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Enhertu approved in EU for HER2-low breast cancer
The European Commission has approved Enhertu in the EU as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
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First CAR T-cell therapy recommended on NHS
NICE’s recommendation of Yescarta® means it is the first time patients will be able to access CAR T-cell therapy long-term on the NHS.
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ebook: Extractables and leachables: a guide to analytical methods
This ebook takes an in-depth look at advanced analytical methods for extractables and leachables analysis in the pharma industry.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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).
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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.
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Miriam Guest
20 January 2023 | By
Principal Microbiologist, New Modalities and Parenteral Development. Pharmaceutical Technology and Development, Global Operations, AstraZeneca UK.
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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.
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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.
