European Pharmaceutical Review

AUGUST 23, 2022

PTSD is a potentially chronic condition that disrupts lives and can lead to or exacerbate existing health issues such as depression, anxiety, eating disorders, and suicidal thoughts. Many people have PTSD, but there [are] few effective pharmacologic treatments and limited drug development for PTSD,” commented Gradus.

Food and Drug Administration 71

Food and Drug Administration Pharmacology Prospecting Medical 71

European Pharmaceutical Review

JULY 13, 2023

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA). This could lead to significant research waste.

Medical 87

Medical Food and Drug Administration Pharmacology Medicine 87

European Pharmaceutical Review

FEBRUARY 14, 2024

The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics.

Food and Drug Administration 79

Food and Drug Administration Manufacturing Engineering Pharmacology 79

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline.

Food and Drug Administration 79

Food and Drug Administration Safety Patients Leads 79

Pharmaceutical Technology

FEBRUARY 13, 2023

However, there is a high level of attrition during the pharmaceutical research and development process, which is an indicator of the vast number of potential drug substances considered for progression. With all this in mind, how do drug developers know which strategy and approach is right for their molecule at this early stage?

Food and Drug Administration 52

Food and Drug Administration Leads Pharmaceutical Pharmaceutical research 52

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. Proteus’s profile grew considerably; it was soon valued at $1.5

Food and Drug Administration 122

Food and Drug Administration FDA Medicine Patients 122