Fast track designation given to Shire’s chronic lung disease drug by FDA

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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MSD’s Bladder cancer treatment, Keytruda approved in EU following superior survival rates

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

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Soliris approved by European Commission to treat adults with gMG, will be picked up by Germany first

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

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New and Improved Regulatory Professionals Website!

Regulatory Professionals, part of the Clinical Professionals Group, are always keen to be at the forefront of technology and innovation within the life science recruitment industry to provide candidates and clients with excellent service and knowledgeable insight and we are delighted to unveil our new Regulatory Professionals website! In addition to the fresh new look,

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GSK submits application in EU to extend use of Relvar Ellipta for use in asthma

GlaxoSmithKline and Innoviva have applied in Europe to market Relvar Ellipta for extended use in patients with asthma who are already adequately controlled on inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy. The treatment, comprised of the ICS fluticasone furoate (FF) and the LABA vilanterol (VI), is currently indicated in Europe for the regular treatment of patients

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