The Food and Drug Administration has approved Fast Track designation for Shire’s SHP607, a treatment used in the prevention of chronic lung disease in extremely premature infants. SHP607, which is currently in Phase 2 Clinical Development, is a recombinant human version of the naturally occurring protein complex of insulin-like growth factor 1 (IGF-1) and its
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Reference Number: J30011 Regulatory Affairs Manager – CMC Midlands & SE England Salary: Competitive + Benefits Regulatory Professionals are currently
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Merck Sharp & Dohme’s Keytruda has received approval in Europe for metastatic urothelial carcinoma allowing it to catch up with its immunotherapy rivals. Although, while BMS’ Opdivo and Roche’s Tecentriq beat MSD to approval in Europe earlier this year, Keytruda is the first treatment to show superior overall survival when compared to using chemotherapy in
Alexion has won new European indication for its ultra-orphan drug, Soliris, and has picked Germany to be its first launch market. Soliris received the green light from the European Commission to treat adults with generalised myasthenia gravis (gMG), who are anti-acetylcholine receptor antibody-positive. The extended indication for the first-in-class inhibitor was based on the back