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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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Clinical Development
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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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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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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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New collaboration could advance small molecule epilepsy therapy
UCB and Praxis Precision Medicines, Inc. will collaborate to advance Praxis’ PRAX-020 small molecule programme for KCNT1 related epilepsies.
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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.
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European Commission approves Pluvicto® for prostate cancer
The European Commission has approved Pluvicto® as the first targeted radioligand therapy for advanced prostate cancer, based on significant results from the Phase III VISION trial.
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Canadian and US developers to trial psychedelic medicines in UK
Canadian and US developers of psychedelic medicines for complex mental health conditions have signed with a UK-based CMO to trial their drugs in London.
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First patient given base-edited CAR T cells
The first ever use of base-edited T-cells have helped to treat a patient with relapsed T-cell acute lymphoblastic leukaemia in a clinical trial.
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The promise of telomerase inhibitors for treating blood cancer
Geron’s CEO Chip Scarlett discusses the company’s leading telomerase inhibitor in this exclusive interview ahead of the 2022 American Society of Hematology Annual Meeting.
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Dostarlimab combination facilitates promising lung cancer survival
The largest head-to-head trial of PD-1 inhibitors for non-squamous non-small cell lung cancer suggested dostarlimab with chemo aided survival.
