Revised general chapter on chemometric methods available for comment
The revised general chapter 5.21 has been published in Pharmeuropa 33.3, the European Pharmacopoeia online forum, for public comment.
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New targeted gene therapy could reverse neurological diseases
Researchers have developed a novel gene therapy that could help treat children with incurable genetic and neurodegenerative diseases.
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, July 2021
The Pharmacovigilance Risk Assessment Committee (PRAC) provided safety warnings on COVID-19 vaccines, and found no evidence linking Zynteglo to blood cancer.
FDA suggests principles for implementing bio-fluorescent particle counters
FDA provides guidance on the validation and regulations for bio-fluorescent particle counting technology as an alternative, continuous method for bioburden testing in air and water systems.
WHO publishes recommendations on human genome editing
To promote the safe and ethical use of genome editing for the treatment of disease and genetic disorders WHO has published the first global recommendations.
Big pharma collaborates on free resource linking genetic variants to human disease
The collaborative work has produced the largest browsable resource linking rare protein-coding genetic variants to human health and disease that will accelerate targeted drug development.
Long-COVID symptoms improved with neuromodulation
All twenty long-COVID patients who received neuromodulation treatment reported significant improvements in their symptoms in just 14 days.
Rabbit pyrogen test to be replaced by European Pharmacopoeia
The European Pharmacopoeia will put an end to the rabbit pyrogen test in the next five years and encourages industry to adopt the monocyte-activation test instead.
Phase III trial to assess pritelivir as a treatment for herpes simplex virus infections
The trial will assess orally administered pritelivir for the treatment of drug resistant mucocutaneous herpes simplex virus (HSV) infections in the immunocompromised.
First people dosed with a quadrivalent seasonal flu mRNA vaccine
The Phase I/II trial will assess the safety, reactogenicity and immunogenicity of Moderna’s mRNA-1010 seasonal flu vaccine.
IL-6 antagonists reduce risk of death in hospitalised COVID-19 patients, finds analysis
WHO recommends IL-6 antagonists plus corticosteroids for hospitalised COVID-19 patients based on their ability to reduce risk of death and the need for mechanical ventilation.
Understanding your cleanroom fungi is key, says expert
New data shows that the majority of fungal genera isolated from a GMP cleanroom are filamentous and likely transferred into the facility from outside.
MHRA and Health Canada release new clinical safety reporting guidance
Under the new guidance, Development Safety Update Reports must include a description of the process used to review the worldwide safety data of the investigational drug.
Global sterilisation monitoring market to value $913mn by 2027
Market research suggests the biological indicators segment will retain the largest share of the global sterilisation monitoring market through 2027.
Ongoing pharma productivity requires a focus on upskilling
Research suggests that if pharma does not address staff capability gaps and support employee training and development, then there will be a significant impact on productivity.
