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.
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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.
First-in-class phosphate absorption inhibitor approved by FDA
A first-in-class treatment with a differentiated mechanism of action has been approved to reduce serum phosphorus in chronic kidney disease (CKD) in individuals for which phosphate binders are not suitable.
Sanofi treatment could slow type 1 diabetes progression
New Sanofi Phase III trial data adds to evidence of the treatment potential for the first disease modifying therapy in type 1 diabetes.
NICE recommends Roche biologic for lymphoma
Glofitamab is the first treatment to be recommended by the National Institute for Health and Care Excellence (NICE) at the same time as it is approved for advanced lymphoma in the UK.
FDA issues draft guidance on alternative tools for facility assessments
As part of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) reauthorisation negotiations, the US Food and Drug Administration (FDA) has issued new draft guidance on alternative tools for assessing drug manufacturing facilities.
Novo Nordisk agrees $1.3bn hypertension acquisition
Novo Nordisk has set its sights on acquiring a medicine with best-in-class potential for hypertension from KBP Biosciences.
