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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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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.
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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.
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UK ATMP clinical trials report 2022 published
T cells were revealed as the most commonly investigated cell type continuing to increase, found CGT Catapult's 2022 UK ATMP clinical trials report.
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Potential treatment identified for septic patients
CER-001 is a potentially game-changing treatment for septic patients at high risk of acute kidney injury, suggested a ABIONYX Pharma VP.
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Pharmaceutical microbiology: key developments 2022
Here, microbiology experts Tim Sandle, Tony Cundell and AstraZeneca’s Miriam Guest reflect on key developments in pharmaceutical microbiology during 2022.
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Moderna joins the Association of the British Pharmaceutical Industry
To support the UK’s investments in manufacturing and R&D, Moderna has joined the Association of the British Pharmaceutical Industry (ABPI).
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T-cell therapy helps overcome stem cell transplant viral infections
A T-cell therapy that targets six viruses commonly contracted by haematology patients after allogeneic stem cell transplantation, offered 95 percent response in a study.
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Pre-filled asthma pen approved for self-administration in EU
Tezspire is the first biologic approved in Europe for severe asthma with no phenotype or biomarker limitation, says AstraZeneca EVP.
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EC approves influenza antiviral for children over one years old
Xofluza® offers the first novel mechanism of action for an influenza antiviral to be approved by the European Commission in almost 20 years.
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Gut microbiome key in Parkinson’s, suggests study
A large metagenomics study determined that gut microbiome is at the centre of Parkinson’s disease pathogenesis.
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Is machine learning the answer for long-acting injectable drugs?
A study from the University of Toronto is one of the first to apply machine learning to the design of polymeric long-acting injectable drug formulations.
