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
SLB to Support Offshore Production Restoration for Brunei Shell Petroleum18.8.2026 14:06:00 CEST | Press release
Integrated execution model combines multiple disciplines to improve recovery from mature offshore assets Global energy technology company SLB (NYSE: SLB) today announced it has been awarded a contract by Brunei Shell Petroleum (BSP) to support production restoration from shut-in wells across multiple offshore fields. The contract scope spans subsurface evaluation, well candidate selection, engineering and offshore execution. Project management, intervention services, monitoring, metering and marine logistics are integrated within a single coordinated execution model designed to support efficient production restoration. “Building on our long collaboration in the region, this contract reflects a shared commitment to maximizing value from existing offshore resources,” said Gokhan Yarim, senior vice president of Integration, SLB. “Together with BSP, we are combining SLB’s production expertise and integrated execution capabilities to help restore production from shut-in wells, increase reco
BeOne Medicines, BeOne Care Foundation, and The Max Foundation Renew Partnership to Expand Access to BRUKINSA® for the Treatment of Chronic Lymphocytic Leukemia in Low- and Middle-Income Countries18.8.2026 12:00:00 CEST | Press release
Renewed collaboration builds on access provided to more than 300 patients with CLL to date and plans to support approximately 1,000 patients through 2028 BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, together with the BeOne Care Foundation, a nonprofit charitable foundation, and The Max Foundation, a leading global health nonprofit organization, today announced the renewal of their partnership through 2028 to expand access to BRUKINSA® (zanubrutinib) for the treatment of chronic lymphocytic leukemia (CLL) in low- and middle-income countries, with the program projected to support approximately 1,000 patients cumulatively. Building on a collaboration launched in 2023, the renewed partnership reflects the organizations’ shared commitment to improving access to innovative cancer treatments in underserved communities. To date, the partnership has enabled access to BRUKINSA for more than 300 patients with CLL across Armenia, Ethiopia, and
Quectel Launches Android 16 Smart Modules for 4G and 5G IoT Devices18.8.2026 10:00:00 CEST | Press release
New SH602FA and SE505FE smart modules combine Android 16 with integrated wireless connectivity to accelerate industrial and commercial IoT development Quectel Wireless Solutions, a global end-to-end IoT solutions provider, today announces the launch of two new Android 16 smart modules: the SH602FA, a high-performance 4G smart module, and the SE505FE, an entry-level 5G smart module. Designed for industrial and commercial IoT applications, the new modules combine Android 16, integrated wireless connectivity and powerful multimedia capabilities in compact form factors that simplify development and accelerate time-to-market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260818272981/en/ Quectel launches Android 16 smart modules for 4G and 5G IoT devices By bringing Android 16 to both 4G and 5G IoT devices, Quectel enables developers to build smarter connected products with richer user interfaces, enhanced multimedia performance
Queue-it Announces Majority Investment from THL Partners18.8.2026 09:00:00 CEST | Press release
Partnership will support continued product innovation and global expansion for the online traffic orchestration platform Queue-it, a global provider of online traffic orchestration solutions, today announced that it has entered a definitive agreement for a majority investment from THL Partners (“THL”), a premier investment firm investing in middle-market growth companies. Together, THL and Queue-it will focus on accelerating product innovation and expanding the company’s global reach. Founded and headquartered in Denmark, Queue-it helps enterprises and public organizations manage online traffic surges, protect digital infrastructure, mitigate bots and abuse, and deliver fair, reliable access to critical online services. Its platform is trusted by organizations around the world and operates across ticketing, retail, government, financial services, and other mission-critical industries. THL’s partnership with Queue-it builds on the firm’s longstanding investment focus on IT Operations &
THL Partners opkøber danske Queue-it af GRO og investerer i næste fase af den spændende vækstrejse18.8.2026 09:00:00 CEST | Pressemeddelelse
Partnerskabet skal understøtte fortsat produktinnovation og global ekspansion for teknologiplatformen til orkestrering af onlinetrafik. Queue-it, global leverandør af løsninger til orkestrering af onlinetrafik, annoncerede i dag, at virksomheden har indgået en endelig aftale om en majoritetsinvestering fra THL Partners ("THL"), et førende investeringsselskab med fokus på mellemstore vækstvirksomheder. Sammen vil THL og Queue-it fokusere på at accelerere produktinnovation og udvide virksomhedens globale rækkevidde. Queue-it blev grundlagt i Danmark i 2010 og har hovedkontor i København men servicerer i dag de største brands og organisationer i hele verden. Virksomheden hjælper virksomheder og offentlige organisationer med at håndtere spidsbelastninger i onlinetrafik, beskytte digital infrastruktur, reducere bot-aktivitet og misbrug samt sikre fair og pålidelig adgang til kritiske digitale tjenester. Platformen anvendes af organisationer over hele verden inden for blandt andet billetsalg
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