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Breakthrough gene therapy gives hope for Artemis-SCID
A new gene therapy developed by UC San Francisco has enabled ten young Artemis-SCID patients to achieve full T-cell immunity.
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Clinical Trials
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Lynparza combination approved in EU for advanced prostate cancer
Patients in the EU with an advanced prostate cancer will benefit from a newly approved Lynparza-based treatment combination for the first time.
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MHRA granted almost £1m to advance digital and data regulation
Almost £1m awarded to MHRA will advance projects to innovate AI and microbiome regulation and develop synthetic clinical trial data.
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Psychedelic research: evaluating the fast-evolving regulatory roadmap
In this article, Aman Khera and Dr Christine Moore of Worldwide Clinical Trials share how regulatory agencies are supporting psychedelic research through expedited pathways and outline some of the key considerations for clinical trials sponsors.
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CHMP recommends fenfluramine for LGS-associated seizures
Positive Phase III study data has prompted the CHMP to recommend FINTEPLA ®▼ (fenfluramine) for seizures associated with Lennox-Gastaut syndrome (LGS).
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Sanofi licenses Innate Pharma’s NK cell platform with €25m upfront payment
Innate Pharma will receive a €25m upfront payment from Sanofi to license its B7H3 ANKETTM platform, which is creating a new class of molecules to induce synthetic cancer immunity.
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Clinical innovation: using digital solutions to deliver the next wave of medicines
Rapid progress in digital health technologies is enriching clinical trial design, improving clinical trial recruitment strategies and harnessing the power of clinical trial data to improve outcomes for patients and guide future research. Here, Natalie Fishburn, Cristina Duran and Serban Ghiorghiu, from R&D at AstraZeneca, discuss the evolving nature of clinical innovation…
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Could ketamine-assisted therapy help treat alcoholism?
The largest clinical trial of its kind will investigate if ketamine-assisted therapy can reduce harmful drinking in people with severe alcohol use disorder.
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FDA approves first gene therapy for high-risk early bladder cancer
The first gene therapy for high-risk non-muscle-invasive bladder cancer has been approved by The US Food and Drug Administration (FDA).
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CHMP adopts positive opinion for haemophilia B gene therapy
Gene therapy etranacogene dezaparvovec has been granted a positive opinion by the CHMP as a haemophilia B treatment for adults in Europe.
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First targeted delivery of siRNA into muscle
A Phase I/II trial demonstrated the first successful targeted delivery of siRNA into muscle, using monoclonal antibody AOC 1001.
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European Commission approves first medicine for prurigo nodularis
Dupixent®, the first and only targeted medicine for prurigo nodularis has been approved by the EC for adults with a moderate-to-severe form of the condition.
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The potential of tryptamines in treatment-resistant depression
There is growing interest in the use of psychedelic-assisted therapy for treatment of mental health conditions. Here, Guy Goodwin, Chief Medical Officer of COMPASS Pathways, explores the potential of tryptamines to treat depression, sharing results from a recent clinical trial.
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Takeda’s $4 billion acquisition to address autoimmune diseases
Takeda will acquire Nimbus Therapeutics for $4 billion and gain rights to its allosteric TYK2 Inhibitor to address multiple immune-mediated diseases.
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mRNA vaccine plus KEYTRUDA® improve melanoma survival
An mRNA vaccine plus KEYTRUDA® significantly improved recurrence-free survival in a Phase II trial for advanced melanoma patients.
