Pharmaceutical Technology

APRIL 12, 2023

However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. This is to ensure patient safety, as outlined in The Medicines for Human Use (Clinical Trials) Regulations 2004.

Pharma 98

Pharma Food and Drug Administration Safety Medicine 98

Pharmaceutical Technology

MAY 31, 2023

The Danish CRISPR biotech SNIPR BIOME has released the first glimpse at the safety profile for SNIPR001, a gene therapy intended to target antibiotic resistance. Interim clinical results from a Phase I trial have demonstrated SNIPR001’s safety in healthy volunteers. SNIPR001 consists of four CRISPR-edited phages targeting E.Coli.

Food and Drug Administration 98

Food and Drug Administration Safety Side effects FDA 98

Pharmaceutical Technology

APRIL 25, 2023

Storage in other conditions can cause damage to the antigen or adjuvant and reduce the vaccine’s safety or efficacy. Long-term storage and delivery of vaccines are vital, especially as governments seek to vaccinate rural and remote communities. The majority of this rise came from the African region.

Food and Drug Administration 69

Food and Drug Administration Government Prospecting Food 69

Pharmaceutical Technology

MAY 1, 2023

After a US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) Advisory Committee (AdCom) meeting in March 2023 voted unanimously in support of GSK’s respiratory syncytial virus vaccine, the odds for an approval have increased.

Food and Drug Administration 52

Food and Drug Administration Medicine Pharmaceutical Marketing 52