AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for patients with moderate to severe systemic lupus erythematosus.
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The FDA have authorised REGEN-COV monoclonal antibody therapy for emergency use as prevention for COVID-19 in certain patients.
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).
Biogen and Ionis announced positive topline data on investigational Alzheimer’s treatment, indicating 50 percent tau protein reduction.
eTheRNA has announced a collaboration and license agreement with renowned Belgian research institution, Ghent University.
With multiple catalysts coming up in late 2021, GlobalData reports a boom in the field of personalised neoantigen immuno-oncology therapeutics.
GSK will support the development of Alector’s immuno-neurology monoclonal antibodies for Parkinson’s disease, frontotemporal dementia and Alzheimer’s.
The European Commission approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for certain metastatic colorectal cancers after a trial found the combination meaningfully improved response rates.
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.
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.
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.
Monoclonal antibody therapies found to reduce progression to severe disease, risk of hospitalisation and death in transplant recipients with mild to moderate COVID-19.
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.
Imbruvica® (ibrutinib) plus Venclexta®/Venclyxto® (venetoclax) resulted in 95 percent of chronic lymphocytic leukaemia patients surviving without disease progression for two years.
Over 50 percent of psoriatic arthritis patients treated with Tremfya® (guselkumab) achieved ≥20 percent improvement in joint symptoms and complete skin clearance at one year.