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BioNTech strengthens neoantigen TCR programme with Kite acquisition
BioNTech acquires Kite’s solid tumour neoantigen T cell receptor research platform and Gaithersburg manufacturing facility for undisclosed amount.
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Immunotherapy
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Saphnelo approved to treat systemic lupus erythematosus
AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for patients with moderate to severe systemic lupus erythematosus.
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FDA approves emergency use of REGEN-COVTM for COVID-19 prevention
The FDA have authorised REGEN-COV monoclonal antibody therapy for emergency use as prevention for COVID-19 in certain patients.
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FDARA implementation guidance for paediatric studies of molecularly targeted oncology drugs
This article addresses early planning for paediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original New Drug Application (NDAs) and Biological License Application (BLAs) are expected to be submitted to FDA, in accordance with The FDA Reauthorization Act (FDARA).
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Alzheimer’s treatment lowers tau by nearly 50 percent in Phase I trials
Biogen and Ionis announced positive topline data on investigational Alzheimer’s treatment, indicating 50 percent tau protein reduction.
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eTheRNA immunotherapies joins forces with Ghent University
eTheRNA has announced a collaboration and license agreement with renowned Belgian research institution, Ghent University.
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2021 a pivotal year for personalised neoantigens, says GlobalData
With multiple catalysts coming up in late 2021, GlobalData reports a boom in the field of personalised neoantigen immuno-oncology therapeutics.
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GSK to collaborate on development of antibodies for neurodegeneration
GSK will support the development of Alector’s immuno-neurology monoclonal antibodies for Parkinson’s disease, frontotemporal dementia and Alzheimer’s.
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EU approves Opdivo plus Yervoy for colorectal cancer
The European Commission approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for certain metastatic colorectal cancers after a trial found the combination meaningfully improved response rates.
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Collaboration to develop an automated CAR T-cell manufacturing system for clinics
German oncology clinics are working with Optima Pharma to create an automated manufacturing unit for decentralised production of CAR T-cell therapies in treatment centres.
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COVID-19 antibody therapeutics – where are they now?
In this article, EPR’s Hannah Balfour explores the current usage of monoclonal antibody therapies for COVID-19, with commentary from Professor Adrian Streinu-Cercel of the Carol Davila University of Medicine and Pharmacy.
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CAR T therapy achieves high remission rate in acute lymphoblastic leukaemia trial
Trial data shows 71 percent of adult B cell acute lymphoblastic leukaemia patients receiving Tecartus® autologous anti-CD19-transduced CD3+ cell infusion achieved complete remission.
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COVID-19 antibody therapies safe and effective for transplant patients
Monoclonal antibody therapies found to reduce progression to severe disease, risk of hospitalisation and death in transplant recipients with mild to moderate COVID-19.
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Imfinzi increases five year survival to 43 percent in Stage III lung cancer trial
New data shows AstraZeneca’s Imfinzi (durvalumab) achieved an unprecedented five year survival rate of over 40 percent in patients with Stage III non-small cell lung cancer.
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Chemotherapy-free combination shows potential in lymphocytic leukaemia trial
Imbruvica® (ibrutinib) plus Venclexta®/Venclyxto® (venetoclax) resulted in 95 percent of chronic lymphocytic leukaemia patients surviving without disease progression for two years.
