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First-in-class telomerase inhibitor aids transfusion independence in clinical trial
Telomerase inhibitor imetelstat benefitted both major subtypes of lower risk MDS in a Phase III trial for the first time.
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Clinical Trials
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EMA validates Enhertu® Type II variation application for lung cancer
The Type II variation application for Enhertu® for adults with advanced non-small cell lung cancer has been validated by the EMA.
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Janssen submits marketing application for bispecific antibody
Approval for Janssen’s talquetamab to treat relapsed/refractory multiple myeloma has been submitted to the European Medicines Agency.
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First patient enrolled in cisplatin-induced ototoxicity Phase II trial
A Phase II proof of concept trial evaluating SENS-401 for cisplatin-induced ototoxicity has enrolled its first patient.
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First treatment approval for advanced ASPS
A Phase II trial has led to the FDA approval of atezolizumab for individuals over two years old with advanced alveolar soft part sarcoma.
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EC approves Zynlonta® for large B-cell lymphoma
Antibody drug conjugate Zynlonta® (loncastuximab tesirine) is approved in the European Union for treatment of relapsed or refractory diffuse large B-cell lymphoma.
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FDA approves first capsid inhibitor for HIV
Gilead’s Sunlenca (lenacapavir) is the first capsid inhibitor to be FDA-approved for treating HIV-1.
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Moderna finalises plans for UK mRNA vaccine manufacturing centre
Moderna is to build an mRNA vaccine manufacturing centre in the UK after finalising a ten-year agreement with the UK government.
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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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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…
