FDA to beef up cell and gene therapy staff

USA – FDA to beef up cell and gene therapy staff

Citing the 800 active INDs for cell therapy and gene therapy candidates and the expectation that it will be receiving more that 200 INDs...
L'année 2019, une année cruciale pour la loi "anti-cadeaux" !

France – L’année 2019, une année cruciale pour la loi « anti-cadeaux » !

En attendant l'application effective de la nouvelle loi "anti-cadeaux" qui devrait intervenir selon nos informations en mars 2019, la Cour d'Appel de Besançon confirme...
Ph. Eur. to replace Histamine Sensitisation Test (HIST) for residual pertussis toxin testing

Europe – Ph. Eur. to replace Histamine Sensitisation Test (HIST) for residual pertussis toxin...

The European Pharmacopoeia (Ph. Eur.) Commission has decided to replace the Histamine Sensitisation Test “HIST” (test in mice) with a standardised CHO cell clustering...
Regulatory Science to 2025

Europe – Regulatory Science to 2025

The European Medicines Agency's (EMA) draft 'Regulatory Science to 2025' strategy is a plan for advancing EMA's engagement with regulatory science over the next...
TGA Plans GCP Inspection Program

Australia – TGA Plans GCP Inspection Program to Ensure Global Recognition of Australian Data

Australia’s Therapeutic Goods Administration (TGA) is planning to run a good clinical practice (GCP) inspection pilot program. TGA sees the pilot as a stepping...
Revised guidance for elaborating monographs on radiopharmaceutical preparations: new section on validation of methods

Europe – Revised guidance for elaborating monographs on radiopharmaceutical preparations: new section on validation...

Monographs and general texts on radiopharmaceutical preparations are elaborated by experts in the field. In order to guide experts on the information to be...
Evaluation of anticancer medicinal products in man :Concept paper on the revision of the guideline

Europe – Evaluation of anticancer medicinal products in man : Concept paper on the...

This concept paper introduces revision 6 proposing amendments and add-ons to the last version of the guideline on the evaluation of anticancer medicinal products...
Revised guideline aims to strengthen global approach to development of new antibacterial medicines

Europe – Revised guideline aims to strengthen global approach to development of new antibacterial...

EMA has published a revision of its guideline on the evaluation of human medicines indicated for the treatment of bacterial infections for a six-month public consultation....
Lilly CEO on future cancer deals, gene therapy and CAR T-cells

USA – Lilly CEO on future cancer deals, gene therapy and CAR T-cells

Eli Lilly and Co remains in the hunt for cancer drugs even after announcing an $8 billion purchase of Loxo Oncology this week, but...
Solution concentrée d’infliximab : première monographie d’anticorps monoclonal dans la Ph. Eur.

Europe – Solution concentrée d’infliximab : première monographie d’anticorps monoclonal dans la Ph. Eur.

En adoptant la monographie « Infliximab (solution concentrée d’) (2928) » lors de sa 159e session (Strasbourg, 21-22 novembre 2017), la Commission européenne de...

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