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76 search results for: MSD

61

We need predictive safety biomarkers

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Every year, drug developers lose billions of euros because of late-stage clinical or postmarking safety problems with drugs. A recently kicked-off IMI consortium now wants to qualify a set of safety biomarkers that allow for the prediction of drug-induced injury of kidney, liver, vasculature, CNS, and pancreas. European Biotechnology spoke with Dr Michael Merz, the coordinator of the TransBioLine Project, and consortium member Prof Dr Stefan Wnendt about the plans and impact of the project.

62

Bioengineers to standardise biomanufacturing

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Biomanufacturing – either for production of biologics or bio-based everyday products – has traditionally suffered from the unpredictably variable response of production cell lines to external stimuli. Synthetic biology groups now wish to create a network of biofoundries that aim to establish reproducibility standards from process design to product purification and – in the long term – intend to switch from cell-based to cell-free bioproduction.

67

Targovax refocussing clinical pipeline post-ASCO

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Despite a 6-month improvement of 2-year-overall survival in pancreatic cancer patients, Norwegian cancer immunotherapy specialist Targovax ASA will terminate development of TG01 in this indication. Instead, development of RAS neoantigen-targeting cancer vaccines will be pushed in colorectal cancer.

68

Concept appoints Matilda Bingham & David Higton

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Concept Life Sciences (Concept), the integrated drug discovery, development and analytical services company, today announced it has appointed Matilda Bingham as Site Director of its Alderley Park site in Cheshire, UK, and David Higton as Principal Scientist (Biotransformation and Metabolite Identification), also based at the Alderley Park site.

69

EU General Court rejects industry’s confidentiality claims

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The European Medicines Agency (EMA) has won a landmark battle about the amount of data from clinical dossiers that may be made public. The European Court of Justics (EJC) rejected the demand of three drug developers not to publish what they called confidential information under the EMA’s transparency rules. 

70

EU ombudsman soft-sells safety concerns on HPV jabs

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A complaint against the EMA’s handling of a referral procedure related to potential side effects of Sanofi/MSD’s HPV vaccine Gardasil and GSK’s HPV jab Cervarix, filed by the Nordic Cochrane Centre and physicians, has been rejected by the European Ombudsman.