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
Ant International’s Alipay+ Adds New Bank Partners Amid Cross-border Mobile Payment Boom in Asia Pacific24.7.2026 06:10:00 CEST | Press release
Through Alipay+, banks are able to quickly build new revenue streams, increase digital engagement and introduce new value-added services for users through cross-border payments Alipay+, Ant International's unified wallet gateway, is adding more bank partners to its network of over 50 leading digital wallets and financial institutions. Its global bank partners range from incumbent banks to fully digital banks. The latest banking partner to join Alipay+ is Hang Seng Bank, Alipay+’s first banking partner in Hong Kong. Hang Seng Mobile App users can now make payments via QR code scan in the Chinese Mainland and overseas by simply using the Hang Seng Mobile App at over 100 million merchants across more than 55 countries/regions. Accelerating revenue growth through cross-border mobile payments Demand for outbound cross-border payments from Asia Pacific is projected to increase faster than the global average. Alongside growing adoption of digital wallets, consumer-to-consumer (C2C) and consum
mimik Operationalizes Agentic AI on the AMD Ryzen™ AI Embedded X100 Series23.7.2026 20:30:00 CEST | Press release
mimik today announced mimOE™ Embedded Edition, a package of its Agentix Operating Engine and a set of purpose-built tools for the AMD Ryzen™ AI Embedded X100 Series processor, the newest processor in a family designed for physical AI, autonomous systems, and industrial automation. Available to download today, mimOE Embedded Edition gives OEMs, tier-1 suppliers, system integrators, and agent developers the path to operationalize Agentix-Native systems (aka Agentic AI), in which autonomous agents can reason, coordinate, and act directly on devices, from PoC to scaled operations with certainty. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260723555565/en/ Agentic AI operations are both CPU and GPU bound. Enterprises can now scale with certainty. Generative AI has centered on the GPU. Agentix-Native systems must spread the work. In a real multi-agent workflow traced by mimik, more than 80 percent of operations were CPU work: d
U.S. Federal Court Permanently Bans 19 Online Sellers of Fake Urolithin A Supplements and Awards $5.3 Million in Damages to Timeline23.7.2026 16:27:00 CEST | Press release
Default judgment follows Timeline’s independent laboratory testing showing products sold under 19 online brands contained no detectable Urolithin A, or far less than advertised Timeline (Amazentis SA), the Swiss life-sciences company that pioneered the postbiotic ingredient Urolithin A and its branded form Mitopure®, together with its U.S. subsidiary Timeline Longevity, Inc., announced today that the U.S. District Court for the District of Massachusetts has granted the companies’ motion for default judgments and permanent injunctions against 19 online sellers found to have marketed and sold nutritional supplements falsely advertised as containing Urolithin A. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722951066/en/ Timeline longevity supplement powered by Mitopure; proprietary, highly pure Urolithin A. The order, entered July 15, 2026 by Judge Myong J. Joun in Amazentis SA et al. v. The Partnerships and Unincorporated
TestMu AI Introduces the Source-to-Verdict Loop in Kane CLI, Carrying Every Requirement to a Ship Decision With Portable Proof23.7.2026 15:45:00 CEST | Press release
Kane CLI now takes a requirement all the way to a ship-or-hold verdict, designing the tests, running them in a real browser, and emitting an open .evidence proof pack that teammates, AI agents, and auditors can all verify, with no server or dashboard required TestMu AI (formerly LambdaTest), the world's first Agentic AI-powered Quality Engineering platform, introduced a source-to-verdict loop in Kane CLI, its natural-language testing tool. Building on Kane CLI's evolution from a browser automation tool, the loop carries a product requirement to a ship decision, writing the tests, running them in the local browser, collecting the proof, measuring coverage from what actually happened, and returning a verdict. As AI agents write, run, and fix tests, a green checkmark is no longer enough: a step that checks nothing passes, a test written against a spec that changed weeks ago passes, and an agent that says “done” without the click ever landing passes. Empty green and earned green are the sa
Norway’s health system adopts Wolters Kluwer UpToDate Enterprise Edition23.7.2026 15:30:00 CEST | Press release
Enterprise Clinical Decision Support solution available to 30,000 clinicians in more than 50 Norwegian hospitals Wolters Kluwer Health announced that Norway’s health system has renewed its adoption of UpToDate Enterprise Edition, a market-leading Clinical Decision Support (CDS) solution, for its nationwide health system which includes over 50 public hospitals and 11,000 beds in over 20 trusts. This extends a 15 year partnership with Helsebiblioteket, now part of the Norwegian Institute of Public Health (NIPH). Helping clinicians on a national scale Kjell Tjensvoll, Team Leader for Helsebiblioteket said, ‘‘Providing frontline teams with easy access to the latest medical knowledge is vital in reducing unwarranted variation and improving patient care on a national scale. UpToDate Enterprise Edition enables this, and we are delighted to strengthen our relationship with Wolters Kluwer and provide continued support for clinicians across the country.’’ UpToDate Enterprise Edition was selected
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