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Novo Nordisk’s once-weekly diabetes jab Kyinsu set for European approval
EMA advisors at the CHMP backed the combination treatment and also recommended Bayer’s menopause drug Lynkuet, putting both on the path to being licensed.
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Type 2 Diabetes Mellitus (T2DM)
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Counterfeit diabetes pens identified in EU and UK
Following shortages of the diabetes medicine Ozempic (semaglutide), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have confirmed cases of falsely labelled pre-filled pens at UK and EU wholesalers.
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CHMP meeting highlights – January 2023
Four new medicines were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s January meeting, with positive opinions given to two type 2 diabetes drugs.
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CHMP meeting highlights – July 2022
At its July meeting, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 medicines for approval and extended the indication of six more, including Imvanex for the prevention of monkeypox.
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EMA’s human medicines committee (CHMP) May 2022 meeting highlights
The latest meeting saw EMA’s human medicines committee (CHMP) recommend the approval of nine new medicines, refuse two biosimilar medications and recommend extensions of therapeutic indication for six medicines.
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FDA issues draft guidance on trials for medical devices to improve glycaemic control
The guidance outlines recommendations for early trials testing the feasibility of medical devices intended to improve glycaemic control for type 2 diabetes.
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Beyond nutrition: vitamins and n-3 polyunsaturated fatty acids as APIs
Active pharmaceutical ingredients (APIs) are important compounds used in the manufacture of pharmaceutical drug products. Eric Ciappio discusses the potential of vitamins and n-3 polyunsaturated fatty acids (PUFAs) as APIs, with a focus on their clinical relevance.
