Nitrogen dioxide (NO2) gas found not to ingress and cause protein degradation when sterilising polymer-based prefilled syringes (P-PFSs), according to study.
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Hansizhuang (serplulimab), the world's first anti-PD-1 monoclonal antibody (mAb) treatment for extensive-stage small cell lung cancer (ES-SCLC), enhanced survival rates compared to chemotherapy, and is projected to be the leading immunotherapy for the disease in the next five years.
The Council of Europe encourages EU Member States to share tissue and cell availability data to support donation access and State self-sufficiency.
A Phase I trial revealed that Bioheng Biotech’s chimeric antigen receptor (CAR) T-cell therapy drug RD13-01 was safe for use and that it could reduce malignant tumours.
Korean researchers developed ground-breaking new technology that manufactured biodegradable microrobots intended for targeted precision therapies at a rate of 100 per minute.
EPR highlights the development of a simple, flexible two-dimensional liquid chromatography-native mass spectrometry method for the in-line analysis of biotherapeutics.
Data demonstrated that a one-time injection of the drug BRII-296 is safe and effective for most patients with postpartum depression (PPD).
Phase III trial confirmed Eisai’s lecanemab significantly decreased cognitive decline in patients with mild Alzheimer’s disease.
Research suggests a Transferable Exclusivity Extension (TEE) system is “the only existing option capable of incentivising antibiotic R&D in a sustainable manner” for Europe.
EPR summarises the development of a HPLC method for the detection, separation and quantification of N-nitrosodimethylamine (NDMA) in both olmesartan API and finished formulations.
Two of the four diabetes drugs tested (insulin glargine and liraglutide) in combination with metformin, extended the blood glucose stability period for patients.
Results from the first real-world clinical trial showed strong evidence that ensuring pregnant women are vaccinated and boosted with mRNA vaccines helps prevent severe COVID-19.
A monograph outlining the analytical methods and acceptance criteria for cannabis chemotypes has been released for comment by USP’s Herbal Medicines Compendium.
New draft guidance by the US Food and Drug Administration (FDA) evaluates the ethics of children participating in clinical studies.
EPR highlights a high-performance liquid chromatography (HPLC) method which enables the detection of both chlorpheniramine maleate and ibuprofen in formulation.