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A Phase III trial for the only therapy approved for both relapsing and primary progressive multiple sclerosis (MS) met its clinical endpoints, Genentech has announced.
The US Food and Drug Administration (FDA) has approved the first bispecific antibody with a fixed-duration treatment in (R/R) diffuse large B-cell lymphoma (DLBCL).
Half of pancreatic ductal adenocarcinoma (PDAC) patients given a personalised mRNA neoantigen vaccine experienced delayed recurrence 18 months post-vaccination.
A first-line B-cell lymphoma treatment shown to reduce the risk of disease progression or relapse by 27 percent has been approved by the FDA.
A new, high-tech, sustainable biologics manufacturing facility at Genentech’s US Oceanside campus will be operational in early 2025.
IMbrave050 is the first Phase III study to show a cancer immunotherapy combo reduced risk of disease recurrence for early-stage hepatocellular carcinoma.
Having recently conducted a project to implement more sustainable, reliable and efficient bacterial endotoxin testing across the global Roche corporation, those involved in the project discuss with EPR’s Hannah Balfour the key takeaways from their implementation and validation, as well as current trends in bacterial endotoxin testing.
Features in this in-depth focus review the advances in bacterial genome sequencing and its role in pharmaceutical microbiology, as well as key considerations for when implementing and validating recombinant Factor C (rFC) endotoxin testing. Plus, coverage of how proposed US pharmaceutical regulation could impact European companies, in-house lentiviral vector manufacturing…
Phase I study shows that mRNA-based individualised neoantigen specific immunotherapy (iNeST) vaccines can be used to stimulate T cells to recognise neoantigens in pancreatic cancer patients.
Behind every technological advance there is often a leadership story just as interesting. In this article, Ben Woollard highlights key leadership behaviours that have been fundamental in biological innovation and suggests how businesses can implement these attributes to strive forward in a new era of biologics.
Five patent issues that European biosimilar developers should consider before entering the US market
As patents on originator biologic medicines begin to expire, there are growing opportunities for biosimilars to enter the market at lower prices. Joshua Whitehill, Natasha Daughtrey and Grace Truong discuss key aspects of US patent law that European developers should consider before entering the American market.