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Pioneering malaria vaccine gains regulatory clearance
University of Oxford-developed R21/Matrix-M malaria vaccine has secured approval in two African countries.
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Clinical Trials
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Injectable small molecule inhibitor could improve vision
Long-term Phase II study data of small molecule inhibitor UBX1325 delivered significant vision improvements in diabetic macular edema (DME).
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Oral drug reduces treatment-resistant migraine frequency
Initial data from study results being presented at the 75th American Academy of Neurology Annual Meeting indicate that an oral CGRP inhibitor reduced episodic migraine frequency.
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FDA approves first new B-cell lymphoma treatment in 20 years
A first-line B-cell lymphoma treatment shown to reduce the risk of disease progression or relapse by 27 percent has been approved by the FDA.
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FDA approves allogeneic stem cell transplant therapy
The first allogeneic stem cell transplant therapy to be approved based on Phase III study results has been granted by the US Food and Drug Administration (FDA).
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Psychedelic medicines: are they gaining traction in Europe?
Carissa Kendall-Windless and Sian Banks of law firm Pinsent Masons discuss the development of psychedelic medicines and the legal and regulatory challenges that must be overcome for psychedelics to become safe and effective treatment options in Europe.
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Personalised blood pressure treatment shows efficacy
A study suggests that personalised blood pressure medication can "probably obtain better protection against future cardiovascular diseases".
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ILAP: Improving access to innovative oncology treatments
With no new first-line treatment for de-differentiated liposarcoma in over forty years, Dr Christoph Zehendner, Medical Director of Boehringer Ingelheim UK and Ireland discusses the company’s ILAP designation of its investigational, innovative treatment.
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Sustained-release chemotherapy has potential for bladder cancer
A study has shown an intravesical sustained-release chemotherapy device demonstrated effectiveness in advanced bladder cancer.
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Eculizumab biosimilar gets positive CHMP opinion
Samsung Bioepis’ first haematology biosimilar, which references Soliris (eculizumab), has been recommended for approval by the CHMP.
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Monoclonal antibodies can lower COVID-19 hospitalisation risk
Over a third of COVID-19 patients reduced their risk of serious outcomes when treated early with monoclonal antibodies, a study shows.
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Treatment shows strong potential for ALK-driven neuroblastoma
A Phase I study has shown significant promise in treating newly diagnosed ALK-driven high-risk neuroblastoma in paediatric patients.
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Novel delivery approach demonstrates efficacy of immunotherapy
A first-in-human study showed a novel approach for delivering intrathecal and intravenous immunotherapy improved survival of melanoma patients with leptomeningeal disease (LMD).
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First immunotherapy recommended for advanced cervical cancer
Final draft guidance published by the National Institute for Health and Care Excellence (NICE) has recommended immunotherapy pembrolizumab drug for advanced cervical cancer.
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First-in-class plaque psoriasis oral therapy approved in EU
Bristol Myers Squibb’s Sotyktu is the only TYK2 inhibitor approved for the treatment of any disease in the European Union.
