CHMP recommends new immunotherapy delivery method
If approved, Roche’s Tecentriq subcutaneous (SC) would be the EU’s first injectable PD-(L)1 cancer immunotherapy.
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If approved, Roche’s Tecentriq subcutaneous (SC) would be the EU’s first injectable PD-(L)1 cancer immunotherapy.
Alongside its new biosimilar facility, Sandoz’s new penicillin production process will help secure European-based antibiotic supply.
Acquisition of Forge Biologics by Ajinomoto Co., Inc. is set to extend global capabilities in AAV and plasmid gene therapy manufacturing for Ajinomoto, Co. Inc.
A new report outlines five critical actions for five of the UK’s leading manufacturing sectors to ensure sustainable innovation growth is achieved.
To create opportunity for glass innovation, the Packaging and Distribution Expert Committee (PD EC) revised the United States Pharmacopeia (USP) General Chapter —Glass.
If approved, momelotinib will be the first treatment in the EU indicated for myelofibrosis patients with moderate to severe anaemia.
A Phase II trial for the small interfering RNA (siRNA) therapeutic lepodisiran is currently underway, assessing its ability to reduce lipoprotein(a) levels.
Future regulatory authorisation is expected in Europe, following the US Food and Drug Administration (FDA)’s accelerated approval of IXCHIQ®.
A major manufacturing facility expansion in Denmark will aim to “reduce water consumption with approximately 40 percent and energy consumption with approximately 50 percent compared to similar API processes in other facilities”, according to Novo Nordisk.
A FLT3 inhibitor that has been shown to significantly improve FLT3-ITD positive acute myeloid leukaemia survival has been authorised in the EU.
In their commitment to tackling global antimicrobial resistance (AMR), the first two Pharma companies have gained independent certification in responsible antibiotic manufacturing.
The only Fc-silent anti- T-cell immunoreceptor with Ig and ITIM domains (TIGIT) antibody in Phase III for upper GI adenocarcinomas could be the first to market for these cancers.
A “potential best-in-class treatment” for adults with KRASG12C-mutated non-small cell lung cancer (NSCLC) has been authorised in the UK.
Increased production of biologic drugs in the global cell line development market is anticipated to bring “significant growth” for mammalian cell line development between 2023-2033, a report shows.
The pharmaceutical industry must work together, applying new initiatives and harnessing digital tools to address Europe’s medicines shortages in 2023 and beyond, regulators and other organisations assert.