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Novartis releases long-term data for SMA gene therapy
Long-term follow-up study data for Zolgensma®, Novartis’ one-time gene therapy for spinal muscular atrophy (SMA), has shown promising overall milestone achievements.
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EMA validates first regulatory submission for CRISPR-based medicine
The first regulatory submission for a CRISPR-based therapy has been validated by the European Medicines Agency, to treat sickle cell disease and transfusion-dependent beta thalassemia.
Largest global clinical site hires all-female key leaders in Europe
Three all-female key leaders in Europe have been hired by Velocity Clinical Research, the largest clinical sites business globally.
Takeda to license potential treatment for colorectal cancer
Takeda and HUTCHMED have entered into an exclusive licensing agreement, to develop tyrosine kinase inhibitor fruquintinib for colorectal cancer outside China.
Onivyde® improves survival in Phase III pancreatic cancer trial
Onivyde® (irinotecan liposome injection) treatment regimen significantly improved survival in a Phase III trial compared to nab-paclitaxel plus gemcitabine.
EU antibiotic shortages being monitored by MSSG
The Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) have stated it is closely monitoring and responding to the current EU antibiotic shortages.
Personalised cancer immunotherapy granted fast track designation
The FDA has granted fast track designation for Evaxion’s personalised cancer vaccine in combination Keytruda® for patients with metastatic melanoma.
Limiting microbial hazards in inhaled cannabis products
FDA researchers found there was some reduction in microbial counts by heating cannabis with a commercial vaporiser to limit microbial contamination, but they were not statistically significant.
FDA issues complete response letter for donanemab
A complete response letter for Eli Lilly's accelerated approval submission of donanemab for early Alzheimer's has been issued by the US Food and Drug Administration (FDA).
MHRA authorises BRUKINSA® in Great Britain for two cancers
BRUKINSA® (zanubrutinib) has been authorised by the MHRA for chronic lymphocytic leukaemia and marginal zone lymphoma in Great Britain.
Clinical trial-first for liver cancer immunotherapy combo
IMbrave050 is the first Phase III study to show a cancer immunotherapy combo reduced risk of disease recurrence for early-stage hepatocellular carcinoma.
Amgen commits $8m to clinical trial diversity programme
The Robert A. Winn Diversity in Clinical Trials Award Program has been pledged $8 million over the next four years by Amgen.
NICE recommends all-oral treatment for multiple myeloma
Ninlaro® (ixazomib) plus lenalidomide and dexamethasone has been recommended by NICE for relapsed/refractory multiple myeloma patients who have had two or three lines of therapy.
Pfizer offers 1.2 billion in poorer countries access to full medicine portfolio
Pfizer has expanded its not-for-profit initiative ‘An Accord for a Healthier World’ to enable 45 lower-income countries access to its full product portfolio.
mRNA vaccine trial shows efficiency in older adults with RSV
Moderna's mRNA vaccine targeting respiratory syncytial virus (RSV) in older adults demonstrated promising efficacy in a Phase III trial.
UK medical cannabis manufacturer granted GMP registration
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a UK manufacturing facility good manufacturing practice (GMP) registration for its cannabis API.
