In another blow to discovering a treatment for Alzheimer’s, Roche revealed that preliminary data from two clinical trials meant it was cancelling studies using crenezumab.
The explosion of the gene therapy industry is leading to supply issues, which has led one company to view producing its own clinical materials as its best option.
The contract market for bringing biologics through the pipeline to commercialisation is growing at a rapid clip, with a recent report suggesting a high CAGR in the sector.
GE Healthcare and G-CON have combined capabilities to offer drug developers ‘readily deployable’ manufacturing platforms for cell therapies and viral vectors.
Celgene and Kyn Therapeutics enter a licensing agreement to develop Kyn’s immuno-oncology pipeline for investigative therapies after Celgene was acquired by BMS.
European generics industry faces opposition while pushing for the SPC manufacturing waiver to be altered so it allows for the production of drugs under patent for non-EU countries.
Reaching the central nervous system is a difficult task, and getting a high enough dose to it poses an issue as well, but innovations are well underway to bridge a path across the blood-brain barrier.
The US FDA is faced with lapsed funding appropriations as the US government shutdown continues, causing the agency to focus on addressing immediate threats to consumer safety.
Biosimilar approvals in the US have increased by 600% and with biologic patent expiration dates approaching, biosimilar applications are on the rise as well.
Fujifilm has launched an upgrade to its subsidiaries manufacturing capabilities, by increasing capacity by 50% at an existing facility and building an entirely new site for cell technology.
2018 saw an increase in the number of biosimilar approvals, and the expiry of patents on major products that allowed the entry of biosimilars across Europe.
Eli Lilly and Innovent announced that their jointly developed anti-PD-1 drug gained approval in China, becoming the second domestically produced treatment of this type.
With nearly 300 cell and gene therapies in development, targeting more than 100 diseases, 2019 could be set to be a big year for cell and gene therapies.
Rentschler Biopharma will buy Shire’s development and manufacturing facility in Milton, Massachusetts, where the latter makes haemophilia A product, Obizur, for commercial production.