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The future of medical cannabis development in Europe

European Pharmaceutical Review

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. This will lead to a higher proportion of these medicines becoming licensed, benefitting a larger number of patients. 2023 Mar 4;16(3):257-66.

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Can Hepatitis C drugs reduce symptoms of PTSD?

European Pharmaceutical Review

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.

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Navigating the unique CMC challenges of oral anaerobic live biotherapeutics

European Pharmaceutical Review

The first drug products to achieve biological licence approval (BLA) from the US Food and Drug Administration (FDA) are whole community products derived from human faecal matter and are indicted for Clostridium difficile infection. Firstly, the pharmacological response to LBPs does not follow traditional pharmacokinetic principles.

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Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

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. Treatment with the mAbs delayed cognitive decline by 2.6 months for lecanemab and 5.5

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Strategies for Streamlining Small Molecule Formulation Development When Bridging from Candidate Selection to First-in-Human Clinical Testing

Pharmaceutical Technology

Key considerations in the candidate selection stage The first step in a drug development program is choosing the optimum molecule from a range of potential leads that have been optimized within drug discovery. We start by using in-silico modeling of any pre-existing data associated with the lead compounds.

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Why aren’t digital pills taking off?

Pharmaceutical Technology

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. These days, he is leading trials involving a system developed by the digital health company etectRx (pronounced as e-tect-are-ex), which works with investigators who can use such real-time data.