Entries by Thomas Gabrielczyk

EU Regulation of Genome Editing in Plants not yet a law

A long-awaited draft regulation from the EU Commission’s DG Sante to deregulate the authorisation, risk assessment and labelling of a whole range of new genetically modified organisms (GMOs) has been published today by the College of the Commission. New Genomic Techniques (NGT) are introduced as an umbrella term for certain genetic engineering techniques that aim to modify DNA more precisely than "old" methods by targeting changes to pre-defined loci in the genome. The proposal creates two distinct pathways for NGT plants to be placed on the market. "Category 1 NGTs" are considered equivalent to conventionally bred plants and no longer require prior case-by-case risk assessment.

Biosimilars climb the alps

Generic and biosimilar manufacturer Sandoz is expanding with a new biologics production facility in Lendava, Slovenia to prepare for more demand in Europe for biosimilar products.

Sweden: Biobank law

The Sweden Biobank Act governs the collection, storage, and usage of identifiable human material samples for specific purposes.

Cell & Gene Therapies: time for celebration?

Six years after the first approved cell and gene therapy, the field is living a renaissance. 5 additional FDA-approved therapies were added in 2022 and could be doubled in 2023, setting a new pace to cell & gene therapies. The BioRN Annual Conference on September 29th in Heidelberg will highlight next-generation approaches in the field.

Cell & Gene Therapies: time for celebration?

Six years after the first approved cell and gene therapy, the field is living a renaissance. 5 additional FDA-approved therapies were added in 2022 and could be doubled in 2023, setting a new pace to cell & gene therapies. The BioRN Annual Conference on September 29th in Heidelberg will highlight next-generation approaches in the field.

Donaldson Acquires Belgian Univercells Technologies for €138m

Donaldson Company, Inc. (NYSE: DCI), a heritage provider of innovative filtration products and solutions, announced the acquisition of Univercells Technologies (Belgium), a global provider of innovative biomanufacturing solutions for cell and gene therapy research, development and commercial manufacturing.

Mega Series C in Switzerland

Alentis is the only company developing potential treatments for solid cancers and fibrosis targeting Claudin-1 (CLDN1). The molecule is significantly involved in the tight junction between cells. Now the company closed a three digit million Seriec C round.