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First paediatric EC approval of HIV drug
The European Commission has granted the first paediatric marketing authorisation for Gilead's low-dose Biktarvy® HIV tablet.
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Research & Development (R&D)
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NEJM publishes lecanemab Alzheimer’s study results
Full study results of Eisai’s Phase III Alzheimer's study suggest lecanemab could slow disease progression.
whitepaper
Application note: Middle-up mass analysis of protease digested cetuximab
Protocol for purification, proteolysis, reduction and UHPLC-MS analysis of unlabelled and labelled monoclonal antibodies
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CPI opens £88 million manufacturing innovation centre
CPI has opened its Medicines Manufacturing Innovation Centre in Scotland to focus on efficient, sustainable manufacturing and advance medicine research.
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Radiation with immunotherapy increases lung cancer survival
Phase I study analysis determined immunotherapy with radiation is more effective than radiotherapy alone for metastatic non-small cell lung cancer.
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First adaptive clinical trial for flu
A £2.9 million trial, the first adaptive platform trial studying flu treatments, could reduce serious illness in patients.
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On-demand webinar: Get your aseptic facility ready for EU GMP Annex 1
Available on-demand: experts discussion and Q&A on the recent annex 1 revision, in the context of Microbiological Environmental Monitoring.
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FDA Fast Track designation for photodynamic cancer therapy
REM-001, a photodynamic therapy for cutaneous metastatic breast cancer has been given Fast Track designation by the US Food and Drug Administration (FDA).
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Nasal spray could help prevent depression relapse
SPRAVATO® nasal spray helped treatment-resistant depression patients remain remission and relapse free in a Phase III trial.
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Framework to enable re-use of patient clinical data
A patient-centric legal framework intends to return clinical trial data to study participants, ready for re-use in further research or healthcare practice.
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First patient dosed with novel RNA modifying enzyme inhibitor
A Phase I trial for solid tumours has begun to assess STC-15, the first RNA methyltransferase modifying enzyme inhibitor.
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EC approves Libtayo® for metastatic cervical cancer
The European Commission has approved Libtayo® for cervical cancer and disease progression while on or after platinum-based chemotherapy, due to positive Phase III trial results.
video
Webinar: Analysis of nitrosamines in drugs
Webinar now on-demand: Analysis of nitrosamines in drugs using chromatographic methods according to regulatory requirements.
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CAR-T therapy aids lupus remission
Researchers demonstrated promising early results for a personalised CAR T-cell therapy, which facilitated remission for lupus patients treated with the anti-CD19 treatment.
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NICE recommends combo therapy for gastroesophageal cancer
Nivolumab together with chemotherapy has been recommended in NICE final draft guidance for treatment of gastroesophageal cancer.
