Entries by Thomas Gabrielczyk

Palbociclib companion biomarker unraveled

Researchers at the Universities of Dundee and Newcastle have identified a previously unknown target for the breast cancer drug palbociclib, which can be used to identify treatment responders. 

GMP and new processes: be prepared for hassle

Poor aseptic practices can rapidly ruin market supply of products outsourced for production. This year, Celltrion came under fire from FDA inspectors. At the end of January, the producer received a warning letter affecting the production of Inflectra biosimilar infliximab-dyyb (CT- P13) co-marketed with Pfizer. In mid-February, the FDA added a warning concerning rituximab and trastuzumab biosimilars produced for Teva, as well as for its fast-track migraine mAb fremanezumab.

German biotech sector growing

The German biotech industry has shown tremendous growth in 2017. According to figures of BIOCOM, turnover, employees or number of start-ups – many key figures for 2017 exceeded those of the record year 2016. 

Germany to boost the bioeconomy

Shortly before the Global Bioeconomy Summit (19.-20.4.2018) in Berlin will begin, Germany’s new Research Minister Anja Karliczek announced three major initiatives to strengthen the biologisation of the industry and the foundation of innovative biotechs.

GSK pass orphan gene therapy assets to Orchard Therapeutics

British drug major GlaxoSmithKline  (GSK) has passed its orphan autologous cell and gene therapy pipeline including its EU-approved ADA-SCID treatment Strimvelis to British/US Orchard Therapeutics. GSK acquired a 19,9% equity stake in Orchard and a board membership.