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
TEC reduces pressure on support teams with proactive outage communications powered by Adtran and GOCare11.8.2026 14:15:00 CEST | Press release
News summary: Fiber broadband providers need faster, more transparent ways to manage outages and reduce support surges TEC is now using GOCare OutageIQ integrated with Adtran’s outage notification API and Mosaic One to automate subscriber messaging Open APIs turn network insight into actionable workflows, improving responsiveness and operational efficiency Adtran and GOCare today announced that Telephone Electronics Corporation (TEC) has improved outage responses and reduced inbound support tickets using GOCare’s OutageIQ solution integrated with Adtran’s outage notification API and Mosaic One. Serving communities across Mississippi, Alabama and Tennessee, TEC delivers fiber broadband services built on a foundation of community investment and reliable service. By combining proactive notifications with real-time network insights, the service provider can now inform customers as issues are detected while equipping support teams with immediate context. This transparency helps build subscr
Kinaxis-Sponsored Study Identifies Supply Chain AI Accountability Gap Amidst Rapid Adoption Expectations11.8.2026 14:07:00 CEST | Press release
Trust, measurable outcomes, and governance lag, even as 41% expect autonomous-at-scale operations within two years Kinaxis® (TSX:KXS), a global leader in supply chain orchestration, today announced the findings of new independent research from IDC. The IDC InfoBrief, sponsored by Kinaxis, “Making Supply Chain AI Accountable,” reveals a growing chasm between organizations’ aggressive ambitions for autonomous AI adoption and their readiness to hold these advanced systems - which we believe underscores the need for a disciplined approach to AI investment and deployment to prevent costly failures and deliver measurable business value. What This Means for Supply Chain Leaders The IDC InfoBrief, which surveyed more than 2,000 supply chain leaders across nine global markets, found that while AI adoption is nearly universal - only 2% of respondents report no AI-enabled capabilities, and just 12% consider themselves AI leaders. Over half (52%) cite trust in AI-driven decisions as a top barrier
One in Four Executives Say AI Errors Have Reached External Audiences or Boards, According to New Research From Workiva11.8.2026 14:00:00 CEST | Press release
Although 84% of executives are at least somewhat confident in AI output without human review, only 11% believe their data quality is sufficient for AI use Workiva Inc. (NYSE: WK), a leading, audit-ready platform for trust, transparency, and accountability, today released findings from its 2026 Midyear Executive Benchmark Survey. Although 84% of surveyed executives say they are at least somewhat confident in the accuracy of AI output without human review, one in four (26%) say internal audits have detected AI errors that reached external audiences or board members. This data suggests there is a disconnect between what executives believe and what evidence shows. As AI reshapes the enterprise at unprecedented speed, a new risk is emerging: transformation could be outpacing the instincts of the leaders tasked with overseeing it. "Confidence in AI without control over data quality is a liability, not a strategy. CFOs need platforms that connect AI to trusted, auditable data so every output
Altasciences Continues to Expand North American Bioanalytical Footprint11.8.2026 14:00:00 CEST | Press release
Altasciences today announced a major expansion of its North American bioanalytical laboratory footprint, reinforcing its commitment to helping sponsors accelerate drug development through increased capacity, advanced automation, and harmonized scientific operations. The expansion includes a 4,000-square-foot addition to the company’s laboratory in Greater Montréal, which is expected to be fully operational by the end of Q3 2026. The company has also announced a new 13,000-square-foot purpose-built laboratory in Harleysville, Pennsylvania. Construction will proceed in phases, with Phase 1 scheduled for completion in Q1 2027. These investments significantly increase Altasciences' ability to support the growing demand for late-stage clinical bioanalysis while providing sponsors with greater flexibility, scalability, and operational resilience. Designed to support increasingly complex development programs, the expanded laboratories will result in increased capacity to conduct larger studie
Alfasigma to Acquire Nordic Group B.V. Expanding Its Specialty Care Portfolio and Presence in Europe11.8.2026 13:30:00 CEST | Press release
Transaction highlights Advances Alfasigma’s M&A-led global growth strategy, purposely focused on immunology and gastroenterology. Synergy with Alfasigma’s specialty rheumatology portfolio, adding Nordic Pharma’s rheumatoid arthritis business, including the Nordimet® franchise. Expands footprint by adding Canada and Japan; strengthens presence in Europe, with direct operations in 18 countries, with 265 employees. Adds approximately €190 million in 2025 revenue. Financial terms of the transaction are not disclosed. Alfasigma S.p.A. (“Alfasigma”), a global pharmaceutical company, today announced that it has entered into a share purchase agreement with SEVER Life Sciences B.V. ("SEVER") for the sale of 100% of the shares of Nordic Group B.V. (“Nordic Pharma”) and its subsidiaries, a privately owned specialty pharmaceutical company with direct operations in Europe, Canada and Japan. The acquisition will add Nordic Pharma’s established rheumatoid arthritis business, led by the Nordimet® meth
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