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
MediaCo Appoints Brian Fisher as President21.7.2026 22:15:00 CEST | Press release
Leadership Appointments Align Executive Team to Support Company's Next Phase of Growth MediaCo Holding Inc. (Nasdaq: MDIA) today announced executive leadership appointments that align the Company's leadership structure to support its long-term growth strategy. Effective immediately, Brian Fisher has been appointed President of MediaCo. Albert Rodriguez will continue to serve as Chief Executive Officer, focusing on the Company's long-term strategy, growth initiatives and shareholder value, while Fisher assumes responsibility for leading the Company's day-to-day operations and execution. The Company also announced that Roberto Castro has been appointed Interim Chief Financial Officer and Interim Treasurer, overseeing the Finance organization while a search is conducted for a permanent Chief Financial Officer. "MediaCo has built tremendous momentum, and these leadership appointments position us well for our next phase of growth," said Albert Rodriguez, Chief Executive Officer of MediaCo.
Footprint Expands Into PE-Free Cups, Bringing a Proven, Recyclable and Home-Compostable Alternative to Plastic-Lined Paper Cups Into Production21.7.2026 18:00:00 CEST | Press release
Move strengthens Footprint’s European manufacturing platform and supports growing demand for practical alternatives to single-use plastic Footprint, a materials science and technology company focused on eliminating single-use plastics, today announced it has acquired a recyclable, home-compostable, polyethylene (PE)-free hot and cold cup platform from Transcend Packaging, along with next-generation paper lid and straw solutions. Transcend Packaging is a European company focused on innovation in sustainable packaging solutions. Together, the cup, lid, and straw expand Footprint’s portfolio with a proven solution for the global cup market. Footprint will begin scaling its new PE-free solution through its Poland facility as the company expands across Europe, with North America to follow. As operations ramp in Poland, Footprint will work with Transcend through a manufacturing partnership to support customer continuity across Europe and meet growing demand for practical alternatives to plas
Spectro Cloud Launches PaletteAI Inference Launchpad to Reduce Enterprise Token Costs by up to 70%21.7.2026 16:00:00 CEST | Press release
New turnkey, locally managed PaletteAI Inference Launchpad helps enterprises control token costs with local-first inference, while expanded PaletteAI support for AMD gives customers more choice across GPUs, models and AI infrastructure stacks. Spectro Cloud, a leading provider of AI infrastructure management software, today launched PaletteAI Inference Launchpad, a turnkey, locally managed solution designed to help enterprises reduce token costs by as much as 70% and run AI inference closer to their data, applications and users. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260721597271/en/ The company also announced expanded PaletteAI support for AMD-powered AI infrastructure, including AMD GPUs, AMD GPU Operator, ROCm™ runtime, and the AMD enterprise AI reference stack — including AMD-optimized models from the AMD Inference Microservices (AIMs) catalog. Together, the announcements expand PaletteAI as one platform for prod
RecVue Launches First AI Native Agentic Revenue Operating System21.7.2026 15:03:00 CEST | Press release
New agentic architecture for RevOS runs enterprise revenue across the order-to-cash lifecycle and surfaces cross-system intelligence RecVue, the leader in billing and revenue management solutions, today announced the evolution of RecVue RevOS into the industry's first Agentic Revenue Operating System. In an architectural shift, the now-native agentic revenue management platform moves revenue operations beyond AI-assisted workflows to fully governed, autonomous execution with more than 50 purpose-built agents that work across contracts, invoices and payment data to predict risk, surface anomalies and escalate exceptions throughout the quote-to-cash lifecycle. Enterprise revenue operations have long suffered from a structural gap between billing systems that generate invoices and ERP systems that record transactions. Finance teams face tedious, manual reconciliation month after month, often resulting in delayed cash, billing errors that generate disputes, revenue leakage from ungoverned
Yubico Extends Passkeys Beyond Trusted Authentication to Verified Authorization with Launch of YubiKey 5.821.7.2026 15:00:00 CEST | Press release
YubiKey 5.8 extends hardware-backed assurance from authentication into emerging digital signature, wallet, payment and agentic approval workflows Yubico (NASDAQ STOCKHOLM: YUBICO), the pioneer of phishing-resistant authentication and creator of the original passkey, the YubiKey, today announced the general availability of its YubiKey 5.8 – marking an expansion of the role of the passkey from secure authentication to include verifiable, hardware-backed authorization. The new firmware delivers a foundation for secure enterprise workflows across identity wallets, document signing, and AI-driven approvals, while also providing developers with the critical capabilities needed to test, design and deploy these next-generation security features early. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260721286409/en/ As generative and agentic AI mature to drive rapid, automated cyberattacks, traditional multi-factor authentication (MFA
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