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Drug products that can be administered through inhalation offer many benefits. While other dosage forms, such as oral solids, are currently more common, inhaled formulations offer direct access to the central nervous system, bypassing the digestive system and liver.

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The United States of America is facing a hugely concerning opioid addiction epidemic, causing roughly 46 deaths per day according to the US Centres for Disease Control.

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Formulating a new candidate drug for first-in-human (FIH) trials must be considered carefully, as the decisions made can directly affect its chances of not only progressing to the next phase, but to achieving regulatory approval.

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Pharma companies hoping to achieve regulatory approval for their candidate drug must be able to show efficacy and demonstrate safety for use in a Phase III trial. However, the journey to late stage trials begins with the complex path from formulation development to first in human (FIH) trials.

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Moving forward there are tough decisions to be made in terms of site rationalisation. Industry consolidation is inevitable.

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There are only a few months left before the introduction of the European Falsified Medicines Directive (EU FMD). Once these regulations are in place, unique codes on pharmaceutical packaging should increase supply chain transparency and make the infiltration of counterfeit medicines more difficult.

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Companies that have been slow in their preparations will need to abandon the idea of customisation and stick to standardised solutions.

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Many factors can result in a drug candidate failing at a phase I trial from problems with the actual medicine, such as unforeseen toxicity, or simple logistics and supply chain issues.

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Drug stability testing is one of the most important parts of the drug production process. These tests aim to determine the performance of a drug under different conditions, such as humidity, sunlight and temperature, and therefore help to decide safe expiry dates.

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As the industry continues its preparations for the European Falsified Medicines Directive (FMD), Recipharm has reached another important milestone in its journey to serialisation compliance.