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Handling HPAPIs safely – what does it take?

European Pharmaceutical Review

1 These substances β€œare pharmacologically and biologically active at low doses,” Dr Kishore Hotha, Global Head of Analytical Research & Development at Veranova, explained. ” Highly potent APIs are pharmacologically and biologically active compounds at low doses. What training is required for employees to handle HPAPIs safely?

Safety 89
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Angion stock falls after agreeing Elicio Therapeutics merger

pharmaphorum

Angion Biomedica ended 2022 in the midst of a strategic review after its lead drug for kidney diseases flamed out, and it has now charted a path forward – a reverse merger with clinical-stage biotech Elicio Therapeutics. Darrell Irvine.

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Navigating the unique CMC challenges of oral anaerobic live biotherapeutics

European Pharmaceutical Review

Firstly, the pharmacological response to LBPs does not follow traditional pharmacokinetic principles. LBP drug substance production considerations Lead candidate strains are often isolated from healthy human subjects to establish a master cell bank (MCB).

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Nine for 2023, part two: healthcare’s hard problem, the prognosis for diagnosis, and key new pharmacotherapy platforms

pharmaphorum

Across swathes of primary care, pharmacological innovation has stalled; the last new antihypertensive class was introduced in 2007 and new antibiotics have trickled in at a dangerously slow pace. Alzheimer’s is currently the seventh-leading cause of death globally and growing fast.

FDA 82
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Advancing AOCs to transform the delivery of RNA therapeutics

European Pharmaceutical Review

Based on learnings from ASOs and siRNAs they also leverage unique engineering and drug delivery techniques that enable them to target a broader set of cell types, including many that have been previously untreatable with RNA therapeutics. Brain pharmacology of intrathecal antisense oligonucleotides revealed through multimodal imaging.

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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