Remove 2022 Remove Pharmacology Remove Safety
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Handling HPAPIs safely – what does it take?

European Pharmaceutical Review

1 These substances “are 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 98
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Lipid Nanoparticles Immunogenicity & Toxicity | December 6-8, 2022

pharmaphorum

The highly anticipated Lipid Nanoparticle Immunogenicity & Toxicity Summit takes place this December to unite 80+ senior leaders as the definitive meeting for clinical pharmacology , immunogenicity , bioanalytical development leaders to stay at the forefront, arming you with practical takeaways and lessons learned.

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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.

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Advancing AOCs to transform the delivery of RNA therapeutics

European Pharmaceutical Review

mAbs have well-established safety profiles, high specificity and affinity and long half-lives – they have been used in drug development for more than 30 years. Known linkers in the RNA field are used to bond together the two pharmacologically active molecular entities and can be applied to multiple oligonucleotide modalities.

Safety 98
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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 10,12 The THR scheme is also limited to products used for oral or external use and/or inhalation.

Marketing 103
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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

In 2022, 54% of FDA new drug approvals were for rare diseases , a significant increase in proportion of approvals in the recent years. Still, Blank suggested that companies enroll the patient population that is most likely to benefit, because early phase studies contain the most safety risks.

FDA 105
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Top-10 ways for Pharma to leverage AI according to…AI

Impetus Digital

In 2022, the AI-fuelled pipeline reportedly expanded at an annual rate of almost 40%. To avoid compliance issues , it is essential to keep up with new regulatory changes, including updated reporting guidelines and safety requirements. Looking back at 2023 , AI for drug discovery saw both wins and losses.

Pharma 94