- Biotechnology
- Wednesday, 24 Jun 2020
Philogen Received Combination Pack Approval for Nidlegy
Philogen S.p.A., a privately-owned biotechnology company, is pleased to announce that, on Jan. 30, 2020, EMA's CHMP expressed a favorable opinion to the request of a combination pack for the to-be-marketed pharmaceutical form of NidlegyTM, a combination of the active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF). NidlegyTM is being developed as a neoadjuvant intralesional treatment for resectable Stage III melanoma patients and in locally advanced, not metastatic nonmelanoma skin cancers. NidlegyTM combination pack has now received confirmation of eligibility to the centralized procedure for submission of an application for a Union Marketing Authorisation under Article 3(1) - Indent 1 - Biotech medicinal product of Regulation (EC) No 726/2004.
"We are extremely pleased to record EMA's agreement to our strategy for the marketing of NidlegyTM as a combination pack that was considered by CHMP 'indispensable for public health reasons,'" commented Prof. Dario Neri, co-founder and President of the Scientific Advisory Board of Philogen.
Related Industry Updates
Microbial Identification Methods Market is expected to reach US$ 8,164.74 million by 2030
Sep 25, 2023
Healthcare Quality Management Market Is Rising With Post COVID-19 Impact Analysis, Development, CAGR , Forecast To 2021-2027
Mar 31, 2021
Intracardiac Echocardiography Market Size and Trends Study Released by Top Publisher at : Abbott oston Scientific Corporation, Koninklijke Philips N.V
Apr 06, 2021
Middle East and Africa Organoids market is expected to Rise US$ 141.26 million in 2027
Mar 15, 2021
Oligonucleotide Synthesis Market 2021-2027: Demand Analysis, Industry Size, Share, Growth Factor, Revenue, Challenges, Segments, Key Manufacturers, Globally Development, Competition Strategies and Forecast to 2027
Feb 17, 2021
Analyzing Impacts Of COVID-19 On Fundus Cameras Market Effects, Aftermath And Forecast To 2027
Apr 20, 2021
Biopsy Devices Market 2021-2027: Demand Analysis, Industry Size, Share, Growth Factor, Revenue, Challenges, Segments, Key Manufacturers, Globally Development, Competition Strategies and Forecast to 2027
Apr 08, 2021
Follow us on
