Endotoxin testing milestone reached with European Pharmacopoeia’s animal shift
The quality control (QC) standards publication sets animal-free bacterial endotoxins testing (BET) as the new norm in Europe.
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The quality control (QC) standards publication sets animal-free bacterial endotoxins testing (BET) as the new norm in Europe.
Data shows treating sickle cell disease patients aged four to 11 years with Oxbryta® (voxelotor) results in increases in haemoglobin associated with improved clinical status.
EU recommends that batches of Janssen COVID-19 Vaccine not be released for use due to a cross contamination report, while the FDA authorises use of drug substance from the facility where the contamination occurred.
Laboratory study shows the blood sera of people vaccinated against COVID-19 with Comirnaty® can neutralise at least six viral variants including three variants of concern.
Scientists, administrators, staff and leaders at the NIH have laid out their framework under the UNITE initiative to end structural racism in the biomedical industry.
Monoclonal antibody therapies found to reduce progression to severe disease, risk of hospitalisation and death in transplant recipients with mild to moderate COVID-19.
DFE Pharma is the latest member of the UK’s Medicines Manufacturing Innovation Centre and will work on Grand Challenge 1: improving the manufacture of oral solid dosage medicines.
Trial shows the single-shot Janssen COVID-19 Vaccine generates robust immune responses against several COVID-19 variants.
Personalised cancer vaccine increases progression free survival by approximately 50 percent in patients with newly diagnosed glioblastoma.
Clinical studies optimising immunisation with Sanaria’s PfSPZ-CVac vaccine resulted in 77 and 75 percent of participants being protected from malaria infection.
The continuous-flow microfluidic device allows scientists to assess crystalline API growth rates, shapes and structures to more quickly identify the best conditions for drug manufacturing.
The European Medicines Agency (EMA) has begun evaluating whether to extend the use of the COVID-19 Vaccine Moderna to include adolescents aged 12 to 17.
Stem cell therapy authorities urge the WHO to create an advisory committee for regenerative medicine and work to combat the rising use of unproven stem cell therapies worldwide.
Aduhelm™ (aducanumab-avwa) is the first new treatment approved for Alzheimer’s since 2003 and the first therapy to target the fundamental pathophysiology of the disease – amyloid plaques.
New data shows AstraZeneca’s Imfinzi (durvalumab) achieved an unprecedented five year survival rate of over 40 percent in patients with Stage III non-small cell lung cancer.
Using a new formulation technique, researchers were able to more than double drug loading of a hydrophobic active pharmaceutical ingredient in tablets. Thus, the new formulation method may lead to smaller pills delivering the same therapeutic benefit.