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RemeGen receives ODD for myasthenia gravis treatment
The FDA has granted ODD to Telitacicept, produced by RemeGen, for the treatment of myasthenia gravis.
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Biopharmaceuticals
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Biosimilar competition saves US healthcare $21 billion
The US biosimilars market experienced dramatic growth in 2022, particularly for therapies helping to treat oncological and inflammatory conditions, Amgen suggested in a recent report.
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Robotic capsule could replace injected biologics
MIT researchers have developed a robotic capsule that tunnels through mucus in the GI tract to deliver large oral protein-based drugs like insulin.
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NICE partners with health technology assessment bodies
Five health technology assessment (HTA) bodies will collaborate with NICE to help resolve regulatory and digital health technology challenges.
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Could first anti-tau therapy be approved for Alzheimer’s?
The oral medication Hydromethylthionine mesylate (HMTM) is the first anti-tau disease-modifying therapy to offer sustained cognitive improvement in Alzheimer’s.
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New initiative will calculate carbon footprint of clinical trials
The new methodology will assess the carbon impact of clinical trials and recommend ways to reduce it.
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Are strategic partnerships the winning model for outsourcing?
A University of Cambridge report assessing the preferred relationship type between pharma and contract research organisations (CROs), showed strategic partnerships will continue as the primary collaboration model.
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Funding boost for CPI’s RNA vaccine innovation centre
The UK Government’s Vaccine Taskforce (VTF) has funded CPI’s innovative training academy and manufacturing facility to further the development of novel RNA therapies and vaccines.
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Novel cancer therapeutic synthesised by Stanford researchers
The natural compound tigilanol tiglate was produced in a lab for the first time by scientists at Stanford University, suggesting it could provide treatment for a variety of cancers.
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NICE recommends first oral S1P receptor modulator for ulcerative colitis
NICE has recommended the drug Zeposia® (ozanimod) for moderate to severe cases of ulcerative colitis.
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OSD contract manufacturing market valued at $54.7 billion by 2030
Outsourcing the production of oral solids is estimated to be the primary influencer for the contract manufacturing market in the next decade, using lessons learnt from the COVID-19 pandemic.
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Cystic fibrosis phage therapy trial commences
The National Institute of Allergy and Infectious Diseases (NIAID)-supported clinical trial will assess whether the bacteriophage therapy WRAIR-PAM-CF1 safely reduces the quantity of Pseudomonas aeruginos bacteria in fibrocystic lungs.
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Collaborations between pharma and academia increase
The pharmaceutical industry is bolstering aid for student research training in the UK, according to a survey produced by The Association of the British Pharmaceutical Industry (ABPI).
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Large bacterial culture volumes can be filtered without centrifuge
The study observed that using a modified vacuum filtration system assisted in the filtration of large volumes of bacterial cultures, removing the need for centrifuges.
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Pilot to support ATMP research and development
Five academic and non-profit organisations developing advanced therapy medicinal products (ATMPs) will benefit from the European Medicines Agency’s (EMA) scheme.
