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MHRA Chief Executive to step down

European Pharmaceutical Review

Leading the MHRA – a five year journey Professor Graham Cooke, interim chair of the MHRA board, remarked that Dame June’s “leadership of the MHRA over the last five years, particularly during the COVID-19 pandemic, has been exceptional.” Her previous role in the agency was as Director of Vigilance and Risk Management of Medicines.

Safety 111
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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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Leading API biologics (protein and peptide) companies in contract marketing

Pharmaceutical Technology

Victoza, Copaxone, Lupron, Zoladex, Sandostatin, and Somatuline are some of the popularly marketed peptide API therapeutic drugs while more than 600 peptide-based pharmacological leads are being investigated worldwide, across various phases of development. Discover the top API protein and peptide companies in contract marketing.

Leads 40
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Regenerative potential: cell?based therapies for heart failure

European Pharmaceutical Review

Cardiovascular diseases are the leading cause of death globally with over 18.5 Cardiovascular diseases are the leading cause of death globally with over 18.5 Despite these trials varying in design, they confirmed the feasibility and safety of the procedure. 1 Furthermore, there are 63.3 1 Furthermore, there are 63.3

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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.

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

Pharmaceutical Technology

Blank acknowledged that in many cases, an exclusively paediatric patient population could lead to difficulties with drawing consent for early phase trials. 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