Nitrogen dioxide for sterilisation of protein-filled polymer-based syringes
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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Serplulimab increases survival in small cell lung cancer patients
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.
Sharing data on human tissue availability across EU
The Council of Europe encourages EU Member States to share tissue and cell availability data to support donation access and State self-sufficiency.
CAR-T therapy safe for relapsed or refractory T-cell malignancies, finds study
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.
Mass producing biodegradable stem cell therapy microrobots
Korean researchers developed ground-breaking new technology that manufactured biodegradable microrobots intended for targeted precision therapies at a rate of 100 per minute.
Enabling multi-dimensional biotherapeutic analysis
EPR highlights the development of a simple, flexible two-dimensional liquid chromatography-native mass spectrometry method for the in-line analysis of biotherapeutics.
Injection could help postpartum depression, says study
Data demonstrated that a one-time injection of the drug BRII-296 is safe and effective for most patients with postpartum depression (PPD).
Lecanemab diminishes mental deterioration in early Alzheimer’s
Phase III trial confirmed Eisai’s lecanemab significantly decreased cognitive decline in patients with mild Alzheimer’s disease.
Is TEE the key for novel antibiotics?
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.
HPLC-MS/MS for NDMA impurity determination in sartans
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.
Large diabetic drug comparison study releases results
Two of the four diabetes drugs tested (insulin glargine and liraglutide) in combination with metformin, extended the blood glucose stability period for patients.
mRNA vaccines protect pregnant women against severe COVID-19
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.
Medicinal cannabis monograph proposed by US Pharmacopeia
A monograph outlining the analytical methods and acceptance criteria for cannabis chemotypes has been released for comment by USP’s Herbal Medicines Compendium.
New ethical guidance for paediatric clinical trials
New draft guidance by the US Food and Drug Administration (FDA) evaluates the ethics of children participating in clinical studies.
HPLC determination of common cold formulations
EPR highlights a high-performance liquid chromatography (HPLC) method which enables the detection of both chlorpheniramine maleate and ibuprofen in formulation.
