Liftstream is an executive search recruitment company in the life sciences sector
Biosimilars – is global development a reality?
Posted in Pharmaceutical business
Tagged animal studies, Biologicals Advice Limited, Biosimilar Medicines Working Party, biosimilars, CHMP, Committee for Advanced Therapies, Committee for Medicine Products for Human Use, comparator, development, Dr Narayanan, EMA, erythropoietin, europe, filgrastim, Gene Therapy Working Party, infliximab, regulatory affairs, somatropin
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PTC Therapeutics appoints Chief Medical Officer and communicates CHMP conditional decision
Authored by Karl Simpson
Posted in Orphan Drugs and Rare Diseases, Pharmaceutical business
Tagged Ariad, Ataluren, Chief Medical Officer, CHMP, DMD, Duchenne, Duchenne Muscular Dystrophy, EMA, europe, GSK, Iclusig, investors, MAA, market authorisation application, Murad Husain, oncology, parents, patients, phase III clinical trial, Prosensa, PTC Therapeutics, Rober J. Spiegel, Sarepta, USA, VP Global Regulatory Affairs
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Roche scores conditional European win with Erivedge
Authored by Karl Simpson
Posted in Pharmaceutical business
Tagged antibody, ASCO, basal cell carcinoma, BCC, BMS, CHMP, Conditional approval, conditional marketing authorization, CUDC-907, Curis Inc, EMA, Erivedge, europe, European Commission, Genentech, HDAC inhibitor, IAP proteins, immunotherapy, Melanoma, Merck, MPDL3280A, oncolgy, PD-1, PI3K, Roche, vismodegib
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