FDA approves new therapy for myelodysplastic syndromes
The first targeted therapy for certain adults with the rare blood cancer myelodysplastic syndromes, has been approved by the US Food and Drug Administration (FDA).
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Guidance on machine learning-enabled medical devices published
The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have issued guidelines to reduce the regulatory burden for machine learning-enabled medical devices.
CPHI selects 2023 Pharma Award winners
Progress, innovation and sustainability across the pharmaceutical supply chain were recognised at the 2023 CPHI Pharma Awards.
Approval-first for meningococcal vaccine
The first single vaccine to immunise against the five most common meningococcal disease serogroups in adolescents has been approved in the US.
Europe’s pharmaceutical packaging market to value over $35bn by 2028
With the pharmaceutical industry placing greater emphasis on sustainability, as a material, paper will play a key role in Europe’s packaging and labelling market between 2023-2028, research predicts.
ESMO 2023: Janssen reveals data for intravesical delivery system
Phase IIb study results show evidence of sustained, durable complete responses beyond one year with an intravesical gemcitabine delivery system for a high-risk bladder cancer.
How to approach die plate adhesion during tableting
A study by IMA and Labomar has illustrated a gentle but effective approach for achieving defect-free tablets and an adhesion-free die plate.
Roche to gain rights to novel antibody for IBD
Roche is set to gain rights to develop, manufacture and commercialise a novel antibody treatment with first-in-class and best-in-disease potential for inflammatory bowel disease (IBD), under a new acquisition agreement.
Could Eli Lilly deliver first-line atopic dermatitis treatment?
Strong evidence of long-term efficacy of the IL-13 inhibitor lebrikizumab for atopic dermatitis has been demonstrated in Eli Lilly’s two-year extension trial.
Sustainability crucial for pharma’s supply chain future
Evidence of sustainability metrics is expected to be important for companies in the pharmaceutical industry in the next few years, according to sustainability results of the CPHI Annual Survey 2023.
Starvation stress key in Micrococcus luteus cleanroom survival
Key factors behind the lengthy survival capabilities of the bacterium Micrococcus luteus (M. luteus) within a cleanroom have been reported in Tim Sandle’s recent paper.
Counterfeit diabetes pens identified in EU and UK
Following shortages of the diabetes medicine Ozempic (semaglutide), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have confirmed cases of falsely labelled pre-filled pens at UK and EU wholesalers.
EACS 2023: Gilead shares real-world evidence for Biktarvy®
Efficiency of Gilead Science’s long-term HIV treatment option with a high barrier to resistance has been further demonstrated in real-world data based on three-year study follow up.
Regulatory-first for gene editing therapy
The world’s first investigational in vivo CRISPR-based gene editing therapy cleared for late-stage clinical development is expected to enter Phase III in late 2023.
Sweden gets new pharmaceutical aseptic filling line
Sever Pharma Solutions’ new aseptic filling line designed for high potent injectable drugs, features the latest automated systems.
