DANISH BIO – DANSK BIOTEK organizes four major plenary meetings for our members throughout the year to increase our members' knowledge regarding specific biotech topics and to facilitate networking. The events usually take place in February, May, September and November.

We also organize approximately four "saloon" meetings annually. They are small, intimate, "meet the expert" meetings with typically 6-20 participants advocating more in-depth discussion and knowledge-sharing on specific themes.

02 Feb 2023

Y-mAbs and the European Medicines Agency Reach Agreement on the Pediatric Investigation Plan for Naxitamab

NEW YORK, Feb. 02, 2023 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the European Medicines Agency (“EMA”) has agreed to the Company’s proposed Pediatric Investigation Plan (“PIP”) for naxitamab. The decision follows a positive opinion from EMA’s Pediatric Committee (“PDCO”). Naxitamab is being developed by Y-mAbs for the treatment of patients with relapsed/refractory high-risk neuroblastoma, which is the indication targeted by the PIP, as well as osteosarcoma.

A PIP outlines a pharmaceutical company’s strategy for investigation of the new medicinal product in the pediatric population and is a required submission as part of the regulatory process for the registration of new medicines in Europe. An approved PIP is a prerequisite for filing a Marketing Authorization Application (“MAA”) for any new medicinal product in Europe.

Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests related to the compound and Y-mAbs.

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