All Clinical Development articles – Page 31
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NewsSurvey 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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NewsFirst 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In final draft guidance, the National Institute for Health and Care Excellence (NICE) has recommended dapagliflozin (Forxiga) for patients with heart failure regardless of ejection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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NewsCould 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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NewsFirst 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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NewsIntratumoural 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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ArticleRecent 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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NewsRWE 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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NewsCould 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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News$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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NewsFDA 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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NewsLaunching 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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ArticleRealising 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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NewsEnzyme 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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NewsEMA 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.
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ArticleTransforming oncology with antibody therapeutics
Martin Vogel, Therapeutic Area Lead for Oncology, Janssen EMEA, discusses the potential of bispecific monoclonal antibodies like amivantamab to address unmet needs in advanced non-small cell lung cancer treatment.
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NewsFirst RSV vaccine approved for older adults
The US Food and Drug Administration (FDA) has approved the first-ever vaccine for respiratory syncytial virus (RSV) in adults over 60 years old.
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NewsEuropean Commission approves CAR T therapy for lymphoma
CD19-directed CAR T-cell therapy Breyanzi has been approved by the European Commission (EC) based on significant results from a lymphoma Phase III trial.
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NewsNovel device opens blood-brain barrier to deliver chemotherapy
A novel ultrasound technique opened the blood-brain barrier to successfully deliver chemotherapy to glioblastoma patients in a first-in-human trial.
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NewsBiologic could be first new hidradenitis suppurativa treatment in a decade
The first and only fully human biologic that directly inhibits interleukin-17A has been granted a positive opinion by the Committee for Medicinal Products for Human Use (CHMP).
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NewsImmunotherapy to become standard treatment for infants with ALL
First-line immunotherapy blinatumomab significantly improved survival in babies with acute lymphoblastic leukaemia in an international trial.