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European Commission approves CAR T therapy for lymphoma
CD19-directed CAR T-cell therapy Breyanzi has been approved by the European Commission (EC) based on significant results from a lymphoma Phase III trial.
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Clinical Trials
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Novel device opens blood-brain barrier to deliver chemotherapy
A novel ultrasound technique opened the blood-brain barrier to successfully deliver chemotherapy to glioblastoma patients in a first-in-human trial.
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Why R&D innovation holds the key to greater patient impact
How can innovation in clinical trials drive greater patient impact? BeiGene’s Dr Nils Eckardt and Dr Mieke Borgs highlight how novel systems and ways of working can support the delivery of high-quality medicines faster and more efficiently, helping to deliver greater and faster patient access in Europe.
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Biologic could be first new hidradenitis suppurativa treatment in a decade
The first and only fully human biologic that directly inhibits interleukin-17A has been granted a positive opinion by the Committee for Medicinal Products for Human Use (CHMP).
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Immunotherapy to become standard treatment for infants with ALL
First-line immunotherapy blinatumomab significantly improved survival in babies with acute lymphoblastic leukaemia in an international trial.
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Novartis releases data for potentially “practice-changing” PNH medicine
Iptacopan achieved "improvement of anaemia never seen before with anti-C5s” in paroxysmal nocturnal haemoglobinuria, showed Novartis data presented at 2023 EBMT.
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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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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.
