All Clinical Trials articles – Page 8
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NewsInvestigational plaque psoriasis treatments show promise in late-stage trials
With the Phase III trials demonstrating sustained skin clearance in plaque psoriasis, this could lead to patients accessing more treatment options to manage the autoimmune inflammatory disease.
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NewsAlzheimer’s drug requires strengthened pharmacovigilance approach
Ongoing real-world safety and effectiveness monitoring of the Alzheimer’s drug lecanemab is needed to protect patients long-term, drug safety researchers urge.
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WebinarSafety reporting in clinical trials: six core considerations for success
This webinar will provide guidance in navigating the terrain of pharmacovigilance, including regulatory challenges, and gain a deeper understanding of the pivotal role played by safety reporting in clinical research.
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ArticlePreparing for a new era in the rare disease sector
To mark Rare Disease Day 2025, EPR interviewed Christina Gkousgkouni, Head of Rare Diseases for Central South Europe, Sanofi.
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NewsNICE recommends novel immunotherapy for leukaemia
The agency’s decision means eligible adult patients in the UK are set to access the combination immunotherapy as a new treatment option for acute lymphoblastic leukaemia (ALL).
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WebinarFast tracking clinical success: choosing the right Fill & Finish CDMO
Selecting the right Fill & Finish CDMO can make or break a product’s commercial success. In this webinar, join industry experts to explore key strategies for navigating this crucial stage, ensuring optimal efficiency where it matters most.
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NewsFirst-in-human data for gene therapy signals potential in childhood blindness
Developed and manufactured under a Manufacturer’s ‘Specials’ Licence (MSL), the gene therapy could provide a novel treatment option for paediatric patients at the earliest stage of the rare eye disease.
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NewsFirst-of-a-kind EU approval granted for oral small molecule
The authorisation provides a new disease modifying treatment option for European patients with the progressive condition.
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NewsBiologic could reduce treatment burden for children with haemophilia A
New data suggests that once-weekly prophylaxis bispecific antibody treatment could provide an efficient and convenient option for young patients with haemophilia A.
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NewsNovel drug approved for diabetes-related vision loss
The monoclonal antibody treatment is now approved in the US for both diabetic macular oedema and wet, or neovascular age-related macular degeneration.
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NewsModerna reports record for UK clinical trials in 2023/24
The announcement follows the completed construction of Moderna’s MITC and progress in its long-term partnership with the UK government.
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NewsMHRA approves SARCLISA for newly diagnosed multiple myeloma
SARCLISA (isaxtuximab) provides a new first-line treatment option for patients with multiple myeloma, offering significant improvements in progression-free survival.
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NewsCHMP meeting highlights – January 2025
In its January meeting, the EMA’s human medicines committee recommended eight new medicines, including biosimilars and a new vaccine.
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NewsNICE recommends gene therapy for severe sickle cell disease
The committee’s approval of the one-time gene therapy means the healthcare inequalities for patients with this genetic blood disorder can begin to be re-addressed.
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NewsUK enhances ILAP to accelerate access to innovative medicines
The MHRA’s refreshed guidance is the only end-to-end access pathway that enables medicine developers to collaborate with the national health system, Regulator, and HTA bodies.
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ArticleBiosimilar medicines: the intersection of access, affordability, and innovation
In this article, Julie Maréchal-Jamil, Director, Biosimilar Policy & Science, Medicines for Europe, explores the strategies needed at European and national levels to secure the benefits of biosimilar medicines in an evolving landscape to deliver a pipeline for these drugs by 2030.
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NewsNew analysis asserts survival benefit for Roche breast cancer therapy
The new data highlights the potential of the ItovebiTM (inavolisib)-based regimen as a new standard of care in advanced PIK3CA-mutated, HR-positive, HER2-negative breast cancer.
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NewsAstraZeneca Canadian investment to drive R&D growth
The US$570m investment will contribute to advancing AstraZeneca’s global clinical pipeline, a key goal of its strategy to 2030.
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ArticleM&A outlook for pharma in 2025
For a strong 2025, dealmaking should be central to the life sciences strategy, says EY’s annual M&A report.
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NewsBiologic demonstrates “tremendous” potential advance in atrial fibrillation
The Phase II study validated an “incredibly safe bleeding profile” for Factor XI inhibitors as a treatment for the common cardiovascular condition.