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In final draft guidance, the National Institute for Health and Care Excellence (NICE) has recommended dapagliflozin (Forxiga) for patients with heart failure regardless of ejection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.
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.
NICE recommends Rinvoq® for Crohn’s
AbbVie’s Rinvoq® will be the first JAK inhibitor available for treatment of Crohn’s in England and Wales, following NICE approval.
EMA guidance aims to prevent medicine shortages
The European Medicines Agency (EMA) has made recommendations for industry on how to prevent medicine shortages and reduce their impact.
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).
Digitalisation to boost quality management systems market
Pharma has been implementing process digitalisation and automated quality management systems to improve efficiency in drug manufacturing, a report says.
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.
AI-driven biosimilar manufacturing partnership announced
Artificial intelligence technology will drive manufacture of high-quality biosimilars at scale under a partnership between Sandoz and Just - Evotec Biologics.
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.
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.
$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.
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.
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.
Sandoz to boost biosimilar development with manufacturing expansion
€25m funding is intended to unite a cutting-edge biotech lab and analytical expertise at Sandoz's German biosimilar manufacturing site.
