European Commission approved AZ’s treatment for locally advanced, unresectable NSCLC

AstraZeneca’s durvalumab has been approved in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). The decision enables doctors to prescribe the drug for adults with stage III NSCLC whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The

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Regulatory Professionals to attend TOPRA 2018 Symposium in Sweden

Regulatory Professionals employees Sarah Goddard, Divisional Director and Kirsty Calow, Divisional Manager will be exhibiting at the 2018 TOPRA Symposium, which is taking place in Sweden October 1-3rd. The Symposium features the following: Information on the latest regulatory developments Insight provided directly from Regulatory experts Opportunity for delegates to expand on their existing knowledge of

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Regulatory Affairs: In an ever changing industry – what are you doing to stand out?

Regulatory Professionals, part of the Clinical Professionals Group, have compiled a report that utilises results from our salary survey along with our specialist industry knowledge, which outlines significant changes within Regulatory Affairs, and can be used as a guide to business development. Divisional Manager, Kirsty Calow, elaborates on the findings and the current state of

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Pfizer’s treatment for ulcerative colitis approved in Europe

European Commission has approved Pfizer’s Xeljanz (tofacitinib citrate) for ulcerative colitis (UC), meaning it is the first oral therapy and Janus kinase inhibitor to be approved for this patient population. The drug is now approved for three indications in the EU, which also includes rheumatoid arthritis and psoriatic arthritis. “Until now, people living with moderately

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EMA approve UCB’s treatment Cimzia for psoriasis

European Medicines Agency has approved a label extension for UCB’s Cimzia allowing it to be used for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. The approval makes Cimzia, the first Fc-free, PEGylated anti-TNF treatment option for use in moderate-to-severe plaque psoriasis “and marks the entry of UCB into immuno-dermatology, where

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