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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First redosable gene therapy approved
The “landmark approval” of a redosable gene therapy for dystrophic epidermolysis bullosa “ushers in a whole new paradigm to treat genetic diseases".
European biotechs choosing Switzerland as base, research shows
The trend for European biotech companies to headquarter in Switzerland appears to be continuing, according to research.
Machine learning can predict outcomes for inkjet printed pharmaceuticals
A paper has shown how machine learning (ML) models predicted the inkjet printing printability of drug formulations with high accuracy.
Benefits of blockchain in limiting counterfeit drug distribution
Smart contracts on blockchain could help prevent distribution of counterfeit drugs in the pharmaceutical supply chain, a review shows.
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”.
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In final draft guidance, the National Institute for Health and Care Excellence (NICE) has recommended dapagliflozin (Forxiga) for patients with heart failure regardless of ejection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.
