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Partnering: VasoDynamics Signs a Long-term Partnership Agreement with Cambrex for the Supply of Active Pharmaceutical Ingredients.
“We are delighted to partner with Cambrex for its large-scale supply capacity and long-standing record of producing high-quality API as well as providing the associated technical and regulatory support for our three topical vasoconstriction products, ahead of global registration trials and commercialisation in the near future.”
Regulatory: VasoDynamics is accepted for Parallel Scientific Advice Meeting with EMA-FDA
We are delighted to have been accepted for PSA and look forward to meeting with EMA & FDA in early 2026. The number of products which have been successfully accepted for PSA is typically around 4-5 per year, we appreciate the recognition of our preventive drug product NG11-2 by EMA-FDA and we look forward to achieving the optimal development and market access path to tackle the severe oral mucositis condition suffered by patients with head and neck cancer undergoing (chemo)radiotherapy.
NG13-2 Clinical Study: MHRA Scientific Advisory Meeting on Clinical Study Design and Approval Path
We are pleased to have received the positive feedback along with detailed supportive advice during a fruitful Scientific Advisory meeting. We appreciate the MHRA granted us this opportunity to discuss the NG13-2 Phase2/3 trial design and further development in detail, providing a roadmap for bringing our NG13-2 product to the market in the near future!
Setting Footprint in Europe: VasoDynamics setting up VDL Pharma B.V. in Leiden Bioscience Park, the Netherlands
We are pleased to have completed the registration of VDL Pharma B.V. at the leading life science cluster, Leiden Bioscience Park, with tremendous support from the Netherlands Foreign Investment Agency and the Innovation Quarter. This represents an important step for VasoDynamics to (re)gain access to the wealth of drug development resources and regulatory support in Europe, and further pave our path to European collaborators, partners and markets.
UK MHRA Scientific Advice on Pivotal Trial of NG13-2, a Novel Product for the Prevention of Chemotherapy-Induced Alopecia
We are pleased to receive the confirmation of the Scientific Advisory meeting date from MHRA. We greatly appreciate the opportunity to discuss and obtain advice on the protocol design for the NG13-2 pivotal trial and the approaches for market approval in UK and beyond. This is a stepping stone for us to clarify the roadmap to bring NG 13-2 to the patients-in-need and the market in the UK and worldwide.
UK MHRA Scientific Advice on Pivotal Trial of NG11-2, a Novel Product for the Prevention of Oral Mucositis
VasoDynamics Ltd, the pharmaceutical company developing patient-friendly therapies for the prevention of debilitating side-effects induced by anti-cancer treatments, is pleased to announce that the company has received supportive feedback from the MHRA on the approach to a pivotal Phase 2b/3 trial and market approval for NG11-2, a novel product for the prevention of severe oral mucositis induced by radiotherapy.