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.
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News
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New draft guidance by the US Food and Drug Administration (FDA) evaluates the ethics of children participating in clinical studies.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.
GM herpes virus fights advanced cancers
A Phase I trial showed early potential in using a genetically engineered herpes virus to combat advanced cancers that exhibited no response to immunotherapies.
AbbVie Cork facility €60 million expansion
The Irish biopharmaceutical plant was given a special update for its pivotal 20th anniversary, expanding the site to offer its future workforce training in new technology.
Pfizer 20vPnC vaccine as safe as Prevenar 13®
The paediatric pneumococcal conjugate vaccine (20vPnC) can help protect against all 20 pneumococcal disease-causing serotypes, says Pfizer.
Ultomiris for generalised myasthenia gravis
The first and only long-acting C5 inhibitor, Ultomiris (ravulizumab), has been permitted in Europe for adults with generalised myasthenia gravis.
FDA and NIH partner to understand ALS
The Critical Path for Rare Neurodegenerative Diseases (CP-RND) partnership was launched to develop breakthrough treatments for neurodegenerative diseases like amyotrophic lateral sclerosis (ALS).
Developing an adaptive auto-synthesiser
EPR highlights the use of HPLC and FTIR in the creation of an auto-synthesiser that can flexibly perform critical actions such as quenching, purging and dosing reagents.
First patient dosed with HIV gene therapy
According to researchers, the CRISPR-based gene therapy, EBT-101, has the potential to change the future of HIV therapeutics.
EMA human medicines committee (CHMP) highlights, September 2022
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval, including those for rare diseases, osteoporosis and cancer.
GSK requires supplier sustainability compliance from 2023
New climate responsibility for the GSK supply chain will come into force from 2023, helping the biopharmaceutical giant to achieve their aspirational environmental targets.
