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Five proposed biosimilars planned for development in Europe
The extended partnership agreement between Alvotech and Advanz Pharmaceutical includes a biosimilar candidate to Entyvio® (vedolizumab).
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Clinical Development
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Survey reports untapped potential for UK clinical trials
With the UK Government’s clinical trials landscape independent review expected, a survey has identified “huge untapped potential for trial recruitment”.
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First NICE-recommended treatment for chronic heart failure
In final draft guidance, the National Institute for Health and Care Excellence (NICE) has recommended dapagliflozin (Forxiga) for patients with heart failure regardless of ejection fraction.
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Could FDA recommend new antibiotic for hospital-acquired pneumonia?
A new combination antibiotic for hospital-acquired pneumonia offers advantages in dosing and tolerability, a Phase III trial has shown.
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First treatment conditionally licensed for chronic hepatitis D
Gilead Science’s antiviral medication for chronic hepatitis D has been recommended by the National Institute for Health and Care Excellence (NICE).
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Intratumoural viral delivery improves glioblastoma survival
“Injecting a virus into a patient’s brain tumour” combined with immunotherapy improved glioblastoma survival outcomes in a clinical trial.
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Recent developments in stem cell therapies
EPR explores recent developments in stem cell therapies across several hard-to-treat diseases and how technology is transforming ATMP manufacture.
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RWE shows efficacy of nirsevimab for infant RSV
New real-world data “adds to the evidence that use of long-acting monoclonal antibody [nirsevimab] may prevent moderate to severe respiratory syncytial virus disease” in infants after single dose.
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Could personalised mRNA vaccine be first for cancer?
Half of pancreatic ductal adenocarcinoma (PDAC) patients given a personalised mRNA neoantigen vaccine experienced delayed recurrence 18 months post-vaccination.
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$1.7b acquisition to develop rare haematology therapy
When CTI BioPharma is acquired by Swedish Orphan Biovitrum AB (Sobi), the companies intend to advance an oral kinase inhibitor treatment for a rare haematological disease.
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FDA publishes paper on AI/ML in drug development
"rapid growth in the number of submissions that reference artificial intelligence and machine learning” has prompted the US Food and Drug Administration (FDA) to seek feedback on AI/ML in drug development.
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Launching Revvity: a scientific solutions company powering innovation from discovery to cure
Leveraging innovation across life sciences, Revvity focuses on transformation to revolutionise next generation scientific breakthroughs that solve the world’s greatest health challenges.
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Realising milestones with gene therapy for SMA
Novartis Gene Therapies' Vice President for Clinical Development & Analytics shares what shaped the success of one of the few commercially-available gene therapies.
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Enzyme replacement therapy approved for Fabry disease
The European Commission (EC) has given approval to the first PEGylated enzyme replacement therapy to treat Fabry disease.
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EMA to review CTIS transparency rules
Public consultation seeks the best methods for balancing transparency with confidentiality in the EU Clinical Trials Information System, says the European Medicines Agency.
