Serialisation of drugs is confronting pharmaceutical companies all over the world with challenges, especially in relation to data handling and the integration of additional equipment and functions into existing packaging lines. Offline solutions, where secondary packaging is serialized directly by the folding-box manufacturer, combined with sophisticated data flow architectures, are a reliable, flexible, and immediately available alternative to inline serialisation.
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The European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) recommended seven medicines for approval, including two orphan medicines, plus three generics at its November 2017 meeting.
More than 4,000 participants from all over the globe visited Berlin in early November to take part in this years BIO-Europe. The event continues to be on the upswing – like the biotech industry itself.
Conversion of agricultural waste into useful products is a worldwide need. As part of the European Project Valor Plus, Spanish biotechindustry association ASEBIO invited its members to visit the recently opened second-generation biorefinery Clamber.
For the first time researchers at universities Bochum (Germany), Salzburg (Austria), and Modena (Italy) have shown that autologous transgenic keratinocyte cultures can regenerate an entire, fully functional epidermis on a seven-year-old child suffering from junctional epidermolysis bullosa (JEB).
German inflammation and autoimmunity specialist InflaRx AG (Jena) announced it will offer 6,667,000 common shares at an Nasdaq initial public offering price of $15.00 per common share, resulting in total gross proceeds of approximately US$100m.
The US Food and Drug Administration (FDA) has lifted the clinical hold due to a patient death on Phase I testing of UCART123 in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Genetic Diseases:?Its a disease that often strikes people in the prime of life, slowly destroying control over body, mind and personality. It inevitably kills the patient, but usually only after at least a decade of suffering. The underlying cause of Huntingtons disease – a dominant mutation on Chromosome IV – was discovered almost 25 years ago. Now the first trials to target the condition at its source have begun. Chances of finding a cure have never been more realistic.
German MAB Discovery GmbH has extended its 2013 collaboration with BioNTech AG by a contract to produce another set of therapeutic antibodies against a range of targets delivered by BioNTec.