Contradictory requests from the US FDA on the statistical analysis of Remsima are one of many regulatory hurdles facing biosimilar developers, according to Celltrion.
Biomay has licensed a yeast-based expression system from fellow Austrian biotech VTU Technologies to use for the commercial production of its recombinant allergens.
As the largest pharma and tech suppliers – from Novartis to GE Healthcare to Thermo Fisher – begin exploring the world of CRISPR/Cas gene editing technology, contract research organizations are also looking into the new tech to explore ways to help clients’ research models.
The EMA has released draft guidelines to aid the gene therapy developers, many of which it says are small companies not familiar with the regulatory environment.
Danaher's acquisition of Pall will not change the competitive landscape in the bioprocessing tech industry says Thermo Fisher, as it earmarks $10bn for further M&A activity.
Top science academics have launched an initiative to consider emerging human gene-editing tools such as CRISPR-Cas9.