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New acquisition to support global gene therapy manufacturing
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.
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Unified vision essential in UK advanced manufacturing
A new report outlines five critical actions for five of the UK’s leading manufacturing sectors to ensure sustainable innovation growth is achieved.
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USP General Chapter <660>—Glass revised
To create opportunity for glass innovation, the Packaging and Distribution Expert Committee (PD EC) revised the United States Pharmacopeia (USP) General Chapter —Glass.
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Could GSK myelofibrosis treatment gain EU-first approval?
If approved, momelotinib will be the first treatment in the EU indicated for myelofibrosis patients with moderate to severe anaemia.
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Novel siRNA therapeutic could lower cardiovascular disease risk
A Phase II trial for the small interfering RNA (siRNA) therapeutic lepodisiran is currently underway, assessing its ability to reduce lipoprotein(a) levels.
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First chikungunya vaccine approved
Future regulatory authorisation is expected in Europe, following the US Food and Drug Administration (FDA)’s accelerated approval of IXCHIQ®.
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Novo Nordisk plans multi-billion Denmark manufacturing expansion
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.
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Targeted therapy for hard-to-treat leukaemia subtype approved in EU
A FLT3 inhibitor that has been shown to significantly improve FLT3-ITD positive acute myeloid leukaemia survival has been authorised in the EU.
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Sandoz and Teva achieve first-of-a-kind manufacturing certification
In their commitment to tackling global antimicrobial resistance (AMR), the first two Pharma companies have gained independent certification in responsible antibiotic manufacturing.
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Gilead reveals positive data for potential first-line adenocarcinoma treatment
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.
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MHRA authorises new treatment for rare lung cancer
A “potential best-in-class treatment” for adults with KRASG12C-mutated non-small cell lung cancer (NSCLC) has been authorised in the UK.
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Global cell line development to surge in next decade
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.
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Mitigating medicines shortages in Europe
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.
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Sustainable biosimilar competition in Europe: can it be achieved?
The Biosimilar Medicines Group has reflected on a new report by IQVIA that outlines factors for achieving sustainable levels of biosimilar competition in Europe.
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New Bill could enhance UK clinical trial regulation
According to a report on policy development in the UK, the Future Clinical Trials Bill will mandate transparent trial registration and facilitate quicker regulatory approval.
