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
SERI Lugano Launches International Scientific Outreach Initiative on Light-Based Neuroscience and Pineal Gland Research18.5.2026 15:38:00 CEST | Press release
Researchers and clinicians from Switzerland expand interdisciplinary communication efforts integrating neuroscience, photobiomodulation, infrasound, and nutraceutical research As scientific interest in light-based stimulation, neuroendocrine regulation, and integrative medicine continues to grow internationally, the Switzerland Eye Research Institute (SERI Lugano) has launched a new international scientific outreach initiative focused on public engagement and interdisciplinary research communication in neuroscience and cellular modulation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260515840289/en/ Ophthalmologist Roberto Pinelli explains, in an engaging personal narrative style, his unique methods for using a combination of light, sound, and nutraceuticals to non-invasively activate the pineal gland to promote cellular rejuvenation, decrease aging, and improve overall well-being. Supported by case studies and peer-revi
TwentyTwo Real Estate to Acquire Terhills Resort in Belgium from LRM18.5.2026 15:00:00 CEST | Press release
TwentyTwo Real Estate, an independent European real estate investment and management firm, announces it has agreed to acquire Terhills Resort in Belgium from LRM. The transaction is expected to close on 29 May 2026. Operated by Center Parcs, the premium holiday park spans 63 hectares and comprises 250 waterfront cottages alongside central leisure facilities, set within a unique natural environment at the gateway to Hoge Kempen National Park. Center Parcs will remain the operator of the resort for at least the next 10 years, ensuring continuity for guests and supporting the long-term positioning of the resort as a leading leisure destination in Limburg, one of Flanders’ most distinctive tourism regions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513424487/en/ Opened in 2021, Terhills Resort forms part of the broader long-term transformation of the surrounding area into a leading nature, tourism and leisure destination.
Thermo Fisher Scientific’s PPD Clinical Research Business Expands Bioanalytical Capabilities with New Laboratory in Gothenburg, Sweden18.5.2026 14:30:00 CEST | Press release
The state-of-the-art facility enhances support for complex modalities across all phases of drug developmentKey facts Thermo Fisher opensnew bioanalytical and biomarker laboratory in Gothenburg, Sweden Designed to deliver comprehensive, full-service bioanalytical and biomarker solutions Supports pharmaceutical and biotechnology customers across all phases of drug development Helps customers globally accelerate innovation and bring new therapies to patients faster Thermo Fisher Scientific, the world leader in serving science, today announced the opening of a new bioanalytical and biomarker laboratory in Gothenburg, Sweden, located within GoCo Health Innovation City. This new facility expands the company’s global bioanalytical capabilities to support pharmaceutical and biotechnology customers across all phases of drug development. With state-of-the-art instrumentation and Good Laboratory Practice (GLP) capabilities, the laboratory provides rapid, reliable bioanalytical and biomarker servi
HistoSonics Receives Landmark TFDA Approval in Taiwan, Accelerating Global Expansion18.5.2026 14:00:00 CEST | Press release
HistoSonics, the developer of the Edison® Histotripsy System and novel histotripsy therapy platform, today announced it has received approval from the Taiwan Food and Drug Administration (TFDA) for the Edison® System, representing a significant milestone in the company’s global expansion efforts and continued growth across Asia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260518694013/en/ HistoSonics Edison® Histotripsy System Taiwan is widely recognized as one of the most advanced and strategically important medical device markets in the region, known for its rigorous regulatory standards and highly innovative physician community. The TFDA approval process included a detailed review of the company’s clinical and regulatory submission package and concluded with unanimous agreement from committee members. The approval further reinforces the growing clinical and regulatory momentum behind histotripsy, a non-invasive, non-th
FurtherAI Appoints Tom Bradley to Lead UK and EU Expansion18.5.2026 14:00:00 CEST | Press release
FurtherAI, the AI platform purpose-built for insurance, today announced the appointment of Tom Bradley to lead its UK and EU operations. This marks a significant step in FurtherAI's international expansion, as the company moves to establish a local presence in one of the world's most important insurance markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260518611218/en/ FurtherAI Appoints Tom Bradley to lead UK & EU expansion FurtherAI is already working with leading partners in the UK, and Tom's appointment will allow the company to deepen those relationships, build a local team, and serve the rapidly growing demand from carriers, MGAs, and brokers across the Lloyd's market and the wider region. A market moving fast on AI The Lloyd's market and the broader UK and European insurance ecosystem are adopting AI at a pace few would have predicted even twelve months ago. From submission gateways to policy audits to claims, o
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