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Quality risk management in radiopharmaceutical production
A quality risk assessment of a Good Manufacturing Practice (GMP) radiopharmaceutical production site found that dispensing was the most critical phase of the process.
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Anti-Cancer Therapeutics
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The future of targeted alpha therapy development and manufacture
Following the first industrial-scale facility for targeted alpha therapy (TAT) production in Europe beginning construction, in this exclusive Q&A, Julien Dodet, CEO of Orano Med, elaborates on the key trends in radioligand therapeutics and why TATs hold significant advantages as cancer treatments.
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New radiopharmaceutical laboratory opens in Germany
Ariceum Therapeutics’ new Berlin-based laboratory gives the company internal capability to progress the development of its lead radiopharmaceutical candidates.
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CHMP meeting highlights: February 2024
Ten new medicines, including a new oligonucleotide therapy for ALS, were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s recent meeting.
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Novel immunotherapy approved for melanoma
The first non-CAR-T adoptive cell therapy to reach the market has been approved by the US Food and Drug Administration (FDA).
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New chemotherapy treatment could benefit multiple cancer types
The innovative treatment significantly increased survival in patients with malignant pleural mesothelioma, a rare, aggressive cancer, according to Phase III data from UK researchers.
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BioNTech agrees collaboration to accelerate autologous CAR-T therapies
The collaboration between BioNTech SE and Autolus Therapeutics utilises manufacturing and commercial infrastructure, supporting a shared goal of advancing autologous CAR-T programmes towards potential market authorisation.
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AstraZeneca to boost cell therapy operations with $300m manufacturing investment
Investment in the US manufacturing facility will accelerate AstraZeneca’s ambition to make next-generation cell therapy a reality, the company asserts.
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Construction of major radioligand therapy manufacturing site begins
The new site will be Europe's first industrial-scale pharmaceutical facility dedicated to the production of lead-212 based radioligand therapies.
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NICE recommends injectable bispecific antibody for aggressive blood cancer
Recommendation of AbbVie’s bispecific antibody for NHS use is based on a Phase I/II trial, which observed a 62 percent overall response rate in diffuse large B-cell lymphoma (DLBCL) patients.
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CHMP meeting highlights: January 2024
In its first meeting of 2024, the CHMP recommended a generic medicine for schizophrenia and refused a marketing authorisation (MA) for geographic atrophy.
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NICE recommends innovative breast cancer drug
The first BRCA-targeted treatment has been recommended for advanced breast or metastatic breast cancer by the National Institute for Health and Care Excellence (NICE).
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UK ATMP sector “robust”, research finds
The cell and gene therapy (CGT) sector in the UK is “robust”, with a stable clinical trials landscape, according to research from Cell and Gene Therapy Catapult (CGT Catapult) and the UK BioIndustry Association (BIA).
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Long-term findings from CAR NK cell therapy trial revealed
One-year results from a cancer therapy trial has reported key findings for the selection criteria for allogeneic cord blood donors in CAR NK cell manufacturing.
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Roche cancer immunotherapy receives new EU approval
16 January 2024 | By
The subcutaneous injection of the novel cancer immunotherapy Tecentriq® (atezolizumab) could provide a quicker alternative to intravenous infusion, research shows.
