Harald Enzmann was elected new Chair of the CHMP. © EMA

The CHMP elected Harald Enzmann as its new Chair on Friday, and recommended thirteen medicines for approval, three thereof orphan medicines.

© Euronext

European stock exchange operator Euronext kicked off its fourth annual capital markets training programme for non-listed companies – this time also including companies from Germany, Italy, Spain, and Switzerland.

© Novo Nordisk

Novo Nordisk A/S (NOVOB:DC) said it plans to restructure its entire Research & Development (R&D) organization. Consequently, the company will lay off 400 employees from R&D roles in Denmark and China.

Prof. Dr. Dolores J Schendel is CEO of Medigene AG. From 19982013, Prof. Schendel was
Director of the Institute of Mole-
cular Immunology of the German Research Center for Environmental Health at the Helmholtz Center in Munich. Previous to this, she served as a university professor for immunology at the Ludwig-Maximilian-University, focusing on human cellular immunology and T cell responses within the field of oncology. Prof. Schendel is the author of more than 200 scientific publications.

Following last year’s approval by the US FDA, the EU’s EMA has  now also approved the first two T-cell-based immunotherapies against certain types of cancer. This marks the ultimate proof-of-concept for the acceptance of patient-individualised cellular immunotherapies. The regulatory authorities have moved fast, together with the companies and manufacturers, to bring these products to patients as quickly as possible. This is a good start but what does the future hold?

© Pharming Group NV

The FDA has requested additional clincal data demonstrating that Pharming Group’s recombinant C1 esterase blocker Ruconest can prevent hereditary angioedema attacks (HAE).

Vanessa King, Virion President & CEO (Photo: Business Wire)

Virion Biotherapeutics announced the appointments of Vanessa King, PhD, as President & Chief Executive Officer this week.

Freezed PEC-Direct cells. © Viacyte Inc.

CRISPR Therapeutics AG announced a development partnership with ViaCyte Inc to develop genome-edited pancreatic islet cells, which do not require immunosuppression, to treat diabetes.

carlbjartmar.jpg

Ascelia Pharma announced on Friday Spetember 14 that Carl Bjartmar, MD, PhD, has been appointed as new Chief Medical Officer (CMO) for Ascelia Pharma. Carl has most recently worked as CMO for Wilson Therapeutics.

Regeneron headquarters in Tarrytown. © Regeneron Inc

Positive Phase 3 results with Sanofi/Regeneron‘s IL4/IL-13-targeting antibody dupilumab (Dupixent) in adolescents with moderate-to-severe atopic dermatitis will form the basis of a regulatory submission in this new patient population, according to announcements of Sanofi.

Bild: Torbjørn Furuseth

Targovax ASA (Targovax or the Company; OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard to treat solid tumors, announces the appointment of Dr. Torbjørn Furuseth as CFO, effective 24 September 2018. Dr. Erik Digman Wiklund, currently Targovax’s CFO, will become Chief Business Officer, replacing Michael Bogenstaetter