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.
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.
Antibody response varies for Big Pharma COVID vaccines
Pfizer, Moderna and Johnson & Johnson COVID-19 vaccines produced varied neutralising antibody levels when assessed for short- and long-term response, says study.
Can GLP-1 obesity therapy restore NK cell function?
Irish researchers have shown that GLP-1 treatment can restore natural anti-cancer immunity via NK cells in people with obesity.
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.
MIT unlocks real-time powder particle size distribution monitoring
Massachusetts Institute of Technology researchers have developed an algorithm that extracts powder particle size distribution from laser speckle in real-time.
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.
First 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.
Digital transformation to drive biomanufacturing market
According to a market report, digital transformation is becoming an essential part of biopharma manufacturing.
European 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.
Novel 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.
FDA releases draft guidance for decentralised clinical trials
Recommendations on the conduct of remote clinical trial visits are included in new US Food and Drug Administration (FDA) draft guidance.
