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Friday, 25 September 2020
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Wednesday, 24 Jun 2020 01:00 pm

Philogen Received Combination Pack Approval for Nidlegy

"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.

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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.

Tags Philogen S.p.A Biotechnology Combination pack Pharmaceutical NidlegyTM Treatment

Neha Pandey

Aware of her elements, Neha writes the best articles across industries including electronics & semiconductors, automotive & transportation and food & beverages. Being from the finance background she has the ability to understand the dynamics of every industry and analyze the news updates to form insightful articles. Neha is an energetic person interested in music, travel, and entertainment. Since past 5 years, she written extensively on sectors like technology, finance and healthcare.


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