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Priority Review granted to pemigatinib for treatment of cholangiocarcinoma
The US FDA has awarded pemigatinib Priority Review, after the drug met its primary and secondary endpoints in a Phase II trial.
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Therapeutics
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Beyond nutrition: vitamins and n-3 polyunsaturated fatty acids as APIs
Active pharmaceutical ingredients (APIs) are important compounds used in the manufacture of pharmaceutical drug products. Eric Ciappio discusses the potential of vitamins and n-3 polyunsaturated fatty acids (PUFAs) as APIs, with a focus on their clinical relevance.
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New methodology allows for deeper understanding of how drugs interact
A methodology has been developed which characterises how drugs influence each other when combined during treatment and sheds new light on how drugs perturb the underlying molecular networks.
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Quality control solutions that fuel confident decisions
As the partner of choice for managing microbial quality control, Charles River’s products and services facilitate confident and objective decision-making, ensuring the integrity of your microbial data, reducing risk, building efficiency and improving your bottom line, while assisting in the journey to bring products to market.
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Global subcutaneous drug delivery devices market expected to grow
A new report has predicted that the global subcutaneous drug delivery devices market will grow to $17,290.47 million in 2027 from $9,243.80 million in 2018.
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NHS England and Vertex announce agreement for cystic fibrosis medicines
A new agreement will allow eligible cystic fibrosis patients in England to have access to CFTR modulators to treat the underlying cause of their disease.
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New breakthrough can effectively deliver medications into the brain
Scientists have found a way to effectively transport medication into the brain which could lead to improved treatments for neurological and neurodegenerative diseases.
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Treatment to increase pain-free light exposure approved
The FDA has approved the first treatment to increase pain-free light exposure in patients with the rare disorder, erythropoietic protoporphyria.
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First treatment for children with rare vasculitis diseases approved
Rituxan (rituximab) is the first approved treatment for children with rare vasculitis diseases, in which a patient’s small blood vessels become inflamed.
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Daratumumab approved for multiple myeloma treatment
The drug daratumumab has been approved for treatment of multiple myeloma, demonstrating increased efficacy when used in combination with other drugs.
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Scientific poster: Common Laboratory Techniques in the Drug Discovery Workflow
The characterization of novel therapeutics involves many chemical processes.
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Can calorimetry provide accurate estimates of long‑term stability for monoclonal antibodies?
Differential scanning calorimetry (DSC) has been one of the most widely used techniques to characterise the temperature stability of monoclonal antibodies (mAbs) and provide important information in formulation optimisation. However, despite its widespread use, not all the information contained in DSC data, especially denaturation kinetics, is routinely extracted. In this…
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Single-use strategies for downstream processing
All therapeutic developers and manufacturers are under intense pressure to improve efficiency and productivity and reduce costs, all while maintaining the highest quality standards.
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Application note: Cell-Based Therapies – Be on the Safe Side
Get QC Results for Advanced Therapy Medicinal Products (ATMPs) Before Treatment.
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British Columbia first province to switch patients to biosimilars
British Columbia has said it will switch as many as 20,400 patients from three branded biologic drugs to cheap biosimilars.
