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Handling HPAPIs safely – what does it take?
Here, Veranova's Global Head of Analytical Research & Development, Dr Kishore Hotha, outlines safety considerations when manufacturing and handling highly potent APIs (HPAPIs).
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Natural allopregnanolone made orally bioavailable
Designed to treat anxiety and postpartum depression, a biotherapeutics company has made natural allopregnanolone orally bioavailable without permanent chemical modification.
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New cell therapy company will treat solid tumours
Adaptimmune Therapeutics and TCR² Therapeutics’ new cell therapy company could gain the first approval for an engineered T-cell receptor (TCR) T-cell therapy for a solid tumour.
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Leading in Pharma: a woman’s pathway
Here, to mark International Women’s Day, Dr Ekaterina Malievskaia from COMPASS Pathways reveals her path to working in mental health and the pharma industry.
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Oral PCSK9 inhibitor substantially reduces cholesterol, study finds
One of the first oral PCSK9 inhibitors tested in clinical trials significantly reduced low-density lipoprotein (LDL) cholesterol levels in patients with high cholesterol and/or heart disease.
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Pistoia Alliance launches Pharma Innovation Council
The Pharma Innovation Council will work to overcome industry barriers such as R&D challenges and the adoption of emerging technologies.
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Learning from lecanemab: a breakthrough treatment
Here, Dr Michael Irizarry, Eisai’s Senior Vice President of Clinical Research and Deputy Chief Clinical Officer for Alzheimer’s Disease and Brain Health discusses its highly anticipated Alzheimer’s drug, lecanemab.
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Combination therapy significantly improves pulmonary hemodynamics
Janssen’s single tablet of macitentan plus tadalafil significantly improved pulmonary hemodynamics in a Phase III trial for pulmonary arterial hypertension (PAH).
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Temperature-stable tuberculosis vaccine induces immune response
A National Institutes of Health (NIH)-supported trial has demonstrated the safety and efficiency of a freeze-dried thermostable tuberculosis vaccine.
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Moderna chooses mRNA vaccine manufacturing centre location
Following finalisation a ten-year strategic partnership with the UK government, Moderna has chosen the location for its Innovation and Technology Centre (MITC).
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New working party to address excipients in Ph. Eur. monographs
The European Pharmacopoeia Commission’s new Excipients Strategy Working Party will address specificities of excipients in European Pharmacopoeia monographs.
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Enhancing bioavailability formulations containing soluble acidic drugs
Research has revealed efficiency of a multi-compartmental dissolution method used to predict in vivo performance of BCS Class IIa compounds.
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EMA’s human medicines committee (CHMP) meeting highlights – February 2023
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval, including an enzyme replacement therapy for a rare disease.
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Prioritising for a data-driven 2023
As the pharmaceutical industry continues to face unprecedented challenges, the need for greater regulatory compliance and process efficiency remains at the forefront. Here, Frits Stulp predicts how new waves of digital transformation can help support companies deliver the best possible patient outcomes.
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Immunotherapy before surgery benefits melanoma patients
In a Phase II trial, immunotherapy drug pembrolizumab significantly lowered the risk of recurrence for stage III-IV melanoma patients when given before and after surgery.
