electronic Specifier at electronica Munich 2026. The forum takes place on 11 November at 9:00 a.m. on the Future Tech Stage and will bring together indus
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