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Developing donanemab – balancing cost versus benefit
This article summarises recent regulatory developments surrounding the Alzheimer’s treatment donanemab and considers the future therapeutic market for this disease.
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Clinical Development
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Eli Lilly secures MHRA authorisation for Alzheimer’s treatment
Authorisation in Great Britain means eligible Alzheimer's patients can access the treatment, which is part of a new class of amyloid targeting therapies.
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Immunotherapy treatment enhances lymphoma survival, landmark study shows
The Phase III findings give evidence for the immunotherapy treatment regimen to become standard of care for advanced Hodgkin lymphoma.
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Sanofi collaboration to advance innovative radioligand therapies
The new partnership between Sanofi and Orano Med, delivered via a new entity valued at nearly $2 billion, will focus on progressing lead-212 based targeted alpha therapies for oncology indications.
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Innovating allergy drug delivery with a needle-free alternative
Dr Sarina Tanimoto, MBA, Co-Founder and Chief Medical Officer of ARS Pharmaceuticals, discusses the company’s EURneffy adrenaline nasal spray as a novel, needle-free option to older approved injectables such as intramuscular injection, following its authorisation in the EU and US.
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Digitalisation propelling automated microbiology market growth to 2033
Increased adoption of artificial intelligence (AI) and machine learning (ML) in microbiology is set to be a key driver of the global automated microbiology market to 2033, research asserts.
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Haemophilia treatment with new delivery method approved
The US FDA has authorised the first treatment for haemophilia A or B that is administered via a pre-filled pen or syringe.
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Eli Lilly appoints Chief AI Officer
The new appointee will create AI and machine learning solutions to support Eli Lilly’s medicines for patients globally.
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First real-world study reveals encouraging efficacy for cell therapy
More than half of the multiple myeloma patients included in this study would have been ineligible for the Phase II CARTITUDE-1 clinical trial, research reports.
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Future of oral small molecule drugs – addressing potential in multiple sclerosis
Advances in selectivity, safety, and patient convenience, oral small molecule drugs continue to be a key focus in drug development. Here, Dr Andreas Muehler and Daniel Vitt, PhD, the co-founders of Immunic Therapeutics, discuss the potential of Vidofludimus calcium as a breakthrough treatment for autoimmune diseases.
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Patient insights into the decentralisation of clinical trials
While a trial is a part of pharma research, despite industry advancement, the patient experience is not often considered for innovation.
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European Pharmaceutical Review Issue 4 2024
European Pharmaceutical Review Issue 4 includes articles on regulation, bioproduction, environmental monitoring, packaging and drug delivery.
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Genentech gains rights to next-generation CDK inhibitors
The oncology-focused deal between Genentech and Regor Pharmaceuticals is worth nearly $900 million and will support development of novel therapies for breast cancer.
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Radiopharmaceutical therapy delivers promising meningioma survival rates
The Phase II clinical trial is the first completed prospective trial for refractory meningiomas with a tumour growth rate of 15 percent or more over six months.
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First-in-class therapy approved for schizophrenia
The “landmark” approval represents the first new class of medicine in several decades for treating schizophrenia.
