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What recent paediatric guidelines mean for drug developers 

Drug Discovery World

Ethical considerations Given the vulnerable status of children, safeguards are needed when including a paediatric population in clinical investigations of drugs and medical devices. The guidance is for pharmaceutical companies conducting paediatric clinical trials in the EU using the PIP procedure.

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Where is the promise for plant-based medicines? Part 1: Cannabis  

Drug Discovery World

With this in mind, the FDA claims to be committed to sound scientific research into the area and has a number of processes in place for those in the medical research community who intend to study cannabis 1. Jazz Pharmaceuticals has supplied the cannabidiol for the trials at no cost.

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Janssen Announces U.S. FDA Approval of INVEGA HAFYERA™ (6-month paliperidone.

The Pharma Data

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. The safety profile observed in the trial was consistent with previous studies of INVEGA SUSTENNA ® and INVEGA TRINZA ® with no new safety signals emerging. About the Clinical Trial. Results found that 92.5

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Novo Nordisk: positivity for haemophilia treatment  

Drug Discovery World

DDW Editor Reece Armstrong speaks to Stephanie Seremetis, Chief Medical Officer, Rare Blood Disorders at Novo Nordisk to get her response to the company’s latest study results for its Mim8 antibody. SS: In FRONTIER1, phase I and phase II was combined into a single clinical trial, thereby expediting the study time.

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BioSpace Global Roundup, Oct. 15

The Pharma Data

AOP Orphan – AOP Orphan Pharmaceuticals took over the Viennese pharmaceutical company Amomed and the Luxembourgish health-tech company SciPharm. AOP anticipates new opportunities in Austria as a hub for research and business. All jobs have been maintained and the workforce has grown from about 220 to 350.