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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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The biggest challenge is often ensuring that limited time, effort and resources are spent developing a suitable formulation for Phase 1, and at the same time ensure that these results pave the way for further development into Phase II/III.

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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.

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Antibody–drug conjugates (ADCs) are an emerging type of biotherapeutics that utilize multiple tissue specific antibodies combined with a range of linker designs to enable the transportation and selective release of cytotoxic drugs in close proximity to tumours.

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Ulf Bremberg, Johan Eriksson-Bajtner, Fredrik Lehmann, Viveca Oltner, Ellen Sölver, and Johan Wennerberg
  Org. Process Res. Dev. 2018, 22, 1360−1364