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UK clinical trial regulation may support haemophilia treatment access
The new Notification scheme by the MHRA helps to reduce the time it takes for the lowest-risk clinical trials to commence, while maintaining patient safety.
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Clinical Trials
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Why patient-centricity is essential to accelerate rare disease clinical research
There is an urgent need for novel treatment options for people living with rare diseases, but carrying out clinical research in this field is notoriously difficult. As Clinical Trials Day approaches, Cezary Statuch, Head of Medical Affairs International and Japan at Alexion Pharmaceuticals, highlights how adopting patient-centric approaches can help…
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FDA approves Amgen T-cell engager for small cell lung cancer
Amgen’s Imdelltra™, previously known as tarlatamab, is approved for the treatment of adult patients with advanced small cell lung cancer.
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Insights into AstraZeneca’s MANDARA Phase III data
In this Q&A, Dr Michael Wechsler, Professor of Medicine, Director of the National Jewish Health (NJH)/Cohen Family Asthma Institute, reveals details of the data from the MANDARA Phase III trial, showing remission is achievable in EGPA with Fasenra.
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Ensuring sterility of a novel anti-VEGF bispecific antibody
Safety of the compounded biologic was confirmed following 28-day storage in two different polypropylene syringe types, research shows.
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Cell therapy could help curb progression of heart failure
New clinical trial data demonstrates the potential for a stem cell treatment as a cardiac regenerative therapy.
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Potential best-in-class antibody shows “remarkable efficacy” in atopic dermatitis
Interim trial results show that the only clinical-stage nondepleting anti-OX40 monoclonal antibody (mAb) provided rapid skin sign improvement in atopic dermatitis (AD).
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Intravesical drug delivery system exhibits bladder cancer benefit
The drug delivery system provides local release of erdafitinib and may offer an alternative treatment for eligible bladder cancer patients with limited options.
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Combination treatment could provide new standard-of-care for aggressive lymphoma
AstraZeneca has released new clinical data demonstrating the first BTK inhibitor to show a favourable trend in overall survival versus standard-of-care chemoimmunotherapy in adults with untreated mantle cell lymphoma (MCL).
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Long-acting antibody demonstrates promising efficacy in infant RSV
New real-world evidence from a long-term follow up study adds to evidence of the high efficacy of Beyfortus in infant RSV.
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What is the future of biologic medicines?
Sigma Mostafa, PhD, Chief Scientific Officer at KBI Biopharma, discusses the current trends in biologics and how technologies such as automation are advancing the field.
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CHMP meeting highlights: April 2024
In its April meeting, the EMA’s human medicines committee recommended eight new medicines, including treatments for cancer and autoimmune diseases.
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Novel haemophilia B gene therapy approved
Pfizer has attained its first approval for a gene therapy from the US Food and Drug Administration (FDA), which is indicated to treat the rare blood disorder haemophilia B.
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AbbVie JAK inhibitor shows potential in novel atopic dermatitis head-to-head trial
Patients with moderate-to-severe atopic dermatitis can strive for both little to no itch and clearer skin with AbbVie’s upadacitinib, topline Phase IIIb/IV study results suggest.
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Research calls for greater investment in Alzheimer’s clinical trials
Despite some challenges, for the Alzheimer’s drug development pipeline, 2024 is a “learning year”, an expert on the disease says.
