Genentech is to build a new biologics facility at its Oceanside, California campus that it says will be at the forefront of next-generation manufacturing and environmentally sustainable production for small-batch commercial biologics.
The two co-founders of JHL Biotech, Racho Jordanov and Rose Lin, were sentenced by the US Department of Justice for their roles in conspiring to commit trade secret theft and wire fraud.
Biogen has exercised its option to participate in the development and commercialization of mosunetuzumab, an investigational T-cell engaging biospecific antibody targeting CD20 and CD3 in development for B-cell non-Hodgkin’s lymphoma and other therapeutic...
The news most interesting to our readers were those featuring collaborations, whether in the production of an Ebola vaccine, biosimilars entering new markets or creating new manufacturing modalities.
The US FDA has followed up a public recall request to AmEx by hosting the manufacturer’s notice of a voluntary recall of Avastin, after sterility concerns.
Genentech will collaborate with biopharma company Parvus to manufacture and commercialize Navacim therapeutics for the treatment of autoimmune disease.
Genentech receives US FDA approval on Herceptin Hylecta, a subcutaneous co-formulation using Halozyme’s recombinant Enhanze technology, for the treatment of HER2-positive metastatic breast cancer.
Major pharmaceutical firms Novartis, Roche, and Pfizer have reacted to the US FDA’s Biosimilar Action Plan, which aims to “strike a balance” between innovation and market competition.
Mylan has struck a deal to commercialise a version of Roche’s Mabthera in Europe made by Polish biotech Mabion using a 2,500L disposable bioreactor system.
Roche is expanding its manufacturing operations to service its biologics pipeline, but the firm says it will continue to outsource approximately 20% of all production.
In direct opposition to a petition raised by GPhA (Generic Pharmaceutical Association) and Novartis, AbbVie, Genentech and Amgen are all looking for the US FDA to call for new non-proprietary names for biosimilars.
Genentech has recommissioned plans to make a Californian facility the largest biologics plant worldwide after anticipated revenue drop from biosimilars did not materialise.
